Foralumab History and Updates

28 events · 2017 – present

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

0
FDA Approvals
0
Label Revisions
28
Trial Milestones
0
Pivotal Publications
Foralumab — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2018201920202021202220232024202520262027Trial: NCT06489548 2025-09-16 → 2026-06-30 (primary completion)Trial: NCT06868628 2025-05-19 → 2027-04-01 (primary completion)Trial: NCT06890923 2025-03-04 → 2026-04-30 (primary completion)Trial: NCT06292923 2023-11-15 → 2025-11-30 (primary completion)Trial: NCT05028946 2022-05-01 → 2023-07-07 (primary completion)Trial: NCT04983446 2022-04-30 → 2022-10-30 (primary completion)Trial: NCT05029609 2021-10-31 → 2022-11-30 (primary completion)Trial: NCT06879067 2018-11-12 → 2019-07-23 (primary completion)Trial: NCT03291249 2017-12-01 → 2018-12-01 (primary completion)today (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 Foralumab since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Past events

2026
2025
Trial started· ClinicalTrials.gov
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
2024
2023
Trial started· ClinicalTrials.gov
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
2022
2021
Trial started· ClinicalTrials.gov
Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS
2019
2018
Trial started· ClinicalTrials.gov
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
2017
Trial started· ClinicalTrials.gov
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM

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.