palovarotene

Trade name: Sohonos

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 16, 2023

Palovarotene, sold under the brand name Sohonos, is a medication used for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva. It is a highly selective retinoic acid receptor gamma (RARγ) agonist. It is taken by mouth. — Wikipedia

Clinical trial activity

12 trials · 9 clinical orgs · 1 marketing orgs

Phase 1
4
Phase 2
8
Phase 3
2
Phase 4
0

Earliest trial started Jan 1, 2007 (NCT00413205)

Timeline

2000s

  1. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jul 21, 2014

    Orphan Drug Designation

  2. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Aug 16, 2023

    Ipsen — Earliest FDA Approval

  2. Aug 16, 2023

    Ipsen — Marketing Organization

  3. Aug 16, 2023

    Ipsen — NDA Secondary Org

  4. Aug 16, 2023

    Ipsen — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAug 16, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CC1(C)CCC(C)(C)c2cc(Cn3cccn3)c(/C=C/c3ccc(C(=O)O)cc3)cc21
Mol. weight
414.55 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningFirst in class

Sources

Also known as

  • clm-001
  • clm-001
  • palovarotene
  • palovarotene
  • palovarotene
  • palovarotene
  • palovarotene
  • r-667
  • r-667
  • r-667
  • rar gamma
  • rar gamma
  • rar gamma1
  • rar gamma2
  • rar gamma3
  • rar-gamma-a protein, mouse
  • rargb protein, zebrafish
  • rarg protein, human
  • rarg protein, mouse
  • retinoic acid receptor gamma
  • retinoic acid receptor gamma-1 protein, human
  • retinoic acid receptor, gamma, human
  • retinoic acid receptor, gamma, mouse
  • rg-667
  • rg-667
  • rg-667
  • ro-3300074
  • ro-3300074
  • ro-3300074

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06908954Phase 1Mar 14, 2025Ipsen
NCT05027802Phase 3Nov 15, 2021Ipsen
NCT04829773Phase 1Jan 3, 2019Clementia Pharmaceuticals Inc., Ipsen
NCT04762355Phase 1Aug 30, 2018Clementia Pharmaceuticals Inc., Ipsen
NCT03442985Phase 2Apr 20, 2018Clementia Pharmaceuticals Inc.
NCT03312634Phase 3Nov 28, 2017Clementia Pharmaceuticals Inc.
NCT02979769Phase 2Nov 1, 2016Clementia Pharmaceuticals Inc.
NCT02521792Phase 2Jan 1, 2016Clementia Pharmaceuticals Inc., University of California, San Francisco, University of London, University of Pennsylvania
NCT04829786Phase 1Sep 1, 2015Clementia Pharmaceuticals Inc., Ipsen
NCT02279095Phase 2Oct 1, 2014Clementia Pharmaceuticals Inc., Hospital Italiano de Buenos Aires, Mayo Clinic, Queensland University of Technology, University of California, San Francisco, University of London, University of Pennsylvania
NCT02190747Phase 2Jul 1, 2014Clementia Pharmaceuticals Inc., University of California, San Francisco, University of London, University of Pennsylvania
NCT00413205Phase 2Jan 1, 2007Roche
Showing 12 of 12 trials
Page 1 / 1

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Clementia Pharmaceuticals Inc.For profit9932014
IpsenFor profit5222015
University of California, San FranciscoAcademic/Hospital3012014
University of LondonAcademic/Hospital3012014
University of PennsylvaniaAcademic/Hospital3012014
Hospital Italiano de Buenos AiresAcademic/Hospital1012014
Mayo ClinicAcademic/Hospital1012014
Queensland University of TechnologyAcademic/Hospital1012014
RocheFor profit1112007
9 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
IpsenFor profitMKTGAug 16, 2023
IpsenFor profitNDA2Aug 16, 2023
IpsenFor profitSYNAug 16, 2023
IpsenFor profitNDAAug 16, 2023
IpsenFor profitSYNAug 16, 2023