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LPCN 1154A · 1 trial · 6 indications
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
| Arm | Type | Description |
|---|---|---|
| LPCN 1154A Tablets | EXPERIMENTAL | LPCN 1154A |
| Placebo Tablets | PLACEBO_COMPARATOR | Placebo Tablets |
| Name | Type | Description |
|---|---|---|
| LPCN 1154A | DRUG | Oral LPCN 1154A tablets for 48 hours |
| Placebo | DRUG | Oral Placebo Tablets for 48 hours |
Key Inclusion Criteria: * Are female between 15 and 45 years of age, inclusive; * Have had a depressive episode that began no earlier than third trimester and later than the first 4 week following delivery * Are \< 12 months postpartum at Screening * Hamilton Depression Rating Scale (HAM-D) 17-item...
LPCN 1154A is an investigational oral small molecule being developed for the treatment of postpartum depression (PPD), a form of depression occurring after childbirth. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
LPCN 1154A is being developed by Lipocine Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LPCN. The company is conducting clinical trials to evaluate the safety and efficacy of this oral therapy for postpartum depression.
LPCN 1154A is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 3 trial has been completed, and the drug remains under clinical investigation for the treatment of postpartum depression.
LPCN 1154A has one completed Phase 3 clinical trial registered as NCT06979544. This randomized, double-blind, placebo-controlled study assessed the safety and efficacy of oral LPCN 1154A in 90 women with severe postpartum depression in the United States.
LPCN 1154A is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for postpartum depression. The completed Phase 3 trial (NCT06979544) evaluated its safety and efficacy, but regulatory approval has not been granted.