Draig Therapeutics announced that the US Food and Drug Administration has cleared its Investigational New Drug (IND) application for a Phase 2 study of DT-101, a next-generation AMPA receptor positive allosteric modulator designed to treat major depressive disorder. The clinical-stage company plans to initiate the trial in Q4 2025, marking a significant milestone in its mission to transform neuropsychiatric disease treatment.
Novel Mechanism Targets Treatment-Resistant Depression
DT-101 represents a new approach to depression treatment through its selective modulation of AMPA receptors, designed to provide effective therapeutic benefits without compromising safety. According to Dr. Inder Kaul, Chief Medical Officer at Draig Therapeutics, "Millions of people worldwide are living with the debilitating effects of depression, and a large proportion of these individuals either do not respond to or cannot tolerate available antidepressants."
The drug candidate addresses a critical unmet medical need, as current antidepressants fail to provide adequate relief for many patients. DT-101's mechanism of action through AMPA receptor positive allosteric modulation offers a potentially differentiated therapeutic approach compared to existing treatments.
Phase 2 Trial Design and Timeline
The Phase 2 study, designated TARIAN-1, will be a multi-center, randomized, double-blind, placebo-controlled trial enrolling more than 300 participants with major depressive disorder. The trial will initially launch in the US before expanding to clinical sites in the UK and selected European Union countries, pending regulatory authorizations.
The primary endpoint will measure changes in participants' Montgomery Åsberg Depression Rating Scale (MADRS) scores compared to placebo. Draig anticipates reporting topline data from the trial in the second half of 2027. The study name TARIAN, meaning "shield" in Welsh, reflects the trial's objective to protect individuals from depression's debilitating effects.
Strong Phase 1 Foundation
The Phase 2 advancement builds on encouraging Phase 1 results from a completed program involving over 60 subjects. In this earlier study, DT-101 demonstrated good tolerability and confirmed target engagement using the novel technique of magnetoencephalography. These positive safety and pharmacodynamic findings provided the foundation for advancing into efficacy testing.
Data from the Phase 1 program will be presented at a future scientific meeting, offering additional insights into the drug's clinical profile and mechanism of action.
Robust Financial Backing Supports Pipeline Expansion
The FDA clearance follows Draig's successful $140 million Series A financing round completed in June 2025. This funding will support not only the DT-101 Phase 2 trial but also advance two additional pipeline candidates, DT-201 and DT-301, which are highly selective GABAA receptor modulators planned to enter clinical development in 2026.
Ruth McKernan, Interim CEO and founder of Draig Therapeutics, emphasized the significance of this milestone: "Initiating our Phase 2 study with DT-101 under a US IND is an important milestone for Draig. This achievement highlights the rapid progress we've made following the closing of our highly successful Series A financing round in June 2025."
Targeting Core Neuropsychiatric Pathways
Draig Therapeutics leverages its founders' expertise in modulating glutamate and GABA pathways, which play critical roles in neuropsychiatric diseases. The company's approach focuses on addressing large unmet patient needs across prevalent and underserved neuropsychiatric disorders.
The company, co-founded by Cardiff University and backed by leading healthcare venture firms including SV Health Investors, Access Biotechnology, Canaan Partners, SR One, Sanofi Ventures, and Schroders Capital, represents a strategic effort to develop best-in-class therapies for neuropsychiatric conditions.
