{"id":"cycloserine","rwe":[{"pmid":"41895511","year":"2026","title":"Emergence of Rv0678 (mmpR5) Mutations Mediating Resistance to Bedaquiline and Clofazimine in a Liver Transplant Recipient with Rifampicin-Susceptible Tuberculosis: A Case Report.","finding":"","journal":"International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases","studyType":"Clinical Study"},{"pmid":"41868031","year":"2026","title":"Patterns of Drug Resistance and Treatment Outcomes in Drug-Resistant Tuberculosis Patients in Fuyang City: A Three-Year Retrospective Study.","finding":"","journal":"Infection and drug resistance","studyType":"Clinical Study"},{"pmid":"41849351","year":"2026","title":"Alanine catabolism as a targetable vulnerability for MYC-driven liver cancer.","finding":"","journal":"Cell reports","studyType":"Clinical Study"},{"pmid":"41845289","year":"2026","title":"Innovating shorter, all-oral, precise, individualized treatment regimen for rifampicin-resistant tuberculosis (INSPIRE TB): study protocol for a pragmatic randomised controlled trial.","finding":"","journal":"BMC infectious diseases","studyType":"Clinical Study"},{"pmid":"41844171","year":"2026","title":"Monitoring UDP-MurNAc (UM)-Stem Peptide Intermediates from the Cellular and Recombinant Acinetobacter baumannii MurCDEF Pathway.","finding":"","journal":"ACS infectious diseases","studyType":"Clinical Study"}],"_fda":{"id":"426b2c99-759d-647a-420f-fc11b205486b","set_id":"8e7e2665-7a3d-3f54-9f92-5fe845f02ef9","openfda":{"unii":["95IK5KI84Z"],"route":["ORAL"],"rxcui":["197551"],"spl_id":["426b2c99-759d-647a-420f-fc11b205486b"],"brand_name":["Cycloserine"],"spl_set_id":["8e7e2665-7a3d-3f54-9f92-5fe845f02ef9"],"package_ndc":["43598-235-10","43598-235-31"],"product_ndc":["43598-235"],"generic_name":["CYCLOSERINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CYCLOSERINE"],"manufacturer_name":["Dr. Reddys Laboratories, Inc."],"application_number":["ANDA060593"],"is_original_packager":[true]},"version":"3","warnings":["WARNINGS Administration of cycloserine should be discontinued or the dosage reduced if the patient develops allergic dermatitis or symptoms of CNS toxicity, such as convulsions, psychosis, somnolence, depression, confusion, hyperreflexia, headache, tremor, vertigo paresis, or dysarthria. The toxicity of cycloserine is closely related to excessive blood levels (above 30 mcg/mL), as determined by high dosage or inadequate renal clearance. The ratio of toxic dose to effective dose in tuberculosis is small. The risk of convulsions is increased in chronic alcoholics. Patients should be monitored by hematologic, renal excretion, blood level, and liver function studies."],"overdosage":["OVERDOSAGE Signs and Symptoms: Acute toxicity from cycloserine can occur if more than 1 g is ingested by an adult. Chronic toxicity from cycloserine is dose related and can occur if more than 500 mg is administered daily. The central nervous system is the most common organ system involved with toxicity. Toxic effects may include headache, vertigo, confusion, drowsiness, hyperirritability, paresthesias, dysarthria, psychosis paresis, convulsions, and coma. Treatment: In adults, many of the neurotoxic effects of cycloserine can be both treated and prevented with the administration of 200 to 300 mg of pyridoxine daily. Hemodialysis has been shown to remove cycloserine from the bloodstream. This procedure should be reserved for patients with life threatening toxicity that is unresponsive to less invasive therapy."],"references":["REFERENCES 1. Jones LR: Colorimetric determination of cycloserine, a new antibiotic. Anal Chem 1956;28:39."],"description":["DESCRIPTION D -Cycloserine, (R)-4-amino-3-isoxazolidinone, is a broad-spectrum antibiotic that is produced by a strain of Streptomyces orchidaceus and has also been synthesized. Cycloserine is a white to off-white powder that is soluble in water and stable in alkaline solution. It is rapidly destroyed at a neutral or acid pH. Cycloserine has a pH between 5.5 and 6.5 in a solution containing 100 mg/mL. The molecular weight of cycloserine is 102.09, and it has an empirical formula of C 3H6N2O 2 . The structural formula of cycloserine is as follows: Each capsule contains cycloserine, 250 mg (2.45 mmol); D & C Yellow No. 10, F D & C Blue No. 1, F D & C Red No. 3, F D & C Yellow No. 6, gelatin, iron oxide, talc, and titanium dioxide. Structural Formula of Cycloserine"],"precautions":["PRECAUTIONS General: Before treatment with cycloserine is initiated, cultures should be taken and the organism’s susceptibility to the drug should be established. In tuberculous infections, the organism’s susceptibility to the other antituberculosis agents in the regimen should also be demonstrated. Anticonvulsant drugs or sedatives may be effective in controlling symptoms of CNS toxicity, such as convulsions, anxiety, and tremor. Patients receiving more than 500 mg of cycloserine daily should be closely observed for such symptoms. The value of pyridoxine in preventing CNS toxicity from cycloserine has not been proved. Administration of cycloserine and other antituberculosis drugs has been associated in a few instances with vitamin B 12 and/or folic- acid deficiency, megaloblastic anemia, and sideroblastic anemia. If evidence of anemia develops during treatment, appropriate studies and therapy should be instituted. Laboratory Tests: Blood levels should be determined at least weekly for patients with reduced renal function, for individuals receiving a daily dosage of more than 500 mg, and for those showing signs and symptoms suggestive of toxicity. The dosage should be adjusted to keep the blood level below 30 mcg/mL. Drug Interactions: Concurrent administration of ethionamide has been reported to potentiate neurotoxic side effects. Alcohol and cycloserine are incompatible, especially during a regimen calling for large doses of the latter. Alcohol increases the possibility and risk of epileptic episodes. Concurrent administration of isoniazid may result in increased incidence of CNS effects, such as dizziness or drowsiness. Dosage adjustments may be necessary and patients should be monitored closely for signs of CNS toxicity. Carcinogenesis, Mutagenicity, and Impairment of Fertility: Studies have not been performed to determine potential for carcinogenicity. The Ames test and unscheduled DNA repair test were negative. A study in 2 generations of rats showed no impairment of fertility relative to controls for the first mating but somewhat lower fertility in the second mating. Pregnancy Category C: There are no adequate and well-controlled studies with the use of Cycloserine in pregnant women. A study in 2 generations of rats given doses up to 100 mg/kg/day (approximately equivalent to the maximum recommended human dose on a body surface area basis) demonstrated no teratogenic effect in