glycerol phenylbutyrate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4745 611168-24-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • glycerol phenylbutyrate
  • ravicti
  • HPN-100
for treating urea cycle disorders
  • Molecular weight: 530.66
  • Formula: C33H38O6
  • CLOGP: 7.87
  • LIPINSKI: 2
  • HAC: 6
  • HDO: 0
  • TPSA: 78.90
  • ALOGS: -7.02
  • ROTB: 20

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
15 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Nov. 27, 2015 EMA Horizon Pharma Ireland Limited
Feb. 1, 2013 FDA HYPERION THERAP INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hyperammonaemic crisis 220.80 48.22 21 331 18 63488652
Ammonia increased 175.95 48.22 29 323 4627 63484043
Hyperammonaemia 104.76 48.22 19 333 5213 63483457
Vomiting 49.44 48.22 33 319 559584 62929086

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hyperammonaemic crisis 177.53 51.37 19 330 44 34956538
Ammonia increased 147.67 51.37 27 322 4342 34952240
Hyperammonaemia 101.51 51.37 21 328 6346 34950236

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Hyperammonaemic crisis 352.14 50.01 37 728 70 79743553
Ammonia increased 304.58 50.01 54 711 7581 79736042
Hyperammonaemia 192.37 50.01 39 726 11054 79732569
Vomiting 58.45 50.01 49 716 665779 79077844
Amino acid level increased 55.51 50.01 9 756 719 79742904

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AX09 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Various alimentary tract and metabolism products

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Disorder of the urea cycle metabolism indication 36444000 DOID:9267




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10045958 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10045959 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10183002 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10183003 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10183004 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10183005 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10183006 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 10668040 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 8642012 Sept. 22, 2030 DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 9561197 Sept. 22, 2030 DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 9962359 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 9999608 Sept. 22, 2030 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 8404215 March 9, 2032 DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 9095559 March 9, 2032 DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 9254278 March 9, 2032 TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL 9326966 March 9, 2032 TREATMENT OF A UREA CYCLE DISORDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.1GM/ML RAVICTI HORIZON THERAP US N203284 Feb. 1, 2013 RX LIQUID ORAL April 28, 2024 FOR USE AS A NITROGEN-BINDING AGENT FOR CHRONIC MANAGEMENT OF PEDIATRIC PATIENTS >=2 MONTHS AND < 2 YEARS OF AGE WITH UREA CYCLE DISORDERS (UCDS) WHO CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE

Bioactivity Summary:

None

External reference:

IDSource
ZH6F1VCV7B UNII
D10127 KEGG_DRUG
4032179 VUID
N0000186573 NUI
4032179 VANDF
C3490329 UMLSCUI
CHEBI:134745 CHEBI
CHEMBL2105745 ChEMBL_ID
10482134 PUBCHEM_CID
DB08909 DRUGBANK_ID
9517 INN_ID
C570223 MESH_SUPPLEMENTAL_RECORD_UI
1368451 RXNORM
198625 MMSL
29164 MMSL
d08005 MMSL
014892 NDDF
782573007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ravicti HUMAN PRESCRIPTION DRUG LABEL 1 75987-050 LIQUID 1.10 g ORAL NDA 32 sections