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: small molecule fluorescent imaging agent composed of the cyclic pentapeptide cRGDyK (cyclo[Arg-Gly-Asp-D-Tyr-Lys]) covalently conjugated to the zwitterionic near-infrared dye ZW800-1 (nizaracianine)
Date Designated: 12/04/2025
Orphan Designation: diagnostic for the management of pancreatic cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Curadel Surgical Innovations, Inc.
28120 Hunters Ridge Blvd
Suite 6-7
Bonita Springs, Florida 34135
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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