PAS-004

November 3, 2026: Pasithea Therapeutics Corp. (NASDAQ: KTTA) said the FDA cleared its IND for PAS-004, an oral macrocyclic MEK inhibitor, enabling a randomized, placebo-controlled Phase 2 trial in patients with neurofibromatosis type 1 (NF1)-associated cutaneous neurofibromas (cNF) under the FDA Division of Dermatology and Dentistry.

The company said cNF affects over 95% of people with NF1 and that there are currently no FDA-approved systemic therapies. Pasithea supported the IND with nonclinical safety data plus clinical safety, tolerability, pharmacokinetic data, and early signals of treatment response from ongoing studies.

Other ongoing PAS-004 programs mentioned: a Phase 1/1b trial in adults with NF1-associated plexiform neurofibromas (NCT06961565) and a Phase 1 trial in adults with advanced cancer (NCT06299839).

The announcement is a regulatory clearance/clinical trial initiation milestone; no Phase 2 efficacy results or trial timing details were provided.