Palovarotene

Palovarotene
Clinical data
Trade namesSohonos
Other namesR-667, RG-667
AHFS/Drugs.comMonograph
MedlinePlusa623038
License data
Pregnancy
category
  • AU: X (High risk)[1]
Routes of
administration		By mouth
Drug classRetinoic acid receptor gamma agonist
ATC code
Legal status
Legal status
Identifiers
  • 4-[(E)-2-[5,5,8,8-tetramethyl-3-(1H-pyrazol-1-ylmethyl)-5,6,7,8-tetrahydronaphthalen-2-yl]ethenyl]benzoic acid
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC27H30N2O2
Molar mass414.549 g·mol−1
3D model (JSmol)
  • CC1(CCC(C2=C1C=C(C(=C2)/C=C/C3=CC=C(C=C3)C(=O)O)CN4C=CC=N4)(C)C)C
  • InChI=1S/C27H30N2O2/c1-26(2)12-13-27(3,4)24-17-22(18-29-15-5-14-28-29)21(16-23(24)26)11-8-19-6-9-20(10-7-19)25(30)31/h5-11,14-17H,12-13,18H2,1-4H3,(H,30,31)/b11-8+
  • Key:YTFHCXIPDIHOIA-DHZHZOJOSA-N

Palovarotene, sold under the brand name Sohonos, is a medication used for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva.[6][7] It is a highly selective retinoic acid receptor gamma (RARγ) agonist.[8] It is taken by mouth.[7]

It was approved for medical use in Canada in June 2022,[6] and in the United States in August 2023.[7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]

  1. ^ a b "Sohonos APMDS". Therapeutic Goods Administration (TGA). 11 December 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
  2. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  3. ^ "Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24]". Health Canada. 24 January 2022. Archived from the original on 29 May 2022. Retrieved 28 May 2022.
  4. ^ "Summary Basis of Decision - Sohonos". Health Canada. 23 October 2014. Archived from the original on 6 August 2022. Retrieved 6 August 2022.
  5. ^ "Sohonos product information". Health Canada. 20 June 2022. Archived from the original on 29 January 2023. Retrieved 28 January 2023.
  6. ^ a b c "Sohonos Product Information". Health Canada. 22 October 2009. Archived from the original on 18 August 2023. Retrieved 17 August 2023.
  7. ^ a b c d "Sohonos- palovarotene capsule". DailyMed. 24 August 2023. Retrieved 6 October 2023.
  8. ^ "Health Canada Approves Ipsen's Sohonos (palovarotene capsules) as the First Approved Treatment for Fibrodysplasia Ossificans Progressiva" (Press release). Ipsen. 24 January 2022. Archived from the original on 29 May 2022. Retrieved 28 May 2022 – via Business Wire.
  9. ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.