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Opicapone - BIAL

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Drug Profile

Opicapone - BIAL

Alternative Names: [14C]-BIA 9-1067; BIA-91067; Ongentys; ONO-2370

Latest Information Update: 15 May 2026

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At a glance

  • Originator BIAL
  • Developer BIAL; Neurocrine Biosciences; Ono Pharmaceutical
  • Class Antiparkinsonians; Nitrobenzenes; Oxadiazoles; Oxides; Pyridines
  • Mechanism of Action Catechol O-methyltransferase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Parkinson's disease

Most Recent Events

  • 31 Dec 2025 Amneal Pharmaceuticals exercises a licensing agreement with BIAL to market and distribute opicapone
  • 05 Apr 2025 Efficacy data from the phase III EPSILON trial in Parkinson’s disease presented at the 77th Annual Meeting of the American Academy of Neurology 2025 (AAN-2025)
  • 26 Jan 2024 BIAL completes a phase III EPSILON trial for Parkinson's disease (Adjunctive treatment) in Czech Republic, Bularia, France, Belgium, Italy and Portugal (EudraCT2020-005011-52)

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