Drugs / Itepekimab
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06114238 | Sep 2021 → Mar 2022 | chronic obstructive pulmonary disease | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03112577 | Jun 2017 → Mar 2019 | allergic asthma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02999711 | Feb 2017 → Aug 2018 | asthma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02958436 | Aug 2016 → Jun 2017 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 27 trials · 1 missed | ||||||
| Phase 2 | NCT06691113 | Dec 2024 → Mar 2026 overdue | chronic rhinosinusitis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06280391 | Feb 2024 → Sep 2025 | bronchiectasis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT05326412 | May 2022 → Mar 2025 | chronic obstructive pulmonary disease | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT03738423 | Nov 2018 → Mar 2020 | atopic eczema | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03736967 | Nov 2018 → Mar 2020 | atopic eczema | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03546907 | Jul 2018 → Oct 2019 | chronic obstructive pulmonary disease | Sanofi | Completed | Missed primary |
| Phase 2 | NCT03387852 | Mar 2018 → Mar 2019 | asthma | Sanofi | Completed | Mixed |
| Phase 37 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07484230 | May 2026 → Oct 2027 expected | chronic rhinosinusitis | Sanofi | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07424144 | Mar 2026 → Dec 2028 expected | chronic rhinosinusitis | Sanofi | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06834347 | Feb 2025 → Oct 2026 expected | chronic rhinosinusitis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06834360 | Feb 2025 → Nov 2026 expected | chronic rhinosinusitis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06208306 | Jan 2024 → Sep 2026 | chronic obstructive pulmonary disease | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT04751487 | Feb 2021 → Apr 2025 | chronic obstructive pulmonary disease | Sanofi | Completed | Missed primary |
| Phase 3 | NCT04701983 | Dec 2020 → Apr 2025 | chronic obstructive pulmonary disease | Sanofi | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-08-01 | Regeneron Pharmaceuticals | Results Regeneron Reports Second Quarter 2025 Financial and Operating Results regeneron.com ↗
A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. |
| 2025-05-30 | Sanofi | Results Press Release: Itepekimab met the primary endpoint in one of two COPD phase 3 studies sanofi.com ↗
AERIFY-1 study met its primary endpoint of a statistically significant reduction in moderate or severe exacerbations in former smokers regardless of eosinophilic phenotype and provided a clinically meaningful benefit |
| 2025-05-30 | Regeneron Pharmaceuticals | Results Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials regeneron.com ↗
A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. |
| 2019-06-21 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Announce Positive Topline Phase 2 Results for IL-33 Antibody in Asthma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Phase 2 proof-of-concept trial evaluating the investigational IL-33 antibody REGN3500 (SAR440340) met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-08-01 | Regeneron Pharmaceuticals | Regeneron Reports Second Quarter 2025 Financial and Operating Results regeneron.com ↗ |
| 2025-05-30 | Sanofi | Press Release: Itepekimab met the primary endpoint in one of two COPD phase 3 studies sanofi.com ↗ |
| 2025-05-30 | Regeneron Pharmaceuticals | Itepekimab Met Primary Endpoint in One of Two Chronic Obstructive Pulmonary Disease (COPD) Phase 3 Trials regeneron.com ↗ |
| 2024-08-26 | Regeneron Pharmaceuticals | Latest Dupixent® (dupilumab) and Itepekimab Data at ERS Highlight Scientific Innovation and Leadership in Respiratory Diseases regeneron.com ↗ |
| 2019-06-21 | Regeneron Pharmaceuticals | Regeneron and Sanofi Announce Positive Topline Phase 2 Results for IL-33 Antibody in Asthma regeneron.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Itepekimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06114238 ↗ |
| Known as | REGN3500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03112577 ↗ |
| Known as | SAR440340 | “SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb)” NCT04751487 ↗9“Drug: Itepekimab (SAR440340)” NCT06280391 ↗ “Drug: Itepekimab (SAR440340)” NCT06834347 ↗ “Itepekimab (SAR440340)” NCT06834360 ↗ “Itepekimab (SAR440340)” NCT07424144 ↗ “Itepekimab (SAR440340)” NCT07484230 ↗ “Itepekimab (SAR440340)” NCT06208306 ↗ “Itepekimab (SAR440340)” NCT06691113 ↗ |
| Action | Inhibit | “Itepekimab (Anti-IL-33 mAb)” NCT04701983 ↗ |
| Modality | Monoclonal antibody | “Itepekimab (Anti-IL-33 mAb)” NCT04701983 ↗ |
| Route | Intravenous | “Intravenous (IV) use” NCT03112577 ↗ |
| Target | IL33 | “Itepekimab (Anti-IL-33 mAb)” NCT04701983 ↗ |