{"id":"riluzole","rwe":[{"pmid":"41905645","year":"2026","title":"Six months of experience at a specialized daytime care center for people with amyotrophic lateral sclerosis (ALS) in the Community of Madrid.","finding":"","journal":"Neurologia","studyType":"Clinical Study"},{"pmid":"41903799","year":"2026","title":"Impact of care by a multidisciplinary team on the assessment of cognitive aspects and decision-making at the end of life in a Spanish population with amyotrophic lateral sclerosis.","finding":"","journal":"Neurologia","studyType":"Clinical Study"},{"pmid":"41863379","year":"2026","title":"Riluzole Restores Circuit and Behavioral Function Altered by Allele-Specific Expression-Mediated LINC02449-CPLX1 Dysregulation.","finding":"","journal":"Schizophrenia bulletin","studyType":"Clinical Study"},{"pmid":"41851217","year":"2026","title":"Anti-inflammatory treatment confirms rsfMRI and TSPO PET as biomarkers of functional connectivity and neuroinflammation in rat contusion spinal cord injuries.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41847699","year":"2026","title":"Impact of corticosteroid administration on glioblastoma progression before and after adjuvant treatments: recent updates on contradictory findings and mechanistic interactions.","finding":"","journal":"Frontiers in oncology","studyType":"Clinical Study"}],"_fda":{"id":"4746bd79-5116-423c-e063-6394a90a17e1","set_id":"0f2b5cfc-a23d-699a-e063-6394a90a67d1","openfda":{"nui":["N0000175740","M0483511"],"unii":["7LJ087RS6F"],"route":["ORAL"],"rxcui":["2058147","2675565"],"spl_id":["4746bd79-5116-423c-e063-6394a90a17e1"],"brand_name":["Teglutik"],"spl_set_id":["0f2b5cfc-a23d-699a-e063-6394a90a67d1"],"package_ndc":["70726-0304-1"],"product_ndc":["70726-0304"],"generic_name":["RILUZOLE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Benzothiazoles [CS]"],"substance_name":["RILUZOLE"],"pharm_class_epc":["Benzothiazole [EPC]"],"manufacturer_name":["EDW PHARMA, INC"],"is_original_packager":[true]},"version":"7","effective_time":"20251231","spl_product_data_elements":["Teglutik Riluzole MAGNESIUM ALUMINUM SILICATE SORBITOL POLYOXYL 20 CETOSTEARYL ETHER WATER SACCHARIN SODIUM SILICON DIOXIDE DIMETHICONE SODIUM LAURYL SULFATE XANTHAN GUM RILUZOLE RILUZOLE slightly brown, opaque"],"health_care_provider_letter":["Important Prescribing Information January 2024 Subject: Temporary importation of TEGLUTIK (riluzole oral suspension, 5 mg/mL) with non-English labeling to address drug shortage in the United States Dear Health Care Provider, The purpose of this letter is to inform you about a temporary importation in the United States (U.S.) of TEGLUTIK (riluzole 5 mg/mL oral suspension) with bottle and carton labels in Greek, in coordination with the U.S. Food and Drug Administration (FDA) to mitigate the current shortage of FDA-approved Tiglutik (riluzole oral suspension, 50 mg/10 mL) in the U.S. This temporary supply of TEGLUTIK is marketed by Italfarmaco in Greece and manufactured in Spain and is not FDA-approved. Riluzole is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Recently, Tiglutik was recalled in the U.S. market due to an out-of-specification test result for viscosity. At this time, no other entity except EDW Pharma, Inc. (formerly Italfarmaco (ITF) Pharma, Inc.) is authorized by the FDA to import or distribute Italfarmaco's TEGLUTIK riluzole oral suspension in the U.S. Effective immediately, and during this temporary period, EDW Pharma, Inc. will distribute the following presentation of riluzole oral suspension to address the critical shortage: Product Name Quantity Descriptions U.S. NDC number Lot Number Expiration Date TEGLUTIK riluzole oral | carton suspension (5 mg/mL) 1 bottle per carton Teglutik is presented as a slightly brown, opaque homogeneous oral suspension after being manually gently shaken. TEGLUTIK is available in a bottle of 300 ml with a plastic graduated oral dosing syringe. The syringe barrel is graduated in milliliters up to 10 ml. 70726-0304-1 23023 11-26 The safety profiles of the FDA-approved Tiglutik and imported TEGLUTIK products are comparable and no specific safety concerns emerged from the comparison of the two products. Please refer to the side-by-side comparison of the labels (enclosed) for additional information. It is important to note that the enclosed side-by-side comparisons, in English, between the U.S. product information and the European product information including the labels, patient leaflet, and SmPC (Summary of Product Characteristics, equivalent to the U.S. Prescribing Information (USPI)) have been included to also provide all applicable information since the labels and leaflet with the imported product are in Greek. Tiglutik is available only by prescription in the U.S. The imported lot does not have the statement \"Rx only\" on its labeling. The barcode on the imported product label may not register accurately on the U.S. scanning systems. Institutions should manually input the imported product information into their systems and confirm that the barcode, if scanned, provides correct information. