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Ziltivekimab B
Ziltivekimab B is a IL-1β inhibitor Small molecule drug developed by Novo Nordisk A/S. It is currently in Phase 3 development for Treatment of generalized pustular psoriasis.
Ziltivekimab B is an interleukin-1 beta (IL-1β) inhibitor.
Ziltivekimab B is an interleukin-6 inhibitor, classified as an antibody and inhibitor drug modality. It is being studied in clinical trials for various conditions, including cardiovascular risk, chronic kidney disease, and inflammation.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
Novo Nordisk A/S is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ziltivekimab B |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Drug class | IL-1β inhibitor |
| Target | IL-1β |
| Modality | Small molecule |
| Therapeutic area | Autoimmune diseases |
| Phase | Phase 3 |
Mechanism of action
It works by binding to IL-1β and preventing its interaction with the IL-1 receptor, thereby reducing inflammation and modulating the immune response.
Approved indications
- Treatment of generalized pustular psoriasis
Common side effects
- Injection site reactions
- Headache
- Nausea
Key clinical trials
- A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab (PHASE1)
- ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ziltivekimab B CI brief — competitive landscape report
- Ziltivekimab B updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI
Frequently asked questions about Ziltivekimab B
What is Ziltivekimab B?
How does Ziltivekimab B work?
What is Ziltivekimab B used for?
Who makes Ziltivekimab B?
What drug class is Ziltivekimab B in?
What development phase is Ziltivekimab B in?
What are the side effects of Ziltivekimab B?
What does Ziltivekimab B target?
Related
- Drug class: All IL-1β inhibitor drugs
- Target: All drugs targeting IL-1β
- Manufacturer: Novo Nordisk A/S — full pipeline
- Therapeutic area: All drugs in Autoimmune diseases
- Indication: Drugs for Treatment of generalized pustular psoriasis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing