Drugs / Amlitelimab
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06686628 | Nov 2024 → Nov 2025 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT05796479 | Apr 2022 → May 2023 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04449939 | Jul → Nov 2020 | immune system disorder | Kymab Limited | Completed | No outcome recorded |
| Phase 1 | NCT03161288 | May 2017 → Mar 2018 | immune system disorder | Kymab Limited | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT06557772 | Aug 2024 → Aug 2026 overdue | celiac disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06444451 | Jun 2024 → Sep 2025 | alopecia areata | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT06195072 | Apr 2024 → Nov 2026 expected | interstitial lung disease, scleroderma | Scleroderma Research Foundation, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06118099 | Nov 2023 → Feb 2025 | hidradenitis | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT06015308 | Oct 2023 → Oct 2025 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT06033833 | Sep 2023 → Sep 2026 expected | asthma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05769777 | Apr 2023 → Jun 2031 expected | atopic eczema | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05421598 | Jun 2022 → Oct 2024 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT05131477 | Dec 2021 → Apr 2023 | atopic eczema | Kymab Limited | Completed | No outcome recorded |
| Phase 2 | NCT03754309 | Dec 2018 → May 2020 | atopic eczema | Kymab Limited | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05492578 | Aug 2022 → Jan 2029 expected | atopic eczema | Sanofi | Enrolling by invitation | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06407934 | May 2024 → Jun 2026 overdue | atopic eczema | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06241118 | Feb 2024 → Sep 2027 expected | atopic eczema | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06224348 | Jan 2024 → Aug 2025 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT06181435 | Dec 2023 → Nov 2025 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT06130566 | Nov 2023 → Jul 2025 | atopic eczema | Sanofi | Completed | No outcome recorded |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Sanofi | Press Release: Sanofi announces decision not to submit amlitelimab in atopic dermatitis for global regulatory reviews sanofi.com ↗ |
| 2026-03-28 | Sanofi | Press Release: AAD: new results from Sanofi's amlitelimab phase 3 studies in atopic dermatitis presented in late-breaking research session sanofi.com ↗ |
| 2026-01-23 | Sanofi | Press Release: Sanofi's amlitelimab confirms its potential in atopic dermatitis sanofi.com ↗ |
| 2025-09-04 | Sanofi | Press Release: Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis sanofi.com ↗ |
| 2024-03-11 | Sanofi | Press Release: New Phase 2b results for amlitelimab support potential for best-in-class maintenance of response in atopic dermatitis sanofi.com ↗ |
| 2023-10-13 | Sanofi | Press Release: Late-breaking amlitelimab Phase 2b data presented at EADV show potential best-in-class profile in atopic dermatitis sanofi.com ↗ |
| 2023-06-27 | Sanofi | Press Release: Positive topline Phase 2b data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody sanofi.com ↗ |
| 2021-09-30 | Sanofi | Press Release: New, late-breaking data at EADV highlights emerging clinical profile of amlitelimab (formerly KY1005) in adults with inadequately controlled moderate-to-severe atopic dermatitis sanofi.com ↗ |
| 2021-01-11 | Sanofi | Sanofi to acquire Kymab, adding KY1005 to its pipeline, a human monoclonal antibody targeting key immune system regulator OX40L sanofi.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amlitelimab | “The safety, tolerability, immunogenicity, and pharmacokinetic (PK) profile of an anti-OX40L monoclonal antibody (KY1005, currently amlitelimab) were evaluated.” PMID 35092305 ↗ Mar 2022 |
| Known as | KY-1005-2D10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594569 ↗ |
| Known as | KY1005 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03161288 ↗ |
| Known as | SAR-445229 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594569 ↗ |
| Action | Inhibit | “Tumor necrosis factor ligand superfamily member 4 inhibitor” CHEMBL4594569 ↗ |
| Modality | Monoclonal antibody | “The safety, tolerability, immunogenicity, and pharmacokinetic (PK) profile of an anti-OX40L monoclonal antibody (KY1005, currently amlitelimab) were evaluated.” PMID 35092305 ↗ Mar 2022 |
| Route | Subcutaneous | “Single lower dose KY1005 by s.c. injection” NCT04449939 ↗ |
| Target | TNFSF4 | “Tumor necrosis factor ligand superfamily member 4 inhibitor” CHEMBL4594569 ↗ |