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- ||| brexanolone extended release (BRII-296) / Brii Biosci
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - Mar 22, 2024
P2, N=11, Completed, Sponsor: Brii Biosciences Limited
Active, not recruiting --> Completed | N=24 --> 11 | Trial completion date: Jun 2024 --> Mar 2024 | Trial primary completion date: Jun 2024 --> Mar 2024
- | brexanolone extended release (BRII-296) / Brii Biosci
Enrollment closed: A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - Jan 11, 2024
P2, N=24, Active, not recruiting, Sponsor: Brii Biosciences Limited
Active, not recruiting --> Completed | N=24 --> 11 | Trial completion date: Jun 2024 --> Mar 2024 | Trial primary completion date: Jun 2024 --> Mar 2024 Recruiting --> Active, not recruiting
- brexanolone extended release (BRII-296) / Brii Biosci
Phase classification: A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - Dec 13, 2023
P2, N=24, Recruiting, Sponsor: Brii Biosciences Limited
Recruiting --> Active, not recruiting Phase classification: P2a --> P2
- || brexanolone extended release (BRII-296) / Brii Biosci
New P2 trial, New P2a trial: A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD) (clinicaltrials.gov) - Sep 28, 2023
P2a, N=24, Recruiting, Sponsor: Brii Biosciences Limited
- Zulresso (brexanolone) / Sage Therapeutics, BRII-296 / Brii Biosci
BRII-296 Demonstrates a Favorable Safety Profile for Sedation - Results from a Phase 1 Study of Safety, and Pharmacokinetics of BRII-296, an Extended-Release Injectable Formulation of Brexanolone in Healthy Adult Subjects (Salon 4) - May 9, 2023 - Abstract #ASCP2023ASCP_400;
No excessive sedation or loss of consciousness was observed. SSS median scores were normal across all cohorts with two isolated reports of sleepiness.