Buphenyl, Ammonaps(phenylbutanoic acid)
Phenylbutanoic acid is a small molecule pharmaceutical. It is currently being investigated in clinical studies.
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Commercial
Therapeutic Areas
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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-020573 RX | 1996-04-30 | 1 products, RLD, RS |
| BUPHENYL | Horizon Therapeutics Public | N-020572 RX | 1996-05-13 | 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
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| amyotrophic lateral sclerosis | EFO_0000253 | D000690 | G12.21 |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
72 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 | 2 | 12 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | 1 | 1 | 3 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | 1 | 1 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | 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 | 4 | 3 | — | 1 | 7 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | 4 | 3 | — | 1 | 7 |
| Sclerosis | D012598 | — | — | 1 | 3 | 3 | — | 1 | 6 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 2 | 3 | — | — | — | 5 |
| Leukemia | D007938 | — | C95 | 2 | 2 | — | — | — | 4 |
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | — | — | — | 4 |
| Fibrosis | D005355 | — | — | 3 | 4 | — | — | — | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 1 | — | — | — | 3 |
| Preleukemia | D011289 | — | — | 2 | 1 | — | — | — | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 3 | 3 | — | — | — | 3 |
| Brain diseases | D001927 | — | G93.40 | 2 | 1 | — | — | — | 3 |
| Muscular atrophy | D009133 | — | — | 3 | 3 | — | — | — | 3 |
| Spinal muscular atrophy | D009134 | EFO_0003823 | G12.1 | 3 | 3 | — | — | — | 3 |
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 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Myositis | D009220 | EFO_0000783 | G72.49 | 1 | — | — | — | — | 1 |
| Inclusion body myositis | D018979 | EFO_0007323 | G72.41 | 1 | — | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | — | — | — | — | 1 |
Show 3 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 | Phenylbutanoic acid |
| INN | — |
| Description | 4-phenylbutyric acid is a monocarboxylic acid the structure of which is that of butyric acid substituted with a phenyl group at C-4. It is a histone deacetylase inhibitor that displays anticancer activity. It inhibits cell proliferation, invasion and migration and induces apoptosis in glioma cells. It also inhibits protein isoprenylation, depletes plasma glutamine, increases production of foetal haemoglobin through transcriptional activation of the gamma-globin gene and affects hPPARgamma activation. It has a role as an EC 3.5.1.98 (histone deacetylase) inhibitor, an antineoplastic agent, an apoptosis inducer and a prodrug. It is functionally related to a butyric acid. It is a conjugate acid of a 4-phenylbutyrate. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O)CCCc1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 1821-12-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1469 |
| ChEBI ID | 41500 |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | — |
Target
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Variants
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Financial
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Olpruva – Zevra Therapeutics
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Buphenyl – Horizon Therapeutics Public
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Tabular view
Estimated US medical usage
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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2,211 adverse events reported
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