ponsegromab History and Updates

15 events · 2022 – present

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

0
FDA Approvals
0
Label Revisions
15
Trial Milestones
0
Pivotal Publications
ponsegromab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications202320242025202620272028Trial: NCT06989437 2025-10-03 → 2028-01-17 (primary completion)Trial: NCT05685264 2023-01-18 → 2023-07-07 (primary completion)Trial: NCT05546476 2022-11-21 → 2024-03-13 (primary completion)Trial: NCT05492500 2022-09-26 → 2025-03-05 (primary completion)Results posted — 2024-10-01 Trial results posted: NCT05685264 A Study to Learn How the Study Medicine (Ponsegromab) is Changed and Eliminated From Healthy Chinese AdultsResults posted — 2025-04-29 Trial results posted: NCT05546476 Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15Results posted — 2026-03-18 Trial results posted: NCT05492500 A Study of Ponsegromab in People With Heart Failuretoday (2026-06-11)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-11Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for ponsegromab since 2022, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (2)

2026
2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 2/Phase 3 primary completion: NCT06989437
A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Lo

Past events

2026
2025
Trial started· ClinicalTrials.gov
Phase 2/Phase 3 trial started: NCT06989437
A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Lo
Results posted· ClinicalTrials.gov
Trial results posted: NCT05546476
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
2024
Results posted· ClinicalTrials.gov
Trial results posted: NCT05685264
A Study to Learn How the Study Medicine (Ponsegromab) is Changed and Eliminated From Healthy Chinese Adults
2023
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05685264
A Study to Learn How the Study Medicine (Ponsegromab) is Changed and Eliminated From Healthy Chinese Adults
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05685264
A Study to Learn How the Study Medicine (Ponsegromab) is Changed and Eliminated From Healthy Chinese Adults
2022
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05546476
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

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.