Draig Therapeutics to Initiate Phase 2 Study of DT-101 for Major Depressive Disorder Following FDA IND Clearance

Draig Therapeutics (Draig), a clinical-stage biotechnology company developing novel therapies for neuropsychiatric diseases, announced plans to initiate a Phase 2 study of DT-101, a next-generation AMPA receptor positive allosteric modulator (PAM), for the treatment of major depressive disorder (MDD) in the United States in Q4 2025. The decision follows U.S. FDA clearance of the Investigational New Drug (IND) application for the Phase 2 trial protocol.

Leadership Commentary

“Initiating our Phase 2 study with DT-101 under a U.S. IND is an important milestone for Draig. This achievement highlights the rapid progress we’ve made following our successful $140 million Series A financing in June 2025 and brings us closer to our mission of delivering innovative treatments for people suffering from neuropsychiatric disorders.”

• Ruth McKernan, Ph.D., Interim CEO and Founder of Draig Therapeutics.

Inder Kaul, M.D., Chief Medical Officer, added:

“Millions live with the burden of depression, yet many either do not respond to or cannot tolerate existing antidepressants. The data we’ve generated on DT-101 provide a strong foundation for this next study, which aims to demonstrate meaningful and sustained relief for patients with MDD.”

About the Phase 2 TARIAN-1 Study

• Design: Multi-centre, randomized, double-blind, placebo-controlled trial
• Participants: >300 individuals diagnosed with MDD
• Primary endpoint: Change in the Montgomery–Åsberg Depression Rating Scale (MADRS) score
• Initial sites: United States, with expansion to the UK and EU pending regulatory authorizations
• Timeline: Topline data expected in H2 2027

The study builds upon positive Phase 1 results from over 60 participants, where DT-101 was well tolerated and demonstrated target engagement using magnetoencephalography (MEG). Data from the Phase 1 program will be presented at an upcoming scientific conference.

Expanding the Pipeline

Draig’s $140 million Series A funding, announced in June 2025, supports the continued development of DT-101 and advancement of DT-201 and DT-301 — two highly selective GABAA receptor modulators, into clinical trials in 2026. These programs aim to demonstrate best-in-class potential across multiple prevalent and underserved neuropsychiatric disorders.

About Draig Therapeutics

Draig Therapeutics is a clinical-stage biopharmaceutical company pioneering next-generation therapies for neuropsychiatric diseases, including major depressive disorder. Its pipeline targets key neurotransmitter systems such as AMPA and GABAA receptors to deliver safer, more effective, and durable treatments.

The name TARIAN, derived from the Welsh word for “shield,” reflects the goal of Draig’s research — to protect individuals from the debilitating effects of depression.

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