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zigakibart

Phase 3

Kidney Diseases | Small molecule | Rare Disease |Novartis AG|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

zigakibart · 2 trials · 9 indications

Phase 3 1Phase 2 1
NCT06858319Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.Kidney Diseases
RECRUITING220 Analytics
PHASE3RECRUITING
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
Kidney Diseases
NCT06858319220
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Study Endpoints

Primary Endpoints

Number of participants with adverse events.
Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment

Number of participants with adverse events will be provided.

Number of participants with serious adverse events.
Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment

Number of participants with serious adverse events will be provided.

Number of participants with adverse events of special interest.
Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment

Number of participants with adverse events of special interest will be provided.

Change in mesangial IgA deposition
Baseline to Week 53 or 105

Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining

Secondary Endpoints

Change in UPCR from Baseline to Week 48 and Week 96.
Baseline visit, Week 48 and Week 96.
Change in eGFR from Baseline to Week 96.
Baseline visit and Week 96.
Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.
Baseline visit and Week 96.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
zigakibartEXPERIMENTALParticipants will receive zigakibart.

Interventions

NameTypeDescription
zigakibartDRUGsolution for subcutaneous injection
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the OLE study. 2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol. 3. Per Investigator's clinical judgment, ...

Countries:United StatesArgentinaAustraliaCanadaMalaysiaMexicoSouth KoreaSpainTaiwanBrazilChinaCzechiaGermanyItalyJapanPoland
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT06858319lastUpdatePostDate: changed
LOWAug 17, 2026NCT06858319lastUpdatePostDate: changed
LOWAug 11, 2026NCT07146906lastUpdatePostDate: changed
LOWAug 11, 2026NCT07146906lastUpdatePostDate: changed
LOWAug 11, 2026NCT07146906lastUpdatePostDate: changed
LOWJul 20, 2026NCT06858319lastUpdatePostDate: changed
LOWJul 20, 2026NCT06858319lastUpdatePostDate: changed
LOWJun 23, 2026NCT07146906lastUpdatePostDate: changed
LOWJun 23, 2026NCT07146906lastUpdatePostDate: changed

Frequently asked questions about zigakibart

What is zigakibart used for?

Zigakibart is an investigational monoclonal antibody being developed for kidney diseases, specifically immunoglobulin A nephropathy (IgAN), a form of glomerulonephritis. It is currently in clinical development and is not yet approved by regulatory authorities.

Who is developing zigakibart?

Zigakibart is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with IgA nephropathy.

What phase is zigakibart in?

Zigakibart is currently in Phase 2 clinical development. A Phase 2 study is actively recruiting participants to assess the drug's effects in IgA nephropathy, and an open-label extension study is also listed as Phase 3, though the overall development program is still investigational.

What clinical trials is zigakibart in?

Zigakibart is being studied in two clinical trials. NCT07146906 is a Phase 2 study assessing the effects of zigakibart on IgA nephropathy, enrolling 32 participants. NCT06858319 is an open-label extension study in adults with IgA nephropathy, enrolling 220 participants across multiple countries.

How does zigakibart work?

Zigakibart is a monoclonal antibody, a type of biologic drug that targets specific proteins involved in disease processes. In IgA nephropathy, it is designed to interfere with the underlying immune mechanisms that contribute to kidney damage, though the precise molecular target has not been specified in available information.

Is zigakibart the same as any other drug?

No alternative names for zigakibart have been reported. It is identified solely by its investigational name zigakibart in clinical trial registrations and is not known to be marketed under any other brand name.