Sodium phenylbutyrate
Ammonaps, Buphenyl, Olpruva, Pheburane, Phenylbutyrate, Relyvrio (sodium phenylbutyrate) is a small molecule pharmaceutical. Sodium phenylbutyrate was first approved as Buphenyl on 1996-04-30. It is used to treat beta-thalassemia, cystic fibrosis, myeloproliferative disorders, and sickle cell anemia in the USA. It has been approved in Europe to treat carbamoyl-phosphate synthase i deficiency disease, citrullinemia, and ornithine carbamoyltransferase deficiency disease.
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Abbreviated New Drug Application (ANDA)
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| buphenyl | New Drug Application | 2024-10-30 |
| olpruva | New Drug Application | 2024-12-18 |
| pheburane | New Drug Application | 2024-12-20 |
| ravicti | New Drug Application | 2021-09-13 |
| sodium phenylbutyrate | ANDA | 2024-07-10 |
Indications
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SODIUM PHENYLBUTYRATE / TAURURSODIOL, RELYVRIO, AMYLYX | |||
| 2029-09-29 | ODE-411 | ||
| 2027-09-29 | NCE | ||
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Clinical
Clinical Trials
72 clinical trials
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Indications Phases 4
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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 | — | 3 | 3 | — | 1 | 6 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 3 | 3 | — | 1 | 6 |
| Sclerosis | D012598 | — | — | — | 2 | 3 | — | 1 | 5 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | 2 | 1 | — | — | 2 |
| Parkinsonian disorders | D020734 | — | G20.C | — | 1 | 1 | — | — | 1 |
| Progressive supranuclear palsy | D013494 | EFO_0002512 | G23.1 | — | 1 | 1 | — | — | 1 |
| Paralysis | D010243 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Wolfram syndrome | D014929 | Orphanet_3463 | E13.8 | — | 1 | — | — | — | 1 |
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Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sodium phenylbutyrate |
| INN | — |
| Description | Sodium phenylbutyrate is the organic sodium salt of 4-phenylbutyric acid. A prodrug for phenylacetate, it is used to treat urea cycle disorders. It has a role as a prodrug, an EC 3.5.1.98 (histone deacetylase) inhibitor, a neuroprotective agent, an orphan drug and a geroprotector. It contains a 4-phenylbutyrate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C([O-])CCCc1ccccc1.[Na+] |
Identifiers
| PDB | — |
| CAS-ID | 1716-12-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1746 |
| ChEBI ID | 75316 |
| PubChem CID | 5258 |
| DrugBank | DBSALT002404 |
| UNII ID | — |
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Olpruva – Zevra Therapeutics
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Buphenyl – Horizon Therapeutics Public
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Safety
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2,218 adverse events reported
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