MIRAPEX
LOE ApproachingNDAORALTABLET
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
4/8 — Partial
MIRAPEX by Boehringer Ingelheim is clinical pharmacology mechanism of action pramipexole is a nonergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the d 2 subfamily of dopamine receptors, binding with higher affinity to d 3 than to d 2 or d 4 receptor subtypes. Approved for the signs, symptoms of idiopathic parkinson's disease, moderate-to-severe primary restless legs syndrome (rls). First approved in 1997.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MIRAPEX (pramipexole) is a nonergot dopamine agonist oral tablet approved in 1997 for idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome. It works by stimulating dopamine receptors in the striatum, with highest affinity for D3 receptor subtypes. The precise therapeutic mechanism remains incompletely understood, though dopaminergic system involvement is well-established in both indications.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), suggesting defensive positioning and potential workforce rightsizing.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Pramipexole is a nonergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D 2 subfamily of dopamine receptors, binding with higher affinity to D 3 than to D 2 or D 4 receptor subtypes. Parkinson’s Disease: The…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.