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Pridopidine - Prilenia Therapeutics

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Drug Profile

Pridopidine - Prilenia Therapeutics

Alternative Names: ACR-16; ASP-2314; FR-310826; Huntexil; Nurzigma; TV-7820

Latest Information Update: 30 Jul 2025

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At a glance

  • Originator NeuroSearch Sweden AB
  • Developer Massachusetts General Hospital; Prilenia Therapeutics; Teva Pharmaceutical Industries
  • Class Antidementias; Antiparkinsonians; Antipsychotics; Eye disorder therapies; Neuropsychotherapeutics; Piperidines; Small molecules; Sulfones
  • Mechanism of Action Dopamine D2 receptor antagonists; Glutamate modulators; Sigma-1 receptor agonists
  • Orphan Drug Status

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

    Yes - Amyotrophic lateral sclerosis; Huntington's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Huntington's disease
  • Phase II/III Amyotrophic lateral sclerosis
  • Phase II Parkinson's disease
  • No development reported Alzheimer's disease; Eye disorders; Fragile X syndrome; Rett syndrome
  • Discontinued Schizophrenia

Most Recent Events

  • 25 Jul 2025 European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends the refusal of the marketing authorization for pridopidine's MAA for Huntington's disease
  • 25 Jul 2025 Prilenia Therapeutics and Ferrer plan to launch pridopidine in Huntington's disease and Amyotrophic lateral sclerosis worldwide
  • 25 Jul 2025 Prilenia Therapeutics and Ferrer plan a potentially global registrational trial for Huntington's disease (PO)

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