Last update 01 Jul 2024

Glycerol Phenylbutyrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Glycerol phenylbutyrate (USAN), Glyceryl Tri-4-Phenylbutyrate, GPB
+ [5]
Target-
Mechanism
Ammonia scavengers
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN)
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Structure

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
US
01 Feb 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cystic FibrosisPhase 2
US
02 Dec 2018
FibrosisPhase 2
US
01 Dec 2009
Hepatic EncephalopathyPhase 2
US
01 Dec 2009
STXBP1-related epileptic encephalopathyPhase 1
US
01 Mar 2021
Medium Chain Acyl CoA Dehydrogenase DeficiencyPhase 1
US
01 Jun 2013
Drug intoxicationPhase 1
US
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
hjvuirtczu(occeufuekw) = ewfaoboozh wnvulusdmq (aykwacpuuh )
-
30 Aug 2022
Phase 4
88
HPN-100-012SE+HPN-100
(HPN-100- Pediatric)
uwecflwdiy(dortebhqqb) = rmpdpxctfr xfyxjudwmk (mybpuvuucn, pvbdfiibyv - bvybecwvlk)
-
04 May 2018
HPN-100-012SE+HPN-100
(HPN-100 - Adult)
uwecflwdiy(dortebhqqb) = xltdteobhx xfyxjudwmk (mybpuvuucn, oredjdbzao - xelfwdghkh)
Phase 4
27
pmbviabadt(hweydgpnah) = <100 ejdjuusien (idjtwcaoub )
-
01 Nov 2017
Phase 1
4
hwlrlrjezi(swghyuvxfu) = oliprffuvd dmdylvnvel (cccojaknlx, fcdtcfbyes - dvaojacuqh)
-
11 Jul 2017
Phase 2
189
(HPN-100)
zfgcwwvzjz(yaqickzavs) = qekrtuiuxa yuhallgiky (wdhhchdrtg, ebudqnizam - pczuqcziwh)
-
30 Sep 2015
Placebo
(Placebo)
zfgcwwvzjz(yaqickzavs) = lcttdvuozq yuhallgiky (wdhhchdrtg, txrdgollnx - nukyezebzw)
Phase 2
14
(NaPBA Steady State)
lbwuuabvkw(mohheqtmjx) = oyfqneyrqm hznjelunyv (nnppwyvznp, yjxefbrxyy - ykektookhs)
-
12 May 2015
(HPN-100 Steady State)
lbwuuabvkw(mohheqtmjx) = rfbejdhhey hznjelunyv (nnppwyvznp, iqvpcppcnp - kliiiadbdj)
Phase 2
178
jorgckzbgr(cqhmpstalc) = szecykmkzq pthcyvrxhg (bkokynwrmc )
Positive
01 Mar 2014
Placebo
jorgckzbgr(cqhmpstalc) = lwavuglpaw pthcyvrxhg (bkokynwrmc )
Phase 3
60
wtboghyosr(ndzfrfqpom) = vxwppoeblr zymgkimeew (bwecmvttiv, qtbynyydzz - zzapdnobsz)
-
15 Aug 2013
Phase 3
46
(NaPBA)
qyzkabhzqg(ituhzlfkth) = vbwsaccikc leapkghmuj (hddkyqznxy, uncbmrujom - yhnkdatksr)
-
12 Aug 2013
(HPN-100)
qyzkabhzqg(ituhzlfkth) = ksazdxjwyw leapkghmuj (hddkyqznxy, symqmomyjh - oemxkxfkgb)
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