Major depressive disorder drug pipeline

Upcoming readouts & recent results

• No guidance — study completed 2 Sep 2025, results undisclosedAnticipatedENX-104Full resultsNCT07253272

  D2/D3 receptor occupancy results from the Phase 1 PET study of single-dose ENX-104 in 10 healthy volunteers (NCT07253272) — the dose-to-occupancy relationship that would anchor Phase 2 dose selection against the intended 10-50% occupancy window. Completed 2 September 2025; nothing disclosed. ↗

• September 2025AnticipatedPsilocybin (COMP360)Topline dataNCT05733546

  Phase 2 COMP360 recurrent-MDD topline anticipated (estimated primary completion Sep 2025); no results reported yet. ↗

• No guidance — study completed 26 Nov 2025, topline undisclosedAnticipatedENX-104Topline dataNCT07253324

  Topline from the Phase 1 multiple-ascending-dose study of ENX-104 in 48 patients with major depressive disorder with anhedonia (NCT07253324) — safety, tolerability, PK and pharmacodynamics, the first data in the target population. Completed 26 November 2025; nothing disclosed. ↗

• July 2026AnticipatedForvisirvatRegistry resultsNCT06254612

  ClinicalTrials.gov estimated primary completion (and estimated study completion) of the confirmatory Phase 2b/3 study NCT06254612: 15 July 2026. ↗

• Q3 2026AnticipatedElunetirom (ABX-002)Topline dataNCT06633016

  AMPLIFY Phase 2 topline (adjunctive MDD): HAMD-17 change at Week 6 vs. placebo, expected Q3 2026. ↗

• Q4 2026AnticipatedCYB003 (deupsilocin)Topline datapendingNCT06564818

  Phase 3 APPROACH (NCT06564818) topline data on track for Q4 2026 ↗

• 2H 2026 / 2027AnticipatedSeltorexant (JNJ-42847922)Topline dataNCT06559306

  Confirmatory Phase 3 MDD3003 anticipated; primary completion estimated end of 2026. ↗

• 2026AnticipatedMilsaperidone (VHX-896)Topline dataNCT06830044

  Topline data anticipated from the Phase 3 adjunctive MDD study of milsaperidone (Bysanti). ↗

• Later in 2026 (2H 2026)AnticipatedForvisirvatTopline dataNCT06254612

  Topline results from the confirmatory Phase 2b/3 study SP-624-202 of forvisirvat 20 mg once daily vs placebo over 4 weeks in MDD (456 randomised; primary efficacy endpoint pre-specified in females), anticipated later in 2026. ↗

• H1 2027AnticipatedAzetukalner (XEN1101)Topline data

  Phase 3 X-NOVA2 topline in major depressive disorder expected H1 2027. ↗

• May 2027AnticipatedDT-101Registry resultsNCT07610473

  ClinicalTrials.gov estimated primary completion of AERON-1, the US Phase 2 adjunctive study of DT-101 in MDD (primary endpoint: change from baseline in MADRS total score at Day 56): May 2027. ↗

• 2H 2027AnticipatedIcalcaprantTopline dataNCT07276997

  Anticipated Phase 2 topline (MADRS change from baseline at week 6) for icalcaprant in major depressive disorder ↗

• 2H 2027AnticipatedDT-101Topline dataNCT07300969

  Topline results from Tarian-1, the global Phase 2 monotherapy study of DT-101 in major depressive disorder (primary endpoint: change from baseline in MADRS total score at Day 42), anticipated in the second half of 2027. ↗

• 2028AnticipatedTNX-102 SL (cyclobenzaprine HCl sublingual)Topline datapendingNCT07621237

  Phase 2 HORIZON topline (MADRS change at Week 6) in MDD anticipated following an estimated February 2028 primary completion.

• 2029AnticipatedApimostinel (GATE-202)Topline dataNCT06400121

  Phase 2 apimostinel +/- ASAT in MDD: primary completion anticipated 2029 ↗

• 2029AnticipatedSolriamfetol (Sunosi)Topline datapendingNCT07484217

  CLARITY Phase 3 (MDD with EDS) topline anticipated after a ~December 2028 primary completion. ↗

• 1H 2029AnticipatedLB-102 (N-methylamisulpride)Topline data

  LB Pharmaceuticals plans to initiate a Phase 2 adjunctive-MDD trial of LB-102 in early 2027, with topline data expected in 1H 2029. ↗

• 2026-07-27ReportedAmmoxetine (S-071031B)Topline datametNCT06827431

  Chinese Phase 3 (HA1406-007) topline: primary met in depression — MADRS change at Week 8 significantly superior to placebo (p<0.0001), numerically superior to active control ↗

• 2026-06-22ReportedLysergide D-tartrate (MM120 / LSD)Topline datamet

  Phase 3 Emerge topline: single-dose DT120 ODT meets primary in MDD (MADRS −8.1 pts vs placebo at Week 6, p<0.0001) ↗

• 2026-06-17ReportedRopanicantTopline datametNCT06836063

  Phase 2b (NCT06836063) topline in major depressive disorder: ropanicant 45 mg twice daily met the primary endpoint, change from baseline in MADRS total score at Week 6, with an ML-estimated mean difference versus placebo of -3.572 in the Full Analysis Set (p = 0.038); no result was disclosed for the 30 mg twice-daily arm. ↗

• 2026-06-15ReportedNavacaprant (NMRA-140)Topline datamissed

  KOASTAL-2 and KOASTAL-3 both missed; Neumora discontinued navacaprant for MDD. ↗

See the full catalyst calendar →

Compounds in development (41)

Also in development for subtypes of Major depressive disorder

• LPCN 1154 (oral brexanolone)Phase 3Lipocine Inc.for Postpartum depression
• Luvesilocin (RE104)Phase 2Reunion Neuroscience Inc.for Postpartum depression
• Mebufotenin (inhaled 5-MeO-DMT, GH001)Phase 2GH Research PLCfor Postpartum depression
• Psilocybin (COMP360)Phase 3COMPASS Pathways plcfor Treatment-resistant depression
• ALTO-207Phase 2Alto Neuroscience, Inc.for Treatment-resistant depression
• BPL-003 (intranasal 5-MeO-DMT benzoate)Phase 2Atai Beckley N.V. (AtaiBeckley)for Treatment-resistant depression
• Mebufotenin (inhaled 5-MeO-DMT, GH001)Phase 2GH Research PLCfor Treatment-resistant depression
• VLS-01Phase 2Atai Beckley N.V. (AtaiBeckley)for Treatment-resistant depression
• AVP-786 (deudextromethorphan-quinidine)DiscontinuedOtsuka Pharmaceutical Co., Ltd.for Treatment-resistant depression
• Mefluleucine (NV-5138)DiscontinuedSupernus Pharmaceuticals, Inc.for Treatment-resistant depression
• MK-1942DiscontinuedMerck & Co., Inc.for Treatment-resistant depression
• TS-161DiscontinuedOOTEMON Co., Ltd.for Treatment-resistant depression

Trials recruiting now (198)

198 drug-interventional major depressive disorder trials recruiting now, of 1,650 registered interventional trials. Browse all on ClinicalTrials.gov →

• Phase 4Stony Brook Medicine Anti-Inflammatory Trial

  Celecoxib, Minocycline

  Stony Brook Universityn=42Started Jun 2027NCT06699966
• Phase 4Teen Vulnerability to Irritability: Brain and Estrogen Changes

  Kurvelo, Placebo COC

  University of North Carolina, Chapel Hilln=50United States · 2 sitesStarted Jun 2026NCT07544966
• Phase 4Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder

  bupropion hydrobromide, Placebo

  Bausch Health Americas, Inc.n=246Started Jun 2026NCT02129751
• Phase 4Understanding the Role of the Kappa Opioid Receptor in Ketamine's Attenuation of Suicidal Thoughts

  Ketamine hydrochloride infusion

  New York State Psychiatric Instituten=12United States · 1 siteStarted May 2026NCT07139106
• Phase 4Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia

  Daridorexant 50 mg, Placebo

  Institut d'Investigació Biomèdica de Bellvitgen=134Spain · 1 siteStarted Apr 2026NCT07555743
• Phase 4RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)

  Vortioxetine, Cariprazine (Augmentation Phase)

  Mayo Clinicn=120United States · 1 siteStarted Feb 2026NCT07266545
• Phase 4Dynamic Networks in Depression Treatment: Mechanisms of Change in Pharmacological, Psychological and Combined Treatment of Depression

  Psychopharmacological treatment

  Goethe Universityn=90Germany · 3 sitesStarted Feb 2026NCT07488910
• Phase 4Discontination of Antidepressants in Remitted Depression

  Hyperbolic tapering, Linear tapering

  Universita di Veronan=150Started Feb 2026NCT07393919
• Phase 4Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse

  Lumateperone 42 mg

  University of Texas at Austinn=50United States · 1 siteStarted Feb 2026NCT07369115
• Phase 4Does Semaglutide Improve Depressive Symptoms in Patients With Major Depressive Disorder and Overweight or Obesity

  Semaglutide Injectable Product, Placebo

  Nordsjaellands Hospitaln=116Denmark · 1 siteStarted Sep 2025NCT07136714
• Phase 4A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

  Valbenazine

  Neurocrine Biosciences, Inc.n=50United States · 22 sitesStarted Aug 2025NCT07105111
• Phase 4Disposition Kinetics of Dolutegravir Among People Living With HIV With Major Depression in Nigeria

  Fluoxetine

  University of Ibadann=168Nigeria · 1 siteStarted Aug 2025NCT07110831

Showing the 12 most advanced of 198 recruiting drug trials · see all on ClinicalTrials.gov →