Pramipexole
Approved · EMAAlso known as Mirapex, (-)-Pramipexole, Pramipexol, (S)-N 6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine+2 more
Mirapex, (-)-Pramipexole, Pramipexol, (S)-N 6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine, Pramipexole Dihydrochloride, Pramipexolum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Precision Care for Major Depressive Disorder
Adjunctive Treatment With Pramipexole for Anhedonic Depression Symptoms in Depression - PRIME-PRAXOL
Non-opioid Pramipexole Suppresses Immune NLRP3 Reactivity for Pain Control
Market withdrawal: Pramipexole Accord (EMA)
Approval: Pramipexole Teva (EMA)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e.… Show full indicationShow less
Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).
Indication: Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the… Show full indicationShow less
Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Indication: Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of… Show full indicationShow less
Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations). Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Precision Care for Major Depressive Disorder
Recent completions
Trials that read out recently, adding to the completed evidence base.
Adjunctive Treatment With Pramipexole for Anhedonic Depression Symptoms in Depression - PRIME-PRAXOL
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes2
Journals, researchers & institutions
- Brain : a journal of neurology1
- The Journal of clinical psychiatry1
- Belloso-Iguerategui A1
- Braga RJ1
- Burdick KE1
- Cotman CW1
- Fernández-Irigoyen J1
- Gago B1
- Malhotra AK1
- Merino-Galan L1
- Center for Applied Medical Research (CIMA)1
- Clinical Neuroproteomics Unit1
- Institute for Memory Impairments and Neurological Disorders1
- Instituto de Neurobiología1
- Mount Sinai School of Medicine1
- Navarra Institute for Health Research (IdiSNA)1
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.