Mirapex
(Pramipexole)ApprovedSmall molecule
Boehringer IngelheimPramipexole is used to treat symptoms of Parkinson's disease, such as tremors and stiffness, and is also used to treat restless leg syndrome, a condition that causes uncomfortable sensations in the legs and an irresistible urge to move them.[2] Mirapex is currently approved and in use across 16 indications[4].[1]
Mirapex is one of 306 small molecule programs targeting Amyotrophic Lateral Sclerosis. It is currently in Approved.
16
Indications
88
Total Trials
7
Active Trials
305
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 16 indications
Competition
Competitive Landscape
120 competitors in Major Depressive Disorder
#DrugCompanyPhaseTrials
1Mirapex
Boehringer IngelheimApproved
Seroquel
EEngelhard Arzneimittel GmbH & Co.KG
Phase 3
Ketalar
Boehringer IngelheimPhase 3
Sunosi
AAxsome Therapeutics, Inc.
Phase 3
Clozaril
LLife Extension Foundation Inc.
Phase 3
Lithobid
SSolvay Pharmaceuticals
Phase 3
Psilocybin
COMPASS PathwaysPhase 3
Esketamine Hydrochloride
TThe Second Hospital of Anhui Medical University
Phase 3
Aticaprant
Johnson & JohnsonPhase 3
Selective Serotonin Reuptake Inhibitor
Johnson & JohnsonPhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Parkinson's Disease16 trials
Show 13 more trials
Restless Legs Syndrome12 trials
Show 9 more trials
Parkinson's Disease (PD)5 trials
IPEX4 trials
Show 1 more trial
SWITCH:Restless Legs Patients Switched to Ropinirole From Pramipexole
Completed·—·Phase 4·NCT00344994·20 enrolled
39 more indications
Idiopathic Parkinson's Disease3 trials
Parkinson disease3 trials
Bipolar Disorder2 trials
Targeting Cognition in Bipolar Disorder With Pramipexole
Completed·—·Phase 4·NCT02397837·103 enrolled
Efficacy and Safety2 trials
Treatment Resistant Depression2 trials
Comparison of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment Resistant Depression
Unknown status·—·Phase 4·NCT04936126·150 enrolled
Major Depressive Disorder2 trials
An Open-Label, Randomized Controlled Trial of Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
Suspended·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06705478·186 enrolled
Oral2 trials
Parkinson1 trial
Antipsychotics1 trial
Opioid Withdrawal1 trial
Sleep Disturbance1 trial
Safety and Efficacy1 trial
Renal Colic1 trial
Pramipexole and Morphine for Renal Colic
Completed·—·Phase 1/2·NCT04160520·19 enrolled
Obsessive-Compulsive Disorder1 trial
Efficacy of Treatment With Pramipexole or Risperidone in Patients With Refractory Obsessive-compulsive Disorder (OCD)
Withdrawn·—·Phase 2·NCT05401019
Tourette syndrome1 trial
Schizoaffective Disorder1 trial
Tourette Disorder1 trial
Female1 trial
Medication Adherence1 trial
Cocaine Dependence1 trial
Pramipexole as a Treatment for Cocaine Dependence
Completed·—·Phase 1·NCT01651377·10 enrolled
Essential Tremor1 trial
Older Adults (65 Years and Older)1 trial
Assessing the 30-Day Risk of Adverse Outcomes With Pramipexole Use in Older Adults With Advanced Chronic Kidney Disease: A Population-Based Cohort Study Research Protocol
Active, not recruiting·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's··NCT07382960·1,100 enrolled
Adrenoleukodystrophy1 trial
Bipolar Disorder (BD)1 trial
Regulatory
FDA Approval Timeline[5]
Jul 1, 1997
MIRAPEX
NDA NDA020667
Feb 19, 2010
MIRAPEX ER
NDA NDA022421
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Mirapex drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Pramipexole. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- D2-Like Dopamine Receptor Agonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company