Trial Profile

A Prospective, Dose Escalating, Open Label, Multi-center, Phase I/IIa Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine.

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 19 Aug 2026

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At a glance

12 Aug 2026 According to a Mapi Pharma media release,planning to submit an IND to the U.S. FDA by the end of 2026 with a partner who is expected to support the Phase 3 and lead marketing. If successful in Phase 3, an NDA submission is planned for 2029.
12 Aug 2026 Initial Clinical Results presented at Mapi Pharma Ltd. media release.
29 Sep 2025 New trial record

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