Which postpartum depression drugs are in Phase 3?

Phase 3 (or later) programs for postpartum depression include LPCN 1154 (oral brexanolone).

How many clinical trials are recruiting for postpartum depression?

8 drug-interventional postpartum depression trials are currently recruiting participants, out of 77 registered interventional trials.

Mood Disorders

Postpartum depression drug pipeline

MeSH D019052
Subtype of Major depressive disorder

3 compounds from 3 companies are in active clinical development for postpartum depression, including 1 at Phase 3 or beyond.

3Compounds

3Companies

1Phase 3+

8Trials recruiting

Phase 3 1
Phase 2 2

Mechanisms: Psychedelic (2) · Neuroactive Steroid (1)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

2026-06-03ReportedMebufotenin (inhaled 5-MeO-DMT, GH001)Full resultsmetNCT05804708
Phase 2a postpartum depression results published in Journal of Clinical Psychiatry (DOI 10.4088/JCP.25m16284) ↗
2026-05-26ReportedLPCN 1154 (oral brexanolone)Full resultsmissedNCT06979544
Full Phase 3 results presented as an oral presentation (Pharmaceutical Pipeline session) and a poster at the 2026 ASCP Annual Meeting, Miami, 26-29 May 2026 — the detailed efficacy, onset, durability-to-day-30 and safety dataset behind the April topline miss. ↗
2026-04-02ReportedLPCN 1154 (oral brexanolone)Topline datamissedNCT06979544
Phase 3 topline in postpartum depression: LPCN 1154 MISSED its primary endpoint — no statistically significant reduction in HAM-D17 total score versus placebo at hour 60 (placebo-adjusted -1.3, N=90) — while showing early separation at hour 12 (-3.9, p<0.01) and a differentiated tolerability profile with no excessive sedation, no loss of consciousness and no treatment-related SAEs. ↗
2026-01-20ReportedLuvesilocin (RE104)Full resultsmetNCT06342310
Full RECONNECT Phase 2 dataset presented at the ACNP Annual Meeting: MADRS separation from Day 1 sustained through Day 28, plus response, remission, HAM-A, CGI-I and Barkin Index of Maternal Function improvements, from a baseline MADRS of 33.4. ↗

See the full catalyst calendar →

Compounds in development (3)

Compound	Company	Phase	Status	Mechanism
LPCN 1154 (oral brexanolone)	Lipocine Inc.	Phase 3	Active	GABA-A receptor PAM
Luvesilocin (RE104)FDA Breakthrough Therapy (Postpartum Depression; Granted 2026-02-23)	Reunion Neuroscience Inc.	Phase 2	Active	5-HT2A Agonist
Mebufotenin (inhaled 5-MeO-DMT, GH001)	GH Research PLC	Phase 2	Active	5-HT2A Agonist

Trials recruiting now (8)

8 drug-interventional postpartum depression trials recruiting now, of 77 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression
Esketamine-dexmedetomidine combination, Placebo
Peking University First Hospitaln=164China · 1 siteStarted Jun 2026NCT07639099
Phase 4Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression
Ferric carboxymaltose IV, TIMOFÉROL®
Assistance Publique - Hôpitaux de Parisn=2,860France · 1 siteStarted Oct 2025NCT06833788
Phase 2A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Woman With Postpartum Depression
KH607 tablet, placebo
Chengdu Kanghong Pharmaceutical Group Co., Ltd.n=72Started Jul 2025NCT07096791
Phase 1/2Maternal Mental Health Trial
Transdermal patch estradiol, Transdermal patch placebo
Vibe G Frøkjær, MD, PhDn=220Denmark · 1 siteStarted Feb 2021NCT04685148
Phase 0Quetiapine Versus Trazadone in Women With Postpartum Depression
Trazodone, Quetiapine
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sn=50Canada · 1 siteStarted Sep 2024NCT06546358
UnknownClinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria
Treatment as Usual (TAU)
Nottingham Trent Universityn=432Started Jul 2026NCT06990802
UnknownIntranasal Dexmedetomidine for Postpartum Depression Prevention
Dexmedetomidine, Placebo
Chengdu Jinjiang Maternity and Child Health Hospitaln=270China · 1 siteStarted May 2026NCT07501728
UnknownEfficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression
Treatment as Usual(Medication Based)
All India Institute of Medical Sciencesn=52Started Apr 2026NCT07515222

Frequently asked

How many drugs are in development for postpartum depression?: 3 compounds from 3 companies are in active clinical development for postpartum depression, including 1 at Phase 3 or beyond.
Which postpartum depression drugs are in Phase 3?: Phase 3 (or later) programs for postpartum depression include LPCN 1154 (oral brexanolone).
How many clinical trials are recruiting for postpartum depression?: 8 drug-interventional postpartum depression trials are currently recruiting participants, out of 77 registered interventional trials.