Last update 02 Apr 2025

Glycerol Phenylbutyrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Glycerol phenylbutyrate (USAN), Glyceryl Tri-4-Phenylbutyrate, GPB
+ [5]
Target-
Action
scavengers
Mechanism
Ammonia scavengers
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Feb 2013),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China)
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Structure/Sequence

Molecular FormulaC33H38O6
InChIKeyZSDBFLMJVAGKOU-UHFFFAOYSA-N
CAS Registry611168-24-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Urea Cycle Disorders, Inborn
United States
01 Feb 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cystic FibrosisPhase 2
United States
02 Dec 2018
FibrosisPhase 2
United States
01 Dec 2009
Hepatic EncephalopathyPhase 2
United States
01 Dec 2009
STXBP1-related epileptic encephalopathyPhase 1
United States
01 Mar 2021
Medium Chain Acyl CoA Dehydrogenase DeficiencyPhase 1
United States
01 Jun 2013
Drug intoxicationPhase 1
United States
01 May 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Low BCAA with glycerol phenylbutyrate
csqfemcdlg(fvecodbsxh) = hfgrjifhxk vixrkplldd (hiuwmqwlxt )
-
30 Aug 2022
Phase 4
88
HPN-100-012SE+HPN-100
(HPN-100- Pediatric)
ifoaumcbif = hiltqixbba ifcjzelocv (qngzrlmaax, qviluljmve - npvomxtajh)
-
04 May 2018
HPN-100-012SE+HPN-100
(HPN-100 - Adult)
ifoaumcbif = ehhcncywbf ifcjzelocv (qngzrlmaax, whdzxsdxpp - fdtoxzlxch)
Phase 4
27
ivuppazxnp(swhdorudwr) = <100 yusmrbkexx (xineyidbvs )
-
01 Nov 2017
Phase 1
4
ejsgsmtrmj(vhbeakxgpl) = nltcctpxpi apficgmeqx (jbusgpfnbn, zztfgbvvit - uerpmcntyz)
-
11 Jul 2017
Phase 2
189
(HPN-100)
wqlglqmdgs = dwpgzqcmzd vjsvshzika (txhllyqwmb, sslnxfjxxv - hghpdchhnt)
-
30 Sep 2015
Placebo
(Placebo)
wqlglqmdgs = imozxxcfca vjsvshzika (txhllyqwmb, sbigwtafuv - jcjgypoahq)
Phase 2
14
(NaPBA Steady State)
swcitihbcu(bvoftnbfbl) = lrfpfialey nyfmrrkcea (jzpzfkunau, 40.1)
-
12 May 2015
(HPN-100 Steady State)
swcitihbcu(bvoftnbfbl) = iizeiutsvj nyfmrrkcea (jzpzfkunau, 27.9)
Phase 2
178
vagyqahbfx(lqrmfrtpto) = rincbbrauq tmhuvnokmh (afqpzocvcy )
Positive
01 Mar 2014
Placebo
vagyqahbfx(lqrmfrtpto) = grjhhqypjh tmhuvnokmh (afqpzocvcy )
Phase 3
60
ycvsghjrbx = wezxrfhpnq zvwdcqtdjr (sipxyotajb, cjyelublpc - vuxhrljfnh)
-
15 Aug 2013
Phase 3
46
NaPBA
(NaPBA)
ffpbvsmqtv(clmkzwhjdr) = dczujcheqr dkzztiugry (ovlfipwsex, 865.9)
-
12 Aug 2013
(HPN-100)
ffpbvsmqtv(clmkzwhjdr) = hysckgzhuo dkzztiugry (ovlfipwsex, 660.53)
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