Prasinezumab History and Updates

10 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
10
Trial Milestones
0
Pivotal Publications
Prasinezumab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20212022202320242025202620272028202920302031Trial: NCT07055087 2025-12-31 → 2030-12-31 (primary completion)Trial: NCT07174310 2025-11-24 → 2029-06-30 (primary completion)Trial: NCT04777331 2021-05-05 → 2024-09-11 (primary completion)Results posted — 2025-12-02 Trial results posted: NCT04777331 A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Diseasetoday (2026-06-08)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Prasinezumab since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07174310
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Past events

2025
Results posted· ClinicalTrials.gov
Trial results posted: NCT04777331
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07174310
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
2024
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04777331
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
2021
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04777331
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.