DT120 (registry title MM120)
- Molecule class
- lysergide d-tartrate, orally disintegrating tablet
- Mechanism
- Not independently verified.
- Phase
- Phase 3 across four trials; Emerge (MDD), Voyage (GAD) and Panorama (GAD) read out positive, Ascend (MDD) pending. Panorama topline 2026-09-14 (8-K Item 7.01, EX-99.1): HAM-A LS mean change at Week 12 -9.8 on 100 ug vs -4.7 placebo, placebo-adjusted -5.1 (p<0.0001, d=0.64); n=96 100 ug, n=97 placebo, n=52 50 ug control arm not powered for comparison, placebo-adjusted -3.6 at Week 12; 245 participants, about 32 sites; no drug-related SAEs, no suicidality signal; TEAE rate 94.8% vs 62.9% placebo. Voyage (2026-08-12) placebo-adjusted -5.4, d=0.81. FDA Breakthrough Therapy designation in MDD announced 2026-09-08 (8-K Item 8.01), the second after GAD
- Indication
- major depressive disorder (Emerge, Ascend); generalised anxiety disorder (Voyage, Panorama)
- Sponsor geography
- US
- Next catalyst
- Pre-NDA meeting guided 4Q 2026; NDA filing guided 1H 2027; Ascend (MDD) topline, by 2026-12-31
- IP status
- Not checked. Recorded as unchecked rather than left blank.
The catalyst above is recorded as guided, not verified. It is this publication's reading of the company's guidance, not a date the company has published.
sec.govregistryverified 2026-09-15
Registered trials
PHASE3 · Generalized Anxiety Disorder · ACTIVE_NOT_RECRUITING · United States
clinicaltrials.govctgov registryverified 2026-09-15
PHASE3 · Generalized Anxiety Disorder · ACTIVE_NOT_RECRUITING · Czechia, France, Germany, Poland, United Kingdom, United States
clinicaltrials.govctgov registryverified 2026-09-08
PHASE3 · Major Depressive Disorder · ACTIVE_NOT_RECRUITING · United States
clinicaltrials.govctgov registryverified 2026-08-31
PHASE3 · Major Depressive Disorder · RECRUITING · United States
clinicaltrials.govctgov registryverified 2026-08-31
Therapeutic confirmatory (Phase III) · Generalized Anxiety Disorder (GAD) · Authorised · Czechia, France, Germany, Poland
euclinicaltrials.euctis registryverified 2026-08-31
In the briefing
Issues tagged DEFINIUM, the owner of this asset.