{"id":"sodium-nitrite","rwe":[{"pmid":"41878890","year":"2026","title":"Targeted detection method for locus-specific m(6)A modifications in low-abundance transcripts based on chemical conversion.","finding":"","journal":"Chemical communications (Cambridge, England)","studyType":"Clinical Study"},{"pmid":"41856308","year":"2026","title":"Dietary exposure to 77 food additives in a sample of Brazilian children aged 1-3 years: a Tier 2b screening assessment.","finding":"","journal":"Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association","studyType":"Clinical Study"},{"pmid":"41853760","year":"2026","title":"Phage P100 resistance in clinical and foodborne Listeria monocytogenes isolates is associated with adsorption-inhibiting mutations and fitness trade-offs.","finding":"","journal":"Current research in microbial sciences","studyType":"Clinical Study"},{"pmid":"41849020","year":"2026","title":"Quality characteristics of nitrite-free emulsified pork sausages with gardenia red-based additive combinations.","finding":"","journal":"Food science of animal resources","studyType":"Clinical Study"},{"pmid":"41848826","year":"2026","title":"Individual and interactive effects of heating temperature, sodium nitrite concentration, and simulated gastric conditions on nitrosamine formation in pork sausages.","finding":"","journal":"Food science of animal resources","studyType":"Clinical Study"}],"_fda":{"id":"e41b302f-4c14-4890-a204-92e7803b8405","set_id":"52f01c6e-172a-47a9-98a6-9eab7651a032","openfda":{"unii":["M0KG633D4F"],"route":["INTRAVENOUS"],"rxcui":["253010"],"spl_id":["e41b302f-4c14-4890-a204-92e7803b8405"],"brand_name":["Sodium Nitrite"],"spl_set_id":["52f01c6e-172a-47a9-98a6-9eab7651a032"],"package_ndc":["60267-311-10"],"product_ndc":["60267-311"],"generic_name":["SODIUM NITRITE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["SODIUM NITRITE"],"manufacturer_name":["Hope Pharmaceuticals"],"application_number":["NDA203922"],"is_original_packager":[true]},"version":"11","pregnancy":["8.1 Pregnancy Risk Summary Life-sustaining therapy should not be withheld. Cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated (see Clinical Considerations ). Therefore, if a pregnant woman has known or suspected cyanide poisoning, Sodium Nitrite Injection for sequential use with Sodium Thiosulfate Injection is recommended [see Indications and Usage (1) ]. There are no available data on Sodium Nitrite Injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. If available, consider alternative therapies not associated with methemoglobinemia. There are no intravenous animal studies to evaluate the effect of sodium nitrite on embryofetal development. In published animal studies, fetal mortality was reported when pregnant guinea pigs were subcutaneously administered sodium nitrite at 1.7 times the maximum recommended human dose (MRHD) of 450 mg sodium nitrite when maternal and fetal methemoglobin concentrations were at their peak. In other published studies, no evidence of malformations were reported in guinea pigs, mice, or rats; however, severe anemia, reduced growth, and increased pup mortality was reported when pregnant rats were treated with 4.7 times the MRHD of sodium nitrite via drinking water during gestation and throughout lactation (see Data ) . Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Cyanide readily crosses the placenta. Cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated. Treatment for cyanide poisoning should not be withheld because of potential concerns regarding the effects of Sodium Nitrite Injection on the fetus. Fetal/neonatal adverse reactions Sodium nitrite produces methemoglobin. Fetal hemoglobin is oxidized to methemoglobin more easily than adult hemoglobin. In addition, the fetus has lower levels of methemoglobin reductase than adults [see Use in Specific Populations (8.4) ] . Based on animal studies, prenatal exposure to sodium nitrite resulted in impaired neural development likely the result of prenatal hypoxia (see Data ) . If available, consider alternative therapy not known to be associated with methemoglobinemia. Data Animal Data There are no intravenous toxicology studies of sodium nitrite that evaluate the potential for reproductive and developmental toxicity. In a published study, sodium nitrite treatment of pregnant guinea pigs with 60 or 70 mg/kg/day resulted in abortion of the litters within 1-4 days of treatment. All animals treated subcutaneously with 70 mg/kg, sodium nitrite died within 60 minutes of treatment. Further studies demonstrated that a dose of 60 mg/kg resulted in measurable blood levels of methemoglobin in the dams and their fetuses for up to 6 hours post treatment. Maternal methemoglobin levels were higher than the levels in the offspring at all times measured. Based on a body surface area comparison, a 60 mg/kg dose in the guinea pig that resulted in death was only 1.7 times higher than the highest clinical dose of sodium nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison). In a published study, treatment of pregnant rats via drinking water with sodium nitrite at concentrations of either 2000 or 3000 mg/L during gestation and throughout lactation resulted in severe anemia, reduced growth and increased mortality in the offspring. This exposure regimen in the rat model would result in dosing of approximately 220 and 300 mg/kg/day (4.7 and 6.5 times the highest clinical dose of sodium nitrite that would be used to treat cyanide poisoning, based on a body surface area comparison). In a published study, treatment of pregnant mice with approximately 243 mg/kg sodium nitrite daily (2.6 times the maximum recommended daily dose of 450 mg/day based on body surface are) via the drinking water (1000 mg/L) from Gestation Day 7-18 did not result in evidence of malformations or embryofetal toxicity or maternal toxicity. Behavioral and neurodevelopmental studies in rats suggest persistent effects of prenatal exposure to sodium nitrite that were detectable postnatally. Specifically, animals that were exposed prenatally to sodium nitrite (2000 mg/L via drinking water) demonstrated impaired discrimination learning behavior (both auditory and visual) and reduced long-term retention of the passive-avoidance response compared to control animals. Additional studies demonstrated a delay in the development of AchE and 5-HT positive fiber ingrowth into the hippocampal dentate gyrus and parietal neocortex during the first week of life of prenatal nitrite treated pups. These changes have been attributed to prenatal hypoxia following nitrite exposure."],"overdosage":["10 OVERDOSAGE Large doses of sodium nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse. Sodium nitrite administration has been reported to cause or significantly contribute to mortality in adults at oral doses as low as 1 g and intravenous doses as low as 600 mg. A death attributed to sodium nitrite has been reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child. Cyanosis may become apparent at a methemoglobin level of 10-20%. Other clinical signs and symptoms of sodium nitrite toxicity (anxiety, dyspnea, nausea, and tachycardia) can be apparent at methemoglobin levels as low as 15%. More serious signs and symptoms, including cardiac dysrhythmias, circulatory failure, and central nervous system depression are seen as methemoglobin levels increase, and levels above 70% are usually fatal. Treatment of overdose involves supplemental oxygen and supportive measures such as exchange transfusion. Treatment of severe methemoglobinemia with intravenous methylene blue has been described in the medical literature; however, this may also cause release of cyanide bound to methemoglobin. Because hypotension appears to be mediated primarily by an increase in venous capacitance, measures to increase venous return may be most appropriate to treat hypotension."],"description":["11 DESCRIPTION Sodium nitrite has the chemical name nitrous acid sodium salt. The chemical formula is NaNO 2 and the molecular weight is 69.0. The structural formula is: Structure of Sodium Nitrite Sodium Nitrite Injection is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of sodium nitrite injection. Sodium nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of sodium nitrite in 10 mL solution (30 mg/mL). Sodium nitrite injection is a clear solution with a pH between 7.0 and 9.0. Chemical Structure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Each Sodium Nitrite carton (NDC 60267-311-10) consists of the following: One 10 mL glass vial of sodium nitrite injection 30 mg/mL (containing 300 mg of sodium nitrite); Storage Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze. (Note: Sodium Thiosulfate must be obtained separately.)"],"boxed_warning":["WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain . Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite . [see Warnings and Precautions (5.1 and 5.2) ] WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION See full prescribing information for complete boxed warning . Sodium nitrite can cause serious adverse reactions and death from: Hypotension ( 5.1 ) Methemoglobin formation ( 5.2 ) Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite."],"geriatric_use":["8.5 Geriatric Use Sodium nitrite is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"pediatric_use":["8.4 Pediatric Use There are case reports in the medical literature of sodium nitrite in conjunction with sodium thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of sodium nitrite in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports. Sodium nitrite must be used with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk. Mortality attributed to sodium nitrite was reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child. [see Dosage and Administration (2) , Warnings and Precautions, (5) , Adverse Reactions (6) ]"],"effective_time":"20251006","clinical_studies":["14 CLINICAL STUDIES Human Data The human data supporting the use of sodium thiosulfate for cyanide poisoning consists primarily of published case reports. There are no randomized controlled clinical trials. Nearly all the human data describing the use of sodium thiosulfate report its use in conjunction with sodium nitrite. Dosing recommendations for humans have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports. There have been no human studies to prospectively and systematically