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glycerol phenylbutyrate

Trade name: ravicti

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 1, 2013

Glycerol phenylbutyrate, sold under the brand name Ravicti, is a nitrogen-binding agent medication used in the treatment of certain inborn urea cycle disorders. The medication works by preventing the harmful buildup of ammonia in the body. It is an FDA-approved prescription drug in the US. It was developed by Hyperion Therapeutics based on the existing medication sodium phenylbutyrate, and received approval in February 2013. — Wikipedia

Clinical trial activity

22 trials · 17 clinical orgs · 12 marketing orgs

Phase 1
8
Phase 2
9
Phase 3
4
Phase 4
3

Earliest trial started Mar 1, 2005 (NCT00977600)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2009

    Earliest Phase 3 Sponsor(trial)

  4. Apr 27, 2009

    Orphan Drug Designation

2010s

  1. Feb 1, 2013

    Hyperion Therapeutics — Earliest FDA Approval

  2. Feb 1, 2013

    Hyperion Therapeutics — NDA Organization

  3. Feb 1, 2013

    Horizon Therapeutics, LLC — NDA Secondary Org

  4. Feb 1, 2013

    Horizon Therapeutics, LLC — Marketing Organization

  5. May 19, 2016

    Par Pharmaceuticals — Marketing Organization

2020s

  1. Dec 2, 2021

    Endo Pharmaceuticals — Marketing Organization

  2. Dec 2, 2021

    Bristol-Myers Squibb — Marketing Organization

  3. Dec 2, 2021

    PH HEALTH — Marketing Organization

  4. Aug 9, 2022

    Annora Pharma — Marketing Organization

  5. Apr 15, 2026

    Aurobindo Pharma — Marketing Organization

  6. Apr 15, 2026

    MSN Laboratories — Marketing Organization

  7. Apr 15, 2026

    Teva — Marketing Organization

  8. Apr 23, 2026

    Navinta — Marketing Organization

  9. Apr 30, 2026

    Lupin — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • GlutamineSEQUESTERING AGENT

    Glutamine sequestering agent

    Removes excess nitrogen, caused by enzyme deficiency

Approval history

  • approvedFast trackFeb 1, 2013

Chemistry & pharmacology

Loading structure…

SMILES

O=C(CCCc1ccccc1)OCC(COC(=O)CCCc1ccccc1)OC(=O)CCCc1ccccc1
Mol. weight
530.66 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glycerol phenylbutyrate
  • glyceryl tri-4-phenylbutyrate
  • glyceryl tri-4-phenylbutyrate
  • gpb
  • gpb
  • gpb
  • gt4p
  • gt4p
  • hpn100
  • hpn 100
  • hpn-100
  • hpn-100
  • hpn-100
  • hpn-100
  • hpn-100
  • ravicti
  • ravicti
  • ravicti
  • ravicti
  • ravicti

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06887777Phase 2May 31, 2025Assistance Publique - Hôpitaux de Paris
NCT05983588Phase 2Dec 31, 2023Technical University of Munich
NCT05019417Phase 2/Phase 3 (Phase 3)Jun 30, 2021Hebrew University, Weizmann Institute of Science
NCT04937062Early Phase 1 (Phase 1)Mar 1, 2021Cornell University
NCT04041232Early Phase 1 (Phase 1)Jul 31, 2019Columbia University
NCT03335488Phase 4Feb 20, 2018Horizon Therapeutics, LLC
NCT02323100Phase 1/Phase 2 (Phase 2)Aug 1, 2017Johns Hopkins University, University of Alabama, Birmingham, University of Colorado, Denver, University of Pennsylvania
NCT02246218Phase 4Dec 1, 2014Horizon Therapeutics, LLC
NCT02094222N/AMar 19, 2014University of Pittsburgh
NCT02046434Phase 1Jan 1, 2014University of Colorado, Denver
NCT01949766N/ASep 20, 2013University of Pittsburgh
NCT01881984Phase 1Jun 1, 2013Horizon Pharma, University of Pittsburgh
NCT01347073Phase 3Jul 1, 2011Horizon Pharma, Hyperion Therapeutics
NCT01257737Phase 4Oct 1, 2010Horizon Pharma, Horizon Therapeutics, LLC
NCT01135680Phase 1May 1, 2010Horizon Pharma
NCT00947544Phase 2Mar 1, 2010Children's National Medical Center, Horizon Pharma
NCT00999167Phase 2Dec 1, 2009Horizon Pharma
NCT00947297Phase 3Nov 1, 2009Baylor University, Horizon Pharma
NCT00992459Phase 3Oct 1, 2009Baylor University, Horizon Pharma
NCT00551200Phase 2Oct 1, 2007Horizon Pharma
Showing 20 of 22 trials
Page 1 / 2

Organizations

Research & Development (17)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Horizon PharmaFor profit11942005
Horizon Therapeutics, LLCFor profit3312010
University of PittsburghAcademic/Hospital3322013
Baylor UniversityAcademic/Hospital2012009
UcyclydFor profit2012005
University of Colorado, DenverAcademic/Hospital2222014
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112025
Children's National Medical CenterAcademic/Hospital1012010
Columbia UniversityAcademic/Hospital1112019
Cornell UniversityAcademic/Hospital1112021
Hebrew UniversityAcademic/Hospital1112021
Hyperion TherapeuticsFor profit1012011
Johns Hopkins UniversityAcademic/Hospital1012017
Technical University of MunichAcademic/Hospital1112023
University of Alabama, BirminghamAcademic/Hospital1012017
University of PennsylvaniaAcademic/Hospital1012017
Weizmann Institute of ScienceAcademic/Hospital1012021
17 organizations
Page 1 / 1

Marketing (13)

OrganizationOrg typeRelationshipDate
Annora PharmaFor profitMKTGAug 9, 2022
Aurobindo PharmaFor profitMKTGApr 15, 2026
Bristol-Myers SquibbFor profitMKTGDec 2, 2021
Endo PharmaceuticalsFor profitMKTGDec 2, 2021
Horizon Therapeutics, LLCFor profitNDA2Feb 1, 2013
Horizon Therapeutics, LLCFor profitMKTGFeb 1, 2013
Hyperion TherapeuticsFor profitNDAFeb 1, 2013
LupinFor profitMKTGApr 30, 2026
MSN LaboratoriesFor profitMKTGApr 15, 2026
NavintaFor profitMKTGApr 23, 2026
PH HEALTHFor profitMKTGDec 2, 2021
Par PharmaceuticalsFor profitMKTGMay 19, 2016
TevaFor profitMKTGApr 15, 2026