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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mitogen-activated protein kinase (MAPK)/extracellular signal-related kinase (ERK) kinase 1/ 2 (MEK1/2) inhibitor
Date Designated: 05/29/2026
Orphan Designation: treatment of amyotrophic lateral sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pasithea Therapeutics Corp.
1111 Lincoln Road, Suite 500
Miami Beach, Florida 33139
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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