Developer · LPCN · United States
Lipocine Inc.
Biopharmaceutical company headquartered in Salt Lake City, Utah (Nasdaq: LPCN) built around a proprietary lipidic oral drug-delivery platform that enables oral administration of poorly absorbed molecules. Its approved product is TLANDO (oral testosterone undecanoate, FDA-approved March 2022, licensed to Verity in the US/Canada and to partners in South Korea, the GCC and Brazil). Its CNS pipeline is centred on endogenous neuroactive steroids: LPCN 1154 (oral brexanolone, BRLIZIO) for postpartum depression is the lead asset, alongside LPCN 2201 for major depressive disorder, LPCN 2101 for epilepsy and LPCN 2203 for essential tremor. Non-CNS assets being partnered include LPCN 1148 (decompensated cirrhosis), LPCN 2401 (obesity/body composition), LPCN 1144 (NASH) and LPCN 1107 (preterm birth).
Pipeline (1)
- Postpartum depressionPhase 3Active
Catalysts · 0 upcoming · 2 reported
Recently reported
- 2026-05-26missed
LPCN 1154 (oral brexanolone)forPostpartum depressionFull results
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.
- 2026-04-02missed
LPCN 1154 (oral brexanolone)forPostpartum depressionTopline data
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.
Recent activity
- May 26, 2026ReadoutLPCN 1154 (oral brexanolone)·Postpartum depressionmissedFull 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.source ↗
- Apr 2, 2026ReadoutLPCN 1154 (oral brexanolone)·Postpartum depressionmissedPhase 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.source ↗
- Jan 20, 2026Phase changeLPCN 1154 (oral brexanolone)·Postpartum depressionPhase 3Enrollment and participant dosing completed with 90 patients randomized (above the 80 planned). No drug discontinuations, excessive sedation, loss of consciousness or drug-related SAEs reported at that point. Last patient last visit followed on 2026-02-18, at which point Lipocine disclosed a mean baseline HAM-D of 28.3 and reported all nervous-system adverse events as mild to moderate. ClinicalTrials.gov records actual primary completion 2026-01-16 and actual study completion 2026-02-17.source ↗
- Jun 26, 2025Phase changeLPCN 1154 (oral brexanolone)·Postpartum depressionPhase 3First patient dosed in the pivotal Phase 3 (NCT06979544), announced with topline guided to Q2 2026 and an NDA submission anticipated in mid-2026. Conducted at multiple US clinical sites in an outpatient setting with no requirement for healthcare-provider medical monitoring. Enrollment tracked publicly thereafter: one third randomized at 2025-09-30, first DSMB review of 30 completers recommended continuing without modification (2025-11-18, 47 dosed, no discontinuations, dose reductions, drug-related SAEs, excessive sedation or loss of consciousness), 66 of a planned 80 randomized at 2025-12-15, second DSMB review of 82 randomized/74 dosed recommending continuation and screening closed (2026-01-12).source ↗
- Mar 26, 2025Phase changeLPCN 1154 (oral brexanolone)·Postpartum depressionPhase 3Lipocine announced initiation of the outpatient pivotal Phase 3 safety and efficacy trial of LPCN 1154 in PPD, with first patient dosing expected in Q2 2025. Two-arm randomized, blinded, placebo-controlled design in women aged 15 and older with severe PPD; 48-hour dosing period; primary endpoint change from baseline in HAM-D; secondary endpoints MADRS and HAM-A; trial size powered on the treatment effect observed with approved injectable brexanolone. Per FDA protocol feedback, patients self-administer at home. This date is used as last_phase_change; the ClinicalTrials.gov actual start date is 2025-06-16.source ↗
- Feb 6, 2025Phase changeLPCN 1154 (oral brexanolone)·Postpartum depressionPhase 1REGULATORY REVERSAL — the pivotal turning point of the program. Following a Q1 2025 meeting to discuss the NDA submission package, FDA advised Lipocine that, in addition to the completed PK dosing-regimen confirmation data, an efficacy and safety study of oral LPCN 1154 in the target population would be required for the 505(b)(2) NDA. The planned Q4 2024 NDA filing did not proceed and Lipocine began planning a Phase 3. No event row was written for this because the closed event vocabulary has no code for an adverse FDA meeting outcome or changed regulatory guidance (fda_crl and fda_clinical_hold both misdescribe it) — reported as a vocabulary gap.source ↗
- Jun 25, 2024Phase changeLPCN 1154 (oral brexanolone)·Postpartum depressionPhase 1Pivotal PK bridging study met all standard bioequivalence criteria against commercial IV brexanolone (open-label randomized crossover, 24 healthy postmenopausal women, versus the approved IV90 high-dose infusion regimen): Cmax GMR 105% (90% CI 92-120%), AUC0-inf 97% (88-107%), AUC0-t 88% (80-99%), Ctrough criterion met with a higher geometric mean trough than IV. At this point FDA had agreed a 505(b)(2) NDA could be supported by the PK bridge alone and Lipocine targeted NDA submission by end of Q4 2024. Treatment was well tolerated with no sedation or somnolence events.source ↗
Competitive landscape
Other companies developing against Lipocine Inc.'s targets or indications.