offspring. Cycloserine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from cycloserine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Usage in Pediatric Patients: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Clinical studies of cycloserine did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug 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. The toxicity of cycloserine is closely related to excessive blood levels (above 30 mcg/mL) as determined by high dosage or inadequate renal clearance (see WARNINGS). Blood levels should be determined at least weekly for patients with reduced renal function, for individuals receiving a daily dosage of more than 500 mg, and for those showing signs and symptoms suggestive of toxicity. The dosage should be adjusted to keep the blood level below 30 mcg/mL (see PRECAUTIONS, Laboratory Tests)."],"how_supplied":["HOW SUPPLIED Cycloserine is available as a 250 mg capsule with an opaque red cap and opaque gray body imprinted with “PGC” and “F04” in edible black ink on both the cap and the body. Cycloserine Capsules, USP are supplied in cartons of 3 cards. Each card is a ten-capsules blister card as follows: NDC 43598-235-31: carton with 3 cards. NDC 43598-235-10 (ten 250mg capsules per card). Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]."],"effective_time":"20240730","adverse_reactions":["ADVERSE REACTIONS Most adverse reactions occurring during therapy with cycloserine involve the nervous system or are manifestations of drug hypersensitivity. The following side effects have been observed in patients receiving cycloserine: Nervous system symptoms (which appear to be related to higher dosages of the drug, i.e., more than 500 mg daily) • Convulsions • Drowsiness and somnolence • Headache • Tremor • Dysarthria • Vertigo • Confusion and disorientation with loss of memory • Psychoses, possibly with suicidal tendencies • Character changes • Hyperirritability • Aggression • Paresis • Hyperreflexia • Paresthesia • Major & minor (localized) clonic seizures • Coma Cardiovascular: Sudden development of congestive heart failure in patients receiving 1 to 1.5 g of cycloserine daily has been reported. Allergy (apparently not related to dosage) Skin rash Miscellaneous: Elevated serum transaminase, especially in patients with preexisting liver disease To report SUSPECTED ADVERSE REACTIONS, contact Cerovene, Inc. at 1-833-304-9569 or FDA at 1‑800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS Administration is contraindicated in patients with any of the following: • Hypersensitivity to cycloserine • Epilepsy • Depression, severe anxiety, or psychosis • Severe renal insufficiency • Excessive concurrent use of alcoho"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY After oral administration, cycloserine is readily absorbed from the gastrointestinal tract, with peak blood levels occurring in 4 to 8 hours. Blood levels of 25 to 30 mcg/mL can generally be maintained with the usual dosage of 250 mg twice a day, although the relationship of plasma levels to dosage is not always consistent. Concentrations in the cerebrospinal fluid, pleural fluid, fetal blood, and mother’s milk approach those found in the serum. Detectable amounts are found in ascitic fluid, file, sputum, amniotic fluid, and lung and lymph tissues. Approximately 65% of a single dose of cycloserine can be recovered in the urine within 72 hours after oral administration. The remaining 35% is apparently metabolized to unknown substances. The maximum excretion rate occurs 2 to 6 hours after administration, with 50% of the drug eliminated in 12 hours. Mechanism of Action: The antibacterial activity of Cycloserine results from inhibition of cell-wall synthesis in susceptible strains of gram-positive and gram-negative bacteria. Antibacterial Activity: Cycloserine has been shown to be active against most isolates of the following microorganism, both in vitro and in clinical infections [see Indications and Usage]: Mycobacterium tuberculosis."],"indications_and_usage":["INDICATIONS AND USAGE Cycloserine is indicated in the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) when the causative organisms are susceptible to this drug and when treatment with the primary medications (streptomycin, isoniazid, rifampin, and ethambutol) has proved inadequate. Like all antituberculosis drugs, cycloserine should be administered in conjunction with other effective chemotherapy and not as the sole therapeutic agent. Cycloserine may be effective in the treatment of acute urinary tract infections caused by susceptible strains of gram-positive and gram- negative bacteria. Use of cycloserine in these infections should be considered only when more conventional therapy has failed and when the organism has been demonstrated to be susceptible to the drug"],"spl_unclassified_section":["Distributed By: Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 Rev 02/23"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Cycloserine is effective orally and is currently administered only by this route. The usual dosage is 500 mg to 1 g daily in divided doses monitored by blood levels. 1 The initial adult dosage most frequently given is 250 mg twice daily at 12-hour intervals for the first 2 weeks. A daily dosage of 1 g should not be exceeded."],"spl_product_data_elements":["Cycloserine Cycloserine CYCLOSERINE CYCLOSERINE Cap: BOQ - Op. Red 353 Body: AWZ - Op. Grey 284 PGC;F04 Imprint on both cap and body"],"package_label_principal_display_panel":["PACKAGE LABEL DISPLAY Cycloserine Capsules USP, 250 mg - Carton Label carton250"]},"tags":[{"label":"cycloserine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glutamate receptor ionotropic, NMDA 2A","category":"target"},{"label":"GRIN2A","category":"gene"},{"label":"GRIN2B","category":"gene"},{"label":"GRIN2D","category":"gene"},{"label":"J04AB01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Acute tuberculosis","category":"indication"},{"label":"Bacterial urinary infection","category":"indication"},{"label":"Escherichia coli urinary tract infection","category":"indication"},{"label":"Pulmonary tuberculosis","category":"indication"},{"label":"Purdue Gmp","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Infective Agents, Urinary","category":"pharmacology"},{"label":"Antibiotics, Antitubercular","category":"pharmacology"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Antitubercular Agents","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"ELECTROCARDIOGRAM QT PROLONGED","source":"FDA FAERS","actionTaken":"282 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"263 reports"},{"date":"","signal":"NEUROPATHY PERIPHERAL","source":"FDA FAERS","actionTaken":"211 reports"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"203 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"171 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"148 reports"},{"date":"","signal":"DRUG