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
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
2010s
Indications
Approved for
Mechanism of action
- Retinoic acid receptor gammaAGONIST
RARG agonist
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
- WikipediaPalovarotene ↗
- ChEMBLCHEMBL2105648 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06908954 | Phase 1 | Mar 14, 2025 | Ipsen |
| NCT05027802 | Phase 3 | Nov 15, 2021 | Ipsen |
| NCT04829773 | Phase 1 | Jan 3, 2019 | Clementia Pharmaceuticals Inc., Ipsen |
| NCT04762355 | Phase 1 | Aug 30, 2018 | Clementia Pharmaceuticals Inc., Ipsen |
| NCT03442985 | Phase 2 | Apr 20, 2018 | Clementia Pharmaceuticals Inc. |
| NCT03312634 | Phase 3 | Nov 28, 2017 | Clementia Pharmaceuticals Inc. |
| NCT02979769 | Phase 2 | Nov 1, 2016 | Clementia Pharmaceuticals Inc. |
| NCT02521792 | Phase 2 | Jan 1, 2016 | Clementia Pharmaceuticals Inc., University of California, San Francisco, University of London, University of Pennsylvania |
| NCT04829786 | Phase 1 | Sep 1, 2015 | Clementia Pharmaceuticals Inc., Ipsen |
| NCT02279095 | Phase 2 | Oct 1, 2014 | Clementia Pharmaceuticals Inc., Hospital Italiano de Buenos Aires, Mayo Clinic, Queensland University of Technology, University of California, San Francisco, University of London, University of Pennsylvania |
| NCT02190747 | Phase 2 | Jul 1, 2014 | Clementia Pharmaceuticals Inc., University of California, San Francisco, University of London, University of Pennsylvania |
| NCT00413205 | Phase 2 | Jan 1, 2007 | Roche |
Showing 12 of 12 trials
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Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Clementia Pharmaceuticals Inc. | For profit | 9 | 9 | 3 | 2014 |
| Ipsen | For profit | 5 | 2 | 2 | 2015 |
| University of California, San Francisco | Academic/Hospital | 3 | 0 | 1 | 2014 |
| University of London | Academic/Hospital | 3 | 0 | 1 | 2014 |
| University of Pennsylvania | Academic/Hospital | 3 | 0 | 1 | 2014 |
| Hospital Italiano de Buenos Aires | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Mayo Clinic | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Queensland University of Technology | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Roche | For profit | 1 | 1 | 1 | 2007 |
9 organizations
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