evaluate the safety of sodium thiosulfate or sodium nitrite in humans. Available human safety information is based largely on anecdotal case reports and case series of limited scope. Animal Data (Cyanide Poisoning) THE EFFECTIVENESS OF SODIUM THIOSULFATE AND SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING HAS NOT BEEN STUDIED IN HUMANS IN ADEQUATE AND WELL-CONTROLLED CLINICAL TRIALS BECAUSE INDUCING THE CONDITION IN HUMANS TO STUDY THE DRUG'S EFFICACY IS NOT ETHICAL. Due to the extreme toxicity of cyanide, experimental evaluation of treatment efficacy has predominantly been completed in animal models. The efficacy of sodium thiosulfate treatment alone to counteract the toxicity of cyanide was initially reported in 1895 by Lang. The efficacy of amyl nitrite treatment in cyanide poisoning of the dog model was first reported in 1888 by Pedigo. Further studies in the dog model, which demonstrated the utility of sodium nitrite as a therapeutic intervention, were reported in 1929 by Mladoveanu and Gheorghiu. However, Hugs and Chen et al. independently reported upon the superior efficacy of the combination of sodium nitrite and sodium thiosulfate in 1932-1933. Treatment consisted of intravenously administered 22.5 mg/kg (half the lethal dose) sodium nitrite or 1 g/kg sodium thiosulfate alone or in sequence immediately after subcutaneous injection of sodium cyanide into dogs over a range of doses. Subsequent doses of 10 mg/kg sodium nitrite and/or 0.5 g/kg sodium thiosulfate were administered when clinical signs or symptoms of poisoning persisted or reappeared. Either therapy administered alone increased the dose of sodium cyanide required to cause death, and when administered together, sodium nitrite and sodium thiosulfate resulted in a synergistic effect in raising the lethal dose of sodium cyanide. The combined therapy appeared to have reduced efficacy when therapy was delayed until signs of poisoning (e.g. convulsions) appeared; however, other investigators have reported survival in dogs that were administered antidotal treatment after respiratory arrest had occurred. Animal studies conducted in other species (e.g., rat, guinea pig, sheep, pigeon and cat) have also supported a synergistic effect of intravenous sodium nitrite and sodium thiosulfate in the treatment of cyanide poisoning. While intravenous injection of sodium nitrite and sodium thiosulfate was effective in reversing the effects of lethal doses of cyanide in dogs, intramuscular injection of sodium nitrite, with or without sodium thiosulfate, was found not to be effective in the same setting."],"pharmacodynamics":["12.2 Pharmacodynamics Sodium Nitrite When 4 mg/kg sodium nitrite was administered intravenously to six healthy human volunteers, the mean peak methemoglobin concentration was 7%, achieved at 30-60 minutes after injection, consistent with reports in cyanide poisoning victims. Supine systolic and diastolic blood pressures dropped approximately 20% within 10 minutes, a drop which was sustained throughout the 40 minutes of testing. This was associated with a 20 beat per minute increase in pulse rate that returned to baseline in 10 minutes. Five of these subjects were unable to withstand orthostatic testing due to fainting. One additional subject, who received a 12 mg/kg dose of sodium nitrite, experienced severe cardiovascular effects and achieved a peak methemoglobin concentration of 30% at 60 minutes following injection. Oral doses of 120 to 180 mg of sodium nitrite administered to healthy volunteers caused minimal cardiovascular changes when subjects were maintained in the horizontal position. However, minutes after being placed in the upright position subjects exhibited tachycardia and hypotension with syncope. The half life for conversion of methemoglobin to normal hemoglobin in a cyanide poisoning victim who has been administered sodium nitrite is estimated to be 55 minutes."],"pharmacokinetics":["12.3 Pharmacokinetics Sodium Nitrite Sodium nitrite is a strong oxidant, and reacts rapidly with hemoglobin to form methemoglobin. The pharmacokinetics of free sodium nitrite in humans have not been well studied. It has been reported that approximately 40% of sodium nitrite is excreted unchanged in the urine while the remaining 60% is metabolized to ammonia and related small molecules. Cyanide The apparent terminal elimination half life and volume of distribution of cyanide, in a patient treated for an acute cyanide poisoning with sodium nitrite and sodium thiosulfate administration, have been reported to be 19 hours and 0.41 L/kg, respectively. Additionally, an initial elimination half life of cyanide has been reported to be approximately 1-3 hours. Thiocyanate After detoxification, in healthy subjects, thiocyanate is excreted mainly in the urine at a rate inversely proportional to creatinine clearance. In healthy subjects, the elimination half-life and volume of distribution of thiocyanate have been reported to be 2.7 days and 0.25 L/kg, respectively. However, in subjects with renal insufficiency the reported elimination half life is approximately 9 days."],"adverse_reactions":["6 ADVERSE REACTIONS There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium nitrite. The medical literature has reported the following adverse events in association with sodium nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed. Cardiovascular system: syncope, hypotension, tachycardia, methemoglobinemia, palpitations, dysrhythmia Hematological: methemoglobinemia Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma Gastrointestinal system: nausea, vomiting, abdominal pain Respiratory system: tachypnea, dyspnea Body as a Whole : anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, urticaria, generalized numbness and tingling Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of sodium nitrite at doses less than twice those recommended for the treatment of cyanide poisoning. Most common adverse reactions are: Syncope, hypotension, tachycardia, palpitations, dysrhythmia, methemoglobinemia, headache, dizziness, blurred vision, seizures, confusion, coma ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["4 CONTRAINDICATIONS None None. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Formal drug interaction studies have not been conducted with Sodium Nitrite Injection."],"mechanism_of_action":["12.1 Mechanism of Action Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well. The synergy resulting from treatment of cyanide poisoning with the combination of sodium nitrite and sodium thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning. Sodium Nitrite Sodium nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide. Cyanide preferentially binds to methemoglobin over cytochrome a 3 , forming the nontoxic cyanomethemoglobin. Methemoglobin displaces cyanide from cytochrome oxidase, allowing resumption of aerobic metabolism. The chemical reaction is as follows: NaNO 2 + Hemoglobin → Methemoglobin HCN + Methemoglobin → Cyanomethemoglobin Vasodilation has also been cited to account for at least part of the therapeutic effect of sodium nitrite. It has been suggested that sodium nitrite-induced methemoglobinemia may be more efficacious against cyanide poisoning than comparable levels of methemoglobinemia induced by other oxidants. Also, sodium nitrite appears to retain some efficacy even when the formation of methemoglobin is inhibited by methylene blue. Sodium Thiosulfate The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN - ), which is relatively nontoxic and readily excreted in the urine. Sodium thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide in the following chemical reaction: Rhodanese Na 2 S 2 O 3 + CN - → SCN - + Na 2 SO 3 ."],"storage_and_handling":["Storage Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze. (Note: Sodium Thiosulfate must be obtained separately.)"],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well. The synergy resulting from treatment of cyanide poisoning with the combination of sodium nitrite and sodium thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning. Sodium Nitrite Sodium nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide. Cyanide preferentially binds to methemoglobin over cytochrome a 3 , forming the nontoxic cyanomethemoglobin. Methemoglobin displaces cyanide from cytochrome oxidase, allowing resumption of aerobic metabolism. The chemical reaction is as follows: NaNO 2 + Hemoglobin → Methemoglobin HCN + Methemoglobin → Cyanomethemoglobin Vasodilation has also been cited to account for at least part of the therapeutic effect of sodium nitrite. It has been suggested that sodium nitrite-induced methemoglobinemia may be more efficacious against cyanide poisoning than comparable levels of methemoglobinemia induced by other oxidants. Also, sodium nitrite appears to retain some efficacy even when the formation of methemoglobin is inhibited by methylene blue. Sodium Thiosulfate The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN - ), which is relatively nontoxic and readily excreted in the urine. Sodium thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide in the following chemical reaction: Rhodanese Na 2 S 2 O 3 + CN - → SCN - + Na 2 SO 3 . 12.2 Pharmacodynamics Sodium Nitrite When 4 mg/kg sodium nitrite was administered intravenously to six healthy human volunteers, the mean peak methemoglobin concentration was 7%, achieved at 30-60 minutes after injection, consistent with reports in cyanide poisoning victims. Supine systolic and diastolic blood pressures dropped approximately 20% within 10 minutes, a drop which was sustained throughout the 40 minutes of testing. This was associated with a 20 beat per minute increase in pulse rate that returned to baseline in 10 minutes. Five of these subjects were unable to withstand orthostatic testing due to fainting. One additional subject, who received a 12 mg/kg dose of sodium nitrite, experienced severe cardiovascular effects and achieved a peak methemoglobin concentration of 30% at 60 minutes following injection. Oral doses of 120 to 180 mg of sodium nitrite administered to healthy volunteers caused minimal cardiovascular changes when subjects were maintained in the horizontal position. However, minutes after being placed in the upright position subjects exhibited tachycardia and hypotension with syncope. The half life for conversion of methemoglobin to normal hemoglobin in a cyanide poisoning victim who has been administered sodium nitrite is estimated to be 55 minutes. 