DS5361b History and Updates

3 events · 2025 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-15Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for DS5361b since 2025, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completionMar 18, 2030· ClinicalTrials.gov

Phase 1 primary completion: NCT07182591

A Study of DS5361b in Participants With Advanced Solid Tumors

Past events

2025

Trial startedOct 2, 2025· ClinicalTrials.gov

Phase 1 trial started: NCT07182591

A Study of DS5361b in Participants With Advanced Solid Tumors

Trial registeredSep 19, 2025· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT07182591

A Study of DS5361b in Participants With Advanced Solid Tumors

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.