Afimkibart History and Updates

37 events · 2023 – present

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

0
FDA Approvals
0
Label Revisions
37
Trial Milestones
0
Pivotal Publications
Afimkibart — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20232024202520262027202820292030203120322033Trial: NCT07298421 2026-06-30 → 2030-05-31 (primary completion)Trial: NCT07620392 2026-06-05 → 2032-06-05 (primary completion)Trial: NCT07158242 2026-04-15 → 2030-03-31 (primary completion)Trial: NCT07223697 2026-01-08 → 2033-03-01 (primary completion)Trial: NCT07137598 2025-12-05 → 2027-04-19 (primary completion)Trial: NCT06819891 2025-05-12 → 2028-12-31 (primary completion)Trial: NCT06863961 2025-04-01 → 2026-10-05 (primary completion)Trial: NCT06819878 2025-03-17 → 2028-12-31 (primary completion)Trial: NCT06588855 2024-12-11 → 2027-01-30 (primary completion)Trial: NCT06589986 2024-09-17 → 2027-01-30 (primary completion)Trial: NCT05910528 2023-07-24 → 2030-12-31 (primary completion)today (2026-06-15)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-15Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Afimkibart since 2023, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07298421
A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Modera
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06863961
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06863961
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06589986
A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06588855
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07137598
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded t
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07137598
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded t
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06819878
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately t
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06819891
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Activ
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07158242
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcer
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07298421
A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Modera
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07620392
An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07223697
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07223697
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

Past events

2026
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07620392
An Extension Study to Assess Long-Term Safety and Efficacy of Afimkibart in Participants With Rheumatoid Arthritis
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07298421
A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Modera
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07158242
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcer
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07223697
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
2025
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07137598
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded t
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06819891
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Activ
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06863961
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06819878
A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately t
2024
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06588855
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06589986
A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With
2023

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.