12.3 Pharmacokinetics Sodium Nitrite Sodium nitrite is a strong oxidant, and reacts rapidly with hemoglobin to form methemoglobin. The pharmacokinetics of free sodium nitrite in humans have not been well studied. It has been reported that approximately 40% of sodium nitrite is excreted unchanged in the urine while the remaining 60% is metabolized to ammonia and related small molecules. Cyanide The apparent terminal elimination half life and volume of distribution of cyanide, in a patient treated for an acute cyanide poisoning with sodium nitrite and sodium thiosulfate administration, have been reported to be 19 hours and 0.41 L/kg, respectively. Additionally, an initial elimination half life of cyanide has been reported to be approximately 1-3 hours. Thiocyanate After detoxification, in healthy subjects, thiocyanate is excreted mainly in the urine at a rate inversely proportional to creatinine clearance. In healthy subjects, the elimination half-life and volume of distribution of thiocyanate have been reported to be 2.7 days and 0.25 L/kg, respectively. However, in subjects with renal insufficiency the reported elimination half life is approximately 9 days."],"indications_and_usage":["1 INDICATIONS AND USAGE Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Sodium Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis. Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate for treatment of acute cyanide poisoning that is judged to be serious or life-threatening. ( 1 ) Use with caution if the diagnosis of cyanide poisoning is uncertain. ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Methemoglobinemia: Sodium nitrite reacts with hemoglobin to form methemoglobin and should be used with caution in patients known to have anemia. Monitor oxyhemoglobin and methemoglobin levels by pulse co-oximetry or other measurements. Optimally, the sodium nitrite dose should be reduced in proportion to the oxygen carrying capacity. ( 5.2 ) Smoke inhalation: Carbon monoxide contained in smoke can result in the formation of carboxyhemoglobin that can reduce the oxygen carrying capacity of the blood. Sodium nitrite should be used with caution in patients with smoke inhalation injury because of the potential for worsening hypoxia due to methemoglobin formation. Carboxyhemoglobin and oxyhemoglobin levels should be monitored by pulse oximetry or other measurements in patients that present with evidence of smoke inhalation. Optimally, the sodium nitrite dose should be reduced in proportion to the oxygen carrying capacity. ( 5.4 ) 5.1 Hypotension Sodium nitrite has been associated with severe hypotension, methemoglobinemia, and death at doses less than twice recommended therapeutic doses. Hypotension may occur concurrently or separately. Sodium nitrite should be used to treat life-threatening cyanide poisoning. When the diagnosis of cyanide poisoning is uncertain and/or the patient is not in extremis, special consideration should be given to administration of sodium nitrite if the patient is known or suspected to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, substantial blood loss, cardiac or respiratory compromise) or to be at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency). 5.2 Methemoglobinemia Supportive care alone may be sufficient treatment without administration of antidotes for many cases of cyanide intoxication, particularly in conscious patients without signs of severe toxicity. Monitor patients closely to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Monitor methemoglobin levels and administer oxygen during treatment with sodium nitrite whenever possible. When sodium nitrite is administered to humans a wide range of methemoglobin concentrations occur. Methemoglobin concentrations as high as 58% have been reported after two 300-mg doses of sodium nitrite administered to an adult. Sodium nitrite should be used with caution in the presence of other drugs that may cause methemoglobinemia such as procaine and nitroprusside. Sodium nitrite should be used with caution in patients who may be particularly susceptible to injury from vasodilation and its related hemodynamic sequelae. Hemodynamics should be monitored closely during and after administration of sodium nitrite, and infusion rates should be slowed if hypotension occurs. 5.3 Anemia Use sodium nitrite with caution in patients with known anemia. Patients with anemia will form more methemoglobin (as a percentage of total hemoglobin) than persons with normal red blood cell (RBC) volumes. Optimally, these patients should receive a sodium nitrite dose that is reduced in proportion to their oxygen carrying capacity. 5.4 Smoke Inhalation Injury Use sodium nitrite should be used with caution in persons with smoke inhalation injury or carbon monoxide poisoning because of the potential for worsening hypoxia due to methemoglobin formation. 5.5 Neonates and Infants Neonates and infants may be more susceptible than adults and older pediatric patients to severe methemoglobinemia when sodium nitrite is administered. Follow reduced dosing guidelines in pediatric patients. 5.6 G6PD Deficiency Because patients with G6PD deficiency are at increased risk of a hemolytic crisis with sodium nitrite administration, consider alternative therapeutic approaches in these patients. Monitor patients with known or suspected G6PD deficiency for an acute drop in hematocrit. Exchange transfusion may be needed for patients with G6PD deficiency who receive sodium nitrite. 5.7 Use with Other Drugs Use sodium nitrite with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: The potential benefit of an acute exposure to sodium nitrite as part of a cyanide antidote outweighs concerns raised by the equivocal findings in chronic rodent studies. Sodium nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 35, 70, or 130 mg/kg for males and 0, 40, 80, or 150 mg/kg for females) was orally administered to rats (Fischer 344 strain) for 2 years via drinking water. There were no significant increases in the incidence of tumor in either male or female rats. Sodium nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 60, 120, or 220 mg/kg for males and 0, 45, 90, or 165 mg/kg for females) was administered to B6C3F1 mice for 2 years via the drinking water. Equivocal results were obtained in female mice. Specifically, there was a positive trend toward an increase in the incidence of squamous cell papilloma or carcinoma in the forestomach of female mice. Although the incidence of hyperplasia of the glandular stomach epithelium was significantly greater in the high-dose male mice compared to controls, there were no significant increases in tumors in the male mice. Numerous reports in the published literature indicate that sodium nitrite may react in vivo with secondary amines to form carcinogenic nitrosamines in the stomach. Concurrent exposure to sodium nitrite and secondary amines in feed or drinking water resulted in an increase in the incidence of tumors in rodents. Mutagenesis: Sodium nitrite is mutagenic in S. typhimurium strains TA100, TA1530, TA1535 with and without metabolic activation; however, it was negative in strain TA98, TA102, DJ460 and E. coli strain WP2UVRA/PKM101. Sodium nitrite has been reported to be genotoxic to V79 hamster cells in vitro and in the mouse lymphoma assay, both assays conducted in the absence of metabolic activation. Sodium nitrite was negative in the in vitro chromosomal aberrations assay using human peripheral blood lymphocytes. Acute administration of sodium nitrite to male rats or male mice did not produce an increased incidence of micronuclei in bone marrow. Likewise, sodium nitrite administration to mice for 14-weeks did not result in an increase in the incidence of micronuclei in the peripheral blood. Impairment of Fertility : Multigenerational fertility and reproduction studies conducted by the National Toxicology Program did not detect any evidence of an effect of sodium nitrite (0.0, 0.06, 0.12, and 0.24% weight/volume) on either fertility or any reproductive parameter in Swiss CD-1 mice. This treatment protocol resulted in approximate doses of 125, 260, and 425 mg/kg/day. The highest exposure in this mouse study is 4.6 times greater than the highest clinical dose of sodium nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison)."],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Sodium Nitrite Injection is indicated for cyanide poisoning and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information. Hypotension and Methemoglobin Formation When feasible, patients should be informed of the possibility of life-threatening hypotension and methemoglobin formation. Monitoring Where feasible, patients should be informed of the need for close monitoring of blood pressure and oxygenation. Lactation Advise women that breastfeeding is not recommended during treatment with Sodium Nitrite Injection [see Use in Specific Populations (8.2) ]."],"spl_unclassified_section":["Hope Pharmaceuticals, Scottsdale, Arizona 85260 US PATENT 8,568,793"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION If clinical suspicion of cyanide poisoning is high, administer Sodium Nitrite Injection without delay and in conjunction with appropriate airway, ventilatory, and circulatory support. ( 2.1 ) The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222. ( 2.1 ) Dosing : Age Intravenous Dose of Sodium Nitrite and Sodium Thiosulfate Adults 1.) Sodium Nitrite -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute 2.) Sodium Thiosulfate - 50 mL of sodium thiosulfate immediately following administration of sodium nitrite. Children 1.) Sodium Nitrite - 0.2 mL/kg (6 mg/kg or 6-8 mL/m 2 BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL 2.) Sodium Thiosulfate - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m 2 of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite. Redosing : If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and sodium thiosulfate. ( 2.2 ) Monitoring : Blood pressure must be monitored during treatment. ( 2.2 ) Sodium nitrite is chemically incompatible with hydroxocobalamin and should not be administered via the same intravenous line. ( 2.4 ) 2.1 Important Dosage and Administration Instructions If clinical suspicion of cyanide poisoning is high, administer Sodium Nitrite Injection without delay. Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Administration of sodium nitrite and sodium thiosulfate should be considered adjunctive to appropriate supportive therapies. Airway, ventilatory and circulatory support, and oxygen administration should not be delayed in order to administer sodium nitrite and sodium thiosulfate [ see Warnings and Precautions (5.1) ]. The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222. Identifying Patients with Cyanide Poisoning Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.. The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication Table 1. Common Signs and Symptoms of Cyanide Poisoning Symptoms Headache Confusion Dyspnea Chest Tightness Nausea Signs Altered Mental Status (e.g., confusion, disorientation) Seizures or Coma Mydriasis Tachypnea/Hyperpnea (early) Bradypnea/Apnea (late) Hypertension (early)/ Hypotension (late) Cardiovascular Collapse Vomiting Plasma Lactate Concentration ≥ 8 mmol/L In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well. Smoke Inhalation Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Sodium Nitrite Injection, smoke-inhalation victims should be assessed for the following: Exposure to fire or smoke in an enclosed area Presence of soot around the mouth, nose, or oropharynx Altered mental status Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed in order to obtain a plasma lactate concentration. Use with Other Cyanide Antidotes The safety of administering other cyanide antidotes simultaneously with Sodium Nitrite Injection has not been established. If a decision is made to administer another cyanide antidote with Sodium Nitrite Injection, these drugs should not be administered concurrently in the same intravenous (IV) line. [ see Dosage and Administration (2.2) ] 2.2 Recommended Dosing Sodium Nitrite Injection and Sodium Thiosulfate Injection are administered by slow intravenous injection. They should be given as early as possible after a diagnosis of acute life-threatening cyanide poisoning has been established. Sodium nitrite should be administered first, followed immediately by sodium thiosulfate. Blood pressure must be monitored during infusion in both adults and children. The rate of infusion should be decreased if significant hypotension is noted. Age Intravenous Dose of Sodium Nitrite and Sodium Thiosulfate Adults 1.) Sodium Nitrite -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute 2.) Sodium Thiosulfate - 50 mL of sodium thiosulfate immediately following administration of sodium nitrite. Children 1.) Sodium Nitrite - 0.2 mL/kg (6 mg/kg or 6-8 mL/m 2 BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL 2.) Sodium Thiosulfate - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m 2 of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite. NOTE: If signs of poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and sodium thiosulfate. In adult and pediatric patients with known anemia, it is recommended that the dosage of sodium nitrite should be reduced proportionately to the hemoglobin concentration. [see Warnings and Precautions (5.2) ] All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.3 Recommended Monitoring Monitor patients for at least 24-48 hours after Sodium Nitrite Injection administration for adequacy of oxygenation and perfusion and for recurrent signs and symptoms of cyanide toxicity. When possible, obtain hemoglobin/hematocrit when treatment is initiated. Measurements of oxygen saturation using standard pulse oximetry and calculated oxygen saturation values based on measured PO 2 are unreliable in the presence of methemoglobinemia. Methemoglobin level : Administrations of sodium nitrite solely to achieve an arbitrary level of methemoglobinemia may be unnecessary and potentially hazardous. The therapeutic effects of sodium nitrite do not appear to be mediated by methemoglobin formation alone [see Clinical Pharmacology (12) ] and clinical responses to sodium nitrite administration have been reported in association with methemoglobin levels of less than 10%. Administration of sodium nitrite beyond the initial dose should be guided primarily by clinical response to treatment (i.e., a second dose should be considered only if there is inadequate clinical response to the first dose). It is generally recommended that methemoglobin concentrations be closely monitored and kept below 30%. Monitor serum methemoglobin levels during treatment using co-oximetry, and discontinue administration of sodium nitrite when methemoglobin levels exceed 30%. Intravenous methylene blue and exchange transfusion have been reported in the literature as treatments for life-threatening methemoglobinemia. 2.4 Incompatibility Information Chemical incompatibility has been reported between sodium nitrite and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between sodium thiosulfate and sodium nitrite, when administered sequentially through the same IV line as described in Dosage and Administration. Simultaneous administration of sodium nitrite and blood products (whole blood, packed red cells, platelet concentrate and/or fresh frozen plasma) through the same intravenous line is not recommended. However, blood products and sodium nitrite can be administered simultaneously using separate intravenous lines (preferably on contralateral extremities, if peripheral lines are being used)."],"mechanism_of_action_table":["<table width=\"50%\" styleCode=\"Noautorules\"><col width=\"100%\" align=\"center\" valign=\"top\"/><tbody><tr><td>Rhodanese Na<sub>2</sub>S<sub>2</sub>O<sub>3</sub> + CN<sup>-</sup> &#x2192; SCN<sup>-</sup> + Na<sub>2</sub>SO<sub>3</sub>.</td></tr></tbody></table>"],"spl_product_data_elements":["Sodium Nitrite Sodium Nitrite Sodium Nitrite Nitrite Ion Water Nitrogen"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Sodium Nitrite Injection consists of: One vial of sodium nitrite injection, USP 300 mg/10mL (30 mg/mL) Administration of the contents of one vial constitutes a single dose. Sodium Nitrite Injection consists of: one vial of sodium nitrite injection, USP 300 mg/10 mL (30 mg/mL) ( 3 )"],"clinical_pharmacology_table":["<table width=\"50%\" styleCode=\"Noautorules\"><col width=\"100%\" align=\"center\" valign=\"top\"/><tbody><tr><td>Rhodanese Na<sub>2</sub>S<sub>2</sub>O<sub>3</sub> + CN<sup>-</sup> &#x2192; SCN<sup>-</sup> + Na<sub>2</sub>SO<sub>3</sub>.</td></tr></tbody></table>"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 ) Renal impairment: Sodium nitrite is substantially excreted by the kidney. The risk of toxic reactions to this drug may be greater in patients with impaired renal function. ( 8.6 ). 8.1 Pregnancy Risk Summary Life-sustaining therapy should not be withheld. Cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated (see Clinical Considerations ). Therefore, if a pregnant woman has known or suspected cyanide poisoning, Sodium Nitrite Injection for sequential use with Sodium Thiosulfate Injection is recommended [see Indications and Usage (1) ]. There are no available data on Sodium Nitrite Injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. If available, consider alternative therapies not associated with methemoglobinemia. There are no intravenous animal studies to evaluate the effect of sodium nitrite on embryofetal development. In published animal studies, fetal mortality was reported when pregnant guinea pigs were subcutaneously administered sodium nitrite at 1.7 times the maximum recommended human dose (MRHD) of 450 mg sodium nitrite when maternal and fetal methemoglobin concentrations were at their peak. In other published studies, no evidence of malformations were reported in guinea pigs, mice, or rats; however, severe anemia, reduced growth, and increased pup mortality was reported when pregnant rats were treated with 4.7 times the MRHD of sodium nitrite via drinking water during gestation and throughout lactation (see Data ) . Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Cyanide readily crosses the placenta. Cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated. Treatment for cyanide poisoning should not be withheld because of potential concerns regarding the effects of Sodium Nitrite Injection on the fetus. Fetal/neonatal adverse reactions Sodium nitrite produces methemoglobin. Fetal hemoglobin is oxidized to methemoglobin more easily than adult hemoglobin. In addition, the fetus has lower levels of methemoglobin reductase than adults [see Use in Specific Populations (8.4) ] . Based on animal studies, prenatal exposure to sodium nitrite resulted in impaired neural development likely the result of prenatal hypoxia (see Data ) . If available, consider alternative therapy not known to be associated with methemoglobinemia. Data Animal Data There are no intravenous toxicology studies of sodium nitrite that evaluate the potential for reproductive and developmental toxicity. In a published study, sodium nitrite treatment of pregnant guinea pigs with 60 or 70 mg/kg/day resulted in abortion of the litters within 1-4 days of treatment. All animals treated subcutaneously with 70 mg/kg, sodium nitrite died within 60 minutes of treatment. Further studies demonstrated that a dose of 60 mg/kg resulted in measurable blood levels of methemoglobin in the dams and their fetuses for up to 6 hours post treatment. Maternal methemoglobin levels were higher than the levels in the offspring at all times measured. Based on a body surface area comparison, a 60 mg/kg dose in the guinea pig that resulted in death was only 1.7 times higher than the highest clinical dose of sodium nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison). In a published study, treatment of pregnant rats via drinking water with sodium nitrite at concentrations of either 2000 or 3000 mg/L during gestation and throughout lactation resulted in severe anemia, reduced growth and increased mortality in the offspring. This exposure regimen in the rat model would result in dosing of approximately 220 and 300 mg/kg/day (4.7 and 6.5 times the highest clinical dose of sodium nitrite that would be used to treat cyanide poisoning, based on a body surface area comparison). In a published study, treatment of pregnant mice with approximately 243 mg/kg sodium nitrite daily (2.6 times the maximum recommended daily dose of 450 mg/day based on body surface are) via the drinking water (1000 mg/L) from Gestation Day 7-18 did not result in evidence of malformations or embryofetal toxicity or maternal toxicity. Behavioral and neurodevelopmental studies in rats suggest persistent effects of prenatal exposure to sodium nitrite that were detectable postnatally. Specifically, animals that were exposed prenatally to sodium nitrite (2000 mg/L via drinking water) demonstrated impaired discrimination learning behavior (both auditory and visual) and reduced long-term retention of the passive-avoidance response compared to control animals. Additional studies demonstrated a delay in the development of AchE and 5-HT positive fiber ingrowth into the hippocampal dentate gyrus and parietal neocortex during the first week of life of prenatal nitrite treated pups. These changes have been attributed to prenatal hypoxia following nitrite exposure. 