Pasithea Therapeutics Announces FDA Clearance of IND for PAS-004 in Neurofibromatosis Type 1 (NF1)-Associated Cutaneous Neurofibromas (cNF)
Key Highlights
- ➤FDA cleared PAS-004 IND for randomized, placebo-controlled Phase 2 NF1-cNF trial
- ➤PAS-004 could become the first FDA-approved systemic NF1-cNF treatment
- ➤NF1-associated cNF affects over 95% of people with NF1
- ➤Pasithea estimates more than 80,000 U.S. NF1 patients have moderate-to-severe cNF burden
Expert Statements
Kartik Krishnan, Chief Medical Officer of Pasithea Therapeutics
“FDA clearance of our IND for PAS-004 in cutaneous neurofibromas is an important milestone for Pasithea and a significant step forward for people living with NF1 who have cNFs.”
Kartik Krishnan, Chief Medical Officer of Pasithea Therapeutics
“Cutaneous neurofibromas are among the most visible and burdensome manifestations of NF1, and there are currently no approved systemic therapies for them.”
Kartik Krishnan, Chief Medical Officer of Pasithea Therapeutics
“PAS-004 is designed to address this unmet need as a once-daily oral MEK inhibitor whose long half-life and flat pharmacokinetic profile may support chronic dosing.”
Tiago Reis Marques, Chief Executive Officer of Pasithea Therapeutics
“We are pleased to expand the clinical development of PAS-004 into NF1-associated cNF, the second indication for which we intend to seek regulatory approval.”
Tiago Reis Marques, Chief Executive Officer of Pasithea Therapeutics
“PAS-004 has the potential to become the first FDA-approved systemic treatment for NF1-associated cNF, addressing a significant unmet medical need and what we believe represents a multibillion-dollar market opportunity.”
Tiago Reis Marques, Chief Executive Officer of Pasithea Therapeutics
“PAS-004 is intended for the more than 80,000 NF1 patients in the United States estimated to have moderate to severe cNF disease burden.”
— FDA clearance allows Pasithea to advance PAS-004 for NF1-associated cNF, a condition affecting over 95% of people with NF1 and for which there are currently no FDA-approved systemic therapies. —
MIAMI, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of chronic diseases, including neurofibromatosis type 1 (NF1)-associated neurofibromas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a randomized, placebo-controlled Phase 2 clinical trial for PAS-004 in patients with NF1 associated cutaneous neurofibromas (cNF). The Phase 2 study will be conducted under an active IND overseen by the FDA Division of Dermatology and Dentistry (DDD).
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