{"id":"taurursodiol","rwe":[{"pmid":"41730326","year":"2026","title":"QbD-based, greenness and whiteness-assessed LC-MS/MS method for simultaneous determination of sodium phenylbutyrate and Taurursodiol with pharmacokinetic application.","finding":"","journal":"Journal of pharmacological and toxicological methods","studyType":"Clinical Study"},{"pmid":"40968767","year":"2025","title":"Disease-Modifying Therapies in Amyotrophic Lateral Sclerosis: A Network Meta-Analysis of Randomized Clinical Trials.","finding":"","journal":"The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques","studyType":"Clinical Study"},{"pmid":"40965373","year":"2025","title":"Real-World Clinical Experience With Sodium Phenylbutyrate and Taurursodiol at a Single Amyotrophic Lateral Sclerosis Center in the United States.","finding":"","journal":"European journal of neurology","studyType":"Clinical Study"},{"pmid":"36701505","year":"2006","title":"Sodium Phenylbutyrate.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"39897290","year":"2025","title":"Amyotrophic Lateral Sclerosis (ALS) Type 8: A Narrative Review.","finding":"","journal":"Cureus","studyType":"Clinical Study"}],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"Phospholipase A2","category":"target"},{"label":"PLA2G1B","category":"gene"},{"label":"ENPP2","category":"gene"},{"label":"Oral","category":"route"},{"label":"Powder","category":"form"},{"label":"Active","category":"status"},{"label":"Amyotrophic lateral sclerosis","category":"indication"},{"label":"Amylyx","category":"company"},{"label":"Approved 2020s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"},{"label":"Cholagogues and Choleretics","category":"pharmacology"},{"label":"Gastrointestinal Agents","category":"pharmacology"}],"phase":"marketed","safety":{"specialPopulations":{"Lactation":"There are no data on the presence of sodium phenylbutyrate or taurursodiol in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for RELYVRIO and any potential adverse effects on the breastfed child from RELYVRIO or from the underlying maternal condition.","Pregnancy":"Based on animal data, may cause fetal harm. There are no available data on RELYVRIO use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal studies, administration of sodium phenylbutyrate and taurursodiol to rats throughout pregnancy and lactation resulted in increased offspring mortality at all doses tested, which were less than or similar to the clinical doses.","Geriatric use":"Of the 89 patients with ALS who received RELYVRIO in Study 1, 25 patients (28%) were 65 years of age or older, while patients (4.5%) were 75 years of age and older with the oldest patient being 79 years old. No overall differences in safety or effectiveness were observed between those patients 65 years of age and older and those <65 years of age. Although differences in responses between the elderly and younger patients were not identified, greater sensitivity of some older individuals cannot be ruled out.","Paediatric use":"Safety and effectiveness of RELYVRIO in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Amylyx","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2040-07-27","territory":"US","patentNumber":"11583542"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-12-24","territory":"US","patentNumber":"10251896"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-12-24","territory":"US","patentNumber":"10857162"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-12-24","territory":"US","patentNumber":"11071742"},{"source":"FDA Orange Book via DrugCentral","expires":"2033-12-24","territory":"US","patentNumber":"9872865"}],"pricing":[],"allNames":"relyvrio","offLabel":[],"synonyms":["taurursodiol","taurursodiol sodium","tauroursdeoxycholic acid","ursodoxicoltaurine"],"timeline":[{"date":"2022-09-29","type":"positive","source":"DrugCentral","milestone":"FDA approval (Amylyx)"}],"approvals":[{"date":"2022-09-29","orphan":true,"company":"AMYLYX","regulator":"FDA"}],"brandName":"Relyvrio","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":"riluzole","slug":"riluzole","company":"Covis Pharma Sarl"},{"name":"tofersen","slug":"tofersen","company":"Biogen Ma"}],"globalPrevalence":308000}],"mechanism":{"target":"Phospholipase A2","novelty":"Follow-on","targets":[{"gene":"PLA2G1B","source":"DrugCentral","target":"Phospholipase A2","protein":"Phospholipase A2"},{"gene":"ENPP2","source":"DrugCentral","target":"Ectonucleotide pyrophosphatase/phosphodiesterase family member 2","protein":"Ectonucleotide pyrophosphatase/phosphodiesterase family member 2"}],"modality":"Small Molecule","explanation":"The mechanism by which RELYVRIO exerts its therapeutic effects in patients with ALS is unknown.","oneSentence":"Relyvrio works by inhibiting the enzyme phospholipase A2, which is involved in the breakdown of lipids in the brain.","technicalDetail":"Taurursodiol, the active ingredient in Relyvrio, acts as a competitive inhibitor of phospholipase A2, thereby reducing the breakdown of phospholipids in the brain and potentially slowing disease progression in ALS patients."