pramipexole

Trade name: mirapex

Small moleculeapproved

Approved

Jul 1, 1997

Pramipexole is a nonergot dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 subfamily of dopamine receptors, binding with higher affinity to D3 than to D2 or D4 receptor subtypes. The relevance of D3 receptor binding in Parkinson's disease is unknown. The precise mechanism of action of Pramipexole as a treatment for Parkinson's disease is unknown, although it is believed to be related to its ability to stimulate dopamine receptors in the striatum. This conclusion is supported by electrophysiologic studies in animals that have demonstrated that Pramipexole influences striatal neuronal firing rates via activation of dopamine receptors in the striatum and the substantia nigra, the site of neurons that send projections to the striatum. Pramipexole is used for the treatment of signs and symptoms of idiopathic Parkinson's disease. — NCATS

Clinical trial activity

109 trials · 82 clinical orgs · 39 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jun 1, 1998 (NCT02233023)

Timeline

1990s

Jul 1, 1997
Pharmacia & Upjohn — Earliest FDA Approval
Jul 1, 1997
Boehringer Ingelheim — NDA Secondary Org
Jul 1, 1997
Pharmacia & Upjohn — NDA Organization
Jan 1, 1998
Boehringer Ingelheim — Earliest Phase 3 Sponsor(trial)

2000s

Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
Jan 1, 2003
Earliest Phase 1 Sponsor(trial)
Feb 19, 2008
Barr Laboratories — Marketing Organization
Feb 19, 2008
Heritage Pharma — Marketing Organization

2010s

Apr 9, 2010
Mylan — Marketing Organization
Jul 6, 2010
Sandoz — Marketing Organization
Jul 6, 2010
Novartis — Marketing Organization
Oct 8, 2010
Alembic — Marketing Organization
Oct 8, 2010
Esteve Labs — Marketing Organization
Oct 8, 2010
Glenmark Pharmaceuticals — Marketing Organization
Oct 8, 2010
Teva — Marketing Organization
Oct 8, 2010
Torrent Pharmaceuticals Limited — Marketing Organization
Oct 8, 2010
Watson Pharmaceuticals — Marketing Organization
Oct 8, 2010
Nostrum Laboratories — Marketing Organization
Oct 8, 2010
Chartwell Pharmaceuticals — Marketing Organization
Oct 8, 2010
Natco Pharma — Marketing Organization
Oct 8, 2010
PHARMOBEDIENT — Marketing Organization
Apr 30, 2012
Zennova — Marketing Organization
Apr 30, 2012
Apotex — Marketing Organization
Sep 20, 2012
Macleods Pharmaceuticals, Ltd — Marketing Organization
Oct 26, 2012
Aurobindo Pharma — Marketing Organization
Mar 27, 2013
Sun Pharmaceuticals — Marketing Organization
Feb 6, 2014
Anchen Pharmaceuticals, Inc — Marketing Organization
Feb 6, 2014
Par Pharmaceuticals — Marketing Organization
Feb 6, 2014
Endo Pharmaceuticals — Marketing Organization
Feb 6, 2014
PH HEALTH — Marketing Organization
Jun 3, 2014
Strides Pharma Science — Marketing Organization
Oct 28, 2014
Sciegen Pharmaceticals — Marketing Organization
Aug 7, 2015
Dr. Reddy's Laboratories — Marketing Organization
Apr 21, 2016
Actavis — Marketing Organization
Apr 21, 2016
Allergan PLC (2015) — Marketing Organization
Jun 24, 2016
Neogen — Marketing Organization
Dec 12, 2017
Zydus Discovery DMCC — Marketing Organization
Oct 3, 2018
Shijiazhuang Pharma Group (CSPC) — Marketing Organization
Oct 3, 2018
Graviti Pharmaceuticals — Marketing Organization
Oct 3, 2018
Rising Pharmaceuticals — Marketing Organization
Dec 19, 2018
Unichem — Marketing Organization

2020s

Jun 11, 2021
LP Pharmaceuticals — Marketing Organization
Feb 3, 2022
Novast Labs — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

D2-like dopamine receptorAGONIST
D2-like dopamine receptor agonist

Approval history

approvedJul 1, 1997

Chemistry & pharmacology

Loading structure…

SMILES

C=CCN1CCc2nc(N)sc2CC1

Mol. weight: 209.32 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Availability: Prescription Only

