Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: (1S,2S,6S)-6-((S)-5-chloro-6-fluoro-2-phenyl-2-((S)-pyrrolidin-2-yl)-2,3-dihydrobenzofuran-4-yl)-7-fluoro-1-hydroxy-N,2-dimethyl-2,3-dihydro-1H-indene-5-carboxamide
Date Designated: 04/17/2025
Orphan Designation: treatment of mesothelioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Kygent Therapeutics (Shanghai) Co., Ltd.
No. 306 Room, No. 5 Building, No. 338, Galileo Road, Pudong New Area
Shanghai, Shanghai 201203
China

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-