GM-1020 · program
Blixeprodil (GM-1020) for Major depressive disorder
Blixeprodil (GM-1020) for MDD. Phase 2a (NCT06309277) completed; positive topline announced 6 Jan 2026: single oral dose gave -6.3 MADRS vs placebo at 24h (p=0.006); 53% remission at Day 42 (multiple-dose arm), sustained through 28-day follow-up. Company intends late-stage studies in 2026.
Development timeline
Clinical trials in Major depressive disorder
NCT06309277Phase 2Completedn=46
Two-Part Study of Single and Multiple Oral Doses of GM-1020 in Major Depressive Disorder
metprimaryMADRS change vs placebo, 24h after single 140mg oral dose — -6.3 points (effect size 0.85) (0.006)
Day 8 -5.1 (p=0.076); 53% remission at Day 42 in the multiple-dose arm, sustained through 28-day follow-up.
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| Blixeprodil oral 140 mg and 210 mg oral doses studied (Phase 2a: 140 mg single dose in Part A; 140 mg or 210 mg twice weekly for 2 weeks in Part B) | Oral | Twice weekly | t½ 4.3 h · Tmax 1.5 h · F 60% |
Mechanism of action
Non-competitive NMDA-receptor antagonist binding the PCP/channel site (voltage-dependent block), non-subunit-selective across GluN2A/GluN2B. Low-micromolar affinities.
| Target | Action | Affinity |
|---|---|---|
| NMDA receptorprimaryGRIN1 | Antagonist | Ki 3.25 µMⓘ |
← Full GM-1020 compound page (identity, identifiers, all indications)
Sources
- Blixeprodil — Wikipedia
- Gilgamesh Pharma Announces Positive Topline Phase 2a Results for Blixeprodil (GM-1020) in Major Depressive Disorder — Gilgamesh / PR Newswire
- GM-1020 Phase 2a MDD (NCT06309277) — ClinicalTrials.gov
- GM-1020: oral NMDA antagonist with antidepressant-like effects — Molecular Psychiatry (PMC)
- prnewswire.com — Reference