RESISTANCE","source":"FDA FAERS","actionTaken":"113 reports"},{"date":"","signal":"HEPATOTOXICITY","source":"FDA FAERS","actionTaken":"110 reports"},{"date":"","signal":"TUBERCULOSIS","source":"FDA FAERS","actionTaken":"95 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"83 reports"}],"commonSideEffects":[{"effect":"Convulsion","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Coma","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Major minor (localized) clonic seizures","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Cardiovascular: Sudden development of congestive heart failure","drugRate":"≥1.5%","severity":"serious","_validated":true},{"effect":"Psychoses, possibly with suicidal tendencies","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Character changes","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Hyperirritability","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Aggression","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Paresis","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Hyperreflexia","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Paresthesia","drugRate":"≥1%","severity":"serious","_validated":true},{"effect":"Drowsiness and somnolence","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Headache","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Tremor","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Dysarthria","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Vertigo","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Confusion and disorientation with loss of memory","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Skin rash","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Elevated serum transaminase","drugRate":"≥1%","severity":"common","_validated":true},{"effect":"Allergy","drugRate":"≥1%","severity":"common","_validated":true}],"contraindications":["Hypersensitivity to cycloserine","Epilepsy","Depression, severe anxiety, or psychosis","Severe renal insufficiency","Excessive concurrent use of alcohol"],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies with the use of Seromycin(R) in pregnant women. study in generations of rats given doses up to 100 mg/kg/day (approximately equivalent to the maximum recommended human dose on body surface area basis) demonstrated no teratogenic effect in offspring. Seromycin(R) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.","Geriatric use":"Clinical studies of Seromycin(R) did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac","Paediatric use":"Safety and effectiveness in pediatric patients have not been established.","Hepatic impairment":"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac"}},"trials":[],"aliases":[],"company":"Purdue Gmp","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CYCLOSERINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:08:28.070636+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:09:08.616913+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:08:33.665666+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:08:27.184858+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CYCLOSERINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:08:34.268935+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:08:25.545758+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:09:01.918376+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:08:25.545788+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":"2026-04-20T00:08:35.742664+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Alanine racemase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:08:35.329046+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL771/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:08:34.962935+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:08:40.647873+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA060593","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:08:25.545793+00:00"}},"allNames":"cyclorin","offLabel":[],"synonyms":["cycloserine","seromycin","oxamycin","farmiserina","miroseryn","cyclorin","(R)-4-amino-1,2-oxazolidin-3-one"],"timeline":[{"date":"1964-06-29","type":"positive","source":"DrugCentral","milestone":"FDA approval (Purdue Gmp)"}],"aiSummary":"Cycloserine (Cyclorin), marketed by Purdue Gmp, is an antibacterial agent indicated for active pulmonary tuberculosis, competing in a class with established drugs like rifampicin and rifabutin. Its key strength lies in its unique mechanism of action, which inhibits bacterial cell wall synthesis, offering an alternative for patients who may be resistant to other treatments. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.","brandName":"Cyclorin","ecosystem":[{"indication":"Acute tuberculosis","otherDrugs":[{"name":"aminosalicylic acid","slug":"aminosalicylic-acid","company":"Consolidated Midland"},{"name":"capreomycin","slug":"capreomycin","company":"Akorn"},{"name":"ethambutol","slug":"ethambutol","company":"Sti Pharma Llc"},{"name":"ethionamide","slug":"ethionamide","company":"Wyeth Pharms Inc"}],"globalPrevalence":1280000},{"indication":"Bacterial urinary infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"avibactam","slug":"avibactam","company":"Cerexa Inc"}],"globalPrevalence":null},{"indication":"Escherichia coli urinary tract infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"aztreonam","slug":"aztreonam","company":"Bristol Myers Squibb"},{"name":"betaine","slug":"betaine","company":"Rare Dis Therap"}],"globalPrevalence":null},{"indication":"Pulmonary tuberculosis","otherDrugs":[{"name":"aminosalicylic acid","slug":"aminosalicylic-acid","company":"Consolidated Midland"},{"name":"bedaquiline","slug":"bedaquiline","company":"Janssen Therap"},{"name":"capreomycin","slug":"capreomycin","company":"Akorn"},{"name":"ethambutol","slug":"ethambutol","company":"Sti Pharma Llc"}],"globalPrevalence":1280000}],"mechanism":{"target":"Glutamate receptor ionotropic, NMDA 2A","novelty":"First-in-class","targets":[{"gene":"GRIN2A","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 2A","protein":"Glutamate receptor ionotropic, NMDA 2A"},{"gene":"GRIN2B","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 2B","protein":"Glutamate receptor ionotropic, NMDA 2B"},{"gene":"GRIN2D","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 2D","protein":"Glutamate receptor ionotropic, NMDA 2D"},{"gene":"GRIN3A","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 3A","protein":"Glutamate receptor ionotropic, NMDA 3A"},{"gene":"GRIN3B","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 3B","protein":"Glutamate receptor ionotropic, NMDA 3B"},{"gene":"GRIN2C","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 2C","protein":"Glutamate receptor ionotropic, NMDA 2C"},{"gene":"GRIN1","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 1","protein":"Glutamate receptor ionotropic, NMDA 1"},{"gene":"CYP3A4","source":"DrugCentral","target":"Cytochrome P450 3A4","protein":"Cytochrome P450 3A4"}],"modality":"Small Molecule","drugClass":"cycloserine","explanation":"","oneSentence":"","technicalDetail":"Cyclorin exerts its antibacterial effects by inhibiting the enzyme alanine racemase, which is essential for the synthesis of the bacterial cell wall. This leads to the accumulation of D-alanine, a precursor to the bacterial cell wall, and ultimately results in the death of the bacteria."