glycerol phenylbutyrate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,MAP3K7,MAPK7,MAPK9,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PRKDC,SIK2,SIK3,STK33,TEK,TTK	34
kinase-selectivity-class	AXL,EPHB4,GRK2,PDK4	4
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

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	227.86	44.93	22	405	34	90627986
Ammonia increased	222.22	44.93	35	392	4951	90623069
Hyperammonaemia	136.75	44.93	24	403	6451	90621569
Vomiting	48.41	44.93	35	392	788258	89839762

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
Ammonia increased	180.50	47.49	32	367	4627	42616309
Hyperammonaemic crisis	178.68	47.49	19	380	44	42620892
Hyperammonaemia	121.56	47.49	25	374	7841	42613095

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	366.72	51.55	38	797	84	110588380
Ammonia increased	347.55	51.55	59	776	8191	110580273
Hyperammonaemia	229.62	51.55	45	790	13687	110574777
Amino acid level increased	63.75	51.55	10	825	826	110587638
Vomiting	59.27	51.55	51	784	910624	109677840

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
CHEBI has role	CHEBI:48407	antiparkinson drug

Related Drugs by ATC class:

A16AX Various alimentary tract and metabolism products 23 drugs

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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	9254278	Sept. 22, 2030	TREATMENT OF A UREA CYCLE DISORDER
1.1GM/ML	RAVICTI	HORIZON THERAP US	N203284	Feb. 1, 2013	RX	LIQUID	ORAL	9326966	Sept. 22, 2030	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

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	GLYCEROL PHENYLBUTYRATE	PH HEALTH	A205742	Dec. 2, 2021	RX	LIQUID	ORAL	April 15, 2026	PATENT CHALLENGE

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
398509	MMSL
d08005	MMSL
014892	NDDF
782573007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Glycerol phenylbutyrate	HUMAN PRESCRIPTION DRUG LABEL	1	0480-3777	LIQUID	1.10 g	ORAL	ANDA	26 sections
Glycerol Phenylbutyrate	HUMAN PRESCRIPTION DRUG LABEL	1	49884-264	LIQUID	1.10 g	ORAL	ANDA	25 sections
Glycerol Phenylbutyrate	Human Prescription Drug Label	1	59651-988	LIQUID	1.10 g	ORAL	ANDA	26 sections
Glycerol Phenylbutyrate	HUMAN PRESCRIPTION DRUG LABEL	1	68475-807	LIQUID	1.10 g	ORAL	ANDA	23 sections
Glycerol Phenylbutyrate	HUMAN PRESCRIPTION DRUG LABEL	1	70710-2193	LIQUID	1.10 g	ORAL	ANDA	23 sections
glycerol phenylbutyrate	HUMAN PRESCRIPTION DRUG LABEL	1	70748-425	LIQUID	1.10 g	ORAL	NDA	25 sections
Glycerol phenylbutyrate	Human Prescription Drug Label	1	72205-331	LIQUID	1.10 g	ORAL	ANDA	24 sections
Ravicti	HUMAN PRESCRIPTION DRUG LABEL	1	75987-050	LIQUID	1.10 g	ORAL	NDA	30 sections