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Pasithea Therapeutics Activates Clinical Trial Sites in South Korea for Phase 1/1b Trial of PAS-004

Pasithea Therapeutics Corp. (KTTA) | September 16, 2025

By Wendy Roberts

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Pasithea Therapeutics announced the activation of two South Korean clinical trial sites for Phase 1/1b trial of PAS-004 in NF1 patients.

The trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of PAS-004 in adult NF1 patients with plexiform neurofibromas.

Key clinical trial sites include ASAN Medical Centre and Severance Hospital Yonsei University Health System.

Purpose of the Trial

Evaluate safety, tolerability, and efficacy of PAS-004 in adult NF1 patients with plexiform neurofibromas.

Clinical Trial Structure

Phase 1/1b study with dose escalation and expansion phases. Five clinical trial sites in Australia, South Korea, and the U.S.

Potential Impact

PAS-004 may offer important benefits for NF1 patients with more convenient dosing and distinct pharmacokinetic profile.

  • Activation of South Korean trial sites enhances global reach and patient diversity in the Phase 1/1b trial for PAS-004.
  • Partnership with leading medical centers in South Korea strengthens Pasithea's position in NF1 research and treatment.
  • Inclusion of world-class facilities and high NF1 patient population in South Korea indicates potential for significant trial success.
  • Distinct pharmacokinetic profile and convenient dosing regimen of PAS-004 may address current treatment limitations for NF1 patients.

The activation of clinical trial sites in South Korea marks a significant step for Pasithea Therapeutics in advancing the development of PAS-004 for NF1 patients. With the collaboration of top medical institutions and access to a substantial patient population, the trial holds promise for improving treatment options in the NF1 community.