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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: fully human monoclonal IgG1 antibody against the type 2 isoform of human Claudin 18 protein (Claudin 18.2).
Date Designated: 04/06/2021
Orphan Designation: Treatment of gastric cancer, including cancer of gastroesophageal junction
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Leap Therapeutics, Inc.
47 Thorndike Street, Suite B-1
Cambridge, Massachusetts 02141
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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