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Bermekimab Monoclonal Antibody
Bermekimab Monoclonal Antibody is a IL-1β inhibitor monoclonal antibody Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 2 development for Inflammatory conditions (Phase 2 development).
Bermekimab is a monoclonal antibody that blocks IL-1β, a key pro-inflammatory cytokine, to reduce inflammation and immune activation.
Bermekimab is a monoclonal antibody that targets Disialoganglioside GD2. It is being studied in clinical trials for various conditions, including metastatic colorectal cancer, atopic dermatitis, eczema, and hidradenitis suppurativa.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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
Janssen Research & Development, LLC 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Bermekimab Monoclonal Antibody |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | IL-1β inhibitor monoclonal antibody |
| Target | IL-1β (Interleukin-1 beta) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Bermekimab binds to and neutralizes interleukin-1 beta (IL-1β), a central mediator of innate immune responses and inflammation. By inhibiting IL-1β signaling, the drug reduces the production of downstream inflammatory mediators and dampens excessive inflammatory responses. This mechanism is intended to treat conditions driven by IL-1β-mediated inflammation.
Approved indications
- Inflammatory conditions (Phase 2 development)
Common side effects
- Infection risk
- Injection site reactions
- Infusion-related reactions
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of Bermekimab in Patients With Moderate to Severe Atopic Dermatitis (PHASE2)
- A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (PHASE2)
- A Study of Bermekimab in Patients With Hidradenitis Suppurativa (PHASE2)
- A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer (PHASE3)
- A Phase II Study of Bermekimab (MABp1) in Patients With Moderate to Severe Atopic Dermatitis (PHASE2)
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:
- Bermekimab Monoclonal Antibody CI brief — competitive landscape report
- Bermekimab Monoclonal Antibody updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Bermekimab Monoclonal Antibody
What is Bermekimab Monoclonal Antibody?
How does Bermekimab Monoclonal Antibody work?
What is Bermekimab Monoclonal Antibody used for?
Who makes Bermekimab Monoclonal Antibody?
What drug class is Bermekimab Monoclonal Antibody in?
What development phase is Bermekimab Monoclonal Antibody in?
What are the side effects of Bermekimab Monoclonal Antibody?
What does Bermekimab Monoclonal Antibody target?
Related
- Drug class: All IL-1β inhibitor monoclonal antibody drugs
- Target: All drugs targeting IL-1β (Interleukin-1 beta)
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Inflammatory conditions (Phase 2 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing