prasinezumab (RG7935) / Roche, Prothena - LARVOL DELTA

Prasinezumab's Impact on Neuromelanin- and Iron-Sensitive MRI Biomarkers in Parkinson's disease: Findings From the PADOVA Phase IIb Study (MDS Congress 2026) - No abstract available

Biomarker • P2b data • CNS Disorders • Movement Disorders • Parkinson's Disease

Prasinezumab in Early-Stage Parkinson’s Disease: Additional Data from the PADOVA Study (MDS Congress 2026) - No abstract available

CNS Disorders • Movement Disorders • Parkinson's Disease

Multitargeted drug strategies for Alzheimer's and Parkinson's diseases. (PubMed, Z Naturforsch C J Biosci) - "A few potential candidates, such as GV-971, Prasinezumab, Huperzine A, curcumin derivatives, and hybrids of MAO-B inhibitors, have shown neuroprotective and cognitive effects in preclinical and clinical studies. However, there are still major obstacles to be overcome, such as the ability to cross the blood-brain barrier, optimizing the pharmacokinetics, the difficulties of transferring from the animal to the human model, and the complexity of the regulatory process. New strategies based on nanomedicine, biomarker-driven trials, personalized medicine, and drug repurposing will enhance therapeutic precision and clinical success."

Journal • Review • Alzheimer's Disease • CNS Disorders • Inflammation • Metabolic Disorders • Movement Disorders • Parkinson's Disease

Active Clinical Development Portfolio (Businesswire) - "Roche is conducting the Phase 3 PARAISO clinical trial in approximately 900 participants with early-stage Parkinson's disease; primary completion expected in 2029 (NCT07174310)."

Trial completion date • Parkinson's Disease

The Efficacy and Safety of Monoclonal Antibodies That Target Alpha-Synuclein in Parkinson's Disease: A Systematic Review. (PubMed, Parkinsons Dis) - P2 | "These assessed Prasinezumab, Cinpanemab, Exidavnemab and Lu-AF82422 with heterogeneity amongst studies. Future trials may benefit from the inclusion of subjects at earlier disease stages, diagnosed before clinical features have emerged. Trial Registration: ClinicalTrials.gov identifier: NCT03100149."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

The conundrum of alpha-synuclein antibody failures in Parkinson's disease: a narrative review of mechanisms and alternative metabolic hypotheses. (PubMed, Ther Adv Neurol Disord) - "However, high-profile Phase II and III clinical trials, such as those for cinpanemab and prasinezumab, failed to demonstrate clinical efficacy. Multifactorial contributors to trial failure include the inadequacy of preclinical models such as MPTP, the insensitivity of the MDS-UPDRS, diagnostic heterogeneity and the statistical reality of neuronal loss rates. Future therapeutic strategies must integrate intracellular neuroprotection alongside extracellular clearance approaches, with significantly earlier intervention."

Journal • Review • CNS Disorders • Metabolic Disorders • Movement Disorders • Parkinson's Disease

PARAISO: A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease (clinicaltrials.gov) - P3 | N=900 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P3 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

PARAISO: A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Hoffmann-La Roche

Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

PARAISO: A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

PARAISO: A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease (clinicaltrials.gov) - P3 | N=900 | Recruiting | Sponsor: Hoffmann-La Roche

Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

PADOVA: A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease (clinicaltrials.gov) - P2 | N=586 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Dec 2026 ➔ Jun 2031

Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

PreCoDe / BN45387: A randomized, double-blind, placebo-controlled, 104-week proof-of-concept study to evaluate the efficacy of intravenous prasinezumab in participants with Parkinson's disease carrying a severe mutation in the GBA gene (prevent cognitive decline in GBA-associated PD) (clinicaltrialsregister.eu) - P1/2 | N=88 | Not yet recruiting | Sponsor: Universitaetsklinikum Tuebingen AR

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease • GBA

Progress of Immunotherapies in Parkinson's Disease. (PubMed, CNS Neurosci Ther) - "Although current α-syn-targeted immunotherapies have shown limited clinical efficacy, ongoing advances in precision immunotherapy and individualized intervention strategies may help overcome existing therapeutic bottlenecks. This review provides a strategic framework for the future development of disease-modifying therapies for PD."

Journal • Review • CNS Disorders • Developmental Disorders • Movement Disorders • Parkinson's Disease

Sustained effect of prasinezumab on Parkinson’s disease motor progression in the open-label extension of the PASADENA trial, 5-year update (WPC 2026) - "The effect of prasinezumab on slowing down motor progression in PD as measured by clinicians and study participants is sustained for up to 5 years relative to an external comparator. Abstract has been submitted for consideration to the 2026 Alzheimer's & Parkinson's Diseases Conference (AD/PD)."

Clinical • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease

Remote monitoring of motor signs in the PADOVA phase IIb study of prasinezumab: the role of the practically-defined OFF state (WPC 2026) - P2 | "The prespecified analyses of remote digital data in PADOVA showed no robust group differences, likely due to mixed ON/OFF L-dopa state data. Post-hoc analyses showed consistent trends favoring prasinezumab in digital data collected in practically defined OFF, but not ON, state. These exploratory results replicate the PASADENA ph2a Simple Sum digital finding and align with the clinical PADOVA readout."