8.2 Lactation Risk Summary There are no data on the presence of sodium nitrite in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Cyanide is present in human milk. Because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment with Sodium Nitrite Injection. There are no data to determine when breastfeeding may be safely restarted following the administration of Sodium Nitrite Injection. 8.4 Pediatric Use There are case reports in the medical literature of sodium nitrite in conjunction with sodium thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of sodium nitrite in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports. Sodium nitrite must be used with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk. Mortality attributed to sodium nitrite was reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child. [see Dosage and Administration (2) , Warnings and Precautions, (5) , Adverse Reactions (6) ] 8.5 Geriatric Use Sodium nitrite is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Renal Impairment Sodium nitrite is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"dosage_and_administration_table":["<table width=\"100%\"><col width=\"15%\" align=\"left\" valign=\"top\"/><col width=\"85%\" align=\"left\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule Rrule\">Age</th><th styleCode=\"Rrule\">Intravenous Dose of Sodium Nitrite and Sodium Thiosulfate</th></tr></thead><tbody><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Adults</content></td><td styleCode=\"Rrule\"><list><item><caption styleCode=\"bold\">1.)</caption><content styleCode=\"bold\">Sodium Nitrite</content> -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute</item><item><caption styleCode=\"bold\">2.)</caption><content styleCode=\"bold\">Sodium Thiosulfate</content> - 50 mL of sodium thiosulfate immediately following administration of sodium nitrite.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Children</content></td><td styleCode=\"Rrule\"><list><item><caption styleCode=\"bold\">1.)</caption><content styleCode=\"bold\">Sodium Nitrite -</content> 0.2 mL/kg (6 mg/kg or 6-8 mL/m<sup>2</sup> BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL</item><item><caption styleCode=\"bold\">2.)</caption><content styleCode=\"bold\">Sodium Thiosulfate -</content> 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m<sup>2</sup> of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite.</item></list></td></tr></tbody></table>","<table width=\"75%\"><caption>Table 1. Common Signs and Symptoms of Cyanide Poisoning</caption><col width=\"45%\" align=\"left\" valign=\"top\"/><col width=\"55%\" align=\"left\" valign=\"top\"/><tbody><tr><td styleCode=\"Lrule Rrule\">Symptoms<list listType=\"unordered\" styleCode=\"disc\"><item>Headache</item><item>Confusion</item><item>Dyspnea</item><item>Chest Tightness</item><item>Nausea</item></list></td><td styleCode=\"Rrule\">Signs<list listType=\"unordered\" styleCode=\"disc\"><item>Altered Mental Status (e.g., confusion, disorientation)</item><item>Seizures or Coma</item><item>Mydriasis</item><item>Tachypnea/Hyperpnea (early)</item><item>Bradypnea/Apnea (late)</item><item>Hypertension (early)/ Hypotension (late)</item><item>Cardiovascular Collapse</item><item>Vomiting</item><item>Plasma Lactate Concentration &#x2265; 8 mmol/L</item></list></td></tr></tbody></table>","<table width=\"60%\"><col width=\"10%\" align=\"left\" valign=\"top\"/><col width=\"90%\" align=\"left\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule Rrule\">Age</th><th styleCode=\"Rrule\">Intravenous Dose of Sodium Nitrite and Sodium Thiosulfate</th></tr></thead><tbody><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Adults</content></td><td styleCode=\"Rrule\"><list><item><caption styleCode=\"bold\">1.)</caption><content styleCode=\"bold\">Sodium Nitrite</content> -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute</item><item><caption styleCode=\"bold\">2.)</caption><content styleCode=\"bold\">Sodium Thiosulfate</content> - 50 mL of sodium thiosulfate immediately following administration of sodium nitrite.</item></list></td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Children</content></td><td styleCode=\"Rrule\"><list><item><caption styleCode=\"bold\">1.)</caption><content styleCode=\"bold\">Sodium Nitrite -</content>0.2 mL/kg (6 mg/kg or 6-8 mL/m<sup>2</sup> BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL</item><item><caption styleCode=\"bold\">2.)</caption><content styleCode=\"bold\">Sodium Thiosulfate -</content> 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m<sup>2</sup> of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite.</item></list></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton NDC 60267-311-10 Rx Only Sodium Nitrite Injection, USP 300 mg/10 mL (30 mg/mL) FOR INTRAVENOUS USE SINGLE USE ONLY Any unused portion of a vial should be discarded. Use with Sodium Thiosulfate for Treatment of Cyanide Poisoning Manufactured for: HOPE PHARMACEUTICALS ™ Scottsdale, AZ 85260 U.S.A. PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: The potential benefit of an acute exposure to sodium nitrite as part of a cyanide antidote outweighs concerns raised by the equivocal findings in chronic rodent studies. Sodium nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 35, 70, or 130 mg/kg for males and 0, 40, 80, or 150 mg/kg for females) was orally administered to rats (Fischer 344 strain) for 2 years via drinking water. There were no significant increases in the incidence of tumor in either male or female rats. Sodium nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 60, 120, or 220 mg/kg for males and 0, 45, 90, or 165 mg/kg for females) was administered to B6C3F1 mice for 2 years via the drinking water. Equivocal results were obtained in female mice. Specifically, there was a positive trend toward an increase in the incidence of squamous cell papilloma or carcinoma in the forestomach of female mice. Although the incidence of hyperplasia of the glandular stomach epithelium was significantly greater in the high-dose male mice compared to controls, there were no significant increases in tumors in the male mice. Numerous reports in the published literature indicate that sodium nitrite may react in vivo with secondary amines to form carcinogenic nitrosamines in the stomach. Concurrent exposure to sodium nitrite and secondary amines in feed or drinking water resulted in an increase in the incidence of tumors in rodents. Mutagenesis: Sodium nitrite is mutagenic in S. typhimurium strains TA100, TA1530, TA1535 with and without metabolic activation; however, it was negative in strain TA98, TA102, DJ460 and E. coli strain WP2UVRA/PKM101. Sodium nitrite has been reported to be genotoxic to V79 hamster cells in vitro and in the mouse lymphoma assay, both assays conducted in the absence of metabolic activation. Sodium nitrite was negative in the in vitro chromosomal aberrations assay using human peripheral blood lymphocytes. Acute administration of sodium nitrite to male rats or male mice did not produce an increased incidence of micronuclei in bone marrow. Likewise, sodium nitrite administration to mice for 14-weeks did not result in an increase in the incidence of micronuclei in the peripheral blood. Impairment of Fertility : Multigenerational fertility and reproduction studies conducted by the National Toxicology Program did not detect any evidence of an effect of sodium nitrite (0.0, 0.06, 0.12, and 0.24% weight/volume) on either fertility or any reproductive parameter in Swiss CD-1 mice. This treatment protocol resulted in approximate doses of 125, 260, and 425 mg/kg/day. The highest exposure in this mouse study is 4.6 times greater than the highest clinical dose of sodium nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison)."]},"tags":[{"label":"sodium nitrite","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Carbonic anhydrase 1","category":"target"},{"label":"CA1","category":"gene"},{"label":"CA2","category":"gene"},{"label":"V03AB08","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Toxic effect of cyanide","category":"indication"},{"label":"Hope Pharms","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Food Additives","category":"pharmacology"},{"label":"Food Preservatives","category":"pharmacology"},{"label":"Indicators and Reagents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain . Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite . [see Warnings and Precautions (5.1 and 5.2) ] WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION See full prescribing information for complete boxed warning . Sodium nitrite can cause serious adverse reactions and death from: Hypotension ( 5.1 ) Methemoglobin formation ( 5.2 ) Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite."],"safetySignals":[{"date":"","signal":"COMPLETED SUICIDE","source":"FDA FAERS","actionTaken":"24 reports"},{"date":"","signal":"METHAEMOGLOBINAEMIA","source":"FDA FAERS","actionTaken":"14 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"12 reports"},{"date":"","signal":"OVERDOSE","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"SUICIDE ATTEMPT","source":"FDA FAERS","actionTaken":"7 reports"},{"date":"","signal":"CARDIAC ARREST","source":"FDA FAERS","actionTaken":"6 reports"},{"date":"","signal":"CYANOSIS","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"ANOXIA","source":"FDA FAERS","actionTaken":"4 reports"},{"date":"","signal":"BRAIN OEDEMA","source":"FDA FAERS","actionTaken":"4 reports"}],"commonSideEffects":[{"effect":"Syncope","drugRate":"6%","severity":"serious","_validated":true},{"effect":"Hypotension","drugRate":"6%","severity":"serious","_validated":true},{"effect":"Tachycardia","drugRate":"6%","severity":"serious","_validated":true},{"effect":"Palpitations","drugRate":"6%","severity":"serious","_validated":true},{"effect":"Dysrhythmia","drugRate":"6%","severity":"serious","_validated":true},{"effect":"Methemoglobinemia","drugRate":"6%","severity":"serious","_validated":true},{"effect":"Seizures","drugRate":"reported","severity":"unknown"},{"effect":"Confusion","drugRate":"reported","severity":"unknown"},{"effect":"Coma","drugRate":"6%","severity":"serious","_validated":true},{"effect":"Headache","drugRate":"reported","severity":"unknown"},{"effect":"Dizziness","drugRate":"reported","severity":"unknown"},{"effect":"Blurred vision","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Pregnancy":"Life-sustaining therapy should not be withheld. Cyanide poisoning is medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated. Therefore, if pregnant woman has known or suspected cyanide poisoning, Sodium Nitrite Injection for sequential use with Sodium Thiosulfate Injection is recommended.","Geriatric use":"Sodium nitrite is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.","Paediatric use":"There are case reports in the medical literature of sodium nitrite in conjunction with sodium thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of sodium nitrite in the pediatric population.","Renal impairment":"Sodium nitrite is substantially excreted by the kidney. The risk of toxic reactions to this drug may be greater in patients with impaired renal function."}},"trials":[],"aliases":[],"company":"Hope Pharms","patents":[{"applNo":"N203922","source":"FDA Orange Book","status":"Active","expires":"Feb 10, 2030","useCode":"U-3394","territory":"US","drugProduct":true,"patentNumber":"9687506","drugSubstance":false},{"applNo":"N203922","source":"FDA Orange Book","status":"Active","expires":"Dec 24, 2031","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8568793","drugSubstance":true}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SODIUM NITRITE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:08:24.514028+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:08:24.513931+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:08:30.922052+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:08:23.487318+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SODIUM NITRITE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:08:31.538089+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:08:21.975308+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING: LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be use","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:08:21.975341+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:08:33.499500+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL93268/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:08:32.705223+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA203922","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:08:21.975346+00:00"}},"allNames":["Nitrous acid, sodium salt","sodium nitrite","nitrite sodium"],"offLabel":[],"synonyms":["Nitrous acid, sodium salt","sodium nitrite","nitrite sodium"],"timeline":[{"date":"2011-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from HOPE PHARMS to Hope Pharms"},{"date":"2031-12-24","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 8568793 expires"}],"approvals":[{"date":"2011-01-14","orphan":false,"company":"HOPE PHARMS","regulator":"FDA"}],"brandName":"Sodium Nitrite","ecosystem":[{"indication":"Toxic effect of cyanide","otherDrugs":[{"name":"amyl nitrite","slug":"amyl-nitrite","company":""},{"name":"cobalamin","slug":"cobalamin","company":""},{"name":"hydroxocobalamin","slug":"hydroxocobalamin","company":"Watson Labs"},{"name":"sodium thiosulfate","slug":"sodium-thiosulfate","company":"Us Army"}],"globalPrevalence":null}],"mechanism":{"target":"Carbonic anhydrase 1","novelty":"Follow-on","targets":[{"gene":"CA1","source":"DrugCentral","target":"Carbonic anhydrase 1","protein":"Carbonic anhydrase 1"},{"gene":"CA2","source":"DrugCentral","target":"Carbonic anhydrase 2","protein":"Carbonic anhydrase 2"}],"modality":"Small Molecule","drugClass":"sodium nitrite","explanation":"Exposure to high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, component of the cytochrome oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well.The synergy resulting from treatment of cyanide poisoning with the combination of sodium nitrite and sodium thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning.. Sodium NitriteSodium nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affi","oneSentence":"Sodium nitrite works by converting hemoglobin to methemoglobin, which binds to cyanide and prevents it from interfering with cellular respiration.","technicalDetail":"Sodium nitrite induces the formation of methemoglobin, which has a higher affinity for cyanide than cytochrome c oxidase, thereby preventing cyanide from inhibiting cellular respiration.","_target_confidence":0.5},"commercial":{"launchDate":"2011","_launchSource":"DrugCentral (FDA 2011-01-14, HOPE PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4797","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=SODIUM%20NITRITE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SODIUM NITRITE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T15:39:18.886738","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:08:37.622940+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"nalorphine","drugSlug":"nalorphine","fdaApproval":"","relationship":"same-class"},{"drugName":"pralidoxime","drugSlug":"pralidoxime","fdaApproval":"1964-03-11","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"prednisolone","drugSlug":"prednisolone","fdaApproval":"1955-06-21","genericCount":42,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"promethazine","drugSlug":"promethazine","fdaApproval":"1951-03-29","genericCount":48,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"dimercaprol","drugSlug":"dimercaprol","fdaApproval":"1946-05-06","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"protamine sulfate","drugSlug":"protamine-sulfate","fdaApproval":"1969-08-13","genericCount":2,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"naloxone","drugSlug":"naloxone","fdaApproval":"1971-04-13","patentExpiry":"Oct 30, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ethanol","drugSlug":"ethanol","fdaApproval":"1946-01-17","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"methylthioninium chloride","drugSlug":"methylthioninium-chloride","fdaApproval":"","relationship":"same-class"},{"drugName":"copper sulfate","drugSlug":"copper-sulfate","fdaApproval":"1987-05-05","relationship":"same-class"},{"drugName":"potassium iodide","drugSlug":"potassium-iodide","fdaApproval":"1979-11-09","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amyl nitrite","drugSlug":"amyl-nitrite","fdaApproval":"","relationship":"same-class"},{"drugName":"acetylcysteine","drugSlug":"acetylcysteine","fdaApproval":"1963-09-14","patentExpiry":"May 8, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"flumazenil","drugSlug":"flumazenil","fdaApproval":"1991-12-20","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"methionine","drugSlug":"methionine","fdaApproval":"","relationship":"same-class"},{"drugName":"prussian blue","drugSlug":"prussian-blue","fdaApproval":"2003-10-02","relationship":"same-class"},{"drugName":"hydroxocobalamin","drugSlug":"hydroxocobalamin","fdaApproval":"1978-08-16","genericCount":5,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"fomepizole","drugSlug":"fomepizole","fdaApproval":"1997-12-04","patentExpiry":"Jun 30, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sugammadex","drugSlug":"sugammadex","fdaApproval":"2015-12-15","patentExpiry":"Jul 27, 2026","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"phentolamine","drugSlug":"phentolamine","fdaApproval":"1952-01-30","patentExpiry":"Oct 25, 2039","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"sodium nitrite","indications":{"approved":[{"name":"Toxic effect of cyanide","source":"DrugCentral","snomedId":66207005,"regulator":"FDA","eligibility":"Use with caution if the diagnosis of cyanide poisoning is uncertain. Patient is not in extremis."}],"offLabel":[],"pipeline":[]},"currentOwner":"Hope Pharms","drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"nalorphine","brandName":"nalorphine","genericName":"nalorphine","approvalYear":"","relationship":"same-class"},{"drugId":"pralidoxime","brandName":"pralidoxime","genericName":"pralidoxime","approvalYear":"1964","relationship":"same-class"},{"drugId":"prednisolone","brandName":"prednisolone","genericName":"prednisolone","approvalYear":"1955","relationship":"same-class"},{"drugId":"promethazine","brandName":"promethazine","genericName":"promethazine","approvalYear":"1951","relationship":"same-class"},{"drugId":"dimercaprol","brandName":"dimercaprol","genericName":"dimercaprol","approvalYear":"1946","relationship":"same-class"},{"drugId":"protamine-sulfate","brandName":"protamine sulfate","genericName":"protamine sulfate","approvalYear":"1969","relationship":"same-class"},{"drugId":"naloxone","brandName":"naloxone","genericName":"naloxone","approvalYear":"1971","relationship":"same-class"},{"drugId":"ethanol","brandName":"ethanol","genericName":"ethanol","approvalYear":"1946","relationship":"same-class"},{"drugId":"methylthioninium-chloride","brandName":"methylthioninium chloride","genericName":"methylthioninium chloride","approvalYear":"","relationship":"same-class"},{"drugId":"copper-sulfate","brandName":"copper sulfate","genericName":"copper sulfate","approvalYear":"1987","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05798481","phase":"EARLY_PHASE1","title":"Effect of Sublingually Generated S-nitroso-N-acetylcysteine on Systemic Blood Pressure.","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2024-03-27","conditions":["Hypertension","Cardiovascular Diseases"],"enrollment":14,"completionDate":"2025-10-05"},{"nctId":"NCT05893160","phase":"PHASE1","title":"Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty","status":"WITHDRAWN","sponsor":"University of Alabama at Birmingham","startDate":"2026-06-01","conditions":["Pain"],"enrollment":0,"completionDate":"2028-08-01"},{"nctId":"NCT02863068","phase":"PHASE2","title":"Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers","status":"TERMINATED","sponsor":"caterina