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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a chemically modified full phosphorothioate-backboned anti-miR-17 oligonucleotide.
Date Designated: 07/28/2020
Orphan Designation: Treatment of autosomal dominant polycystic kidney disease
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 08/06/2025
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Regulus Therapeutics, Inc.
10628 Science Center Drive,
Suite 225
San Diego, California 92121
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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