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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Cyclo[-L-Glycyl-L-2-Allylproline]
Date Designated: 11/01/2026
Orphan Designation: treatment of neonatal hypoxic ischemic encephalopathy (HIE)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Neuren Pharmaceuticals Limited
697 Burke Rd
Ste 201
Camberwell, Victoria VIC3124
Australia

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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