Drugs / zigakibart
last change Jun 2026 re-read 9 days ago

zigakibart

also known as BION-1301 · C-90401

Monoclonal antibody

Developed for
IgA glomerulonephritis · plasma cell myeloma
Investigated by
Novartis Pharmaceuticals · Chinook Therapeutics, Inc.

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05508204 Jul → Dec 2022 — Chinook Therapeutics, Inc. Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT03945318 Apr 2019 → Jun 2026 IgA glomerulonephritis Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT03340883 Nov 2017 → Jun 2019 plasma cell myeloma Chinook Therapeutics, Inc. Terminated No outcome recorded
Phase 21 trial
Phase 2 NCT07146906 Mar 2026 → Jul 2030 expected IgA glomerulonephritis Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 33 trials · 1 met primary
Phase 3 NCT06858319 Jul 2025 → Jun 2031 expected IgA glomerulonephritis, chronic kidney disease Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT05852938 Jul 2023 → Aug 2027 expected IgA glomerulonephritis Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 3 NCT04573478 Dec 2020 → Apr 2028 expected IgA glomerulonephritis Novartis Pharmaceuticals Active not recruiting Met primary
Comparator or background therapy1 trial
Phase 3 NCT07850752 Background Dec 2026 → Sep 2028 expected IgA glomerulonephritis Novartis Pharmaceuticals Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-11-04 Novartis Pharmaceuticals Results New Novartis data at ASN Kidney Week and AHA Scientific Sessions demonstrate momentum of broad CRM portfolio and pipeline novartis.com ↗
Long-Term Stabilization of Kidney Function Regardless of Baseline eGFR and Urine Protein-to-Creatinine Ratio (UPCR) in Patients with IgAN
2025-07-17 Novartis Pharmaceuticals Results Novartis reports strong Q2 with double-digit sales growth and core margin expansion; raises FY 2025 core operating income guidance novartis.com ↗
Updated results from the Phase I/II study for zigakibart in IgAN showed a robust and clinically meaningful reduction in proteinuria of 60.4% from baseline and eGFR stabilization over 100 weeks of treatment.
2024-05-25 Novartis Pharmaceuticals Results Novartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically significant 35.1% proteinuria reduction vs. placebo novartis.com ↗
One Year of Zigakibart Treatment Shows Clinically Meaningful Proteinuria Reduction and Good Tolerability in a Phase 1/2 Study of IgA Nephropathy.

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as zigakibart ClinicalTrials.gov intervention name — accepted as the source's own label NCT06858319 ↗
3

NCT07146906 ↗

NCT07850752 ↗

NCT04573478 ↗

Known as BION-1301 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03340883 ↗
3

NCT05508204 ↗

NCT03945318 ↗

NCT05852938 ↗

Known as C-90401 ChEMBL registry synonym — accepted as the source's own label CHEMBL5095316 ↗
Action Inhibit “durable reductions in levels of free APRIL” PMID 40482854 ↗ Jun 2025
Modality Monoclonal antibody “a humanized monoclonal antibody” NCT03340883 ↗
Route Intravenous “administered by intravenous (IV) infusion” NCT03945318 ↗