P minniti","startDate":"2018-04-06","conditions":["Sickle Cell Disease"],"enrollment":18,"completionDate":"2023-11-24"},{"nctId":"NCT04386070","phase":"PHASE3","title":"Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19","status":"SUSPENDED","sponsor":"University of Birmingham","startDate":"2022-05-16","conditions":["Pulmonary Complications in Surgical Patients","COVID","Severe Acute Respiratory Syndrome"],"enrollment":6400,"completionDate":"2027-03-01"},{"nctId":"NCT05956314","phase":"PHASE1","title":"Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC","status":"COMPLETED","sponsor":"Kamari Pharma Ltd","startDate":"2023-03-06","conditions":["Punctate Palmoplantar Keratoderma Type 1","Pachyonychia Congenita"],"enrollment":18,"completionDate":"2024-11-07"},{"nctId":"NCT05435638","phase":"PHASE1","title":"Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases","status":"COMPLETED","sponsor":"Kamari Pharma Ltd","startDate":"2022-07-17","conditions":["Punctate Palmoplantar Keratoderma Type 1","Pachyonychia Congenita"],"enrollment":14,"completionDate":"2024-09-05"},{"nctId":"NCT04405180","phase":"PHASE2","title":"Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age","status":"COMPLETED","sponsor":"Gladwin, Mark, MD","startDate":"2021-04-23","conditions":["Aging","Sedentary Lifestyle","Frailty"],"enrollment":64,"completionDate":"2023-07-14"},{"nctId":"NCT02694393","phase":"PHASE1,PHASE2","title":"Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis","status":"TERMINATED","sponsor":"Schmidhofer, Mark, MD","startDate":"2016-02","conditions":["Cystic Fibrosis"],"enrollment":4,"completionDate":"2022-07-21"},{"nctId":"NCT03015402","phase":"PHASE2","title":"Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2017-10-30","conditions":["Pulmonary Hypertension Secondary","Heart Failure"],"enrollment":33,"completionDate":"2023-01-25"},{"nctId":"NCT04842331","phase":"PHASE2,PHASE3","title":"PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)","status":"WITHDRAWN","sponsor":"Thirty Respiratory Limited","startDate":"2021-09","conditions":["Respiratory Viral Infection","Respiratory Tract Diseases","COVID-19 Respiratory Infection"],"enrollment":0,"completionDate":"2022-01"},{"nctId":"NCT03452917","phase":"PHASE2,PHASE3","title":"Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest","status":"COMPLETED","sponsor":"University of Washington","startDate":"2018-02-08","conditions":["Out-Of-Hospital Cardiac Arrest"],"enrollment":1502,"completionDate":"2020-04-30"},{"nctId":"NCT02713126","phase":"PHASE2","title":"Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training)","status":"COMPLETED","sponsor":"Barry Borlaug","startDate":"2016-09","conditions":["Heart Failure"],"enrollment":92,"completionDate":"2022-04-12"},{"nctId":"NCT05494827","phase":"NA","title":"The Impact of a Regular Borjomi® Consumption on an Anaerobic Performance","status":"COMPLETED","sponsor":"Zaynudin Zaynudinov, MD, PhD","startDate":"2020-07-01","conditions":["Healthy"],"enrollment":51,"completionDate":"2020-12-31"},{"nctId":"NCT05045807","phase":"NA","title":"Nitrate INFORMER Nitrosamine Study","status":"COMPLETED","sponsor":"Edith Cowan University","startDate":"2021-10-11","conditions":["Health Risk Behaviors"],"enrollment":6,"completionDate":"2021-12-31"},{"nctId":"NCT03289481","phase":"EARLY_PHASE1","title":"Treatment of HFpEF With Nitrate Supplement","status":"COMPLETED","sponsor":"MaineHealth","startDate":"2017-06-29","conditions":["Heart Failure With Normal Ejection Fraction"],"enrollment":13,"completionDate":"2018-08-22"},{"nctId":"NCT02433977","phase":"PHASE2","title":"The Effects of NOx and Conjugated Linoleic Acid on Asthmatics","status":"COMPLETED","sponsor":"Gladwin, Mark, MD","startDate":"2015-09","conditions":["Asthma"],"enrollment":6,"completionDate":"2019-11"},{"nctId":"NCT02552888","phase":"PHASE2","title":"Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial","status":"COMPLETED","sponsor":"Tulane University","startDate":"2016-03","conditions":["Chronic Kidney Disease"],"enrollment":70,"completionDate":"2017-06"},{"nctId":"NCT02517697","phase":"PHASE2","title":"Oral Nitrite Trial for Hypertension and Metabolic Syndrome","status":"WITHDRAWN","sponsor":"Gladwin, Mark, MD","startDate":"2020-10","conditions":["Metabolic Syndrome","Hypertension"],"enrollment":0,"completionDate":"2021-04-13"},{"nctId":"NCT04289558","phase":"PHASE1","title":"Nitrite Infusion in Children With Malaria","status":"WITHDRAWN","sponsor":"Duke University","startDate":"2021-06-01","conditions":["Falciparum Malaria"],"enrollment":0,"completionDate":"2021-10-01"},{"nctId":"NCT03544242","phase":"PHASE2","title":"Nitrite Infusion in Islet Cell Transplantation","status":"TERMINATED","sponsor":"University of Alabama at Birmingham","startDate":"2017-05-07","conditions":["Diabetes"],"enrollment":4,"completionDate":"2019-06-27"},{"nctId":"NCT04401527","phase":"PHASE2","title":"Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite","status":"WITHDRAWN","sponsor":"Hope Pharmaceuticals","startDate":"2020-07-22","conditions":["COVID-19","Acute Respiratory Distress Syndrome","Acute Respiratory Failure"],"enrollment":0,"completionDate":"2020-08-15"},{"nctId":"NCT00873015","phase":"PHASE2","title":"Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm","status":"COMPLETED","sponsor":"Hope Pharmaceuticals","startDate":"2010-04","conditions":["Subarachnoid Hemorrhage"],"enrollment":19,"completionDate":"2012-08"},{"nctId":"NCT02412852","phase":"PHASE2","title":"A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain","status":"COMPLETED","sponsor":"TheraVasc Inc.","startDate":"2015-04-28","conditions":["Diabetes"],"enrollment":26,"completionDate":"2017-04-03"},{"nctId":"NCT01401517","phase":"PHASE2","title":"Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC","status":"COMPLETED","sponsor":"TheraVasc Inc.","startDate":"2011-07","conditions":["Peripheral Arterial Disease"],"enrollment":55,"completionDate":"2013-01"},{"nctId":"NCT04354051","phase":"PHASE1,PHASE2","title":"The Nitrite and Coronary Flow Study","status":"COMPLETED","sponsor":"University of East Anglia","startDate":"2018-07-01","conditions":["Cardiovascular Diseases","Vasodilation","Hypoxia"],"enrollment":14,"completionDate":"2018-12-01"},{"nctId":"NCT02918552","phase":"PHASE2","title":"Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction","status":"COMPLETED","sponsor":"Gladwin, Mark, MD","startDate":"2017-04-03","conditions":["Heart Failure"],"enrollment":15,"completionDate":"2018-12-31"},{"nctId":"NCT02393742","phase":"NA","title":"Nitrite Supplementation for Improving Physiological Function in Older Adults","status":"COMPLETED","sponsor":"University of Colorado, Boulder","startDate":"2015-03","conditions":["Ageing"],"enrollment":49,"completionDate":"2019-05"},{"nctId":"NCT00095472","phase":"PHASE1","title":"Therapeutic Application of Intravascular Nitrite for Sickle Cell Disease","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2004-11-01","conditions":["Sickle Cell Anemia"],"enrollment":18,"completionDate":"2007-08-24"},{"nctId":"NCT04001283","phase":"PHASE2","title":"Nitrite Effects on Cardiac Muscle in CABG","status":"UNKNOWN","sponsor":"University of East Anglia","startDate":"2013-01-21","conditions":["Coronary Artery Disease","Atherosclerosis","Vascular Diseases","Cardiac Disease","Diabetes Mellitus"],"enrollment":75,"completionDate":"2019-07-01"},{"nctId":"NCT02677623","phase":"PHASE4","title":"Evaluation of Ureteral Patency in the Post-indigo Carmine Era","status":"COMPLETED","sponsor":"Columbia University","startDate":"2015-03","conditions":["Ureteral Patency"],"enrollment":140,"completionDate":"2016-08"},{"nctId":"NCT01681810","phase":"PHASE2","title":"Oral Nitrite in Adults With Metabolic Syndrome and Hypertension","status":"COMPLETED","sponsor":"Gladwin, Mark, MD","startDate":"2012-10","conditions":["Metabolic Syndrome","Hypertension"],"enrollment":20,"completionDate":"2018-03-08"},{"nctId":"NCT01431313","phase":"PHASE2","title":"Inhaled Nitrite in Subjects With Pulmonary Hypertension","status":"COMPLETED","sponsor":"Schmidhofer, Mark, MD","startDate":"2012-06","conditions":["Pulmonary Hypertension","Heart Failure, Diastolic"],"enrollment":48,"completionDate":"2017-10"},{"nctId":"NCT02742129","phase":"PHASE2","title":"Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF","status":"COMPLETED","sponsor":"Adrian Hernandez","startDate":"2016-08-10","conditions":["Heart Failure"],"enrollment":105,"completionDate":"2017-12-27"},{"nctId":"NCT01316796","phase":"PHASE1","title":"Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2011-03-15","conditions":["Sickle Cell Anemia","Sickle Cell Disease","Chronic Hemolytic Disorders"],"enrollment":28,"completionDate":"2018-10-12"},{"nctId":"NCT03331146","phase":"PHASE3","title":"Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass","status":"WITHDRAWN","sponsor":"University of Alabama at Birmingham","startDate":"2018-10-01","conditions":["Acute Kidney Injury"],"enrollment":0,"completionDate":"2020-12-01"},{"nctId":"NCT02457260","phase":"PHASE2","title":"Oral Nitrite for Older Heart Failure Patients","status":"COMPLETED","sponsor":"Gladwin, Mark, MD","startDate":"2016-01-08","conditions":["Heart Failure"],"enrollment":21,"completionDate":"2017-03-06"},{"nctId":"NCT01681836","phase":"PHASE1","title":"Oral Nitrite and Nitrate in Healthy Normal Volunteer Adults","status":"COMPLETED","sponsor":"Gladwin, Mark, MD","startDate":"2012-10","conditions":["Focus of Study of Healthy Adults"],"enrollment":11,"completionDate":"2013-10"},{"nctId":"NCT01715883","phase":"PHASE2","title":"Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction","status":"TERMINATED","sponsor":"Gladwin, Mark, MD","startDate":"2011-10","conditions":["Primary Graft Dysfunction"],"enrollment":3,"completionDate":"2017-05"},{"nctId":"NCT00105222","phase":"PHASE1","title":"Effect of Nitrite on Exercise Physiology and Metabolism","status":"TERMINATED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2005-03-08","conditions":["Healthy","Healthy Volunteer","HV"],"enrollment":15,"completionDate":"2013-08-16"},{"nctId":"NCT00924118","phase":"PHASE2","title":"Sodium Nitrite in Acute Myocardial Infarction","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2009-07","conditions":["Acute Myocardial