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
Latest Information Update: 04 Jun 2024
At a glance
- Drugs Pramipexole/rasagiline (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Sponsors Pharma Two B
- 18 Apr 2024 Integrated analysis Results(phase 2 (NCT01968460) and phase 3 (NCT03329508), n=199) evaluating safety and tolerability profile, presented at the 76th Annual Meeting of the American Academy of Neurology 2024
- 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.