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Ravicti(glycerol phenylbutyrate)
Ravicti (glycerol phenylbutyrate) is a small molecule pharmaceutical. Glycerol phenylbutyrate was first approved as Ravicti on 2013-02-01. It has been approved in Europe to treat inborn urea cycle disorders.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Ravicti (generic drugs available since 2021-12-02)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glycerol phenylbutyrate
Tradename
Company
Number
Date
Products
RAVICTIHORIZON THERAP USN-203284 RX2013-02-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ravictiNew Drug Application2020-01-28
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
GLYCEROL PHENYLBUTYRATE, RAVICTI, HORIZON THERAP US
2024-04-28ODE-157
Patent Expiration
Patent
Expires
Flag
FDA Information
Glycerol Phenylbutyrate, Ravicti, Horizon Therap Us
84042152032-03-09U-1383
90955592032-03-09U-1383
92542782032-03-09U-1816
93269662032-03-09U-1816
86420122030-09-22U-1383
95611972030-09-22U-1383
99623592030-09-22U-1816
99996082030-09-22U-1816
100459582030-09-22U-1816
100459592030-09-22U-1816
101830022030-09-22U-1816
101830032030-09-22U-1816
101830042030-09-22U-1816
101830052030-09-22U-1816
101830062030-09-22U-1816
106680402030-09-22U-1816
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
— A16AX09: Glycerol phenylbutyrate
HCPCS
No data
Clinical
Clinical Trials
19 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 disordersD056806E72.21233—9
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemophilia bD002836D67—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic encephalopathyD006501K72.9111———2
Cystic fibrosisD003550EFO_0000390E8411———1
Liver cirrhosisD008103EFO_0001422K74.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G201————1
Drug-related side effects and adverse reactionsD064420T88.71————1
Healthy volunteers/patients—1————1
EpilepsyD004827EFO_0000474G40.91————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGLYCEROL PHENYLBUTYRATE
INNglycerol phenylbutyrate
Description
Glycerol phenylbutyrate is a triglyceride.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C(CCCc1ccccc1)OCC(COC(=O)CCCc1ccccc1)OC(=O)CCCc1ccccc1
Identifiers
PDB—
CAS-ID611168-24-2
RxCUI1368451
ChEMBL IDCHEMBL2105745
ChEBI ID—
PubChem CID10482134
DrugBankDB08909
UNII IDZH6F1VCV7B (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ravicti - 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 251 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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10,825 adverse events reported
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