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients. In addition, the package of the imported product does not include a product identifier as required under the Drug Supply Chain Security Act (DSCSA). Specifically, each package does not include the NDC, unique serial number, lot number, and expiration date in both human- readable and a two-dimensional data matrix barcode. Additionally, the imported product may not be accompanied with DSCSA-required product tracing documentation (transaction information, transaction history, and transaction statement). Reporting Adverse Events Health care providers and patients are encouraged to report adverse events and medication errors in patients taking TEGLUTIK to AnovoRx at 1-844-763-1198. You are encouraged to report negative side effects of prescription drugs to the FDA. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax: Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178 (1-800-332-0178). You may also contact AnovoRx at 1-844-763-1198 if you have any questions about the information contained in this letter or the safe and effective use of TEGLUTIK. This letter is not intended as a complete description of the benefits and risks related to the use of TEGLUTIK. Please refer to the enclosed TEGLUTIK SmPC and Tiglutik USPI side-by- side comparison. For additional information, please visit www.tiglutik.com and www.edwpharma.com. Sincerely, Peter Cook CEO and President EDW Pharma, Inc. (Formerly ITF Pharma, Inc.) (ENGLISH TRANSLATION OF GREEK BOTTLE label - TEXT) (u.s. BOTTLE label - TEXT) NAME OF THE MEDICINAL PRODUCT TEGLUTIK 5 mg/ml oral suspension riluzole NAME OF THE MEDICINAL PRODUCT TIGLUTIK® riluzole oral suspension 50mg/10ml(5mg/ml) STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains: 5 mg of riluzole STATEMENT OF ACTIVE SUBSTANCE(S) Contains: TIGLUTIK® 50 mg/10 mL (5 mg/mL) LIST OF EXCIPIENTS Also contains: liquid sorbitol (E420) ------- PHARMACEUTICAL FORM AND CONTENTS Oral suspension Bottle of 300 ml PHARMACEUTICAL FORM AND CONTENTS s product is a ling Information. TIGLUTIK® 50 mg/10 mL (5 mg/mL) oral suspension is a slightly brown, opaque, homogeneous suspension when mixed, containing 50 mg of riluzole per 10 mL of suspension METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use Administration via enteral feeding tubes Shake gently before use METHOD AND ROUTE(S) OF ADMINISTRATION Before use, please read the enclosed Prescribing Information. For oral administration Shake gently before use The bottle must be gently shaken for at least 30 seconds by continuously rotating the bottle 180° until the visual appearance of the suspension is homogeneous. DOSAGE ----- DOSAGE The recommended dose is 10 mL of TIGLUTIK® oral suspension, containing 50 mg of riluzole, taken orally twice daily, every 12 hours. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of reach of children. SPECIAL STORAGE CONDITIONS Expiry: Once opened, use within 15 days SPECIAL STORAGE CONDITIONS Store TIGLUTIK® at controlled room temperature between 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) and protect from bright light. Do not freeze. Store upright. Once opened, the bottle of TIGLUTIK® should be used within 15 days. Keep bottle tightly closed between each use. GENERAL CLASSIFICATION FOR SUPPLY Greece: Limited medical prescription from a specialist physician and monitoring during treatment. Cyprus: Pharmaceutical product for which a medical prescription is required. GENERAL CLASSIFICATION FOR SUPPLY Rx only NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER ITF Hellas A.E. Άρεως 103 & Αγίας Τριάδος 36, 17562 Παλαιό Φάληρο Ελλάδα Τηλέφωνο: +30 210 9373330 ITF Pharma Manufactured for: ITF Pharma, Inc. Berwyn, PA 19312 USA TIGLUTIK is a registered trademark of Italfarmaco S.A. ©2019 ITF Pharma, Inc. All rights reserved. TOCXXXXXX greel label US"],"health_care_provider_letter_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Product Name</td><td>Quantity</td><td>Descriptions</td><td>U.S. NDC number</td><td>Lot Number</td><td>Expiration Date</td></tr><tr><td><paragraph>TEGLUTIK</paragraph><paragraph>riluzole oral | carton</paragraph><paragraph>suspension</paragraph><paragraph>(5 mg/mL)</paragraph></td><td>1 bottle per carton</td><td><paragraph>Teglutik is presented</paragraph><paragraph>as a slightly brown,</paragraph><paragraph>opaque homogeneous oral</paragraph><paragraph>suspension after being</paragraph><paragraph>manually gently shaken.