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Also known as Brexanolone
LPCN 1154A · 2 trials · 7 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 activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, 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 Tablets |
| 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 second trimester and no later than the first 4 weeks following delivery * Are \< 18 months postpartum at Screening * Hamilton Depression Rating Scale (HAM-D) 17...
LPCN 1154A is an investigational oral small molecule being developed for postpartum depression (PPD), also described as postnatal, post-natal, or peripartum depression. It is being studied in women aged 15 years and older. It is not approved for any use and remains in clinical development.
LPCN 1154A is being developed by Lipocine Inc., which trades on the Nasdaq under the ticker LPCN. The company is the sponsor of the clinical program evaluating the drug in postpartum depression.
LPCN 1154A is in Phase 3 development. Two Phase 3 trials have been run in postpartum depression: one has completed and one is currently recruiting. The drug is investigational and has not been approved by the FDA.
LPCN 1154A has been studied in two Phase 3 postpartum depression trials. NCT06979544, a completed Phase 3 study of oral LPCN 1154A in women with severe PPD, enrolled 90 participants. NCT07822321, titled Brexanolone Lifting Outcomes Of Moms, is a recruiting Phase 3 trial with planned enrollment of 120.
The LPCN 1154A Phase 3 trials are randomized, double-blind, and placebo-controlled, and they enroll only female participants aged 15 years and older. The completed study NCT06979544 enrolled 90 women with severe postpartum depression, and the recruiting study NCT07822321 plans to enroll 120 participants in the United States.
LPCN 1154A is an oral small molecule developed by Lipocine, while brexanolone is a separate intravenously administered therapy. The recruiting Phase 3 trial NCT07822321 carries the title Brexanolone Lifting Outcomes Of Moms, but LPCN 1154A itself is the oral investigational candidate being tested in that study.