• 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: ARQ 531, a reversible non-covalent ATP competitive inhibitor of BTK
Date Designated: 12/07/2020
Orphan Designation: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
ArQule, Inc., a wholly owned subsidiary of Merck Sharp & Dohme, LLC
126 East Lincoln Ave
P.O. Box 2000
Rahway, New Jersey 07065
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.