Itepekimab (SAR440340) History and Updates

35 events · 2020 – present

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

0
FDA Approvals
0
Label Revisions
35
Trial Milestones
0
Pivotal Publications
Itepekimab (SAR440340) — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications202120222023202420252026202720282029Trial: NCT07484230 2026-05-08 → 2027-10-20 (primary completion)Trial: NCT07424144 2026-03-12 → 2028-12-12 (primary completion)Trial: NCT06834347 2025-02-12 → 2027-01-08 (primary completion)Trial: NCT06834360 2025-02-06 → 2027-01-08 (primary completion)Trial: NCT06691113 2024-12-16 → 2026-03-31 (primary completion)Trial: NCT06280391 2024-02-20 → 2025-09-16 (primary completion)Trial: NCT06208306 2024-01-11 → 2026-12-01 (primary completion)Trial: NCT05326412 2022-05-19 → 2025-03-05 (primary completion)Trial: NCT06114238 2021-09-16 → 2022-03-08 (primary completion)Trial: NCT04751487 2021-02-12 → 2025-04-21 (primary completion)Trial: NCT04701983 2020-12-16 → 2025-04-11 (primary completion)today (2026-06-03)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-03Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Itepekimab (SAR440340) since 2020, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (2)

2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06834347
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06834360
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06834360
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06834347
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07484230
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequa
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07424144
An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chr

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07484230
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequa
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06691113
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinos
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07424144
An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chr
2025
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06280391
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibr
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04751487
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04701983
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06834347
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06834360
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06691113
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinos
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06280391
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibr
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06208306
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
2023
2022
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05326412
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06114238
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
2021
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06114238
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04751487
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
2020
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04701983
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

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.