},"commercial":{"launchDate":"1964","_launchSource":"DrugCentral (FDA 1964-06-29, PURDUE GMP)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/759","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CYCLOSERINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CYCLOSERINE","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":"2026-03-30T02:39:54.010719","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T00:09:08.617331+00:00","fieldsConflicting":4,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"rifampicin","drugSlug":"rifampicin","fdaApproval":"1971-05-21","relationship":"same-class"},{"drugName":"rifamycin","drugSlug":"rifamycin","fdaApproval":"2018-11-16","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"rifabutin","drugSlug":"rifabutin","fdaApproval":"1992-12-23","genericCount":2,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"rifapentine","drugSlug":"rifapentine","fdaApproval":"1998-06-22","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"capreomycin","drugSlug":"capreomycin","fdaApproval":"1971-06-02","genericCount":2,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"cycloserine","indications":{"approved":[{"id":"cycloserine-active-pulmonary-tuberculosis","name":"Active Pulmonary Tuberculosis","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with active pulmonary tuberculosis","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with active pulmonary tuberculosis","diagnosticRequired":"Susceptibility testing for cycloserine","brandNameForIndication":"Cyclorin"},{"id":"cycloserine-active-extrapulmonary-tubercul","name":"Active Extrapulmonary Tuberculosis","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with active extrapulmonary tuberculosis, including renal disease","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with active extrapulmonary tuberculosis, including renal disease","diagnosticRequired":"Susceptibility testing for cycloserine","brandNameForIndication":"Cyclorin"},{"id":"cycloserine-acute-urinary-tract-infections","name":"Acute Urinary Tract Infections","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with acute urinary tract infections","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with acute urinary tract infections","diagnosticRequired":"Susceptibility testing for cycloserine","brandNameForIndication":"Cyclorin"}],"offLabel":[{"name":"Mycobacteriosis","source":"DrugCentral","drugName":"CYCLOSERINE","evidenceCount":1143,"evidenceLevel":"strong"},{"name":"Tuberculosis of meninges","source":"DrugCentral","drugName":"CYCLOSERINE","evidenceCount":20,"evidenceLevel":"moderate"}],"pipeline":[]},"drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"rifampicin","brandName":"rifampicin","genericName":"rifampicin","approvalYear":"1971","relationship":"same-class"},{"drugId":"rifamycin","brandName":"rifamycin","genericName":"rifamycin","approvalYear":"2018","relationship":"same-class"},{"drugId":"rifabutin","brandName":"rifabutin","genericName":"rifabutin","approvalYear":"1992","relationship":"same-class"},{"drugId":"rifapentine","brandName":"rifapentine","genericName":"rifapentine","approvalYear":"1998","relationship":"same-class"},{"drugId":"capreomycin","brandName":"capreomycin","genericName":"capreomycin","approvalYear":"1971","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07460947","phase":"PHASE1,PHASE2","title":"A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder","status":"NOT_YET_RECRUITING","sponsor":"Mclean Hospital","startDate":"2026-03","conditions":["Borderline Personality Disorder (BPD)"],"enrollment":20,"completionDate":"2027-12"},{"nctId":"NCT03780829","phase":"EARLY_PHASE1","title":"AIH for Spinal Cord Repair","status":"TERMINATED","sponsor":"VA Office of Research and Development","startDate":"2020-02-25","conditions":["SCI"],"enrollment":50,"completionDate":"2026-02-05"},{"nctId":"NCT05994703","phase":"PHASE2","title":"Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine","status":"COMPLETED","sponsor":"Rose Research Center, LLC","startDate":"2023-10-20","conditions":["Smoking Cessation","Harm Reduction"],"enrollment":25,"completionDate":"2026-01-12"},{"nctId":"NCT05591677","phase":"PHASE2","title":"D-Cycloserine Augmentation of Intermittent Theta Burst Stimulation (iTBS) in Depression (COGENT)","status":"ACTIVE_NOT_RECRUITING","sponsor":"The Alfred","startDate":"2023-04-21","conditions":["Major Depressive Disorder"],"enrollment":180,"completionDate":"2026-05-29"},{"nctId":"NCT00042289","phase":"","title":"Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2003-06-09","conditions":["HIV Infections"],"enrollment":1578,"completionDate":"2020-09-30"},{"nctId":"NCT07227103","phase":"PHASE2,PHASE3","title":"A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Transcranial Magnetic Stimulation for Treatment Resistant Depression","status":"NOT_YET_RECRUITING","sponsor":"NeuroRx, Inc.","startDate":"2026-03-01","conditions":["Treatment Resistant Depression"],"enrollment":120,"completionDate":"2027-03-31"},{"nctId":"NCT07198685","phase":"NA","title":"6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province","status":"NOT_YET_RECRUITING","sponsor":"Wuhan Pulmonary Hospital","startDate":"2025-09-30","conditions":["Treat to Target","Treatment Duration"],"enrollment":52,"completionDate":"2028-09-30"},{"nctId":"NCT06632015","phase":"NA","title":"Effect of DCS on Post-Endodontic Pain","status":"COMPLETED","sponsor":"Mustafa Kemal University","startDate":"2024-01-22","conditions":["Post Endodontic Pain"],"enrollment":90,"completionDate":"2024-05-24"},{"nctId":"NCT05395494","phase":"PHASE2","title":"iTBS-DCS in Fibromyalgia","status":"TERMINATED","sponsor":"University of Calgary","startDate":"2022-08-29","conditions":["Fibromyalgia"],"enrollment":47,"completionDate":"2025-07-31"},{"nctId":"NCT00903591","phase":"","title":"Study of Radiation Exposure and Bilateral Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2009-05","conditions":["Breast Cancer"],"enrollment":1699,"completionDate":"2026-05"},{"nctId":"NCT05081401","phase":"PHASE3","title":"Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)","status":"RECRUITING","sponsor":"Huashan Hospital","startDate":"2022-05-23","conditions":["Multidrug Resistant Tuberculosis","Rifampicin Resistant Tuberculosis","Pre-XDR-TB"],"enrollment":1050,"completionDate":"2027-12-01"},{"nctId":"NCT06081361","phase":"PHASE3","title":"Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort","status":"ACTIVE_NOT_RECRUITING","sponsor":"Beijing