Initiation of the Phase 3 study for the second long-acting injectable antipsychotic using MedinCell’s technology (program mdc-TJK)

The Phase 3 study conducted in the U.S. will assess the efficacy and safety of the first subcutaneous long-acting Injectable (LAI) formulation of olanzapine for the treatment of patients with schizophrenia

MedinCell’s partner Teva, who finances and pilots the regulatory development of the product (TEV-44749), has just published details of the study protocol on clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT05693935?term=Teva&recrs=ab&phase=2&draw=2&rank=9).

Enrollment of the first patients is expected in the coming days.

mdc-TJK follows mdc-IRM (LAI risperidone), the first subcutaneous antipsychotic based on MedinCell’s technology currently under regulatory review by the U.S. FDA, with a launch target set for H1 2023.