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zigakibart

Phase 3

Kidney Diseases | Small molecule | Nephrology |Novartis AG|Last Updated: Jun 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment220
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06858319Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.PHASE3 RECRUITING 220 — — Jul 28, 2025Jun 25, 2031Jun 1, 202618 United States, Argentina +3
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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.

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 — 100 Years
SexALL
Healthy VolunteersNo
Study Sites18

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 StatesArgentinaAustraliaMalaysiaSouth Korea
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06858319lastUpdatePostDate: changed
LOWJun 2, 2026NCT06858319lastUpdatePostDate: changed
LOWJun 2, 2026NCT06858319lastUpdatePostDate: changed
LOWMay 26, 2026NCT06858319primaryCompletionDate: changed
LOWMay 24, 2026NCT06858319studyFirstPostDate: changed