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Pramipexole

Generic Name
Pramipexole
Brand Names
Mirapex, Mirapexin, Sifrol, Pramipexole Teva, Oprymea
Drug Type
Small Molecule
Chemical Formula
C10H17N3S
CAS Number
104632-26-0
Unique Ingredient Identifier
83619PEU5T

Overview

Pramipexole is a drug used to treat the symptoms of Parkinson's Disease (PD). It is a non-ergot dopamine agonist drug that is efficacious in treating various Parkinson's symptoms such as tremor, rigidity, and bradykinesia (slow movement) . It was first approved by the FDA in 1997 . Parkinson's Disease is one of the most common neurodegenerative disorders and causes a high level of disability in patients , leading to increased difficulty in performing activities of daily living due to symptoms that progress over time . The prevalence of Parkinson's Disease worldwide has increased from approximately 2.5 million in 1990 to about 6.1 million in 2016 . This increase may be attributed to an aging population along with other contributing factors . In addition to the above FDA approval for Parkinson's Disease, pramipexole was also approved by the FDA in 2006 for the treatment of Restless Legs Syndrome (RLS) . RLS is a sleep-related disorder characterized by unpleasant sensations in the lower extremities, often accompanied by an uncontrollable urge to move the legs .

Background

Pramipexole is a drug used to treat the symptoms of Parkinson's Disease (PD). It is a non-ergot dopamine agonist drug that is efficacious in treating various Parkinson's symptoms such as tremor, rigidity, and bradykinesia (slow movement) . It was first approved by the FDA in 1997 . Parkinson's Disease is one of the most common neurodegenerative disorders and causes a high level of disability in patients , leading to increased difficulty in performing activities of daily living due to symptoms that progress over time . The prevalence of Parkinson's Disease worldwide has increased from approximately 2.5 million in 1990 to about 6.1 million in 2016 . This increase may be attributed to an aging population along with other contributing factors . In addition to the above FDA approval for Parkinson's Disease, pramipexole was also approved by the FDA in 2006 for the treatment of Restless Legs Syndrome (RLS) . RLS is a sleep-related disorder characterized by unpleasant sensations in the lower extremities, often accompanied by an uncontrollable urge to move the legs .

Indication

This drug is indicated for the symptomatic treatment of Parkinson’s disease . This drug can be administered as monotherapy or in conjunction with levodopa. It is also indicated for symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS) .

Associated Conditions

  • Moderate restless legs syndrome (RLS)
  • Parkinson's Disease (PD)
  • Severe restless legs syndrome (RLS)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/15
Phase 2
Not yet recruiting
2024/11/26
Phase 2
Not yet recruiting
2024/09/25
Phase 2
Recruiting
Clinical Academic Center (2CA-Braga)
2024/08/30
Phase 4
ENROLLING_BY_INVITATION
2024/06/13
Phase 1
Completed
2024/02/21
Phase 2
Recruiting
2023/04/24
Phase 3
Recruiting
2022/06/02
Phase 2
Not yet recruiting
Clinical Academic Center (2CA-Braga)
2022/05/02
Phase 3
Active, not recruiting
2021/08/12
Phase 4
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
ScieGen Pharmaceuticals Inc
50228-129
ORAL
0.75 mg in 1 1
1/7/2023
Zydus Lifesciences Limited
65841-735
ORAL
0.25 mg in 1 1
12/16/2022
Alembic Pharmaceuticals Limited
46708-612
ORAL
0.25 mg in 1 1
12/8/2023
Torrent Pharmaceuticals Limited
13668-092
ORAL
0.25 mg in 1 1
4/5/2022
Physicians Total Care, Inc.
54868-6237
ORAL
0.125 mg in 1 1
1/3/2012
Alembic Pharmaceuticals Limited
46708-579
ORAL
3.75 mg in 1 1
4/3/2019
ScieGen Pharmaceuticals Inc
50228-130
ORAL
1 mg in 1 1
1/7/2023
Boehringer Ingelheim Pharmaceuticals, Inc.
0597-0286
ORAL
2.25 mg in 1 1
11/8/2023
A-S Medication Solutions
50090-2217
ORAL
0.5 mg in 1 1
3/31/2021
Alembic Pharmaceuticals Limited
46708-004
ORAL
0.25 mg in 1 1
11/20/2017

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Pramipexole Dihydrochloride Tablets
国药准字HJ20140917
化学药品
片剂
8/15/2024
Pramipexole Dihydrochloride Tablets
国药准字HJ20140916
化学药品
片剂
8/15/2024
Pramipexole Dihydrochloride Tablets
国药准字H20213911
化学药品
片剂
11/30/2021
Pramipexole Dihydrochloride Tablets
国药准字HJ20140918
化学药品
片剂
8/15/2024
Pramipexole Dihydrochloride Tablets
国药准字H20203723
化学药品
片剂
12/29/2020
Pramipexole Dihydrochloride Tablets
国药准字H20203724
化学药品
片剂
12/29/2020
Pramipexole Dihydrochloride Tablets
国药准字H20193412
化学药品
片剂
12/26/2019
Pramipexole Dihydrochloride Tablets
国药准字H20213573
化学药品
片剂
7/12/2021
Pramipexole Dihydrochloride Tablets
国药准字H20213572
化学药品
片剂
7/12/2021
Pramipexole Dihydrochloride Tablets
国药准字J20180038
化学药品
片剂
12/23/2019

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
PMS-PRAMIPEXOLE TABLETS 1MG
N/A
N/A
N/A
1/31/2013
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