Mapi Pharma Enrolls First Patient in Phase I/II Study for Cariprazine Injection.

Mapi Pharma has enrolled the first patient in a Phase I/II study for its cariprazine once-monthly injection, which aims to address the unmet need in the treatment of schizophrenia and bipolar disorder. The product, developed using Mapi's patented Depot technology, has demonstrated a long-acting release profile for one monthly injection. It is designed to improve upon the current daily oral dosing of cariprazine, which is already approved for these indications.

BioXcel Therapeutics, Inc. (BTAI) has released topline exploratory efficacy data from its SERENITY At-Home Pivotal Phase 3 safety trial, which demonstrated the continued effectiveness and consistent benefits of its proprietary sublingual film formulation of dexmedetomidine, Igalmi. The trial evaluated a 120 mcg dose of BXCL501 in the home setting for agitation associated with bipolar disorders or schizophrenia.

The trial results showed a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours. Patients experienced a complete resolution of agitation symptoms at significantly higher rates with BXCL501 compared to placebo, with an overall resolution of 50% in the BXCL501 arm, compared to 33% on placebo. The drug showed particularly strong performance in resolving severe and moderate agitation episodes, with 61% and 43% of episodes fully resolving in the BXCL501 arm, respectively, compared to 18% and 34% on placebo.

The data from the trial will form the basis of the sNDA submission for label expansion of Igalmi in the at-home setting, planned for the first quarter of 2026. Igalmi is currently FDA-approved and marketed for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings.

BTAI shares were up 3.07% at $3.69 at the time of publication on Wednesday, trading within its 52-week range of $1.17 to $13.36 BioXcel Drug Calms Agitation At Home For Schizophrenia, Bipolar Patients^[1].