Teva Pharmaceuticals has informed MedinCell of its decision to initiate the Phase 3 clinical trial for mdc-TJK.
MedinCell will immediately receive a $3 million payment from Teva Pharmaceuticals for reaching this stage of project development.
The Phase 3 study will evaluate the efficacy and safety of what may be the first subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of patients with schizophrenia.
mdc-TJK follows on from mdc-IRM (risperidone LAI), the first subcutaneous antipsychotic based on MedinCell’s technology currently under regulatory review by the US FDA, expected to launch in 2023.