Mirapex, Sifrol(pramipexole)
Mirapex, Mirapexin, 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.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Mirapex (generic drugs available since 2010-07-06)
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 ER | Boehringer Ingelheim | N-022421 RX | 2010-02-19 | 7 products, RLD |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| mirapex | New Drug Application | 2021-08-27 |
| pramipexole dihydrochloride | ANDA | 2023-04-06 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| depressive disorder | EFO_1002014 | D003866 | F32.A |
| parkinson disease | EFO_0002508 | D010300 | G20 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
128 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 6 | 16 | 11 | 14 | 47 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | 4 | 7 | 8 | 3 | 21 |
| Healthy volunteers/patients | — | 10 | — | — | 1 | 1 | 12 | ||
| Depression | D003863 | F33.9 | — | — | 1 | 4 | 2 | 7 | |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | 2 | — | 5 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | 1 | 1 | — | 2 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | 1 | — | 1 | ||
| Adrenoleukodystrophy | D000326 | Orphanet_43 | E71.52 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | 6 | 4 | 2 | — | 1 | 11 |
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | 1 | 1 | — | — | 2 |
| Anhedonia | D059445 | R45.84 | — | 1 | 1 | — | — | 2 | |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | 1 | — | — | 2 |
| Eosinophilia | D004802 | HP_0001880 | D72.1 | — | 1 | 1 | — | — | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 1 | — | — | 1 |
| Psychotic disorders | D011618 | F20.81 | — | — | 1 | — | — | 1 | |
| Essential tremor | D020329 | EFO_0003108 | G25.0 | — | — | 1 | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | 1 | — | — | 1 |
| Sleep wake disorders | D012893 | G47 | — | 1 | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | 1 | — | — | — | 2 |
| Parkinsonian disorders | D020734 | HP_0001300 | — | 1 | — | — | — | 1 | |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | — | — | — | 1 |
| Renal colic | D056844 | EFO_1001412 | N23 | 1 | 1 | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | — | — | 1 |
| Dysthymic disorder | D019263 | EFO_0008623 | F34.1 | — | 1 | — | — | — | 1 |
| Nasal polyps | D009298 | HP_0100582 | J33 | — | 1 | — | — | — | 1 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | — | 1 | — | — | — | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | F14 | 1 | — | — | — | — | 1 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Chronic pain | D059350 | HP_0012532 | 1 | — | — | — | — | 1 | |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Emotions | D004644 | — | — | — | — | 1 | 1 | ||
| Motivation | D009042 | — | — | — | — | 1 | 1 | ||
| Reward | D012201 | — | — | — | — | 1 | 1 | ||
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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 | 746741 |
| ChEMBL ID | CHEMBL301265 |
| ChEBI ID | 8356 |
| PubChem CID | 119570 |
| DrugBank | DB00413 |
| UNII ID | 83619PEU5T (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 5,364 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
878 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more