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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Trade Name
FDA
EMA
Phenylbutyrate
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
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
No data
Clinical
Clinical Trials
80 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
Show 2 more
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
View more details
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
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Buphenyl – Horizon Therapeutics Public
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Olpruva – Zevra Therapeutics
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 2,220 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
1,022 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use