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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: peripherally restricted, selective, small molecule inhibitor of NLRP3 (NLR [nucleotide-binding domain and leucine-rich repeat] family, pyrin domain containing 3)
Date Designated: 02/13/2026
Orphan Designation: treatment of pericarditis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Zomagen Biosciences Ltd, a wholly owned subsidiary of Ventyx Biosciences, Ltd.
5 New Street Square
London EC4A 3TW
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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