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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: small-molecule mitotic checkpoint inhibitor (MCI) with dual inhibition of threonine tyrosine kinase (TTK/MPS1) and polo-like kinase 1 (PLK1)
Date Designated: 08/24/2026
Orphan Designation: treatment of acute myeloid leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
SillaJen Inc.
3rd Floor, 106, Cheonggyecheon-ro, Jung-gu
Seoul, Seoul 04542
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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