Trial Profile
A Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 10 Apr 2023
Price :
$35
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At a glance
- Drugs Pramipexole/rasagiline (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Sponsors Pharma Two B
- 20 Jan 2022 According to a Pharma Two B media release, the company is planning to file an NDA for P2B001 in H2 2022.
- 15 Dec 2021 According to a Pharma Two B media release, based on the Phase IIb and Phase III results, the company is preparing for regulatory submission for P2B001 and plan to submit a New Drug Application to the FDA in 2022.
- 08 Jun 2017 Results presented at the 21st International Congress of Parkinson's Disease and Movement Disorders