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Itepekimab (SAR440340)
Itepekimab (SAR440340) is a IL-11 receptor antagonist (monoclonal antibody) Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Idiopathic pulmonary fibrosis (IPF), Systemic sclerosis-associated interstitial lung disease (SSc-ILD). Also known as: REGN3500.
Itepekimab is a monoclonal antibody that blocks IL-11 signaling to reduce fibrosis and inflammation.
Itepekimab (SAR440340) is an interleukin-33 inhibitor, a type of antibody that belongs to the drug class of inhibitors. It is being studied for various conditions, including Chronic Obstructive Pulmonary Disease, Bronchiectasis, Chronic Rhinosinusitis With Nasal Polyps, and Asthma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Itepekimab (SAR440340) |
|---|---|
| Also known as | REGN3500 |
| Sponsor | Sanofi |
| Drug class | IL-11 receptor antagonist (monoclonal antibody) |
| Target | IL-11 (Interleukin-11) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Fibrosis |
| Phase | Phase 3 |
Mechanism of action
IL-11 is a pro-fibrotic and pro-inflammatory cytokine implicated in tissue remodeling and organ damage. By neutralizing IL-11, itepekimab aims to inhibit pathological fibrosis and reduce inflammatory responses in affected tissues. This mechanism is being explored in conditions characterized by excessive fibrosis and inflammation.
Approved indications
- Idiopathic pulmonary fibrosis (IPF)
- Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Common side effects
- Infection
- Infusion-related reactions
- Fatigue
Key clinical trials
- 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 (PHASE3)
- An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (PHASE3)
- Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD (PHASE2)
- 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 (PHASE3)
- 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 (PHASE3)
- 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 (PHASE2)
- 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 (PHASE2)
- Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Itepekimab (SAR440340) CI brief — competitive landscape report
- Itepekimab (SAR440340) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Itepekimab (SAR440340)
What is Itepekimab (SAR440340)?
How does Itepekimab (SAR440340) work?
What is Itepekimab (SAR440340) used for?
Who makes Itepekimab (SAR440340)?
Is Itepekimab (SAR440340) also known as anything else?
What drug class is Itepekimab (SAR440340) in?
What development phase is Itepekimab (SAR440340) in?
What are the side effects of Itepekimab (SAR440340)?
What does Itepekimab (SAR440340) target?
Related
- Drug class: All IL-11 receptor antagonist (monoclonal antibody) drugs
- Target: All drugs targeting IL-11 (Interleukin-11)
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Immunology / Fibrosis
- Indication: Drugs for Idiopathic pulmonary fibrosis (IPF)
- Indication: Drugs for Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
- Also known as: REGN3500
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing