Mirapex, Sifrol(pramipexole)
Mirapexin, Oprymea, Pramipexole, Sifrol (pramipexole) is a small molecule pharmaceutical. Pramipexole was first approved as Mirapex on 1997-07-01. It is used to treat depressive disorder and parkinson disease in the USA. It has been approved in Europe to treat parkinson disease and restless legs syndrome. The pharmaceutical is active against D(3) dopamine receptor and D(2) dopamine receptor.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Pramipexole (discontinued: Mirapex, Pramipexole)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pramipexole dihydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MIRAPEX | Boehringer Ingelheim | N-020667 DISCN | 1997-07-01 | 7 products, RLD |
| MIRAPEX ER | Boehringer Ingelheim | N-022421 DISCN | 2010-02-19 | 7 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mirapex | New Drug Application | 2010-12-29 |
| pramipexole | ANDA | 2016-10-13 |
| pramipexole dihydrochloride | ANDA | 2025-07-15 |
| pramipexole dihydrochloride pramipexole dihydrochloride | ANDA | 2024-07-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| parkinson disease | EFO_0002508 | D010300 | G20 |
| depressive disorder | EFO_1002014 | D003866 | F32.A |
Agency Specific
FDA
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Clinical
Clinical Trials
174 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 2 | 11 | 7 | 23 | 43 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | 3 | 6 | 4 | 7 | 20 |
| Syndrome | D013577 | — | — | — | 3 | 6 | 4 | 6 | 19 |
| Psychomotor agitation | D011595 | — | — | — | 3 | 5 | 4 | 6 | 18 |
| Depression | D003863 | — | F33.9 | — | — | — | 2 | 3 | 5 |
| Dyssomnias | D020920 | — | — | — | — | — | 1 | — | 1 |
| Parasomnias | D020447 | — | G47.5 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | 1 | — | — | — | 1 |
| Parkinsonian disorders | D020734 | — | G20.C | — | 1 | — | — | — | 1 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | — | — | — | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Impulse control disruptive and conduct disorders | D007174 | — | F63.2 | — | — | — | — | 1 | 1 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pramipexole |
| INN | pramipexole |
| Description | Pramipexole is a member of the class of benzothiazoles that is 4,5,6,7-tetrahydro-1,3-benzothiazole in which the hydrogens at the 2 and 6-pro-S-positions are substituted by amino and propylamino groups, respectively. It has a role as an antiparkinson drug, a dopamine agonist, an antidyskinesia agent and a radical scavenger. It is a member of benzothiazoles and a diamine. It is a conjugate base of a pramipexole(2+). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCN[C@H]1CCc2nc(N)sc2C1 |
Identifiers
| PDB | — |
| CAS-ID | 104632-26-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL301265 |
| ChEBI ID | 8356 |
| PubChem CID | 119570 |
| DrugBank | DB00413 |
| UNII ID | 83619PEU5T (ChemIDplus, GSRS) |
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Estimated US medical usage
Pramipexole
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Trends
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Safety
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8,266 adverse events reported
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