ABBV-400 History and Updates

9 events · 2021 – present

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

0
FDA Approvals
0
Label Revisions
9
Trial Milestones
0
Pivotal Publications
ABBV-400 — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2022202320242025202620272028Trial: NCT06107413 2023-11-12 → 2026-12-31 (primary completion)Trial: NCT06084481 2023-11-09 → 2026-07-31 (primary completion)Trial: NCT05029882 2021-10-13 → 2027-11-30 (primary completion)today (2026-05-08)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for ABBV-400 since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving I
Primary completion· ClinicalTrials.gov
Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 W
Primary completion· ClinicalTrials.gov
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) AB

Past events

2023
Trial started· ClinicalTrials.gov
Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 W
Trial started· ClinicalTrials.gov
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving I
2021
Trial started· ClinicalTrials.gov
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) AB

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.