</paragraph><paragraph>TEGLUTIK is</paragraph><paragraph>available in a bottle</paragraph><paragraph>of 300 ml with a</paragraph><paragraph>plastic graduated oral dosing</paragraph><paragraph>syringe. The</paragraph><paragraph>syringe barrel is</paragraph><paragraph>graduated in</paragraph><paragraph>milliliters up to 10 ml.</paragraph></td><td>70726-0304-1</td><td>23023</td><td>11-26</td></tr></tbody></table>","<table border=\"0\" width=\"100%\"><tbody><tr><td><renderMultiMedia referencedObject=\"img_0f513b7f-b778-6ef7-e063-6394a90a141e\"/></td><td><renderMultiMedia referencedObject=\"img_10e6b32e-6b1e-f891-e063-6394a90ac266\"/></td></tr><tr><td><paragraph>(ENGLISH TRANSLATION OF GREEK BOTTLE label - TEXT)</paragraph></td><td><paragraph>(u.s. BOTTLE label - TEXT)</paragraph></td></tr><tr><td><paragraph>NAME OF THE MEDICINAL PRODUCT</paragraph><paragraph>TEGLUTIK 5 mg/ml oral suspension   riluzole </paragraph></td><td><paragraph>NAME OF THE MEDICINAL PRODUCT</paragraph><paragraph>TIGLUTIK&#xAE;   riluzole   oral suspension   50mg/10ml(5mg/ml) </paragraph></td></tr><tr><td><paragraph>STATEMENT OF ACTIVE SUBSTANCE(S)</paragraph><paragraph>1 ml contains: 5 mg of riluzole</paragraph></td><td><paragraph>STATEMENT OF ACTIVE SUBSTANCE(S)</paragraph><paragraph>Contains: TIGLUTIK&#xAE; 50 mg/10 mL (5 mg/mL)</paragraph></td></tr><tr><td><paragraph>LIST OF EXCIPIENTS</paragraph><paragraph>Also contains: liquid sorbitol (E420)</paragraph></td><td><paragraph>-------</paragraph></td></tr><tr><td><paragraph>PHARMACEUTICAL FORM AND CONTENTS</paragraph><paragraph>Oral suspension</paragraph><paragraph>Bottle of 300 ml</paragraph></td><td><paragraph>PHARMACEUTICAL FORM AND CONTENTS</paragraph><paragraph>s product is a ling Information.</paragraph><paragraph>TIGLUTIK&#xAE; 50 mg/10 mL (5 mg/mL) oral suspension is a slightly brown, opaque,</paragraph><paragraph>homogeneous suspension when mixed, containing 50 mg of riluzole per 10 mL of suspension</paragraph></td></tr><tr><td><paragraph>METHOD AND ROUTE(S) OF ADMINISTRATION</paragraph><paragraph>Read the package leaflet before use</paragraph><paragraph>Oral use</paragraph><paragraph>Administration via enteral feeding tubes</paragraph><paragraph>Shake gently before use</paragraph></td><td><paragraph>METHOD AND ROUTE(S) OF ADMINISTRATION</paragraph><paragraph>Before use, please read the enclosed Prescribing Information.</paragraph><paragraph>For oral administration</paragraph><paragraph>Shake gently before use</paragraph><paragraph>The bottle must be gently shaken for at least 30 seconds by continuously rotating the bottle 180&#xB0; until the visual appearance of the suspension is homogeneous.</paragraph></td></tr><tr><td><paragraph>DOSAGE</paragraph><paragraph>-----</paragraph></td><td><paragraph>DOSAGE</paragraph><paragraph>The recommended dose is 10 mL of TIGLUTIK&#xAE; oral suspension, containing 50 mg of riluzole, taken orally twice daily, every 12 hours.</paragraph></td></tr><tr><td><paragraph>SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN</paragraph><paragraph>Keep out of the sight and reach of children</paragraph></td><td><paragraph>SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN</paragraph><paragraph>Keep out of reach of children.</paragraph></td></tr><tr><td><paragraph>SPECIAL STORAGE CONDITIONS</paragraph><paragraph>Expiry:</paragraph><paragraph>Once opened, use within 15 days</paragraph></td><td><paragraph>SPECIAL STORAGE CONDITIONS</paragraph><paragraph>Store TIGLUTIK&#xAE; at controlled room temperature between 20&#xB0;-25&#xB0;C (68&#xB0;-77&#xB0;F), excursions permitted to 15&#xB0;-30&#xB0;C (59&#xB0;-86&#xB0;F) and protect from bright light.</paragraph><paragraph>Do not freeze. Store upright.</paragraph><paragraph>Once opened, the bottle of TIGLUTIK&#xAE; should be used within 15 days. Keep bottle tightly closed between each use.</paragraph></td></tr><tr><td><paragraph>GENERAL CLASSIFICATION FOR SUPPLY</paragraph><paragraph>Greece: Limited medical prescription from a specialist physician and monitoring during treatment.   