Infarction"],"enrollment":30,"completionDate":"2016-06"},{"nctId":"NCT02987088","phase":"PHASE1","title":"Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest","status":"COMPLETED","sponsor":"University of Washington","startDate":"2016-12","conditions":["Out-Of-Hospital Cardiac Arrest"],"enrollment":120,"completionDate":"2017-05-02"},{"nctId":"NCT02176837","phase":"PHASE2","title":"Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage","status":"TERMINATED","sponsor":"Hope Pharmaceuticals","startDate":"2014-06","conditions":["Subarachnoid Hemorrhage"],"enrollment":6,"completionDate":"2017-01-15"},{"nctId":"NCT01584453","phase":"PHASE2","title":"Safety and Effectiveness of Intra-coronary Nitrite in Acute Myocardial Infarction","status":"COMPLETED","sponsor":"Barts & The London NHS Trust","startDate":"2012-04","conditions":["Myocardial Infarction","Reperfusion Injury","Myocardial Ischemia","Cardiovascular Diseases"],"enrollment":80,"completionDate":"2016-01"},{"nctId":"NCT03251287","phase":"PHASE1","title":"Nitrite in Hypertrophic Cardiomyopathy (HCM) Study","status":"UNKNOWN","sponsor":"University of East Anglia","startDate":"2017-11","conditions":["Cardiomyopathy, Hypertrophic"],"enrollment":18,"completionDate":"2019-01"},{"nctId":"NCT01033227","phase":"PHASE1,PHASE2","title":"Safety and Efficacy of Sodium Nitrite in Sickle Cell Disease","status":"TERMINATED","sponsor":"Children's Hospital Los Angeles","startDate":"2009-12","conditions":["Sickle Cell Disease"],"enrollment":5,"completionDate":"2012-06"},{"nctId":"NCT02262078","phase":"PHASE2","title":"Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction","status":"COMPLETED","sponsor":"Mayo Clinic","startDate":"2014-10","conditions":["Heart Failure"],"enrollment":26,"completionDate":"2015-12"},{"nctId":"NCT00250185","phase":"PHASE1","title":"The Role of Nitrite in Preconditioning Mediated Tolerance to Ischemic Stress","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2005-11-01","conditions":["Ischemic Stress","Transient Non-Lethal Ischemia"],"enrollment":135,"completionDate":"2007-06-09"},{"nctId":"NCT00102271","phase":"PHASE1","title":"Nitrite Infusion Studies","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2005-01-19","conditions":["Healthy"],"enrollment":36,"completionDate":"2011-04-12"},{"nctId":"NCT00103025","phase":"PHASE1","title":"Nitrite Infusion in Healthy Volunteers","status":"COMPLETED","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","startDate":"2005-02-04","conditions":["Healthy"],"enrollment":12,"completionDate":"2011-05-10"},{"nctId":"NCT01178359","phase":"PHASE1","title":"Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients","status":"COMPLETED","sponsor":"University of Washington","startDate":"2010-01","conditions":["Cardiac Arrest"],"enrollment":11,"completionDate":"2016-04"},{"nctId":"NCT02015260","phase":"PHASE2","title":"A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts","status":"COMPLETED","sponsor":"University of Aberdeen","startDate":"2001-09","conditions":["Anogenital Warts","Condylomata Acuminata"],"enrollment":299,"completionDate":"2003-05"},{"nctId":"NCT03077763","phase":"PHASE1","title":"The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation","status":"UNKNOWN","sponsor":"University of East Anglia","startDate":"2016-12","conditions":["Healthy Volunteers"],"enrollment":41,"completionDate":"2018-03"},{"nctId":"NCT02934438","phase":"NA","title":"Effect of Neo40 on PAD","status":"UNKNOWN","sponsor":"HumanN","startDate":"2016-10","conditions":["Peripheral Artery Disease"],"enrollment":30,"completionDate":"2017-10"},{"nctId":"NCT01388504","phase":"PHASE2,PHASE3","title":"Nitrites in Acute Myocardial Infarction","status":"COMPLETED","sponsor":"University of Aberdeen","startDate":"2011-07","conditions":["Acute ST Elevation Myocardial Infarction"],"enrollment":200,"completionDate":"2014-01"},{"nctId":"NCT02527837","phase":"PHASE1","title":"The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Hypertensive Versus Healthy Subjects","status":"UNKNOWN","sponsor":"Erling Bjerregaard Pedersen","startDate":"2015-05","conditions":["Hypertension"],"enrollment":30,"completionDate":"2016-10"},{"nctId":"NCT02022670","phase":"PHASE1,PHASE2","title":"Sodium Nitrite to Treat Arterial Aging","status":"COMPLETED","sponsor":"University of Colorado, Boulder","startDate":"2011-10","conditions":["Vascular Aging"],"enrollment":33,"completionDate":"2013-12"},{"nctId":"NCT01633086","phase":"PHASE2","title":"A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy","status":"COMPLETED","sponsor":"China Medical University Hospital","startDate":"2012-07","conditions":["Neuropathic Pain"],"enrollment":24,"completionDate":"2013-02"},{"nctId":"NCT02078908","phase":"PHASE1","title":"The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Healthy Humans. A Dose-response Study","status":"COMPLETED","sponsor":"Erling Bjerregaard Pedersen","startDate":"2013-09","conditions":["Healthy"],"enrollment":12,"completionDate":"2014-06"},{"nctId":"NCT01725269","phase":"PHASE2","title":"Long-term Study of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension Who Completed AIR001-CS05","status":"TERMINATED","sponsor":"Aires Pharmaceuticals, Inc.","startDate":"2013-03","conditions":["Pulmonary Arterial Hypertension"],"enrollment":17,"completionDate":"2014-04"},{"nctId":"NCT01725256","phase":"PHASE2","title":"A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)","status":"TERMINATED","sponsor":"Aires Pharmaceuticals, Inc.","startDate":"2012-11","conditions":["Pulmonary Arterial Hypertension"],"enrollment":29,"completionDate":"2014-02"},{"nctId":"NCT02022176","phase":"NA","title":"Modulation of Metabolic Rate by Inorganic Nitrate","status":"COMPLETED","sponsor":"Karolinska Institutet","startDate":"2008-03","conditions":["Resting Metabolic Rate"],"enrollment":55,"completionDate":"2013-09"},{"nctId":"NCT01347957","phase":"PHASE1,PHASE2","title":"Safety and Efficacy of Nitric Oxide Gel in Promoting Hair Growth in Male Human Subjects With Androgenetic Alopecia","status":"UNKNOWN","sponsor":"China Medical University Hospital","startDate":"2012-08","conditions":["Alopecia Androgenica"],"enrollment":60,"completionDate":"2013-08"},{"nctId":"NCT01409122","phase":"PHASE1","title":"Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects","status":"COMPLETED","sponsor":"Aires Pharmaceuticals, Inc.","startDate":"2011-07","conditions":["Pulmonary Hypertension","Pulmonary Arterial Hypertension"],"enrollment":42,"completionDate":"2012-01"},{"nctId":"NCT00814645","phase":"PHASE1","title":"Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers","status":"COMPLETED","sponsor":"Aires Pharmaceuticals, Inc.","startDate":"2008-12","conditions":["Pulmonary Arterial Hypertension"],"enrollment":25,"completionDate":"2009-06"},{"nctId":"NCT01098409","phase":"PHASE2","title":"Nitrite Mediated Cardioprotection During Coronary Artery Bypass Surgery","status":"UNKNOWN","sponsor":"University Hospital Birmingham NHS Foundation Trust","startDate":"2010-02","conditions":["Coronary Artery Bypass Surgery"],"enrollment":50,"completionDate":"2012-07"},{"nctId":"NCT00048477","phase":"PHASE2","title":"Effects of Nitrite on Blood Vessel Dilation in Normal Volunteers","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"2002-10","conditions":["Nitric Oxide","Endothelium-Derived Relaxing Factor","Healthy"],"enrollment":42,"completionDate":"2003-11"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Injection","formulations":[{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Sodium Nitrite"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000145900","MMSL":"47919","NDDF":"000682","UNII":"M0KG633D4F","VUID":"4017515","CHEBI":"CHEBI:78870","VANDF":"4017515","RXNORM":"9894","UMLSCUI":"C0037532","chemblId":"CHEMBL93268","ChEMBL_ID":"CHEMBL93268","KEGG_DRUG":"D05865","PUBCHEM_CID":"23668193","SNOMEDCT_US":"10377000","MESH_DESCRIPTOR_UI":"D012977"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2011-","companyName":"Hope Pharms","relationship":"Original Developer"}],"publicationCount":2902,"therapeuticAreas":["Metabolic"],"atcClassification":{"source":"DrugCentral","atcCode":"V03AB08","allCodes":["V03AB08"]},"biosimilarFilings":[],"originalDeveloper":"Hope Pharms","recentPublications":[{"date":"2026 Mar 25","pmid":"41878890","title":"Targeted detection method for locus-specific m(6)A modifications in low-abundance transcripts based on chemical conversion.","journal":"Chemical communications (Cambridge, England)"},{"date":"2026 Mar 18","pmid":"41856308","title":"Dietary exposure to 77 food additives in a sample of Brazilian children aged 1-3 years: a Tier 2b screening assessment.","journal":"Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association"},{"date":"2026","pmid":"41853760","title":"Phage P100 resistance in clinical and foodborne Listeria monocytogenes isolates is associated with adsorption-inhibiting mutations and fitness trade-offs.","journal":"Current research in microbial sciences"},{"date":"2026 Feb 11","pmid":"41849020","title":"Quality characteristics of nitrite-free emulsified pork sausages with gardenia red-based additive combinations.","journal":"Food science of animal resources"},{"date":"2026 Feb 11","pmid":"41848826","title":"Individual and interactive effects of heating temperature, sodium nitrite concentration, and simulated gastric conditions on nitrosamine formation in pork sausages.","journal":"Food science of animal resources"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Hope Pharms","companyId":"hope-pharms","modality":"Small molecule","firstApprovalDate":"2011","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2011-01-14T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"2011-01-14T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"2011-01-14T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"2011-01-14T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"2011-01-14T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"2011-01-14T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2013-04-08T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":"NDA201444"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2017-10-19T00:00:00.000Z","mah":"HOPE PHARMS","brand_name_local":null,"application_number":"NDA203922"},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":10,"withResults":1},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:08:37.622940+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}