Drugs / iscalimab

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 No outcome recorded
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 No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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

Press releases naming this drug 1 release

DateIssuerRelease
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.

FieldValueCited 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 2020
4

“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

NCT04541589

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
11

NCT02217410

NCT02565576

NCT02089087

NCT03656562

NCT03781414

NCT03610516

NCT02713256

NCT03905525

NCT03827798

NCT04129528

NCT03663335

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 antibodyPMID 31647605 Dec 2019
Route Intravenous “single doses of intravenous iscalimab” PMID 31647605 Dec 2019
Target CD40 CD40 pathway blocking” PMID 31647605 Dec 2019