NESS ZIONA, Israel, August 12, 2026
Mapi Pharma Ltd. announced initial clinical results from its ongoing Phase I/IIa study of Cariprazine Depot, supporting continued development of the company’s once-monthly subcutaneous long-acting injectable formulation of cariprazine. The investigational therapy is being developed to provide sustained drug release over approximately one month and potentially offer an alternative to the currently available once-daily oral cariprazine for patients with schizophrenia, bipolar disorder and major depressive disorder (MDD). Initial results from Cohort 1 showed a safety and tolerability profile consistent with the established profile of oral cariprazine, with no serious adverse events reported and treatment-related adverse events characterized as mild. Mapi said the results support further clinical development and its plans to pursue a U.S. FDA Investigational New Drug (IND) submission by the end of 2026.
Phase I/IIa Study Evaluates Once-Monthly Cariprazine Depot
The ongoing prospective, dose-escalating, open-label, multicenter Phase I/IIa clinical trial is evaluating the pharmacokinetics, safety and tolerability of once-monthly subcutaneous injections of Cariprazine Depot in participants eligible for oral cariprazine treatment. Following a washout period, participants in Cohort 1 received a single 22 mg subcutaneous injection of the investigational depot formulation. The company reported that Cariprazine Depot demonstrated a safety profile consistent with the known profile of oral cariprazine. No serious adverse events were observed, while treatment-related adverse events were mild. Injection-site reactions were also mild, with injection-site pain resolving rapidly and having a mean duration of less than one day. These findings provide an initial clinical basis for continuing development, although the early results are limited to the available cohort and do not yet establish the efficacy or long-term safety of the once-monthly formulation.
Long-Acting Formulation Could Address Treatment Adherence Challenges
Cariprazine is an established atypical antipsychotic approved for schizophrenia, bipolar I disorder and MDD, but it is currently administered as a daily oral therapy. Mapi is developing Cariprazine Depot using its proprietary depot technology, with the goal of maintaining therapeutic drug exposure through a once-monthly injection. Long-acting injectable formulations can potentially simplify treatment schedules and support medication adherence in patients requiring chronic psychiatric treatment. In the Phase I/IIa study, Mapi reported that treatment-related non-injection-site adverse events occurred in fewer participants and were less frequent with Cariprazine Depot than with oral cariprazine in the study’s within-patient comparison. However, these findings should be interpreted cautiously because the study is early-stage, open-label and designed primarily to assess PK, safety and tolerability, rather than demonstrate comparative clinical efficacy.
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Mapi Pharma Plans FDA Submission and Potential Phase 3 Development
The positive initial safety findings provide a development milestone as Mapi Pharma prepares for the next stages of the Cariprazine Depot program. CEO Ehud Marom said the company plans to submit an IND application to the U.S. FDA by the end of 2026, with a partner expected to support Phase 3 development and commercialization. Mapi also expects to remain responsible for manufacturing clinical and commercial supplies from its GMP-approved facilities. If the program successfully advances through Phase 3, the company currently anticipates an NDA submission in 2029. Cariprazine has demonstrated significant commercial demand through its established oral formulation, creating a potentially attractive market opportunity for a long-acting injectable version. Nevertheless, Cariprazine Depot remains investigational, and successful Phase 3 efficacy, safety, regulatory review and approval will be required before it can become an approved monthly treatment option.
Source:Mapi Pharma, press release
