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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 11-Fluoro-N-[(42S, 43S)-13,15,22--trifluoro-5-oxo-8-oxa-4(2,1)-piperidina-1(1,2),2(1,3)-dibenzenacyclooctaphane-43-yl] cyclopropane-1-sulfonamide
Date Designated: 06/04/2026
Orphan Designation: treatment of idiopathic hypersomnia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Centessa Pharmaceuticals (UK) Limited
3rd Floor 1 Ashley Road
Altrincham, Cheshire WA14 2DT
United Kingdom

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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