Lipocine Inc. LPCN

Nasdaq · Phase 3 · CNS/neurology/psychiatry · small molecule · EDGAR · Updated Oct 24, 2026

Lipocine Inc. (Nasdaq: LPCN) is a CNS/neurology/psychiatry drug developer. Its lead program, LPCN 1154, is in Phase 3 for Postpartum depression.

Upcoming catalysts

No catalyst is dated to the next 30 days or to an FDA action date.

Program	Indication	Modality	Stage
LPCN 1154	Postpartum depression	small molecule	Phase 3
LPCN 1148	Decompensated cirrhosis	small molecule	Phase 2
LPCN 1107	Prevention of preterm birth	small molecule	Phase 2
LPCN 2201	MDD	small molecule	Pre-clinical
LPCN 2203	Essential tremor	small molecule	Pre-clinical
LPCN 2101	Epilepsy	small molecule	Pre-clinical
LPCN 2401	Obesity body composition	small molecule	Pre-clinical

Sep 14, 2026
started Company announced initiation of BLOOM, a ~120-participant Phase 3 placebo-controlled PPD study; first participant dosing expected early Q4 2026.First participant dosing is expected in early Q4 2026. Filing
Aug 4, 2026
started Company says it has initiated a new placebo-controlled trial in PPD to complement the existing LPCN 1154 database; FDA guidance meeting scheduled for Q3 2026.We have initiated a new placebo controlled clinical trial for PPD to complement the existing LPCN 1154 clinical database, and to further characterize the efficacy and safety of LPCN 1154. Filing
Jul 8, 2026
approval Ex-US regulatory action: Pharmalink received UAE marketing authorization for TESTYRA (TLANDO) on July 8, 2026.On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA® (TLANDO) in the UAE. Filing

3 more on record.

Cash runway against each catalyst, with the company's own runway statement
Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
Expected move for each dated catalyst, from comparable past events
Phase 2 evidence behind each Phase 3 readout
Companies on the same target or class
Full catalyst list with filing sentences, deals, registered trials, Excel export