Home / Drugs & Interventions / Foralumab / History Foralumab History and Updates 28 events · 2017 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026 .
Foralumab — history and updates FDA approvals, label revisions, recalls, trials, and pivotal publications FDA approvals Label revisions Recalls + safety Trials Publications 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 Trial: 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 approval Label revision Recall or safety Trial activity Pivotal publication
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-11 Download 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 Primary completion Jun 30, 2026 · ClinicalTrials.gov
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
Primary completion Apr 1, 2027 · ClinicalTrials.gov
A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)
Past events 2026
Primary completion Apr 30, 2026 · ClinicalTrials.gov
Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
2025
Primary completion Nov 30, 2025 · ClinicalTrials.gov
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
Trial started Sep 16, 2025 · ClinicalTrials.gov
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
Trial started May 19, 2025 · ClinicalTrials.gov
A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)
Trial registered Mar 24, 2025 · ClinicalTrials.gov
Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Trial registered Mar 17, 2025 · ClinicalTrials.gov
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
Trial registered Mar 11, 2025 · ClinicalTrials.gov
A Phase 2a Study of Foralumab Nasal in Patients With Multiple System Atrophy (MSA)
Trial started Mar 4, 2025 · ClinicalTrials.gov
Nasal Foralumab in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Trial registered Jan 31, 2025 · ClinicalTrials.gov
Intermediate-Size Patient Population Expanded Access: Foralumab in Non-Active Secondary Progressive MS Patients
2024
Trial registered Jul 8, 2024 · ClinicalTrials.gov
Assessment of Foralumab Safety and Modulation of Microglial Activation in Alzheimer's Disease
Trial registered Mar 5, 2024 · ClinicalTrials.gov
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
2023
Trial started Nov 15, 2023 · ClinicalTrials.gov
A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients
Primary completion Jul 7, 2023 · ClinicalTrials.gov
A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease
2022
Primary completion Nov 30, 2022 · ClinicalTrials.gov
Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS
Primary completion Oct 30, 2022 · ClinicalTrials.gov
In-patient COVID-19 Study of Intranasal Foralumab
Trial started May 1, 2022 · ClinicalTrials.gov
A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease
Trial started Apr 30, 2022 · ClinicalTrials.gov
In-patient COVID-19 Study of Intranasal Foralumab
2021
Trial started Oct 31, 2021 · ClinicalTrials.gov
Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS
Trial registered Aug 31, 2021 · ClinicalTrials.gov
Phase 1b Multiple Ascending Dose Study of Foralumab in Primary and Secondary Progressive MS
Trial registered Aug 31, 2021 · ClinicalTrials.gov
A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease
Trial registered Jul 30, 2021 · ClinicalTrials.gov
In-patient COVID-19 Study of Intranasal Foralumab
2019
Primary completion Jul 23, 2019 · ClinicalTrials.gov
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
2018
Primary completion Dec 1, 2018 · ClinicalTrials.gov
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
Trial started Nov 12, 2018 · ClinicalTrials.gov
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
2017
Trial started Dec 1, 2017 · ClinicalTrials.gov
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
Trial registered Sep 25, 2017 · 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.