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Buphenyl, Ammonaps(sodium phenylbutyrate)
Ammonaps, Buphenyl, Olpruva, Pheburane, 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
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
respiratory tract diseasesD012140
nervous system diseasesD009422
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Buphenyl, Olpruva, Pheburane (generic drugs available since 2013-03-22)
Combinations
Relyvrio
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, RS
BUPHENYLHORIZON THERAP USN-020572 RX1996-05-13
1 products, RLD, RS
BUPHENYLHORIZON THERAP USN-020573 RX1996-04-30
1 products, RLD, RS
PHEBURANEMedunikN-216513 RX2022-06-17
1 products, RLD, RS
Sodium phenylbutyrate
+
Taurursodiol
Tradename
Company
Number
Date
Products
RELYVRIOAmylyx PharmaceuticalsN-216660 RX2022-09-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
buphenylNew Drug Application2020-03-11
olpruvaNew Drug Application2022-12-22
pheburaneNew Drug Application2022-08-24
relyvrioNew Drug Application2022-09-30
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
beta-thalassemiaOrphanet_848D017086D56.1
cystic fibrosisEFO_0000390D003550E84
myeloproliferative disorders—D009196D47.1
sickle cell anemiaEFO_0000697D000755D57
Agency Specific
FDA
EMA
Expiration
Code
SODIUM PHENYLBUTYRATE / TAURURSODIOL, RELYVRIO, AMYLYX
2029-09-29ODE-411
2027-09-29NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Sodium Phenylbutyrate / Taurursodiol, Relyvrio, Amylyx
115835422040-07-27DP
98728652033-12-24U-3460
102518962033-12-24U-3460
108571622033-12-24U-3460
110717422033-12-24DP
Sodium Phenylbutyrate, Olpruva, Acer
111545212036-10-17DP
112027672036-10-17U-3502
114330412036-10-17DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AX: Various alimentary tract and metabolism products
— A16AX03: Sodium phenylbutyrate
HCPCS
No data
Clinical
Clinical Trials
40 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614———112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Inborn urea cycle disordersD056806E72.2—21—14
Inborn genetic diseasesD030342EFO_0000508—11——1
Intrahepatic cholestasisD002780—11——1
Maple syrup urine diseaseD008375E71.0—11——1
Hemophilia bD002836D67—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C9522———4
LymphomaD008223C85.922———4
Myelodysplastic syndromesD009190D4621———3
Pulmonary tuberculosisD014397EFO_1000049A15—2———2
Cystic fibrosisD003550EFO_0000390E8422———2
Spinal muscular atrophies of childhoodD014897Orphanet_83419G12.022———2
Inborn errors amino acid metabolismD000592E72.9—2———2
Brain neoplasmsD001932EFO_0003833C7111———2
Prostatic neoplasmsD011471C61—1———1
Lung neoplasmsD008175C34.90—1———1
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C802————2
Myelodysplastic-myeloproliferative diseasesD0544372————2
Parkinson diseaseD010300EFO_0002508G201————1
Healthy volunteers/patients—1————1
Inclusion body myositisD018979EFO_0007323G72.411————1
NeuroblastomaD009447EFO_00006211————1
EpilepsyD004827EFO_0000474G40.91————1
HyperammonemiaD022124HP_0001987E72.201————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSODIUM 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-ID1716-12-7
RxCUI214837
ChEMBL IDCHEMBL1746
ChEBI ID75316
PubChem CID5258
DrugBankDBSALT002404
UNII ID—
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Buphenyl - Horizon Therapeutics Public
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,277 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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57,915 adverse events reported
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