Last reviewed 2026-04-20 · How we verify

PRAMIPEXOLE

Pramipexole is a marketed drug primarily indicated for Parkinson's Disease. Its key strength lies in its established market presence, supported by a key composition patent expiring in 2028. The primary risk is the eventual loss of exclusivity post-2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Parkinson's Disease

Common side effects

• Nausea
• Dizziness
• Somnolence
• Insomnia
• Constipation
• Asthenia
• Hallucinations
• Postural Hypotension
• Dyskinesia
• Extrapyramidal Syndrome
• Headache
• Confusion

Serious adverse events

• Hallucinations
• Somnolence
• Dizziness
• Nausea
• Headache
• Confusion

Drug interactions

• Dopamine antagonists (e.g., neuroleptics, phenothiazines, butyrophenones, thioxanthenes, metoclopramide)

Key clinical trials

• Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy (PHASE4)
• Single-dose,First-in-human of KLA478 (PHASE1)
• Pramipexole and the Risk of Serious Adverse Events
• Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV (PHASE2)
• Stanford RAD-AT Study (Research on Anxiety and Depression - Anhedonia Treatment)
• A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. (PHASE3)
• Phase III Long-Term Extension Study With Dexpramipexole (PHASE3)
• A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.