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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: inhibitor of mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1)
Date Designated: 10/21/2025
Orphan Designation: treatment of Waldenstrom’s macroglobulinemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Schrödinger, Inc.
1540 Broadway, 24th Floor
New York, New York 10036
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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