Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BION-1301, BION-1301 Single Dose, FUB523, BION-1301 Multiple Doses
Zigakibart · 5 trials · 12 indications
Relative difference between treatment groups in mean change of natural log 24-hour UPCR from Baseline to Week 36, expressed as percent reduction
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 + atrasentan | EXPERIMENTAL | Patients receive zigakibart and atrasentan |
| zigakibart + placebo | ACTIVE_COMPARATOR | Patients receive zigakibart and matching placebo |
| 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 | BIOLOGICAL | Solution for injection via PFS-NSD |
| atrasentan | DRUG | Tablet |
| Placebo | DRUG | Tablet |
| BION-1301 | DRUG | BION-1301 Pre-Filled Syringe (PFS) 600mg 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: * Aged ≥ 18 years at the time of signing the informed consent, prior to initiation of any study specific activities/procedures * Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. If...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 12 | PHASE3 | Zigakibart, Atrasentan, Iptacopan |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Vertex Pharmaceuticals Incorporated | VRTX | 4 | PHASE3 | Povetacicept, Sibeprenlimab |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Biogen Inc. | BIIB | 2 | PHASE3 | Felzartamab |
| Biohaven Ltd. | BHVN | 2 | PHASE3 | BHV-1400 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Sefaxersen |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| argenx SE Sponsored ADR | ARGX | 1 | PHASE2 | ARGX-121 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-097 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |
Zigakibart is being developed for the treatment of IgA nephropathy, also called immunoglobulin A nephropathy or IgAN, a chronic kidney disease. It is also being studied in broader kidney disease and glomerulonephritis populations. It is an investigational therapy and has not been approved for any indication.
Zigakibart is being developed by Novartis AG, which trades under the ticker NVS. Novartis is running the clinical development program for the drug across multiple Phase 2 and Phase 3 studies in IgA nephropathy and related kidney diseases.
Zigakibart is in Phase 3 clinical development. Its program includes Phase 3 trials such as NCT05852938, NCT06858319, and NCT07850752, along with a Phase 2 study, NCT07146906. It remains investigational and has not received FDA approval.
Zigakibart is being studied in four registered trials. These include the Phase 3 study NCT05852938 in adults with IgA nephropathy, the Phase 3 open-label extension NCT06858319, the Phase 3 combination study NCT07850752 with atrasentan, and the Phase 2 study NCT07146906.
Yes, Zigakibart is also known as BION-1301. BION-1301 was the earlier designation used for the same investigational compound, and it has also appeared as BION-1301 Single Dose in study listings. Both names refer to the same drug candidate being developed by Novartis for IgA nephropathy.
The Zigakibart clinical program has a total planned enrollment of 826 patients across its trials. Individual studies range from 32 patients in the Phase 2 trial NCT07146906 to 383 patients in the Phase 3 trial NCT05852938. All trials enroll adults aged 18 years and older.