Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: zenocutuzumab-zbco
Trade Name: Bizengri
Date Designated: 01/29/2026
Orphan Designation: treatment of cholangiocarcinoma
Orphan Designation Status: Designated/Approved
Partner Therapeutics, Inc.
19 Muzzey St.
Lexington, Massachusetts 02421
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: zenocutuzumab-zbco
Trade Name: Bizengri
Marketing Approval Date: 05/08/2026
Approved Labeled Indication: treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-