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
Trade Name
FDA
EMA
Combinations
Relyvrio
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 RX | 2022-09-29 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
relyvrio | New Drug Application | 2022-09-30 |
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
No data
HCPCS
No data
Clinical
Clinical Trials
19 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 |
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 | — | 1 | 1 | — | — | 2 |
Biliary liver cirrhosis | D008105 | K74.3 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 1 | — | — | — | 1 |
Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 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 | — | — | — | — | 2 | 2 | |
Endoplasmic reticulum stress | D059865 | EFO_1001886 | — | — | — | — | 1 | 1 | |
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
Cholestasis | D002779 | K83.1 | — | — | — | — | 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 | DB08834 |
UNII ID | 60EUX8MN5X (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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