Drug Overview
Ongentys (Neurocrine/Bial/Ono Pharmaceutical) is a once-daily formulation of the catechol-O-methyltransferase (COMT) inhibitor opicapone, approved as an add-on therapy to levodopa for the treatment of Parkinson’s disease patients with end-of-dose motor fluctuations. Being a COMT inhibitor, Ongentys limits peripheral levodopa metabolism, thus increasing the molecules delivery to the brain. This prolongs the effect of each levodopa dose, and helps patients to remain free of motor symptoms for longer. In addition, as a third-generation COMT inhibitor, Ongentys is hypothesized to provide inhibitory potency while avoiding cell toxicity.
Ongentys was first approved in the EU in July 2016, where it is marketed by Bial. In February 2017, Bial and Neurocrine entered into a licensing agreement for the development and marketing of Ongentys in North America. Neurocrine anticipates filing Ongentys for regulatory approval in the US in H1 2019, without needing to conduct a separate US clinical trial. Ono Pharmaceutical has exclusive rights to develop and commercialize Ongentys in Japan.
Ongentys (Neurocrine/Bial/Ono Pharmaceutical) is a once-daily formulation of the catechol-O-methyltransferase (COMT) inhibitor opicapone, approved as an add-on therapy to levodopa for the treatment of Parkinson’s disease patients with end-of-dose motor fluctuations. Being a COMT inhibitor, Ongentys limits peripheral levodopa metabolism, thus increasing the molecules delivery to the brain. This prolongs the effect of each levodopa dose, and helps patients to remain free of motor symptoms for longer. In addition, as a third-generation COMT inhibitor, Ongentys is hypothesized to provide inhibitory potency while avoiding cell toxicity.
Ongentys was first approved in the EU in July 2016, where it is marketed by Bial. In February 2017, Bial and Neurocrine entered into a licensing agreement for the development and marketing of Ongentys in North America. Neurocrine anticipates filing Ongentys for regulatory approval in the US in H1 2019, without needing to conduct a separate US clinical trial. Ono Pharmaceutical has exclusive rights to develop and commercialize Ongentys in Japan.
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