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
Trade Name
FDA
EMA
Ravicti (discontinued: Glycerol phenylbutyrate)
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 |
|---|---|---|---|---|
| RAVICTI | Horizon Therapeutics Public | N-203284 RX | 2013-02-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ravicti | New Drug Application | 2021-09-13 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
GLYCEROL PHENYLBUTYRATE, RAVICTI, HORIZON THERAP US | |||
| 2024-04-28 | ODE-157 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Glycerol Phenylbutyrate, Ravicti, Horizon Therap Us | |||
| 8404215 | 2032-03-09 | U-1383 | |
| 9254278 | 2032-03-09 | U-1816 | |
| 9326966 | 2032-03-09 | U-1816 | |
| 8642012 | 2030-09-22 | U-1383 | |
| 9561197 | 2030-09-22 | U-1383 | |
| 9962359 | 2030-09-22 | U-1816 | |
| 9999608 | 2030-09-22 | U-1816 | |
| 10045958 | 2030-09-22 | U-1816 | |
| 10045959 | 2030-09-22 | U-1816 | |
| 10183002 | 2030-09-22 | U-1816 | |
| 10183003 | 2030-09-22 | U-1816 | |
| 10183004 | 2030-09-22 | U-1816 | |
| 10183005 | 2030-09-22 | U-1816 | |
| 10183006 | 2030-09-22 | U-1816 | |
| 10668040 | 2030-09-22 | U-1816 | |
HCPCS
No data
Clinical
Clinical Trials
22 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 | 2 | 3 | 3 | 1 | 10 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemophilia b | D002836 | — | D67 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain diseases | D001927 | HP_0001298 | G93.40 | 2 | 1 | — | — | — | 3 |
| Fibrosis | D005355 | — | — | 1 | 2 | — | — | — | 2 |
| Hepatic encephalopathy | D006501 | — | K72.91 | 1 | 1 | — | — | — | 2 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 1 | — | — | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Corticobasal degeneration | D000088282 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | — | — | — | — | 1 |
| Neurodevelopmental disorders | D065886 | — | F89 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intrahepatic cholestasis | D002780 | — | — | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Glycerol phenylbutyrate |
| INN | glycerol 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-ID | 611168-24-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2105745 |
| ChEBI ID | — |
| PubChem CID | 10482134 |
| DrugBank | DB08909 |
| UNII ID | ZH6F1VCV7B (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Ravicti – Horizon Therapeutics Public
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Trends
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Additional graphs summarizing 298 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,090 adverse events reported
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