Buphenyl, Ammonaps(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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Commercial
Trade Name
FDA
EMA
Buphenyl, Olpruva, Pheburane, Phenylbutyrate (discontinued: Phenylbutyrate)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sodium phenylbutyrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OLPRUVA | Acer Therapeutics | N-214860 RX | 2022-12-22 | 6 products, RLD |
| BUPHENYL | Horizon Therapeutics Public | N-020572 RX | 1996-05-13 | 1 products, RLD, RS |
| BUPHENYL | Horizon Therapeutics Public | N-020573 RX | 1996-04-30 | 1 products, RLD, RS |
| PHEBURANE | Medunik | N-216513 RX | 2022-06-17 | 1 products, RLD, RS |
Sodium phenylbutyrate
+
Taurursodiol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RELYVRIO | Amylyx Pharmaceuticals | N-216660 DISCN | 2022-09-29 | 1 products, RLD |
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Labels
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 |
| sodium phenylbutyrate | ANDA | 2024-07-10 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SODIUM PHENYLBUTYRATE / TAURURSODIOL, RELYVRIO, AMYLYX | |||
| 2029-09-29 | ODE-411 | ||
| 2027-09-29 | NCE | ||
Patent Expiration
HCPCS
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Clinical
Clinical Trials
80 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inborn urea cycle disorders | D056806 | — | E72.2 | 1 | 3 | 3 | 3 | 3 | 13 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | 6 | 1 | 1 | 9 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 6 | 1 | — | 7 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | 1 | 1 | 2 |
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 | 4 | 3 | — | 1 | 7 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | 4 | 3 | — | 1 | 7 |
| Sclerosis | D012598 | — | — | 1 | 4 | 3 | — | 1 | 7 |
| Intrahepatic cholestasis | D002780 | — | — | — | 1 | 1 | — | 3 | 4 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | 2 | 1 | — | — | 2 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | 1 | 1 | — | — | 1 |
| Cholestasis | D002779 | — | K83.1 | — | 1 | 1 | — | — | 1 |
| Maple syrup urine disease | D008375 | — | E71.0 | — | 1 | 1 | — | — | 1 |
| Hemophilia b | D002836 | — | D67 | — | 1 | 1 | — | — | 1 |
| Parkinsonian disorders | D020734 | — | G20.C | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 2 | 2 | — | — | — | 4 |
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | — | — | — | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 1 | — | — | — | 3 |
| Syndrome | D013577 | — | — | 1 | 2 | — | — | — | 3 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | — | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 3 | 3 | — | — | — | 3 |
| Muscular atrophy | D009133 | — | — | 3 | 3 | — | — | — | 3 |
| Spinal muscular atrophy | D009134 | EFO_0003823 | G12.1 | 3 | 3 | — | — | — | 3 |
| Atrophy | D001284 | — | — | 3 | 3 | — | — | — | 3 |
| Preleukemia | D011289 | — | — | 1 | 1 | — | — | — | 2 |
Show 49 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 2 | — | — | — | — | 2 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 2 | — | — | — | — | 2 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | — | — | — | 1 |
| Color vision defects | D003117 | — | H53.5 | 1 | — | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | — | — | — | — | 1 |
Show 9 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
Epidemiology
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 | — |
Target
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Buphenyl – Horizon Therapeutics Public
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Olpruva – Zevra Therapeutics
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Tabular view
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Safety
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1,022 adverse events reported
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