Mapi Pharma Reports Positive Phase I/IIa Results for Once-Monthly Cariprazine Depot

Long-Acting Injectable Cariprazine Shows Encouraging Safety Results

Mapi Pharma Ltd. has announced initial clinical results from its ongoing Phase I/IIa study of Cariprazine Depot, a once-monthly injectable formulation being developed for patients who need cariprazine treatment.

The early results support the continued development of the long-acting injectable therapy. Mapi said the treatment showed a safety profile consistent with the established safety profile of oral cariprazine.

The company is developing Cariprazine Depot as a potential alternative to the current once-daily oral form of cariprazine.

Cariprazine Is Currently Available as a Daily Oral Treatment

Cariprazine is an atypical antipsychotic used to treat schizophrenia, bipolar I disorder and major depressive disorder (MDD).

At present, cariprazine is available as a once-daily oral treatment.

For people living with chronic psychiatric conditions, taking medication every day can sometimes be difficult. Long-acting injectable treatments can help reduce the number of doses a patient needs to remember and may support better treatment adherence.

This is where Mapi's Cariprazine Depot is being developed.

Mapi Is Developing a Once-Monthly Injection

Cariprazine Depot is a subcutaneous long-acting injectable formulation designed to be given once a month.

The company is using its proprietary depot technology to slowly release cariprazine over approximately one month.

Instead of taking an oral dose every day, patients could potentially receive a monthly injection if the treatment successfully completes clinical development and receives regulatory approval.

The formulation is being studied for potential use in schizophrenia, bipolar disorder and MDD.

Phase I/IIa Study Evaluates Safety and Drug Exposure

The ongoing Phase I/IIa study is a prospective, dose-escalating, open-label and multicenter clinical trial.

The study is evaluating the pharmacokinetics, safety and tolerability of once-monthly subcutaneous Cariprazine Depot in people who are eligible to receive oral cariprazine.

After a washout period, participants received a single 22 mg subcutaneous injection of Cariprazine Depot.

The study is registered on ClinicalTrials.gov under identifier NCT07185815.

Cohort 1 Shows No Serious Adverse Events

Mapi has now reported the topline results from Cohort 1.

No serious adverse events were reported among participants receiving Cariprazine Depot.

The company also reported that treatment-related adverse events were mild.

Injection site reactions were also described as mild. Injection site pain resolved quickly, with an average duration of less than one day.

These early findings provide an initial look at how the injectable formulation was tolerated by participants.

Fewer Treatment-Related Events Reported With the Depot

Mapi also reported differences in treatment-related non-injection-site adverse events.

These events occurred in fewer participants and were less frequent with Cariprazine Depot than with oral cariprazine.

Participants were initially treated with oral cariprazine, allowing the company to analyze their data in relation to both treatment approaches.

Overall, Mapi reported that once-monthly Cariprazine Depot used as add-on therapy was safe and well tolerated in the first cohort.

The company plans to continue evaluating the therapy as the Phase I/IIa study progresses.

Why a Monthly Cariprazine Treatment Could Matter

Long-term treatment for psychiatric conditions can involve a number of challenges.

Patients may miss daily doses, stop treatment because of inconvenience or struggle to maintain a consistent medication routine.

A long-acting injectable can reduce the number of times medication needs to be administered.

For clinicians, a monthly treatment could also make it easier to monitor whether a patient is receiving their medication as planned.

Mapi is therefore developing Cariprazine Depot around a simple idea: maintain cariprazine exposure while reducing the need for daily oral dosing.

Cariprazine Has a Large Commercial Market

Cariprazine is already an established medicine.

Vraylar, the branded cariprazine capsule marketed in the United States by AbbVie, generated approximately $3.6 billion in global net revenues in 2025.

The patent covering Vraylar is expected to expire in 2029.

This existing market gives long-acting cariprazine a potentially significant commercial opportunity if Cariprazine Depot can demonstrate its benefits in later-stage clinical trials and gain regulatory approval.

Mapi Plans to Submit a U.S. IND

Mapi Pharma said it plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration by the end of 2026.

The company expects to work with a partner that would support Phase 3 development and lead marketing activities.

Mapi plans to remain responsible for manufacturing the drug for clinical studies and future commercial supply from its GMP-approved manufacturing facilities.

If the Phase 3 program is successful, Mapi currently plans to submit a New Drug Application in 2029.

Mapi CEO Highlights Next Development Steps

Ehud Marom, chairman and chief executive officer of Mapi Pharma, said the company is encouraged by the clinical results.

He also highlighted the company's plans to move the program toward U.S. regulatory development and work with a partner for the next stage of clinical development and commercialization.

The company expects its manufacturing facilities to support both clinical development and potential commercial supply.

Mapi's Long-Acting Injectable Pipeline

Cariprazine Depot is part of Mapi Pharma's broader portfolio of complex injectable medicines.

The company focuses on therapies where formulation technology, manufacturing capabilities and intellectual property can create barriers to entry.

Its pipeline includes long-acting formulations targeting central nervous system disorders and metabolic diseases.

Mapi is also developing long-acting versions of GLP-1 therapies, including semaglutide and tirzepatide, for diabetes and weight management.

The company is developing an AB-rated generic version of naltrexone, marketed as Vivitrol, and also markets generic versions of fingolimod and apremilast in selected regions.

Manufacturing and Formulation Capabilities Support the Pipeline

Mapi combines expertise in chemistry, pharmaceutical development and clinical execution with an intellectual property portfolio focused largely on drug formulations.

The company operates dedicated research and development facilities as well as aseptic manufacturing facilities for long-acting injectable products.

For Cariprazine Depot, these capabilities are expected to support the program as it moves from early clinical testing toward potential Phase 3 development.

The next major steps for the program include continued clinical evaluation, preparation of the planned U.S. IND submission and selection of a development and commercial partner for the later stages of development.