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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 (heterocyclic compound) that epigenetically regulates gene expression through bromodomain and extra-terminal domain inhibition
Date Designated: 10/24/2025
Orphan Designation: treatment of nuclear protein in testis (NUT) carcinoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Zenith Epigenetics Ltd.
4820 Richard Road SW, Suite 300
Calgary, AB T3E 6L1
Canada

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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