Itepekimab AI

Phase 3Monoclonal antibody

Itepekimab AI is one of 90 small molecule programs targeting Chronic Rhinosinusitis Without Nasal Polyps. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Rhinosinusitis Without Nasal PolypsActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Chronic Rhinosinusitis With Nasal PolypsActive, not recruiting

Cystic FibrosisActive, not recruiting

Chronic Rhinosinusitis Without Nasal PolypsPhase 2

Active, not recruiting

Chronic Obstructive Pulmonary DiseasePhase 3

Active, not recruiting

Chronic Rhinosinusitis With Nasal PolypsPhase 3

Active, not recruiting

Cystic FibrosisPhase 2

Active, not recruiting

Competition

Competitive Landscape

557 competitors in Chronic Obstructive Pulmonary Disease

#DrugCompanyPhaseTrials

Itepekimab AI

Sanofi

Phase 3

2 2

Veramyst

GSK

Preclinical

26 3

Flovent

GSK

Preclinical

6 4

Formoterol Fumarate

AstraZeneca

Preclinical

11 5

Proventil

Mylan Pharmaceuticals Inc

Preclinical

3 6

Duragesic

CCephalon

Preclinical

2 7

Narcan

SScienture

Preclinical

1 8

Zoloft

VViatris Specialty LLC

Preclinical

1 9

Qvar

Chiesi Farmaceutici S.p.A.

Preclinical

—10

Versed

CConrado Roberto Hoffmann Filho

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

COPD

NCT06208306

Q1 2027

Phase 2Active, not recruiting

Chronic Rhinosinusitis Without Nasal Polyps

NCT06691113

Q4 2027

Phase 3Recruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT06834360

Phase 3Recruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT06834347

Q4 2028

Phase 3Not yet recruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT07484230

Clinical

Trials by Indication[1]

Chronic Rhinosinusitis With Nasal Polyps4 trials

A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06834360·210 enrolled

A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06834347·210 enrolled

A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Not yet recruiting· Sanofi logo

Sanofi·Phase 3·NCT07484230·20 enrolled

Show 1 more trial

A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Participated in Either EFC18418 or EFC18419 Clinical Studies

Enrolling by invitation· Sanofi logo

Sanofi·Phase 3·NCT07424144·380 enrolled

Chronic Obstructive Pulmonary Disease2 trials

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04701983·1,127 enrolled

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04751487·1,239 enrolled

MPA1 trial

Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe

Completed· Sanofi logo

Sanofi·Phase 1·NCT06114238·90 enrolled

Chronic Rhinosinusitis Without Nasal Polyps1 trial

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT06691113·60 enrolled

COPD1 trial

A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06208306·700 enrolled

2 more indications

Cystic Fibrosis1 trial

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

Completed· Sanofi logo

Sanofi·Phase 2·NCT06280391·312 enrolled

Inflammation1 trial

Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD

Completed· Sanofi logo

Sanofi·Phase 2·NCT05326412·49 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Itepekimab AI. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Itepekimab AI compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Itepekimab AI. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Sanofi

Itepekimab AI

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Chronic Rhinosinusitis With Nasal Polyps4 trials

Chronic Obstructive Pulmonary Disease2 trials

MPA1 trial

Chronic Rhinosinusitis Without Nasal Polyps1 trial

COPD1 trial

Cystic Fibrosis1 trial

Inflammation1 trial

References

Drug Info

Quick Facts

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