RO7823653 History and Updates

3 events · 2026 – present

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

0
FDA Approvals
0
Label Revisions
3
Trial Milestones
0
Pivotal Publications
RO7823653 — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2026202720282029Trial: NCT07425522 2026-04-21 → 2028-11-17 (primary completion)today (2026-05-21)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-21Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for RO7823653 since 2026, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07425522
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edem

Past events

2026
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07425522
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edem

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.