Drug Profile

Pridopidine - Prilenia Therapeutics

Alternative Names: ACR-16; ASP-2314; FNP 253; FNP-254; FR-310826; Huntexil; Nurzigma; TV-7820

Latest Information Update: 13 Jul 2026

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At a glance

Originator NeuroSearch Sweden AB
Developer Ferrer; 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

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

07 Jul 2026 Prilenia in collaboration with Ferrer initiates phase III PRECISE-HD trial in Huntington’s Disease in US (PO, Capsules) (NCT07609108)
07 Jul 2026 Prilenia in collaboration with Ferrer plans a registrational phase III trial for Huntington's disease (PO, Capsule) in June 2026 (NCT07609108)
01 Feb 2026 Phase-III clinical trials in Amyotrophic lateral sclerosis in United Kingdom, Sweden, Spain, Poland, Netherlands, Italy, Israel, Germany, France, Canada, Belgium (PO) (NCT07322003)

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