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Drug ReportsPhenylbutyric acid
Buphenyl, Ammonaps(phenylbutanoic acid)
Phenylbutanoic acid is a small molecule pharmaceutical. It is currently being investigated in clinical studies.
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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
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Commercial
Therapeutic Areas
No data
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
OLPRUVAAcer TherapeuticsN-214860 RX2022-12-22
6 products, RLD
BUPHENYLHorizon Therapeutics PublicN-020573 RX1996-04-30
1 products, RLD, RS
BUPHENYLHorizon Therapeutics PublicN-020572 RX1996-05-13
1 products, RLD, RS
PHEBURANEMedunikN-216513 RX2022-06-17
1 products, RLD, RS
Sodium phenylbutyrate
+
Taurursodiol
Tradename
Company
Number
Date
Products
RELYVRIOAmylyx PharmaceuticalsN-216660 DISCN2022-09-29
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
buphenylNew Drug Application2024-10-30
olpruvaNew Drug Application2024-12-18
pheburaneNew Drug Application2024-12-20
sodium phenylbutyrateANDA2024-07-10
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
72 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Amyotrophic lateral sclerosisD000690EFO_0000253G12.21—33—16
Motor neuron diseaseD016472EFO_0003782G12.2—33—16
SclerosisD012598———23—15
Neurodegenerative diseasesD019636EFO_0005772G31.9—21——2
Parkinsonian disordersD020734—G20.C—11——1
Progressive supranuclear palsyD013494EFO_0002512G23.1—11——1
ParalysisD010243———11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F03—1———1
Central nervous system diseasesD002493—G96.9—1———1
Nervous system diseasesD009422—G00-G99—1———1
Spinal cord diseasesD013118—G95.9—1———1
Tdp-43 proteinopathiesD057177———1———1
Neuromuscular diseasesD009468EFO_1001902G70.9—1———1
SyndromeD013577———1———1
Wolfram syndromeD014929Orphanet_3463E13.8—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePhenylbutanoic 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—
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Structure (InChI/SMILES or Protein Sequence)
O=C(O)CCCc1ccccc1
Identifiers
PDB—
CAS-ID1821-12-1
RxCUI—
ChEMBL IDCHEMBL1469
ChEBI ID41500
PubChem CID—
DrugBank—
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Olpruva – Zevra Therapeutics
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Buphenyl – Horizon Therapeutics Public
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Tabular view
Estimated US medical usage
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,211 adverse events reported
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