Oral

Parenteral

Topical

Sources

Also known as

2,6-benzothiazolediamine, 4,5,6,7-tetrahydro-n6-propyl-, (s)-
2,6-benzothiazolediamine, 4,5,6,7-tetrahydro-n(sup 6)-propyl-, (s)-
2,6-benzothiazolediamine, 4,5,6,7-tetrahydro-n(sup 6)-propyl-, (s)-
2-amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole
2-amino-6-allyl-5,6,7,8-tetrahydro-4h-thiazolo-(5,4-d)azepin-dihydrochloride
2-amino-6-propylaminotetrahydrobenzothiazole
4,5,6,7-tetrahydro-n6-propyl-2,6-benzothiazole-diamine
4h-thiazolo(4,5-d)azepin-2-amine, 5,6,7,8-tetrahydro-6-(2-propenyl)-, dihydrochloride
6,7-tetrahydro-n6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate
6-allyl-2-amino-5,6,7,8-tetrahydro-4h-thiazolo(4,5-d)azepin dihydrochloride
bht920
b ht920
b-ht 920
bht 920
domin
kns760704
kns 760704
kns-760704
kns-760704
kns-760704
kns-760704
mirapex
mirapex
mirapex
mirapex
mirapex
mirapex er
mirapex er
mirapex extended release
mirapexin
mirapexin
mirapexin
mirapexin
neliprax
oprymea
oprymea
oprymea
pipexus
pnu-98528e
pnu-98528e
pramipexol
pramipexol
pramipexol
pramipexol
pramipexol dihydrobromide
pramipexol dihydrobromide, (+-)-isomer
pramipexol dihydrochloride, (s)-isomer
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
pramipexole
(-)-pramipexole
(-)-pramipexole
pramipexole dihydrochloride
pramipexole dihydrochloride
pramipexole dihydrochloride
pramipexole dihydrochloride
pramipexole dihydrochloride
pramipexole dihydrochloride monohydrate
pramipexole dihydrochloride monohydrate
pramipexole dihydrochloride monohydrate
pramipexole dihydrochloride monohydrate
pramipexole hcl
pramipexole hcl
pramipexole hydrochloride
pramipexole hydrochloride
pramipexole hydrochloride
pramipexole hydrochloride
pramipexole hydrochloride
pramipexole hydrochloride hydrate
pramipexol, (+-)-isomer
pramipexol, (r)-isomer
pramipexolum
pramipexolum
sifrol
sifrole
(s)-n 6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
(s)-n 6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine
snd-919
snd919cl2x
snd 919cl2x
snd-919cl2x
snd919cl2y
snd919cl2y
snd-919cl2y
snd-919cl2y
(s)-pramipexole
sud-919cl2y
sud-919cl2y
talipexole
talipexole
talipexole
talipexole
talipexole
talipexole hcl
talipexole hydrochloride
talipexole hydrochloride
talipexole hydrochloride
talipexole hydrochloride
u-98528e
u-98528e

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07240675	Phase 1	Nov 26, 2025	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
NCT07022405	Phase 2	Aug 31, 2025	National Institute of Mental Health (NIMH), Stanford University
NCT06705478	Phase 2	Jan 17, 2025	Cipla, National Institute of Allergy and Infectious Diseases (NIAID)
NCT06580041	Phase 4	Nov 12, 2024	University of California, San Francisco
NCT06611592	Phase 2	Aug 20, 2024	Clinical Academic Center, 2CA-Braga, Portugal
NCT06457204	Phase 1	Jun 27, 2024	Boehringer Ingelheim
NCT06269146	Phase 2	May 13, 2024	Columbia University, National Institute of Mental Health (NIMH), University of California, San Diego
NCT05825235	Phase 3	Apr 21, 2023	Lund University, Region Skane
NCT05355337	Phase 3	Nov 30, 2022	Lund University, Region Skane
NCT05401019	Phase 2	Jun 30, 2022	Clinical Academic Center, 2CA-Braga, Portugal, University of Minho
NCT04759703	Phase 2/Phase 3 (Phase 3)	Oct 1, 2021	Harvard University
NCT05003648	Phase 4	Sep 30, 2021	European Leukodystrophy Association, Harvard University
NCT04936126	Phase 4	Aug 7, 2021	All India Institute of Medical Sciences, Indian Council of Medical Research
NCT04275492	N/A	Apr 30, 2020	Zhejiang University
NCT04249544	Phase 1	Feb 29, 2020	Department of Defense, Vanderbilt University
NCT04160520	Phase 1/Phase 2 (Phase 2)	Oct 28, 2019	East Carolina University
NCT04121091	Phase 2	Oct 4, 2019	Lund University, Region Skane
NCT03817554	Phase 4	Jul 1, 2019	Peking University
NCT03842709	Early Phase 1 (Phase 1)	May 1, 2019	University of New Mexico
NCT03845387	Phase 2	Feb 28, 2019	Kissei Pharmaceuticals

