Approval Probability
TA Base Rate
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Also known as BION-1301, BION-1301 Single Dose
Zigakibart · 5 trials · 12 indications
Number of participants with adverse events will be provided.
Number of participants with serious adverse events will be provided.
Number of participants with adverse events of special interest will be provided.
Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation
Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining
TEAEs and SAEs are assessed throughout each participant's study participation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
| Arm | Type | Description |
|---|---|---|
| zigakibart | EXPERIMENTAL | Participants will receive zigakibart. |
| BION-1301 | EXPERIMENTAL | 600mg subcutaneous administration every 2 weeks for 104 weeks |
| Placebo | PLACEBO_COMPARATOR | subcutaneous administration every 2 weeks for 104 weeks |
| Part 1: BION-1301 | EXPERIMENTAL | Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Healthy Volunteers receive a single dose of placebo administered by IV infusion. |
| Part 2: BION-1301 | EXPERIMENTAL | Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Healthy Volunteers receive placebo by IV infusion. |
| Part 3: BION-1301 | EXPERIMENTAL | Two cohorts of participants with IgAN receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly. |
| Part 4 Retreatment: BION-1301 | EXPERIMENTAL | Eligible participants with IgAN from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly. |
| Name | Type | Description |
|---|---|---|
| zigakibart | DRUG | solution for subcutaneous injection |
| BION-1301 | DRUG | BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks. |
| Placebo | DRUG | Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks. |
| BION-1301 Single Dose | DRUG | A single IV infusion infusion of BION-1301 at doses ranging from 10 to 1350 mg, administered once |
| Placebo Single Dose | DRUG | A single IV infusion of placebo |
| BION-1301 Multiple Doses | DRUG | Part 2: Multiple IV infusions of BION 1301 administered every 2 weeks (Q2W) at doses of 50 mg, 150 mg or 450 mg for up to 3 doses. Part 3: Repeated dosing of BION 1301: 450 mg IV Q2W for ≥24 weeks followed by 600 mg SC Q2W, or 600 mg SC Q2W throughout. |
| Placebo Multiple Doses | DRUG | Multiple IV infusions of placebo administered every 2 weeks for up to 3 doses |
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, ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 10 | PHASE3 | BION-1301 |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Travere Therapeutics, Inc. | TVTX | 2 | PHASE3 | sparsentan, irbesartan, Dapagliflozin |
| Biogen Inc. | BIIB | 1 | PHASE3 | Felzartamab |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Vertex Pharmaceuticals Incorporated | VRTX | 2 | PHASE3 | Povetacicept |
| Biohaven Ltd. | BHVN | 1 | PHASE1 | BHV-1400 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-097 |
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.
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.
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.
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.
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.
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.