Cyprus: Pharmaceutical product for which a medical prescription is required. </paragraph></td><td><paragraph>GENERAL CLASSIFICATION FOR SUPPLY</paragraph><paragraph>Rx only</paragraph></td></tr><tr><td><paragraph>NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER</paragraph><paragraph>ITF Hellas A.E.</paragraph><paragraph>&#x386;&#x3C1;&#x3B5;&#x3C9;&#x3C2; 103 &amp; &#x391;&#x3B3;&#x3AF;&#x3B1;&#x3C2; &#x3A4;&#x3C1;&#x3B9;&#x3AC;&#x3B4;&#x3BF;&#x3C2; 36, 17562 &#x3A0;&#x3B1;&#x3BB;&#x3B1;&#x3B9;&#x3CC; &#x3A6;&#x3AC;&#x3BB;&#x3B7;&#x3C1;&#x3BF;</paragraph><paragraph>&#x395;&#x3BB;&#x3BB;&#x3AC;&#x3B4;&#x3B1;</paragraph><paragraph>&#x3A4;&#x3B7;&#x3BB;&#x3AD;&#x3C6;&#x3C9;&#x3BD;&#x3BF;: +30 210 9373330</paragraph></td><td><paragraph>ITF Pharma</paragraph><paragraph>Manufactured for:</paragraph><paragraph>ITF Pharma, Inc.</paragraph><paragraph>Berwyn, PA 19312 USA</paragraph><paragraph>TIGLUTIK is a registered trademark of Italfarmaco S.A.</paragraph><paragraph>&#xA9;2019 ITF Pharma, Inc. All rights reserved.</paragraph><paragraph>TOCXXXXXX</paragraph></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 300 mL Bottle Carton greek"]},"tags":[{"label":"Benzothiazole","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sodium-dependent noradrenaline transporter","category":"target"},{"label":"SLC6A2","category":"gene"},{"label":"KCNN4","category":"gene"},{"label":"TRPC5","category":"gene"},{"label":"N07XX02","category":"atc"},{"label":"Oral","category":"route"},{"label":"Film","category":"form"},{"label":"Liquid","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Amyotrophic lateral sclerosis","category":"indication"},{"label":"Covis","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anticonvulsants","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Excitatory Amino Acid Antagonists","category":"pharmacology"},{"label":"Neuroprotective Agents","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"299 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"149 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"135 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"97 reports"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"92 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"88 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"84 reports"},{"date":"","signal":"AMYOTROPHIC LATERAL SCLEROSIS","source":"FDA FAERS","actionTaken":"80 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"77 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"73 reports"}],"commonSideEffects":[{"effect":"Asthenia","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Decreased lung function","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Alcoholism","Drug-induced hepatitis","Fever greater than 100.4 Fahrenheit","Hyperbilirubinemia","Interstitial pneumonia","Jaundice","Liver function tests abnormal","Neutropenic disorder"],"specialPopulations":{"Pregnancy":"Based on animal data, may cause fetal harm. There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. Women should be advised of possible risk to the fetus associated with use of TIGLUTIK during pregnancy.","Geriatric use":"No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"Safety and effectiveness of riluzole tablets in pediatric patients have not been established."},"seriousAdverseEvents":[{"effect":"Hepatic injury","drugRate":"","severity":"serious"},{"effect":"Acute hepatitis","drugRate":"","severity":"serious"},{"effect":"Icteric toxic hepatitis","drugRate":"","severity":"serious"},{"effect":"Neutropenia","drugRate":"","severity":"serious"},{"effect":"Interstitial lung disease","drugRate":"","severity":"serious"},{"effect":"Pancreatitis","drugRate":"","severity":"serious"},{"effect":"Renal tubular impairment","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Covis","patents":[{"type":"Formulation","number":"8765150","applicant":"ITALFARMACO SA","territory":"US","tradeName":"TIGLUTIK KIT","expiryDate":"2029-03-12"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.4731/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$173","description":"RILUZOLE 50 