Chest Hospital","startDate":"2023-12-22","conditions":["Pulmonary Tuberculosis","Rifampicin-resistant Tuberculosis"],"enrollment":186,"completionDate":"2026-12-31"},{"nctId":"NCT02365623","phase":"PHASE2","title":"An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)","status":"COMPLETED","sponsor":"Janssen Pharmaceutical K.K.","startDate":"2015-02-18","conditions":["Tuberculosis, Multidrug-Resistant"],"enrollment":6,"completionDate":"2018-11-08"},{"nctId":"NCT01286766","phase":"PHASE2","title":"Neoadjuvant Combination Chemotherapy of DCS and DCF in Patients With Locally Advanced Gastric Adenocarcinoma","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2009-09","conditions":["Gastric Cancer"],"enrollment":6,"completionDate":"2012-06"},{"nctId":"NCT06713031","phase":"NA","title":"Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures","status":"NOT_YET_RECRUITING","sponsor":"Chinese PLA General Hospital","startDate":"2024-12-10","conditions":["Fracture of Neck of Femur"],"enrollment":400,"completionDate":"2026-10-31"},{"nctId":"NCT04717908","phase":"NA","title":"Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2021-01-20","conditions":["Multidrug Resistant Tuberculosis"],"enrollment":89,"completionDate":"2024-06-22"},{"nctId":"NCT06121284","phase":"PHASE2","title":"iTBS+D-Cycloserine for Youth Suicide","status":"RECRUITING","sponsor":"University of Calgary","startDate":"2024-03-11","conditions":["Suicidal Ideation","Suicide, Attempted","Depression, Anxiety"],"enrollment":54,"completionDate":"2026-09"},{"nctId":"NCT03867136","phase":"PHASE4","title":"Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2020-06-01","conditions":["Multidrug Resistant Tuberculosis"],"enrollment":354,"completionDate":"2024-08-10"},{"nctId":"NCT03891602","phase":"","title":"DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement","status":"COMPLETED","sponsor":"Hackensack Meridian Health","startDate":"2019-03-22","conditions":["Smoking","Smoking, Tobacco","Smoking, Cigarette","Lung Cancer"],"enrollment":654,"completionDate":"2023-01-10"},{"nctId":"NCT03535688","phase":"PHASE2","title":"D-cycloserine for the Treatment of Chronic, Refractory Low Back Pain","status":"TERMINATED","sponsor":"Northwestern University","startDate":"2018-03-30","conditions":["Low Back Pain","Pain"],"enrollment":203,"completionDate":"2024-02-07"},{"nctId":"NCT03395392","phase":"PHASE2,PHASE3","title":"NRX-101 for Bipolar Depression With Subacute Suicidal Ideation","status":"COMPLETED","sponsor":"NeuroRx, Inc.","startDate":"2022-05-12","conditions":["Bipolar Depression","Suicidal Ideation and Behavior"],"enrollment":74,"completionDate":"2024-03-30"},{"nctId":"NCT01450306","phase":"NA","title":"Exposure, D-cycloserine Enhancement, and Functional Magnetic Resonance Imaging (fMRI) in Snake Phobics","status":"COMPLETED","sponsor":"Hartford Hospital","startDate":"2010-07","conditions":["Specific Phobia"],"enrollment":20,"completionDate":"2011-12"},{"nctId":"NCT03396068","phase":"PHASE3","title":"NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation","status":"UNKNOWN","sponsor":"NeuroRx, Inc.","startDate":"2019-12-01","conditions":["Bipolar Depression","Suicidal Ideation"],"enrollment":72,"completionDate":"2024-12-31"},{"nctId":"NCT06128213","phase":"PHASE2","title":"NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis","status":"UNKNOWN","sponsor":"NeuroRx, Inc.","startDate":"2024-03-31","conditions":["Urinary Tract Infections","Pyelonephritis"],"enrollment":13,"completionDate":"2024-09-30"},{"nctId":"NCT05177601","phase":"PHASE2","title":"iTBS-DCS in Obsessive Compulsive Disorder","status":"UNKNOWN","sponsor":"University of Calgary","startDate":"2021-11-26","conditions":["Obsessive-Compulsive Disorder"],"enrollment":81,"completionDate":"2025-10"},{"nctId":"NCT05731323","phase":"PHASE1","title":"D-Cycloserine+iTBS PK Study","status":"COMPLETED","sponsor":"University of Calgary","startDate":"2022-10-12","conditions":["Major Depressive Disorder"],"enrollment":12,"completionDate":"2023-06-22"},{"nctId":"NCT05081986","phase":"PHASE2","title":"Repeated iTBS Cycloserine Motor Plasticity","status":"COMPLETED","sponsor":"University of Calgary","startDate":"2021-08-18","conditions":["Motor Activity"],"enrollment":20,"completionDate":"2022-02-23"},{"nctId":"NCT03237182","phase":"PHASE4","title":"The Individualized M(X) Drug-resistant TB Treatment Strategy Study","status":"TERMINATED","sponsor":"Centre for the AIDS Programme of Research in South Africa","startDate":"2017-06-14","conditions":["Tuberculosis, Multidrug-Resistant"],"enrollment":205,"completionDate":"2022-12-19"},{"nctId":"NCT02385266","phase":"PHASE4","title":"Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain","status":"TERMINATED","sponsor":"Northwestern University","startDate":"2013-09","conditions":["Chronic Prostatitis With Chronic Pelvic Pain Syndrome"],"enrollment":24,"completionDate":"2016-06"},{"nctId":"NCT02099825","phase":"PHASE1","title":"Medication Enhanced Rapid Therapy","status":"TERMINATED","sponsor":"Washington University School of Medicine","startDate":"2014-01-13","conditions":["Anxiety Disorders"],"enrollment":15,"completionDate":"2022-10"},{"nctId":"NCT04357951","phase":"EARLY_PHASE1","title":"D-cycloserine Augmented Treatment for Youth With Tic Disorders","status":"WITHDRAWN","sponsor":"Johns Hopkins University","startDate":"2023-04-15","conditions":["Tourette Syndrome"],"enrollment":0,"completionDate":"2024-09"},{"nctId":"NCT05779267","phase":"","title":"NRX-101 Expanded Access","status":"AVAILABLE","sponsor":"NeuroRx, Inc.","startDate":"","conditions":["Bipolar Depression","Bipolar Affective Disorder"],"enrollment":0,"completionDate":""},{"nctId":"NCT03216356","phase":"PHASE2,PHASE3","title":"Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD","status":"WITHDRAWN","sponsor":"Boston University Charles River Campus","startDate":"2016-09","conditions":["PTSD"],"enrollment":0,"completionDate":"2024-12"},{"nctId":"NCT01512316","phase":"NA","title":"Exploring Learning and Unlearning of Fear","status":"WITHDRAWN","sponsor":"Universitaire Ziekenhuizen KU Leuven","startDate":"","conditions":["Healthy Individuals"],"enrollment":0,"completionDate":""},{"nctId":"NCT05306223","phase":"PHASE4","title":"A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China","status":"UNKNOWN","sponsor":"Beijing Chest Hospital","startDate":"2022-05-10","conditions":["Tuberculosis, Multidrug-Resistant"],"enrollment":212,"completionDate":"2025-08-08"},{"nctId":"NCT03830671","phase":"PHASE4","title":"The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB","status":"COMPLETED","sponsor":"Beijing Chest Hospital","startDate":"2019-03-08","conditions":["Multi-drug Resistant Tuberculosis"],"enrollment":515,"completionDate":"2022-06-08"},{"nctId":"NCT03402152","phase":"PHASE2,PHASE3","title":"NRX101 