Itepekimab AI

Phase 3Monoclonal antibody

Itepekimab AI is one of 12 small molecule programs targeting Chronic Rhinosinusitis With Nasal Polyps. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Chronic Rhinosinusitis With Nasal PolypsRecruiting

Chronic Rhinosinusitis With Nasal PolypsPhase 3

Recruiting

Competition

Competitive Landscape

11 competitors in Chronic Rhinosinusitis With Nasal Polyps

#DrugCompanyPhaseTrials

Asmanex

PPerrigo Company

Approved

5 2

Nucala

GGlaxo Dba Glaxosmithkline

Approved

5 3

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Approved

3 4

Tezspire

AstraZeneca

Phase 3

3 5

Stapokibart

CChengdu Kangnuoxing Biopharma,Inc.

Phase 3

2 6

Lunsekimig

Sanofi

Phase 2

2 7

SAR440340

Sanofi

Phase 3

2 8

SHR-1905

Guangdong Hengrui Pharmaceutical Co., Ltd

Phase 3

2 9

Itepekimab AI

Sanofi

Phase 3

4 10

LP-003

LLongbio Pharma

Phase 2

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

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT07424144

Q4 2027

Phase 3Recruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT06834360

Phase 3Recruiting

Chronic Rhinosinusitis With Nasal Polyps

NCT06834347

Clinical

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease4 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

A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies

Completed· Sanofi logo

Sanofi·Phase 3·NCT06208306·669 enrolled

Show 1 more trial

A Phase 2a, Open-label, Two-part Study to Evaluate the Mechanism of Action of Itepekimab (Anti-IL-33 mAb) on Airway Inflammation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Sanofi logo

Sanofi·Phase 2·NCT05326412·49 enrolled

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 Randomized, Double-blind, Parallel-group, 52-week Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Withdrawn· Sanofi logo

Sanofi·Phase 3·NCT07484230

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

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT07424144·59 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

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

Chronic Rhinosinusitis Without Nasal Polyps1 trial

A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab in Participants With Inadequately Controlled Chronic Rhinosinusitis Without Nasal Polyps

Completed· Sanofi logo

Sanofi·Phase 2·NCT06691113·66 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

Q1 2027

Q4 2027

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease4 trials

Chronic Rhinosinusitis With Nasal Polyps4 trials

MPA1 trial

Cystic Fibrosis1 trial

Chronic Rhinosinusitis Without Nasal Polyps1 trial

References

Drug Info

Quick Facts

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