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: [3-({[5-cyano-6-oxo-4-(thiophen-2-yl)-1,6-dihydropyrimidin-2-yl]sulfanyl}methyl)phenyl]acetic acid
Date Designated: 07/10/2026
Orphan Designation: prevention of delayed graft function after renal transplantation
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Tes Pharma S.r.l.
Via Giovine Italia
Solomeo, Corciano (PG) 1 – 06073
Italy

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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