Glx Biomarker Validation Study","status":"COMPLETED","sponsor":"NeuroRx, Inc.","startDate":"2018-11-01","conditions":["Bipolar Depression","Suicidal Ideation"],"enrollment":8,"completionDate":"2021-06-01"},{"nctId":"NCT04762836","phase":"NA","title":"Pain, Learning, and Nocebo","status":"COMPLETED","sponsor":"Leiden University Medical Center","startDate":"2021-02-28","conditions":["Chronic Pain","Pain Syndrome"],"enrollment":53,"completionDate":"2021-08-20"},{"nctId":"NCT03937596","phase":"PHASE2","title":"Adjunctive D-Cycloserine in Major Depressive Disorder","status":"COMPLETED","sponsor":"University of Calgary","startDate":"2019-12-01","conditions":["Major Depressive Disorder"],"enrollment":50,"completionDate":"2020-12-24"},{"nctId":"NCT03511599","phase":"PHASE1","title":"Cycloserine rTMS Plasticity Augmentation in Depression","status":"COMPLETED","sponsor":"University of Calgary","startDate":"2018-09-03","conditions":["Major Depressive Disorder"],"enrollment":12,"completionDate":"2021-04-21"},{"nctId":"NCT00000796","phase":"NA","title":"A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":["HIV Infections","Tuberculosis"],"enrollment":525,"completionDate":"1998-10"},{"nctId":"NCT00875342","phase":"NA","title":"Imaginal Exposure & D-Cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)","status":"TERMINATED","sponsor":"Weill Medical College of Cornell University","startDate":"2008-05","conditions":["Posttraumatic Stress Disorder"],"enrollment":41,"completionDate":"2018-02-28"},{"nctId":"NCT02635893","phase":"PHASE4","title":"Lower Limb Function After Spinal Cord Injury","status":"COMPLETED","sponsor":"Shirley Ryan AbilityLab","startDate":"2019-06-21","conditions":["Spinal Cord Injury"],"enrollment":257,"completionDate":"2021-04-11"},{"nctId":"NCT02974010","phase":"PHASE2","title":"Sequential Therapy for the Treatment of Severe Bipolar Depression.","status":"COMPLETED","sponsor":"NeuroRx, Inc.","startDate":"2018-01-15","conditions":["Bipolar Depression","Suicidal Ideas","Suicidal Ideation","Suicide, Attempted"],"enrollment":22,"completionDate":"2019-11-20"},{"nctId":"NCT01944423","phase":"EARLY_PHASE1","title":"Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine","status":"COMPLETED","sponsor":"University of Texas at Austin","startDate":"2013-10","conditions":["Nicotine Addiction","Panic Attack"],"enrollment":53,"completionDate":"2018-10"},{"nctId":"NCT02099240","phase":"EARLY_PHASE1","title":"Patients Response to Early Switch To Oral:Osteomyelitis Study","status":"TERMINATED","sponsor":"Julio Ramirez","startDate":"2014-03-06","conditions":["Osteomyelitis"],"enrollment":11,"completionDate":"2018-11-07"},{"nctId":"NCT01361633","phase":"PHASE2","title":"The Cognitive Enhancing Effects of D-Cycloserine Among Non-Demented Elderly","status":"COMPLETED","sponsor":"Hartford Hospital","startDate":"2008-01","conditions":["Treatment","Placebo"],"enrollment":51,"completionDate":"2009-02"},{"nctId":"NCT04035603","phase":"PHASE2","title":"Multimodal Cue Exposure Therapy for Smoking Cessation","status":"WITHDRAWN","sponsor":"Boston University Charles River Campus","startDate":"2020-10-01","conditions":["Smoking Cessation"],"enrollment":0,"completionDate":"2021-01-31"},{"nctId":"NCT02656342","phase":"PHASE4","title":"Translational Approach to the Understanding and Treatment of Obsessive-Compulsive Disorder (OCD). Can D-Cycloserine Enhance and Stabilize the Treatment-response in Relapsed and Non-responding OCD-patients?","status":"COMPLETED","sponsor":"Haukeland University Hospital","startDate":"2015-11","conditions":["Obsessive-Compulsive Disorder"],"enrollment":163,"completionDate":"2019-02"},{"nctId":"NCT01907594","phase":"PHASE2","title":"Effects of Nicotine Replacement Therapy and D-cycloserine on Nicotine Treatment Seekers","status":"WITHDRAWN","sponsor":"New York State Psychiatric Institute","startDate":"2013-08","conditions":["Cigarette Smoking"],"enrollment":0,"completionDate":"2016-09"},{"nctId":"NCT04545788","phase":"NA","title":"Randomized Controlled Multi-center Short Course Treatment for Rifampicin Resistant Tuberculosis","status":"UNKNOWN","sponsor":"Beijing Chest Hospital","startDate":"2020-08-01","conditions":["Tuberculosis"],"enrollment":200,"completionDate":"2022-12-31"},{"nctId":"NCT03062150","phase":"NA","title":"Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression","status":"COMPLETED","sponsor":"Charite University, Berlin, Germany","startDate":"2016-09-27","conditions":["Major Depression"],"enrollment":232,"completionDate":"2019-02-11"},{"nctId":"NCT01934972","phase":"PHASE3","title":"A Randomized Controlled Trial of Cognitive Remediation and D-cycloserine for Individuals With Bipolar Disorder","status":"COMPLETED","sponsor":"University of Arizona","startDate":"2013-03","conditions":["Bipolar Disorder"],"enrollment":30,"completionDate":"2017-04"},{"nctId":"NCT02066792","phase":"EARLY_PHASE1","title":"Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder","status":"COMPLETED","sponsor":"University of Texas at Austin","startDate":"2014-04","conditions":["Social Anxiety Disorder"],"enrollment":152,"completionDate":"2018-07-01"},{"nctId":"NCT02687165","phase":"NA","title":"Uncovering Neural and Immune Mechanisms of Chronic Pain in Post Treatment Lyme Syndrome","status":"TERMINATED","sponsor":"New York State Psychiatric Institute","startDate":"2016-01-16","conditions":["Post Treatment Lyme Syndrome (PTLS)","Chronic Pain"],"enrollment":4,"completionDate":"2017-01-16"},{"nctId":"NCT01981759","phase":"PHASE4","title":"D-Cycloserine Augmentation of Cognitive Behavioral Therapy for Delusions","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2014-02","conditions":["Schizophrenia","Schizoaffective Disorder","Delusional Disorder"],"enrollment":58,"completionDate":"2017-10"},{"nctId":"NCT02735694","phase":"PHASE1","title":"Cycloserine in the Treatment of Sleep Apnea","status":"TERMINATED","sponsor":"University of Manitoba","startDate":"2015-09","conditions":["Sleep Apnea Syndromes"],"enrollment":18,"completionDate":"2016-11"},{"nctId":"NCT00222235","phase":"PHASE2,PHASE3","title":"Adjunctive Treatment for Decreasing Symptoms of Schizophrenia","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2000-01","conditions":["Schizophrenia","Schizoaffective Disorder"],"enrollment":240,"completionDate":"2004-06"},{"nctId":"NCT01352637","phase":"PHASE3","title":"Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer","status":"COMPLETED","sponsor":"Weill Medical College of Cornell University","startDate":"2011-05","conditions":["Post Traumatic Stress Disorder"],"enrollment":192,"completionDate":"2018-09"},{"nctId":"NCT00842309","phase":"EARLY_PHASE1","title":"D-Cycloserine Augmentation of Behavior Therapy for Individuals With Body Dysmorphic Disorder","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2008-11","conditions":["Body