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=RILUZOLE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:47:37.340037+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:47:37.339555+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:47:44.052990+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:47:35.963463+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=RILUZOLE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:47:44.779741+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:34.809961+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:34.810013+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:47:34.810021+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":"2026-04-20T00:47:46.255726+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Sodium channel alpha subunit blocker","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:47:45.351629+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL744/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:47:45.248018+00:00"}},"allNames":"rilutek","offLabel":[],"synonyms":["riluzole","rilutek","rilutor","6-Trifluoromethoxybenzothiazol-2-ylamine","riluzole hydrochloride","riluzole HCl","RP54274","RP-54274"],"timeline":[{"date":"1995-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from COVIS PHARMA SARL to Covis"},{"date":"1995-12-12","type":"positive","source":"DrugCentral","milestone":"FDA approval (Covis Pharma Sarl)"},{"date":"2018-09-05","type":"positive","source":"FDA Orange Book","milestone":"Tiglutik Kit approved — 50MG/10ML"},{"date":"2019-11-22","type":"positive","source":"FDA Orange Book","milestone":"Exservan approved — 50MG"},{"date":"2024-08-22","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 8 manufacturers approved"}],"aiSummary":"Rilutek (Riluzole) is a small molecule benzothiazole drug developed by Covis Pharma SARL and currently owned by Covis. It targets the sodium-dependent noradrenaline transporter and is FDA-approved since 1995 for the treatment of Amyotrophic Lateral Sclerosis (ALS). Rilutek is off-patent and has multiple generic manufacturers. It has a half-life of 12 hours and bioavailability of 64%. Key safety considerations include its potential to cause liver enzyme elevations and gastrointestinal side effects.","approvals":[{"date":"1995-12-12","orphan":true,"company":"COVIS PHARMA SARL","regulator":"FDA"}],"brandName":"Rilutek","ecosystem":[{"indication":"Amyotrophic lateral sclerosis","otherDrugs":[{"name":"edaravone","slug":"edaravone","company":"Mitsubishi Tanabe Pharma Development America Inc"},{"name":"phenylbutanoic acid","slug":"phenylbutanoic-acid","company":"Hyperion Theraps Inc"},{"name":"taurursodiol","slug":"taurursodiol","company":"Amylyx"},{"name":"tofersen","slug":"tofersen","company":"Biogen Ma"}],"globalPrevalence":308000}],"mechanism":{"target":"Sodium-dependent noradrenaline transporter","novelty":"Follow-on","targets":[{"gene":"SLC6A2","source":"DrugCentral","target":"Sodium-dependent noradrenaline transporter","protein":"Sodium-dependent noradrenaline transporter"},{"gene":"KCNN4","source":"DrugCentral","target":"Intermediate conductance calcium-activated potassium channel protein 4","protein":"Intermediate conductance calcium-activated potassium channel protein 4"},{"gene":"TRPC5","source":"DrugCentral","target":"Short transient receptor potential channel 5","protein":"Short transient receptor potential channel 5"},{"gene":"KCNN3","source":"DrugCentral","target":"Small conductance calcium-activated potassium channel protein 3","protein":"Small conductance calcium-activated potassium channel protein 3"},{"gene":"KCNN1","source":"DrugCentral","target":"Small conductance calcium-activated potassium channel protein 1","protein":"Small conductance calcium-activated potassium channel protein 1"},{"gene":"KCNH2","source":"DrugCentral","target":"Potassium voltage-gated channel subfamily H member 2","protein":"Potassium voltage-gated channel subfamily H member 2"},{"gene":"GRIN3A","source":"DrugCentral","target":"Glutamate receptor ionotropic, NMDA 3A","protein":"Glutamate receptor ionotropic, NMDA 3A"},{"gene":"SCN5A","source":"DrugCentral","target":"Sodium channel protein type 5 subunit alpha","protein":"Sodium channel protein type 5 subunit alpha"}],"modality":"Small Molecule","drugClass":"Benzothiazole [EPC]","explanation":"","oneSentence":"","technicalDetail":"Riluzole acts as a competitive antagonist at the sodium-dependent noradrenaline transporter (NET) and a non-competitive antagonist at the glutamate transporter (GLT-1), thereby reducing the excitotoxicity associated with excessive glutamate release in the spinal cord and motor neurons."},"commercial":{"launchDate":"1995","_launchSource":"DrugCentral (FDA 1995-12-12, COVIS PHARMA 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