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First long-acting injectable (LAI) antipsychotic using MedinCell’s technology reaches Phase 3 clinical study primary completion date

November 12, 2020

The primary completion date1 for the pivotal efficacy study to investigate mdc-IRM, an investigational subcutaneous
risperidone, was reached on September 30, 2020. The estimated study completion date2 has been moved forward to November 24, 2020 from January 31, 2021.

Phase 3 safety investigations continue with an estimated study completion date scheduled on December 31, 2020.
“We are pleased that mdc-IRM continues to progress through the development process,” stated Christophe Douat, CEO of MedinCell. “We are excited that the first long-acting injectable antipsychotic using our proprietary technology has reached this Phase 3 clinical milestone. Our partner anticipates having the readout of the trial sometime in Q1 2021.”

mdc-IRM is the most advanced in development of three antipsychotic products based on MedinCell’s technology and is being developed by Teva Pharmaceuticals. There is another investigational product currently in Phase 1 (mdc-TJK), and another in preclinical development (mdc-ANG).


1 The primary completion date is the date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. The primary outcome measure is the most important for evaluating the effect of a treatment.
2 Study completion date is the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant’s last visit).

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