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Find Drugs in Development News & Deals for Pramipexole Dihydrochloride

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  • TABLET;ORAL - 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Details:

P2B001 showed superior efficacy to each of its individual components in the trial and comparable efficacy to marketed doses of Pramipexole ER, but with reduced adverse events related to dopaminergic side effects and sleepiness, and with less worsening on the ESS.


Lead Product(s): Pramipexole Dihydrochloride,Rasagiline Mesylate

Therapeutic Area: Neurology Product Name: P2B001

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 15, 2022

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Details:

Results demonstrated that P2B001, a combination of dopamine agonist, pramipexole, and MAO-B inhibitor, rasagiline has symptomatic benefits comparable to higher doses of marketed pramipexole ER, yet with less dopaminergic side effects and significantly less daytime sleepiness.


Lead Product(s): Pramipexole Dihydrochloride,Rasagiline Mesylate

Therapeutic Area: Neurology Product Name: P2B001

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 05, 2022

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Details:

Results demonstrate P2B001 (pramipexole) distinctive combination of efficacy and enhanced safety, supporting its potential as a first-line treatment option for people with early PD.


Lead Product(s): Pramipexole Dihydrochloride,Rasagiline Mesylate

Therapeutic Area: Neurology Product Name: P2B001

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 20, 2022

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Details:

Under the terms of the agreement, Myung In Pharm will seek regulatory approval for P2B001 in South Korea and will manufacture, commercialize and distribute P2B001 in the region.


Lead Product(s): Pramipexole Dihydrochloride,Rasagiline Mesylate

Therapeutic Area: Neurology Product Name: P2B001

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Myung In Pharm

Deal Size: $5.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement November 18, 2021

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Details:

The proceeds will support Phase 3 pivotal trials for CTC-501 for the treatment of Major Depressive Disorder (MDD) and CTC-413 for the treatment of Parkinson’s Disease (PD) as well as completion of the development and validation of a diagnostic product for Parkinson’s Disease.


Lead Product(s): Pramipexole Dihydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: CTC-501

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Chinalink Asia Holdings

Deal Size: $20.0 million Upfront Cash: Undisclosed

Deal Type: Series B Financing October 20, 2021

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