Knight Seeks COFEPRIS Approval for Parkinson’s Drug in Mexico

Knight Therapeutics, through its Mexican subsidiary Grupo Biotoscana de Especialidad, has submitted a marketing authorization application to COFEPRIS for CREXONT, an extended-release oral formulation of Carbidopa/Levodopa (CD/LD) intended for the treatment of Parkinson’s disease.

The submission marks a key step in Knight Therapeutics' regional strategy to expand its neurology portfolio across Latin America. CREXONT combines immediate-release granules and extended-release microspheres to address motor fluctuations in patients requiring consistent dopamine levels. The formulation targets Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism following carbon monoxide or manganese poisoning.

Knight Therapeutics obtained exclusive rights to seek regulatory approval and commercialize CREXONT in Canada and Latin America through an agreement signed in January 2024 with Amneal Pharmaceuticals. In July 2025, Health Canada accepted Knight Therapeutics’ submission of the product for review.

According to the Instituto Nacional de Neurología y Neurocirugía, Parkinson’s disease affects an estimated 500,000 people between ages 45 and 60 in Mexico. Globally, it is one of the fastest-growing neurological conditions. Although not classified as fatal, Parkinson’s disease is associated with significant disability and healthcare burden, particularly in aging populations.

Pending approval, CREXONT would offer a new treatment option for Mexican patients with Parkinson’s disease, complementing current therapies while potentially reducing the frequency of daily dosing.