},"commercial":{"launchDate":"2022","_launchSource":"DrugCentral (FDA 2022-09-29, AMYLYX)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5679","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TAURURSODIOL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TAURURSODIOL","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T15:47:05.737885","biosimilars":[],"competitors":[{"drugName":"ursodiol","drugSlug":"ursodiol","fdaApproval":"1987-12-31","genericCount":19,"patentStatus":"Off-patent — generic available","relationship":"same-target"}],"genericName":"taurursodiol","indications":{"approved":[{"name":"Amyotrophic lateral sclerosis","source":"DrugCentral","snomedId":86044005,"regulator":"FDA","eligibility":"adults","usPrevalence":null,"globalPrevalence":308000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (21665992[PMID])"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"ursodiol","brandName":"ursodiol","genericName":"ursodiol","approvalYear":"1987","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT03431896","phase":"","title":"Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2018-02-01","conditions":["Amyloidosis","Amyloid","Amyloid Neuropathies, Familial","Amyloid Cardiomyopathy","Amyloid - Primary","Transthyretin Amyloidosis","AL Amyloidosis"],"enrollment":37,"completionDate":"2026-03-09"},{"nctId":"NCT04114292","phase":"PHASE1","title":"TUDCA as a Therapy for Ulcerative Colitis (UC)","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2019-01-17","conditions":["Ulcerative Colitis"],"enrollment":14,"completionDate":"2022-06-07"},{"nctId":"NCT07457632","phase":"PHASE2","title":"Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.","status":"NOT_YET_RECRUITING","sponsor":"University of Alabama at Birmingham","startDate":"2026-04-01","conditions":["Diabetic Macular Edema (DME)"],"enrollment":69,"completionDate":"2028-12-31"},{"nctId":"NCT07357467","phase":"","title":"Effect of Oral Supplement on Influenza Vaccine Long-term Response","status":"NOT_YET_RECRUITING","sponsor":"Tsinghua University","startDate":"2026-03","conditions":["Influenza","Immunosenescence"],"enrollment":30,"completionDate":"2026-07"},{"nctId":"NCT07328009","phase":"PHASE2","title":"A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma","status":"NOT_YET_RECRUITING","sponsor":"Fudan University","startDate":"2026-01-25","conditions":["Hepato Cellular Carcinoma (HCC)"],"enrollment":350,"completionDate":"2029-01-15"},{"nctId":"NCT04244630","phase":"PHASE2","title":"Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial","status":"RECRUITING","sponsor":"Dallas VA Medical Center","startDate":"2023-11-02","conditions":["Amyotrophic Lateral Sclerosis (ALS)"],"enrollment":60,"completionDate":"2025-12"},{"nctId":"NCT07100392","phase":"PHASE2","title":"Tauroursodeoxycholic Acid (TUDCA) Plus Camrelizumab and Regorafenib in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab","status":"RECRUITING","sponsor":"Fudan University","startDate":"2025-08-14","conditions":["Hepatocellular Carcinoma (HCC)"],"enrollment":141,"completionDate":"2028-08-01"},{"nctId":"NCT03488524","phase":"PHASE2","title":"Open Label Extension Study of AMX0035 in Patients With ALS","status":"COMPLETED","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2018-03-29","conditions":["Amyotrophic Lateral Sclerosis","ALS"],"enrollment":90,"completionDate":"2021-03-01"},{"nctId":"NCT07064668","phase":"PHASE2","title":"Tauroursodeoxycholic Acid Combined With PD-1/PD-L1 Immunotherapy in Advanced Hepatocellular Carcinoma: A Prospective Study","status":"NOT_YET_RECRUITING","sponsor":"Tongji Hospital","startDate":"2025-07-30","conditions":["Hepatocellular Carcinoma"],"enrollment":300,"completionDate":"2027-12-30"},{"nctId":"NCT02218619","phase":"PHASE2","title":"Tauroursodeoxycholic Acid (TUDCA) in New-Onset Type 1 Diabetes","status":"COMPLETED","sponsor":"Robin Goland, MD","startDate":"2015-08","conditions":["Type 1 Diabetes"],"enrollment":20,"completionDate":"2019-12-31"},{"nctId":"NCT04001647","phase":"EARLY_PHASE1","title":"Targeting ER Stress in Vascular Dysfunction","status":"TERMINATED","sponsor":"Colorado State University","startDate":"2019-06-01","conditions":["Vasodilation","Arterial Stiffness"],"enrollment":17,"completionDate":"2022-08-16"},{"nctId":"NCT05676034","phase":"PHASE2","title":"AMX0035 in Adult Patients With Wolfram Syndrome","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amylyx Pharmaceuticals Inc.","startDate":"2023-03-03","conditions":["Wolfram 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It is a patented medication with unknown half-life and bioavailability. Relyvrio's commercial status is proprietary, and its generic manufacturers are not yet established. Key safety considerations are not specified. Relyvrio is a treatment option for patients with ALS.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-09-29T00:00:00.000Z","mah":"AMYLYX","brand_name_local":null,"application_number":""},{"country_code":"CA","regulator":"Health Canada","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}],"patentsNormalised":[{"patent_number":"11071742","territory":"US","patent_type":null,"expiry_date":"2033-12-24T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"9872865","territory":"US","patent_type":null,"expiry_date":"2033-12-24T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10251896","territory":"US","patent_type":null,"expiry_date":"2033-12-24T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"10857162","territory":"US","patent_type":null,"expiry_date":"2033-12-24T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"11583542","territory":"US","patent_type":null,"expiry_date":"2040-07-27T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}