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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: selective inhibitor of dual-specific protein kinase mitogen-activated protein kinase kinase 4 (MKK4)
Date Designated: 08/10/2026
Orphan Designation: prevention of post-hepatectomy liver failure
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
HepaRegeniX GmbH
Eisenbahnstrasse 63
Tubingen, NA 72072
Germany

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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