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

Stem definition	Drug id	CAS RN
	4745	611168-24-2

Description:

Molecule

Description

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:

Dose	Unit	Route
15	g	O

ADMET properties:

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

Approvals:

Date	Agency	Company	Orphan
Nov. 27, 2015	EMA	Horizon Pharma Ireland Limited
Feb. 1, 2013	FDA	HYPERION THERAP INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Ravicti	HUMAN PRESCRIPTION DRUG LABEL	1	75987-050	LIQUID	1.10 g	ORAL	NDA	32 sections