In short
DT-101 is a chemically synthesised, investigational substance being studied as a potential treatment for adults with major depressive disorder (MDD). It is given as a capsule by mouth. One Phase 2 clinical trial, authorised in the EU, is currently evaluating different dose levels of DT-101 against placebo in 398 participants. The main measure is the change in depressive symptoms on the Montgomery Åsberg Depression Rating Scale (MADRS).
Key points
- DT-101 is an investigational chemical substance with no marketing authorisation, developed by Draig Therapeutics Limited.
- The single registered trial is a Phase 2 study in adults with major depressive disorder.
- The trial is authorised and plans to enrol 398 participants.
- DT-101 is given as a capsule by oral use.
- The primary outcome is the change in the MADRS depression rating scale score.
- The study compares different dose levels of DT-101 with a matching placebo.
What is DT-101?
DT-101 is a chemically synthesised substance that is being developed as an investigational medicine for major depressive disorder (MDD). It is not an authorised medicine; the product records show no marketing authorisation for DT-101. The substance is supplied by Draig Therapeutics Limited. In the EU Clinical Trials Information System (CTIS), DT-101 is classified under the therapeutic area of psychiatry and psychology, specifically mental disorders.
How does DT-101 work?
The registered trial data does not describe the mechanism of action of DT-101. No molecular target or pharmacological pathway is stated in the available sources. The study is designed to assess the effects of different dose levels of DT-101 and placebo on depressive symptoms in people with MDD, but how the substance acts in the body is not explained in the registry information.
Which conditions is DT-101 studied for?
- Major depressive disorder (MDD) — a mental health condition characterised by persistent low mood and loss of interest or pleasure in activities. The registered trial investigates DT-101 in adults with this condition.
How is DT-101 given?
DT-101 is formulated as a capsule and is given by oral use, meaning it is taken by mouth. The trial also includes a matching placebo capsule for oral administration as a comparison arm. The registered dose is listed as 0.00 mg, which means the specific dose levels were not reported in the registry record.
What do the clinical trials show?
One Phase 2 interventional trial is registered for DT-101 in adults with major depressive disorder. The trial is authorised, meaning it has received regulatory approval to proceed. It plans to enrol 398 participants. The study compares different dose levels of DT-101 with a matching placebo. The primary outcome is the change in participants' scores on the Montgomery Åsberg Depression Rating Scale (MADRS), a clinician-rated scale used to measure the severity of depressive symptoms. The trial record does not report secondary outcomes or detailed eligibility criteria beyond the adult population with MDD.
What side effects are known?
The available sources do not report side effects for DT-101. No safety data from the trial or from supplementary sources is provided in the registry information.