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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: macrocyclic, ATP-competitive small molecule inhibitor of CDC-like kinase 1/2/4 (CLK1/2/4)
Date Designated: 03/02/2026
Orphan Designation: treatment of acute myeloid leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
BlossomHill Therapeutics
10255 Science Center Drive
Suite 200
San Diego, California 92121
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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