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Drug ReportsPramipexole
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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YTD
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
mental disordersD001523
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
MIRAPEXBoehringer IngelheimN-020667 DISCN1997-07-01
7 products, RLD
MIRAPEX ERBoehringer IngelheimN-022421 DISCN2010-02-19
7 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
mirapexNew Drug Application2010-12-29
pramipexoleANDA2016-10-13
pramipexole dihydrochlorideANDA2024-10-09
pramipexole dihydrochloride pramipexole dihydrochlorideANDA2024-07-23
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Pramipexole Dihydrochloride, Mirapex Er, Boehringer Ingelheim
86795332029-09-08DPU-219
76957342028-04-26DP
ATC Codes
N: Nervous system drugs
— N04: Anti-parkinson drugs
— N04B: Dopaminergic agents
— N04BC: Dopamine agonists
— N04BC05: Pramipexole
HCPCS
No data
Clinical
Clinical Trials
172 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 diseaseD010300EFO_0002508G2021021172674
Restless legs syndromeD012148EFO_0004270G25.81—4911730
SyndromeD013577——1498628
Psychomotor agitationD011595———499627
DepressionD003863—F33.9—539522
Healthy volunteers/patients———12——1114
Depressive disorderD003866EFO_1002014F32.A—425213
Major depressive disorderD003865EFO_0003761F22—213—6
Bipolar disorderD001714EFO_0000289F30.9—3—2—5
Treatment-resistant depressive disorderD061218—————213
Show 15 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Amyotrophic lateral sclerosisD000690HP_0007354G12.21742—112
Motor neuron diseaseD016472EFO_0003782G12.2742—112
SclerosisD012598——242—17
EosinophiliaD004802HP_0001880D72.1—24——6
AsthmaD001249EFO_0000270J45—14——5
Pulmonary eosinophiliaD011657EFO_0007257J82.81—14——5
AnhedoniaD059445—R45.84—12——3
Tourette syndromeD005879EFO_0004895F95.2—11——2
SchizophreniaD012559EFO_0000692F20——1——1
Psychotic disordersD011618—F20.81——1——1
Show 12 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Nervous system diseasesD009422—G00-G99—2——13
Obsessive-compulsive disorderD009771EFO_0004242F4212———3
Compulsive personality disorderD003193—F60.512———3
Central nervous system diseasesD002493HP_0002011G96.9—2———2
Brain diseasesD001927HP_0001298G93.40—2———2
Movement disordersD009069HP_0100022——2———2
Neurodegenerative diseasesD019636EFO_0005772G31.9—2———2
Parkinsonian disordersD020734HP_0001300G20.C—1——12
DyskinesiasD020820HP_0002310G24—2———2
Anxiety disordersD001008EFO_0006788F41.1—1——12
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191———12
Compulsive behaviorD003192—R46.811————1
Cocaine-related disordersD019970—F141————1
Substance-related disordersD019966EFO_0003890F131————1
Chronic painD059350HP_0012532—1————1
Basal ganglia diseasesD001480HP_0002134—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Shy-drager syndromeD012791EFO_1001050—————11
Multiple system atrophyD019578——————11
Neurologic gait disordersD020233HP_0003376R26.1————11
Huntington diseaseD006816Orphanet_399G10————11
Progressive supranuclear palsyD013494EFO_0002512G23.1————11
Corticobasal degenerationD000088282——————11
EmotionsD004644——————11
MotivationD009042——————11
RewardD012201——————11
Heart failureD006333HP_0001635I50————11
Show 1 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePramipexole
INNpramipexole
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—
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Structure (InChI/SMILES or Protein Sequence)
CCCN[C@H]1CCc2nc(N)sc2C1
Identifiers
PDB—
CAS-ID104632-26-0
RxCUI—
ChEMBL IDCHEMBL301265
ChEBI ID8356
PubChem CID119570
DrugBankDB00413
UNII ID83619PEU5T (ChemIDplus, GSRS)
Target
Agency Approved
DRD3
DRD3
DRD2
DRD2
Organism
Homo sapiens
Gene name
DRD3
Gene synonyms
NCBI Gene ID
Protein name
D(3) dopamine receptor
Protein synonyms
Dopamine D3 receptor, essential tremor 1
Uniprot ID
Mouse ortholog
Drd3 (13490)
D(3) dopamine receptor (P30728)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Pramipexole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,173 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,936 adverse events reported
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