Drugs / iscalimab
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02089087 | Jan 2013 → Feb 2017 | rheumatoid arthritis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02217410 | Feb 2015 → Nov 2017 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT04541589 | Jan 2021 → Aug 2024 | Sjogren syndrome | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03781414 | Oct 2019 → Apr 2023 | transplant rejection | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03905525 | Oct 2019 → Sep 2022 | Sjogren syndrome | Novartis Pharmaceuticals | Completed | Mixed |
| Phase 2 | NCT03827798 | Feb 2019 → Dec 2024 overdue | hidradenitis suppurativa | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03656562 | Dec 2018 → Jul 2022 | systemic lupus erythematosus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03663335 | Nov 2018 → Oct 2021 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03610516 | Sep 2018 → Jun 2023 | lupus nephritis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02713256 | Apr 2016 → Apr 2017 | Graves disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02291029 | Oct 2014 → Jun 2018 | Sjogren syndrome | Novartis Pharmaceuticals | Completed | Mixed |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT04129528 Comparator | Nov 2019 → Jan 2024 | type 1 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02565576 Comparator | Sep 2015 → Jul 2017 | generalized myasthenia gravis | Novartis Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-07-18 | Novartis Pharmaceuticals | Results Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased novartis.com ↗
Iscalimab (CFZ533) data were presented at the American Transplant Congress showing 60% of iscalimab-treated transplant patients have normal kidney histology at least 1 year after transplant vs 0% with tacrolimus (current standard of care). |
| 2019-06-06 | Novartis Pharmaceuticals | Results Novartis presents first-of-its-kind histology data with iscalimab (CFZ533) suggesting the extended survival of transplanted organs may be possible novartis.com ↗
In this analysis, iscalimab demonstrated lower chronic allograft damage index (CADI) scores compared with tacrolimus (current standard-of-care), with normal renal histology seen in three of five patients (60%) on iscalimab vs none of seven on tacrolimus[1]. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-12-05 | XOMA (US) LLC | Iscalimab (CFZ533) Update xoma.com ↗ |
| 2019-07-18 | Novartis Pharmaceuticals | Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased novartis.com ↗ |
| 2019-06-06 | Novartis Pharmaceuticals | Novartis presents first-of-its-kind histology data with iscalimab (CFZ533) suggesting the extended survival of transplanted organs may be possible novartis.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | iscalimab | “Therefore, we investigated the safety and preliminary efficacy of iscalimab (CFZ533), a novel anti-CD40 monoclonal antibody, in patients with primary Sjögren's syndrome.” PMID 38263652 ↗ Jan 20204“The study was terminated following less favorable efficacy by Iscalimab (CFZ533) in liver transplant patients compared to tacrolimus.” NCT03781414 ↗ “Iscalimab is a fully human, CD40 pathway blocking, nondepleting monoclonal antibody being developed as an immunosuppressive agent.” PMID 31647605 ↗ Dec 2019 “Iscalimab (CFZ533) is a novel, anti-CD40 monoclonal antibody.” PMID 40813108 ↗ Aug 2025 |
| Known as | CFZ533 | “Therefore, we investigated the safety and preliminary efficacy of iscalimab (CFZ533), a novel anti-CD40 monoclonal antibody, in patients with primary Sjögren's syndrome.” PMID 38263652 ↗ Jan 2020 |
| Known as | NVP-CFZ533 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298210 ↗ |
| Action | Inhibit | “CD40 pathway blocking” PMID 31647605 ↗ Dec 2019 |
| Modality | Monoclonal antibody | “nondepleting monoclonal antibody” PMID 31647605 ↗ Dec 2019 |
| Route | Intravenous | “single doses of intravenous iscalimab” PMID 31647605 ↗ Dec 2019 |
| Target | CD40 | “CD40 pathway blocking” PMID 31647605 ↗ Dec 2019 |