Drugs / Prasinezumab
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 2 met primary | ||||||
| Phase 1 | NCT02157714 | Jun 2014 → Sep 2016 | Parkinson disease | Prothena Biosciences Ltd. | Completed | Met primary |
| Phase 1 | NCT02095171 | Mar → Dec 2014 | Parkinson disease | Prothena Biosciences Ltd. | Completed | Met primary |
| Phase 23 trials · 2 missed | ||||||
| Phase 2 | NCT07055087 | Dec 2025 → Dec 2030 expected | Parkinson disease | University Hospital Tuebingen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04777331 | May 2021 → Sep 2024 overdue | Parkinson disease | Hoffmann-La Roche | Active not recruiting | Missed primary |
| Phase 2 | NCT03100149 | Jun 2017 → Nov 2019 overdue | Parkinson disease | Hoffmann-La Roche | Active not recruiting | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07174310 | Nov 2025 → Jun 2029 expected | Parkinson disease | Hoffmann-La Roche | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-06-16 | Hoffmann-La Roche | Results Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease roche.com ↗
Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson’s disease. |
| 2025-06-16 | Prothena Biosciences Ltd. | Results Prothena’s Partner Roche to Advance Prasinezumab into Phase III Development for Early-Stage Parkinson's Disease prothena.com ↗
Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson’s disease. |
| 2025-04-03 | Hoffmann-La Roche | Results Roche presents novel therapeutic and diagnostic advancements in Alzheimer’s at AD/PD 2025 roche.com ↗
Results from the Phase IIb PADOVA study were presented for the first time, investigating prasinezumab in 586 people with early-stage Parkinson’s disease while on stable symptomatic treatment. |
| 2024-12-19 | Hoffmann-La Roche | Results Roche’s Phase IIb study of prasinezumab missed primary endpoint, but suggests possible benefit in early-stage Parkinson’s disease roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the Phase IIb PADOVA study investigating prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. |
| 2024-12-19 | Prothena Biosciences Ltd. | Results Roche’s Phase IIb Study of Prasinezumab Missed Primary Endpoint, But Suggests Possible Clinical Benefit in Early-Stage Parkinson’s Disease prothena.com ↗
Prothena Corporation plc (NASDAQ:PRTA), today announced results from the Phase IIb PADOVA study conducted by partner Roche investigating prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. |
| 2022-03-16 | Prothena Biosciences Ltd. | Results Prothena Presents New Data for Alzheimer’s and Parkinson’s Disease Programs at AD/PD 2022 prothena.com ↗
Oral presentation by partner Roche on the Phase 2 PASADENA study of prasinezumab, an α-synuclein antibody being developed for the treatment of Parkinson’s, further supports a potential effect on delaying motor progression in patients |
| 2021-06-15 | Hoffmann-La Roche | Results Roche data at EAN 2021 showcase significant impact of therapies across diverse neuroscience portfolio roche.com ↗
In the PASADENA study, prasinezumab was the first anti-alpha-synuclein antibody to show evidence of slowing clinical decline of PD motor signs and demonstrated a favourable safety profile. |
| 2021-03-08 | Prothena Biosciences Ltd. | Results Prothena to Hold Investor Webcast to Review Three Oral Presentations from AD/PD 2021 prothena.com ↗
New analyses of prasinezumab continue to support potential disease modifying effect of prasinezumab in Parkinson’s disease; |
| 2020-09-11 | Prothena Biosciences Ltd. | Results Prasinezumab Slows Progression on Measures of Parkinson’s Disease in Phase 2 Study prothena.com ↗
In the study, prasinezumab significantly reduced decline in motor function by 35% (pooled dose levels) vs. placebo after one year of treatment |
| 2020-04-22 | Prothena Biosciences Ltd. | Results Update on Phase 2 PASADENA Study of Prasinezumab (PRX002/RG7935) in Parkinson’s Disease prothena.com ↗
As updated by Roche during its 1Q20 earnings announcement , the study did not meet the primary objective, but showed signals of efficacy. |
| 2018-06-19 | Prothena Biosciences Ltd. | Results Prothena Announces Phase 1b Clinical Trial Results of PRX002/RG7935 for Parkinson's Disease Published in JAMA Neurology prothena.com ↗
CNS penetration was demonstrated by a dose-dependent increase in PRX002/RG7935 levels in CSF, and a mean concentration of PRX002/RG7935 in CSF of 0.3 percent relative to serum across all dose levels. |
| 2017-04-02 | Prothena Biosciences Ltd. | Results Clinical Results Presented from Prothena's Phase 1b Study of PRX002/RG7935 Demonstrating Robust Antibody CNS Penetration and Significant Reduction of Free Serum Alpha-synuclein in Patients with Parkinson's Disease prothena.com ↗
All dose levels of PRX002/RG7935 found to have an acceptable safety and tolerability profile, meeting the primary objective of this study |
| 2016-12-13 | Prothena Biosciences Ltd. | Results First-In-Human Assessment of PRX002, Prothena's Anti-Alpha Synuclein Antibody for Parkinson's Disease, Published in Movement Disorders Journal prothena.com ↗
The data, which was previously presented in June 2015 as part of the late breaking oral session at the 19th International Congress of Parkinson's Disease and Movement Disorders, demonstrated that PRX002 was generally safe and well-tolerated in healthy volunteers, meeting the primary objective of the study. |
| 2016-11-09 | Prothena Biosciences Ltd. | Results Prothena Reports Results from Phase 1b Study of PRX002 Demonstrating Robust Antibody CNS Penetration and Significant Reduction of Free Serum Alpha-synuclein in Patients with Parkinson's Disease prothena.com ↗ |
| 2015-06-17 | Prothena Biosciences Ltd. | Results Prothena Presents Clinical Results Demonstrating Robust, Rapid Reduction in Levels of Free Serum Alpha-Synuclein of Up to 96% After Single Dose of PRX002, Novel Protein Immunotherapy for Parkinson's Disease prothena.com ↗ |
| 2015-03-19 | Prothena Biosciences Ltd. | Results Prothena Reports Robust Reduction of Free Serum Alpha-Synuclein of up to 96% After Single Dose of PRX002, a Novel Protein Immunotherapy for Parkinson's Disease prothena.com ↗
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced positive results from a Phase 1 single ascending dose study of PRX002, a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies. |
All press releases naming this drug 24 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Prasinezumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07055087 ↗ |
| Known as | PRX002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02095171 ↗ |
| Known as | RG7935 | “PRX002/RG7935 (PRX002) is a humanized monoclonal” PMID 29913017 ↗ Oct 2018 |
| Known as | RO7046015 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03100149 ↗ |
| Modality | Monoclonal antibody | “monoclonal anti-α-synuclein antibody prasinezumab” NCT07055087 ↗ |
| Route | Intravenous | “Administered by Intravenous Infusion” NCT02095171 ↗ |
| Target | SNCA | “Alpha-synuclein binding agent” CHEMBL4298077 ↗ |