Lipocine Inc. LPCN
Lipocine Inc. (Nasdaq: LPCN) is a CNS/neurology/psychiatry drug developer. Its lead program, LPCN 1154 (Brlizio), is in Phase 3 for Postpartum depression (PPD). Its next catalyst on record is LPCN 1154: BLOOM Phase 3 study completion (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: LPCN 1154 — BLOOM Phase 3 study completion (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| TLANDO | Testosterone replacement therapy | small molecule | Approved |
| LPCN 1154 (Brlizio) | Postpartum depression | small molecule | Phase 3 |
| LPCN 1107 | Prevention of recurrent preterm birth | small molecule | Phase 2 |
| LPCN 2203 | Essential tremor | small molecule | Phase 1 |
| LPCN 2101 | Drug-resistant epilepsy / women with epilepsy | small molecule | Phase 1 |
| LPCN 2201 | Major depressive disorder (MDD) | small molecule | Pre-clinical |
| LPCN 1111 (TLANDO XR) | Testosterone replacement therapy | small molecule | Pre-clinical |
| LPCN 1148 | Decompensated cirrhosis / overt hepatic encephalopathy prevention | small molecule | Pre-clinical |
| LPCN 2401 | Obesity management (body composition adjunct to incretin mimetics) | small molecule | Pre-clinical |
Recent results and decisions
- Sep 14, 2026started 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 - started Lipocine initiated the BLOOM Phase 3 placebo-controlled outpatient study for LPCN 1154 in postpartum depression, expected to enroll approximately 120 participants.
In September 2026, Lipocine announced the initiation of the BLOOM (Brexanolone Lifting Outcomes of Moms) study.
Filing - approval Health Canada approved TLANDO for testosterone replacement therapy in adult males with conditions associated with testosterone deficiency.
In September 2026, Health Canada approved TLANDO® (testosterone undecanoate) capsules for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism).
Filing
5 more on record.
For subscribers
- 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
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.