Itepekimab

Summary

Itepekimab (CHEMBL4594594) is a phase-3 clinical-stage antibody; indicated across 3 conditions including chronic obstructive pulmonary disease and atopic eczema.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 3 conditions
• Clinical trials: 17

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4594594
Name	Itepekimab
Type	Antibody
Max phase	3

Also known as: Itepekimab, REGN-3500, Regn3500, REGN3500, SAR-440340, Sar440340, SAR440340, ITEPEKIMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
chronic obstructive pulmonary disease	3	MONDO:0005002	EFO:0000341
atopic eczema	2	MONDO:0004980	EFO:0000274
asthma	2	MONDO:0004979	MONDO:0004979

Clinical trials

Total trials: 17.

Phase distribution

Phase	Trials
PHASE3	7
PHASE2	7
PHASE1	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06208306	PHASE3	ACTIVE_NOT_RECRUITING	A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
NCT06834347	PHASE3	ACTIVE_NOT_RECRUITING	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
NCT06834360	PHASE3	RECRUITING	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
NCT07424144	PHASE3	ENROLLING_BY_INVITATION	An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps
NCT07484230	PHASE3	NOT_YET_RECRUITING	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
NCT04701983	PHASE3	COMPLETED	Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
NCT04751487	PHASE3	COMPLETED	Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
NCT06691113	PHASE2	ACTIVE_NOT_RECRUITING	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
NCT03387852	PHASE2	COMPLETED	Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
NCT03546907	PHASE2	COMPLETED	Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
NCT03736967	PHASE2	TERMINATED	Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis
NCT03738423	PHASE2	TERMINATED	Efficacy, Safety, and Pharmacokinetic Profiles of REGN3500 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
NCT05326412	PHASE2	COMPLETED	Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
NCT06280391	PHASE2	COMPLETED	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
NCT02958436	PHASE1	COMPLETED	A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects
NCT02999711	PHASE1	COMPLETED	Study of Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REGN3500 in Adults With Moderate Asthma
NCT03112577	PHASE1	COMPLETED	Study of REGN3500 and Dupilumab in Patients With Asthma

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).