P2b data • CNS Disorders • Movement Disorders • Parkinson's Disease

Prasinezumab's impact on neuromelanin- and iron-sensitive MRI biomarkers in Parkinson's disease: findings from the PADOVA Phase IIb study (WPC 2026) - P2 | "Exploratory biomarker analysis of PADOVA suggests that prasinezumab is biologically active. This is supported by imaging biomarkers crucial to PD pathology, showing a slowing in the progressive loss of NM signal in SNpc and reduced iron accumulation in the putamen. Abstract has been submitted for consideration to the 2026 Alzheimer's & Parkinson's Diseases Conference (AD/PD)."

Biomarker • P2b data • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease

Prasinezumab in early-stage Parkinson's disease: additional data from the PADOVA study (WPC 2026) - P2 | "Although the primary endpoint of PADOVA was missed, the totality of evidence suggests a possible clinical benefit of prasinezumab in slowing down disease progression in early-stage PD on top of symptomatic medication. Effects observed during double-blind treatment appear to be sustained over an additional 6 months of open-label treatment. These results warrant further exploration in Phase III."

Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease

Prasinezumab: what have we learned from PASADENA and PADOVA? (PubMed, Lancet) - No abstract available

Journal

Efficacy and safety of intravenous prasinezumab in individuals with early-stage Parkinson's disease on stable symptomatic monotherapy (PADOVA): a phase 2b, multicentre, randomised, double-blind, placebo-controlled study. (PubMed, Lancet) - P2, P3 | "Although PADOVA did not meet the primary endpoint, prespecified exploratory evidence suggests clinical activity of prasinezumab in early-stage Parkinson's disease, supporting continued investigation in the ongoing phase 3 PARAISO trial (NCT07174310)."

Clinical • Journal • Monotherapy • P2b data • CNS Disorders • Movement Disorders • Parkinson's Disease

Business Highlights and Upcoming Milestones (Businesswire) - "Roche is conducting the Phase 3 PARAISO clinical trial in approximately 900 participants with early-stage Parkinson's disease; primary completion expected in 2029 (NCT07174310)...Roche has stated that prasinezumab has peak sales potential greater than $3.5 billion...Bristol Myers Squibb is conducting the Phase 2 TargetTau-1 clinical trial in approximately 310 patients with early Alzheimer’s disease; primary completion expected in 1H 2027 (NCT06268886)...PRX019, a potential treatment of neurodegenerative diseases in development in collaboration with Bristol Myers Squibb...Prothena could potentially earn a $55 million clinical milestone payment if Bristol Myers Squibb decides to advance the program; BMS decision expected by YE 2026."

Pipeline update • Sales • Trial completion date • Alzheimer's Disease • Parkinson's Disease

SUSTAINED EFFECT OF PRASINEZUMAB ON PARKINSON'S DISEASE MOTOR PROGRESSION IN THE OPEN-LABEL EXTENSION OF THE PASADENA TRIAL, 5-YEAR UPDATE (ADPD 2026) - "The effect of prasinezumab on slowing motor progression in PD as measured by clinicians and study participants is sustained for 5 years versus an external comparator."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

DIGITAL HEALTH TECHNOLOGY DETECTS GROUP DIFFERENCES IN PRACTICALLY-DEFINED OFF L-DOPA STATE: RESULTS OF PADOVA PH IIB STUDY OF PRASINEZUMAB (ADPD 2026) - P2 | "Post-hoc DHT analyses showed consistent trends favoring prasinezumab in digital data collected in the practically-defined OFF L-DOPA state, in line with the PASADENA ph2a Simple Sum digital finding and clinical PADOVA readout."

CNS Disorders • Movement Disorders • Parkinson's Disease

PRASINEZUMAB'S IMPACT ON NEUROMELANIN- AND IRON-SENSITIVE MRI BIOMARKERS IN PARKINSON'S DISEASE: FINDINGS FROM THE PADOVA PHASE IIB STUDY (ADPD 2026) - P2 | "Exploratory biomarker analysis of PADOVA suggests that prasinezumab is biologically active. This is supported by imaging biomarkers crucial to PD pathology, showing a slowing in the progressive loss of NM signal in SNpc and reduced iron accumulation in the putamen."

Biomarker • P2b data • CNS Disorders • Movement Disorders • Parkinson's Disease

THE EFFICACY AND SAFETY OF MONOCLONAL ANTIBODIES THAT TARGET ALPHA-SYNUCLEIN IN PARKINSON'S DISEASE: A SYSTEMATIC REVIEW (ADPD 2026) - "Results were synthesised narratively, and sensitivity analysis removing studies with high risks of bias was performed. After screening 1509 articles, 10 publications comprising a total of 13 studies were included, investigating Prasinezumab, Cinpanemab, Exidavnemab, and Lu-AF82422. Monoclonal antibodies that target alpha-synuclein in Parkinson's disease have a favourable safety profile, but their efficacy remains unclear. Future trials may benefit from including subjects at earlier disease stages, diagnosed using biomarkers or recognised preclinical features prior to the onset of clinical symptoms. Longer duration of future studies may increase sensitivity to delayed therapeutic effects."

Clinical • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

PRASINEZUMAB IN EARLY-STAGE PARKINSON'S DISEASE: ADDITIONAL DATA FROM THE PADOVA STUDY (ADPD 2026) - P2 | "Although the primary endpoint of PADOVA was missed, the totality of evidence suggests a possible clinical benefit of prasinezumab in slowing down disease progression in early-stage PD on top of symptomatic medication. Effects observed during double-blind treatment appear to be sustained over an additional 6 months of open-label treatment. These results warrant further exploration in Phase III."

CNS Disorders • Movement Disorders • Parkinson's Disease