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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: H-D-valyl1-D-alanyl-D-glutamyl-D-alanyl-D-arginyl5-D-glutamyl-D-glutamyl-D-leucyl-D-glutamyl-D-arginyl10-D-leucyl-D-glutamyl-D-alanyl-D-arginyl-D-leucyl15-glycyl-D-glutaminyl-D-alanyl-D-arginyl-glycyl20-D-glutamyl-D-leucyl-D-lysyl-D-lysyl-D-tryptophyl25-D-lysyl-D-methionyl-D-arginyl-D-arginyl-D-asparaginyl30-D-glutaminyl-D-phenylalanyl-D-tryptophyl-D-leucyl-D-lysyl35-D-leucyl-D-glutaminyl-D-arginine
Date Designated: 04/25/2022
Orphan Designation: Treatment of stage IIB-IV melanoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sapience Therapeutics, Inc.
500 Mamaroneck Ave, Suite 320
Harrison, New York 10528
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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