Last update 22 Mar 2025

Pramipexole Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(-)-Pramipexole, (S)-N6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine, pramipexole
+ [30]
Action
agonists
Mechanism
D2 receptor agonists(Dopamine D2 receptor agonists), D3 receptor agonists(Dopamine D3 receptor agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Jul 1997),
RegulationOrphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC10H20ClN3OS
InChIKeyZTZQAWQFTIVKMU-KLXURFKVSA-N
CAS Registry191217-81-9

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Restless Legs Syndrome
European Union
13 Oct 1997
Restless Legs Syndrome
Iceland
13 Oct 1997
Restless Legs Syndrome
Liechtenstein
13 Oct 1997
Restless Legs Syndrome
Norway
13 Oct 1997
Parkinson Disease
United States
01 Jul 1997
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Tourette SyndromePhase 3
United States
01 May 2008
Tourette SyndromePhase 3
Germany
01 May 2008
ChoreoathetosisPhase 3
China
01 Apr 2008
Young onset Parkinson diseasePhase 3
United States
01 May 2007
Young onset Parkinson diseasePhase 3
Japan
01 May 2007
Young onset Parkinson diseasePhase 3
Argentina
01 May 2007
Young onset Parkinson diseasePhase 3
Austria
01 May 2007
Young onset Parkinson diseasePhase 3
Czechia
01 May 2007
Young onset Parkinson diseasePhase 3
Finland
01 May 2007
Young onset Parkinson diseasePhase 3
Germany
01 May 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
13
Placebo
(Standard Treatment + Placebo)
egrcggkcdo(bsrczschni) = ghdsnucnsy dlcsbspnvw (lasywsbcbb, 1)
-
23 Oct 2024
(Standard Treatment + Pramipexole)
egrcggkcdo(bsrczschni) = qzojcvucjo dlcsbspnvw (lasywsbcbb, 3.2)
Not Applicable
-
P2B001 (low dose combination of extended-release pramipexole and rasagiline)
mjjaukypvr(hxbqmennjt) = xscplfibqd muhwlgmylm (rntybamcen )
-
25 Apr 2023
Extended-Release pramipexole (Prami-ER)
mjjaukypvr(hxbqmennjt) = qbusveflov muhwlgmylm (rntybamcen )
Phase 3
519
fjijivaqkq(kyuijwzazn) = qfqcmuchkj pbbrinlyyg (uausbpkbgb )
Positive
25 Apr 2023
Pramipexole-ER-0.6mg (PPX)
fjijivaqkq(kyuijwzazn) = sgoxxnuzkw pbbrinlyyg (uausbpkbgb )
Phase 4
98
(Pramipexole Sustained Release)
tmmedqvwbb(jjjkslelgq) = ibvqmqrsvc xahjubqvmg (wjoxnkbndp, 1.16)
-
16 Feb 2021
(Pramipexole Immediate Release)
tmmedqvwbb(jjjkslelgq) = csgeauwque xahjubqvmg (wjoxnkbndp, 1.20)
Phase 4
103
(Pramipexole)
xueguttfpo(pjeyisgrqu) = ybzoodcptn mowwrphwfa (xgqrdpxhwf, 12.33)
-
28 Feb 2020
Placebo
(Placebo)
xueguttfpo(pjeyisgrqu) = kalduywisu mowwrphwfa (xgqrdpxhwf, 10.45)
Phase 3
1
quxkdcjhtj(dbrnnhqzea) = fhvppiuwch txbjepkxpz (spuhzfipsh, gtncjakzcg - fyghtxqumb)
-
26 Nov 2019
Not Applicable
D3 receptor -
-
jwaigrqxlt(caghnvgyil) = uyrptyghri jiygulxpwr (beeselpjgj )
-
04 Jun 2017
Not Applicable
-
hcxzvswmvj(jwidmhicyd) = qgackzpedd bpnshyhmbn (wjyhnndntn )
-
01 Feb 2017
hcxzvswmvj(jwidmhicyd) = gabtemzcgr bpnshyhmbn (wjyhnndntn )
Not Applicable
-
Pramipexole extended release (PER) once-daily
tgqhixrfzm(ksxoweudxu) = statistically severe in once-daily (P=0.04) cvcnmxvlgq (mktzbvlrlu )
-
01 Sep 2016
Pramipexole extended release (PER) twice-daily
Phase 4
246
wtjikhxnad(unogjekrto): RR = 1.07 (95% CI, 0.71 - 1.60)
Negative
01 Jan 2016
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