Taurursodiol
Relyvrio (taurursodiol) is a small molecule pharmaceutical. Taurursodiol was first approved as Relyvrio on 2022-09-29. It is used to treat amyotrophic lateral sclerosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sodium phenylbutyrate
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Taurursodiol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RELYVRIO | Amylyx Pharmaceuticals | N-216660 DISCN | 2022-09-29 | 1 products, RLD |
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FDA
EMA
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amyotrophic lateral sclerosis | EFO_0000253 | D000690 | G12.21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SODIUM PHENYLBUTYRATE / TAURURSODIOL, RELYVRIO, AMYLYX | |||
| 2029-09-29 | ODE-411 | ||
| 2027-09-29 | NCE | ||
ATC Codes
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HCPCS
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Clinical
Clinical Trials
35 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gallstones | D042882 | EFO_0004210 | — | — | — | — | 1 | — | 1 |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | — | 1 | — | 1 |
| Cholecystolithiasis | D041761 | EFO_1000864 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 4 | 5 | — | 1 | 9 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 4 | 5 | — | 1 | 9 |
| Sclerosis | D012598 | — | — | 1 | 4 | 4 | — | 1 | 8 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 2 | 1 | — | 1 | 4 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | 2 | 1 | — | — | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | 1 | — | — | 2 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | 1 | 2 |
| Cholestasis | D002779 | — | K83.1 | — | — | 1 | — | 1 | 2 |
| Biliary liver cirrhosis | D008105 | — | K74.3 | — | — | 1 | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | 2 | 3 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | 1 | — | — | 1 | 2 |
| Familial amyloid neuropathies | D028227 | — | E85.1 | — | 1 | — | — | 1 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
| Central nervous system diseases | D002493 | — | G96.9 | — | 1 | — | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | — | 1 | — | — | — | 1 |
| Spinal cord diseases | D013118 | — | G95.9 | — | 1 | — | — | — | 1 |
| Tdp-43 proteinopathies | D057177 | — | — | — | 1 | — | — | — | 1 |
| Neuromuscular diseases | D009468 | EFO_1001902 | G70.9 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vascular stiffness | D059289 | — | — | 1 | — | — | — | — | 1 |
| Vasodilation | D014664 | — | — | 1 | — | — | — | — | 1 |
| Huntington disease | D006816 | Orphanet_399 | G10 | 1 | — | — | — | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | 1 | — | — | — | — | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 2 | 2 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 2 | 2 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | — | — | — | 1 | 1 |
| Amyloid neuropathies | D017772 | — | — | — | — | — | — | 1 | 1 |
| Endoplasmic reticulum stress | D059865 | EFO_1001886 | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Taurursodiol |
| INN | ursodoxicoltaurine |
| Description | Tauroursodeoxycholic acid is a bile acid taurine conjugate derived from ursoodeoxycholic acid. It has a role as a human metabolite, an anti-inflammatory agent, a neuroprotective agent, an apoptosis inhibitor, a cardioprotective agent and a bone density conservation agent. It is functionally related to an ursodeoxycholic acid. It is a conjugate acid of a tauroursodeoxycholate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](CCC(=O)NCCS(=O)(=O)O)[C@H]1CC[C@H]2[C@@H]3[C@@H](O)C[C@@H]4C[C@H](O)CC[C@]4(C)[C@H]3CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 14605-22-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL272427 |
| ChEBI ID | 80774 |
| PubChem CID | 9848818 |
| DrugBank | — |
| UNII ID | 60EUX8MN5X (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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664 adverse events reported
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