Duvakitug History and Updates

15 events · 2025 – present

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

0
FDA Approvals
0
Label Revisions
15
Trial Milestones
0
Pivotal Publications
Duvakitug — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20262027202820292030Trial: NCT07812116 2026-10-13 → 2028-06-16 (primary completion)Trial: NCT07184944 2026-01-22 → 2029-08-13 (primary completion)Trial: NCT07185009 2026-01-16 → 2028-09-21 (primary completion)Trial: NCT07184996 2025-10-08 → 2028-05-09 (primary completion)Trial: NCT07184931 2025-10-01 → 2029-05-14 (primary completion)today (2026-09-24)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-24Download chart as PNG

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

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07184996
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07812116
A Study to Investigate Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07185009
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Coliti
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07184931
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07184944
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

Past events

2026
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07812116
A Study to Investigate Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07184944
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07185009
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Coliti
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07184996
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07184931
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn'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.