Showing 20 of 109 trials

Page 1 / 6

Organizations

Research & Development (82)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Boehringer Ingelheim	For profit	45	42	5	1998
National Institute of Mental Health (NIMH)	Government	7	2	2	2001
Harvard University	Academic/Hospital	5	4	3	2003
Bennett, James P., Jr., M.D., Ph.D.	Academic/Hospital	3	3	2	2005
Columbia University	Academic/Hospital	3	1	3	2014
GlaxoSmithKline	For profit	3	1	3	2006
Lund University	Academic/Hospital	3	0	2	2019
Region Skane	Government	3	3	2	2019
Teva	For profit	3	3	2	2005
Chase Therapeutics	For profit	2	2	1	2018
Clinical Academic Center, 2CA-Braga, Portugal	Academic/Hospital	2	2	1	2022
Department of Defense	Government	2	0	2	2004
Icahn School of Medicine at Mount Sinai	Academic/Hospital	2	0	1	2014
Knopp Biosciences	For profit	2	2	1	2008
Northwell Health	Academic/Hospital	2	1	1	2005
Peking University	Academic/Hospital	2	2	1	2018
Pfizer	For profit	2	2	1	2008
Pharma Two B Ltd.	For profit	2	2	1	2013
PRACS	For profit	2	0	1	2005
Research Foundation for Mental Hygiene, Inc.	Academic/Hospital	2	1	2	2014

82 organizations

Page 1 / 5

Marketing (48)

Organization	Org type	Relationship	Date
Actavis	For profit	MKTG	Apr 21, 2016
Actavis	For profit	SYN	Nov 30, 2010
Alembic	For profit	MKTG	Oct 8, 2010
Alembic	For profit	SYN	Oct 8, 2010
Allergan PLC (2015)	For profit	MKTG	Apr 21, 2016
Anchen Pharmaceuticals, Inc	For profit	MKTG	Feb 6, 2014
Apotex	For profit	MKTG	Apr 30, 2012
Aurobindo Pharma	For profit	MKTG	Oct 26, 2012
Barr Laboratories	For profit	MKTG	Feb 19, 2008
Boehringer Ingelheim	For profit	NDA2	Jul 1, 1997
Chartwell Pharmaceuticals	For profit	MKTG	Oct 8, 2010
Dr. Reddy's Laboratories	For profit	MKTG	Aug 7, 2015
Dr. Reddy's Laboratories	For profit	SYN	Aug 7, 2015
Endo Pharmaceuticals	For profit	MKTG	Feb 6, 2014
Esteve Labs	For profit	MKTG	Oct 8, 2010
Glenmark Pharmaceuticals	For profit	MKTG	Oct 8, 2010
Glenmark Pharmaceuticals	For profit	SYN	Oct 8, 2010
Graviti Pharmaceuticals	For profit	MKTG	Oct 3, 2018
Heritage Pharma	For profit	SYN	Feb 19, 2008
Heritage Pharma	For profit	MKTG	Feb 19, 2008
LP Pharmaceuticals	For profit	MKTG	Jun 11, 2021
Macleods Pharmaceuticals, Ltd	For profit	MKTG	Sep 20, 2012
Mylan	For profit	MKTG	Apr 9, 2010
Natco Pharma	For profit	MKTG	Oct 8, 2010
Natco Pharma	For profit	SYN	Apr 9, 2010
Neogen	For profit	MKTG	Jun 24, 2016
Nostrum Laboratories	For profit	MKTG	Oct 8, 2010
Novartis	For profit	MKTG	Jul 6, 2010
Novast Labs	For profit	MKTG	Feb 3, 2022
PH HEALTH	For profit	MKTG	Feb 6, 2014
PHARMOBEDIENT	For profit	MKTG	Oct 8, 2010
Par Pharmaceuticals	For profit	MKTG	Feb 6, 2014
Pharmacia & Upjohn	For profit	NDA	Jul 1, 1997
Rising Pharmaceuticals	For profit	MKTG	Oct 3, 2018
Sandoz	For profit	MKTG	Jul 6, 2010
Sandoz	For profit	SYN	Dec 4, 2014
Sciegen Pharmaceticals	For profit	MKTG	Oct 28, 2014
Shijiazhuang Pharma Group (CSPC)	For profit	MKTG	Oct 3, 2018
Strides Pharma Science	For profit	MKTG	Jun 3, 2014
Sun Pharmaceuticals	For profit	MKTG	Mar 27, 2013
Teva	For profit	MKTG	Oct 8, 2010
Torrent Pharmaceuticals Limited	For profit	MKTG	Oct 8, 2010
Unichem	For profit	MKTG	Dec 19, 2018
Unichem	For profit	SYN	Dec 19, 2018
Watson Pharmaceuticals	For profit	MKTG	Oct 8, 2010
Zennova	For profit	MKTG	Apr 30, 2012
Zydus Discovery DMCC	For profit	MKTG	Dec 12, 2017
Zydus Discovery DMCC	For profit	SYN	Jul 6, 2010