Dysmorphic Disorder"],"enrollment":68,"completionDate":"2018-08"},{"nctId":"NCT00674570","phase":"PHASE4","title":"Veteran Stress and Learning Study","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2009-01-13","conditions":["Stress Disorders, Posttraumatic"],"enrollment":111,"completionDate":"2015-06-22"},{"nctId":"NCT03961464","phase":"NA","title":"The Effect of D-cycloserine on Emotional Processing","status":"COMPLETED","sponsor":"University of Oxford","startDate":"2018-08-10","conditions":["Cycloserine","Healthy Volunteer"],"enrollment":40,"completionDate":"2018-12-05"},{"nctId":"NCT02582515","phase":"NA","title":"Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2015-10","conditions":["Tourette Disorder","Chronic Tic Disorder"],"enrollment":20,"completionDate":"2017-08"},{"nctId":"NCT00198107","phase":"PHASE3","title":"Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism","status":"COMPLETED","sponsor":"Indiana University","startDate":"2005-09","conditions":["Autistic Disorder"],"enrollment":81,"completionDate":"2011-09"},{"nctId":"NCT00515879","phase":"PHASE3","title":"Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia","status":"COMPLETED","sponsor":"Boston University Charles River Campus","startDate":"2007-12","conditions":["Social Anxiety Disorder"],"enrollment":169,"completionDate":"2011-12"},{"nctId":"NCT02983734","phase":"PHASE2","title":"D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)","status":"UNKNOWN","sponsor":"Boston University Charles River Campus","startDate":"2015-10","conditions":["Gulf War Illness"],"enrollment":56,"completionDate":"2019-09"},{"nctId":"NCT03432689","phase":"PHASE1","title":"Cycloserine rTMS Plasticity Augmentation","status":"COMPLETED","sponsor":"University of Calgary","startDate":"2018-08-06","conditions":["Motor Activity"],"enrollment":12,"completionDate":"2018-11-07"},{"nctId":"NCT02082912","phase":"PHASE2","title":"NMDA Receptors in Motor Learning in Humans","status":"COMPLETED","sponsor":"Emory University","startDate":"2010-06","conditions":["Stroke"],"enrollment":14,"completionDate":"2012-04"},{"nctId":"NCT01985750","phase":"EARLY_PHASE1","title":"Understanding the Importance of Plasticity in the Brain Mechanisms of Dyspnoea Perception","status":"UNKNOWN","sponsor":"University of Oxford","startDate":"2013-11","conditions":["Chronic Obstructive Pulmonary Disease"],"enrollment":90,"completionDate":"2020-02"},{"nctId":"NCT01399866","phase":"PHASE3","title":"Cognitive Remediation With D-Cycloserine","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2011-05","conditions":["Smoking Cessation"],"enrollment":150,"completionDate":"2013-10"},{"nctId":"NCT02376257","phase":"PHASE2","title":"Improving Therapeutic Learning in Depression: Proof of Concept","status":"COMPLETED","sponsor":"Boston University Charles River Campus","startDate":"2014-09-16","conditions":["Major Depressive Disorder"],"enrollment":36,"completionDate":"2017-05"},{"nctId":"NCT03665766","phase":"","title":"Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2014-05-15","conditions":["Liver Transplantation"],"enrollment":126,"completionDate":"2018-04-02"},{"nctId":"NCT01842334","phase":"PHASE1,PHASE2","title":"D-cycloserine (DCS) Pretreatment + CBT + Nicotine Replacement Therapy for Smoking Cessation (DCS)","status":"TERMINATED","sponsor":"Mclean Hospital","startDate":"2013-04","conditions":["Nicotine Dependence","Smoking Cessation"],"enrollment":22,"completionDate":"2017-08"},{"nctId":"NCT03625739","phase":"","title":"Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis","status":"RECRUITING","sponsor":"Beijing Children's Hospital","startDate":"2018-07-01","conditions":["Tuberculosis"],"enrollment":800,"completionDate":"2026-12-31"},{"nctId":"NCT03604848","phase":"NA","title":"NGS-Guided(G) Regimens(R) of Anti-tuberculosis(A) Drugs for the Control(C) and Eradication(E) of MDR-TB","status":"UNKNOWN","sponsor":"Huashan Hospital","startDate":"2018-08-05","conditions":["Multidrug Resistant Tuberculosis"],"enrollment":488,"completionDate":"2024-08-04"},{"nctId":"NCT00780442","phase":"PHASE2","title":"D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2006-09","conditions":["Cocaine Use Disorders"],"enrollment":27,"completionDate":"2008-07"},{"nctId":"NCT00430573","phase":"PHASE2","title":"Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use","status":"TERMINATED","sponsor":"Boston University Charles River Campus","startDate":"2007-02","conditions":["Substance-Related Disorders"],"enrollment":15,"completionDate":"2009-06"},{"nctId":"NCT01680107","phase":"PHASE3","title":"D-cycloserine Augmented CBT for Panic Disorder","status":"TERMINATED","sponsor":"University of Oxford","startDate":"2012-10","conditions":["Panic Disorder"],"enrollment":33,"completionDate":"2018-04-30"},{"nctId":"NCT02933684","phase":"PHASE2","title":"D-Cycloserine and Virtual Reality Exposure Therapy","status":"WITHDRAWN","sponsor":"Georgia State University","startDate":"2015-01-01","conditions":["Social Anxiety Disorder"],"enrollment":0,"completionDate":"2016-12-31"},{"nctId":"NCT00790868","phase":"PHASE2","title":"Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder","status":"COMPLETED","sponsor":"Boston University Charles River Campus","startDate":"2008-04","conditions":["Panic Disorder"],"enrollment":180,"completionDate":"2014-08"},{"nctId":"NCT00963924","phase":"NA","title":"D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2009-08","conditions":["Schizophrenia"],"enrollment":54,"completionDate":"2011-06"},{"nctId":"NCT01411774","phase":"PHASE3","title":"D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)","status":"COMPLETED","sponsor":"University of South Florida","startDate":"2011-06","conditions":["Obsessive-compulsive Disorder"],"enrollment":142,"completionDate":"2017-06"},{"nctId":"NCT00742079","phase":"PHASE4","title":"Using D-cycloserine to Enhance the Benefits of Cognitive Behavioral Therapy for Schizophrenia","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2006-09","conditions":["Schizophrenia"],"enrollment":21,"completionDate":"2010-12"},{"nctId":"NCT02304432","phase":"EARLY_PHASE1","title":"Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine","status":"COMPLETED","sponsor":"Mclean Hospital","startDate":"2015-09-27","conditions":["Schizophrenia","Bipolar Disorder"],"enrollment":2,"completionDate":"2017-07-31"},{"nctId":"NCT02975570","phase":"PHASE3","title":"Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin","status":"WITHDRAWN","sponsor":"Boston University","startDate":"2017-08","conditions":["Tuberculosis Multi Drug Resistant Active"],"enrollment":0,"completionDate":"2022-08"},{"nctId":"NCT00352586","phase":"","title":"Effect of D-cycloserine on Extinction of Fear Conditioning","status":"COMPLETED","sponsor":"National Institute of Mental Health (NIMH)","startDate":"2002-04-03","conditions":["Fear"],"enrollment":160,"completionDate":"2008-02-01"},{"nctId":"NCT01490697","phase":"PHASE4","title":"Developing Memory Reconsolidation Blockers as Novel Posttraumatic Stress Disorder (PTSD) Treatments","status":"COMPLETED","sponsor":"Roger K. Pitman, MD","startDate":"2009-03","conditions":["Post-traumatic Stress Disorder"],"enrollment":34,"completionDate":"2015-09"},{"nctId":"NCT01157429","phase":"PHASE2","title":"D-cycloserine Adjunctive Treatment for Posttraumatic Stress Disorder (PTSD) in Adolescents","status":"COMPLETED","sponsor":"Tulane University School of Medicine","startDate":"2010-06","conditions":["Posttraumatic Stress Disorder","PTSD"],"enrollment":24,"completionDate":"2012-06"},{"nctId":"NCT00591825","phase":"PHASE2","title":"fMRI Study Examining Effects of D-cycloserine in Specific Phobia","status":"COMPLETED","sponsor":"University of Kansas Medical Center","startDate":"2006-03","conditions":["Phobias"],"enrollment":54,"completionDate":"2012-12"},{"nctId":"NCT01733030","phase":"","title":"The Effects of D-cycloserine on Stimulus Generalization of Conditioned Fear Healthy Controls.","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2013-01","conditions":["Post Traumatic Stress Syndrome"],"enrollment":56,"completionDate":"2015-10-01"},{"nctId":"NCT00827281","phase":"PHASE2","title":"D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation (DCSSmoking)","status":"WITHDRAWN","sponsor":"Boston University Charles River Campus","startDate":"2008-08","conditions":["Smokers"],"enrollment":0,"completionDate":"2015-07-15"},{"nctId":"NCT01157416","phase":"PHASE2","title":"Effect of D-cycloserine on Treatment of Posttraumatic Stress Disorder (PTSD) in Youth","status":"COMPLETED","sponsor":"Tulane University School of Medicine","startDate":"2010-06","conditions":["Posttraumatic Stress Disorders","PTSD"],"enrollment":33,"completionDate":"2012-06"},{"nctId":"NCT01404208","phase":"NA","title":"2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2011-07","conditions":["Obsessive-Compulsive Disorder"],"enrollment":206,"completionDate":"2016-12"},{"nctId":"NCT01526538","phase":"PHASE2","title":"Improving Learning-based Treatment of Cocaine Dependence With Medication","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2011-09","conditions":["COCAINE-RELATED DISORDERS"],"enrollment":52,"completionDate":"2013-03"},{"nctId":"NCT00125528","phase":"PHASE2","title":"D-cycloserine in the Management of Chronic Low Back Pain","status":"COMPLETED","sponsor":"Thomas J. Schnitzer","startDate":"2012-07","conditions":["Low Back Pain","Pain"],"enrollment":41,"completionDate":"2014-11"},{"nctId":"NCT00635102","phase":"NA","title":"Glycine and Oral D-Cycloserine in Alcoholic Patients and Healthy Subjects","status":"COMPLETED","sponsor":"Yale University","startDate":"1997-10","conditions":["Alcohol Dependence"],"enrollment":57,"completionDate":"2008-02"},{"nctId":"NCT01649895","phase":"PHASE4","title":"D-Cycloserine as an Adjunct to Internet-CBT for OCD","status":"COMPLETED","sponsor":"Christian Rück","startDate":"2012-08","conditions":["Obsessive-compulsive Disorder"],"enrollment":128,"completionDate":"2016-06"},{"nctId":"NCT01833897","phase":"PHASE4","title":"NMDA Antagonists in Bipolar Depression","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2013-03","conditions":["Bipolar Disorder"],"enrollment":8,"completionDate":"2016-03"},{"nctId":"NCT02772211","phase":"PHASE4","title":"D-cycloserine for Relapse Prevention Following Intravenous Ketamine in Treatment-resistant Depression","status":"UNKNOWN","sponsor":"Sheba Medical Center","startDate":"2016-06","conditions":["Treatment Resistant Depression"],"enrollment":60,"completionDate":"2017-01"},{"nctId":"NCT02769936","phase":"PHASE1","title":"Glutamate, Learning, and Working Memory","status":"COMPLETED","sponsor":"University of California, Los Angeles","startDate":"2013-11","conditions":["Schizophrenia"],"enrollment":110,"completionDate":"2015-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral","formulation":"Capsule","formulations":[{"form":"CAPSULE","route":"ORAL","productName":"CYCLOSERINE"},{"form":"CAPSULE","route":"ORAL","productName":"Cycloserine"},{"form":"CAPSULE","route":"ORAL","productName":"SEROMYCIN"},{"form":"CAPSULE","route":"ORAL","productName":"Seromycin"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000147483","MMSL":"1617","NDDF":"002788","UNII":"95IK5KI84Z","VUID":"4019284","CHEBI":"CHEBI:23503","VANDF":"4019284","INN_ID":"577","RXNORM":"204225","UMLSCUI":"C0010590","chemblId":"CHEMBL771","ChEMBL_ID":"CHEMBL771","KEGG_DRUG":"D00877","DRUGBANK_ID":"DB00260","PDB_CHEM_ID":"4AX","PUBCHEM_CID":"6234","SNOMEDCT_US":"387282000","MESH_DESCRIPTOR_UI":"D003523"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"1964-","companyName":"Purdue Gmp","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","bioavailability":"80%"},"publicationCount":3138,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J04AB01","allCodes":["J04AB01"]},"biosimilarFilings":[],"originalDeveloper":"Purdue Gmp","recentPublications":[{"date":"2026 Mar 25","pmid":"41895511","title":"Emergence of Rv0678 (mmpR5) Mutations Mediating Resistance to Bedaquiline and Clofazimine in a Liver Transplant Recipient with Rifampicin-Susceptible Tuberculosis: A Case Report.","journal":"International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases"},{"date":"2026","pmid":"41868031","title":"Patterns of Drug Resistance and Treatment Outcomes in Drug-Resistant Tuberculosis Patients in Fuyang City: A Three-Year Retrospective Study.","journal":"Infection and drug resistance"},{"date":"2026 Mar 17","pmid":"41849351","title":"Alanine catabolism as a targetable vulnerability for MYC-driven liver cancer.","journal":"Cell reports"},{"date":"2026 Mar 17","pmid":"41845289","title":"Innovating shorter, all-oral, precise, individualized treatment regimen for rifampicin-resistant tuberculosis (INSPIRE TB): study protocol for a pragmatic randomised controlled trial.","journal":"BMC infectious diseases"},{"date":"2026 Mar 17","pmid":"41844171","title":"Monitoring UDP-MurNAc (UM)-Stem Peptide Intermediates from the Cellular and Recombinant Acinetobacter baumannii MurCDEF Pathway.","journal":"ACS infectious diseases"}],"companionDiagnostics":[],"genericManufacturers":1,"_genericFilersChecked":true,"genericManufacturerList":["Sanaluz"],"status":"approved","companyName":"Purdue Gmp","companyId":"purdue-gmp","modality":"Small molecule","firstApprovalDate":"1964","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2001-12-10T00:00:00.000Z","mah":"SANALUZ","brand_name_local":null,"application_number":"ANDA060593"},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","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":1,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T00:09:08.617331+00:00","fieldsConflicting":4,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}