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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ATI-450, an orally available small molecule inhibitor of the p38alpha mitogen activated protein kinase (MAPK)/MAPK-activated protein kinase 2 (MK2) inflammatory signaling pathway
Date Designated: 01/21/2021
Orphan Designation: Treatment of cryopyrin-associated periodic syndrome
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/03/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Aclaris Theapeutics Inc.
701 Lee Road, Suite 103
Wayne, Pennsylvania 19087
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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