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KW-2246
KW-2246 is a OX40 agonist monoclonal antibody Small molecule drug developed by Kyowa Kirin Co., Ltd.. It is currently in Phase 3 development for Advanced or metastatic solid tumors (Phase 3 development).
KW-2246 is a humanized monoclonal antibody that binds to and inhibits OX40, a co-stimulatory immune checkpoint receptor, to enhance T-cell activation and anti-tumor immunity.
KW-2246 is a small molecule used in clinical trials for the treatment of pain, cancer, and breakthrough pain in cancer patients. It has been studied in a Phase III clinical trial as a potential treatment for breakthrough pain in cancer patients.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | KW-2246 |
|---|---|
| Sponsor | Kyowa Kirin Co., Ltd. |
| Drug class | OX40 agonist monoclonal antibody |
| Target | OX40 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
OX40 is an inducible T-cell co-stimulatory molecule that plays a key role in T-cell proliferation and survival. By blocking OX40 signaling, KW-2246 enhances T-cell mediated immune responses against cancer cells. This approach aims to overcome immune tolerance and improve anti-tumor efficacy, potentially as monotherapy or in combination with other immunotherapies.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
- Immune-related adverse events (irAEs)
- Fatigue
- Rash
- Diarrhea
Key clinical trials
- A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients (PHASE3)
- A Phase III Clinical Study of KW-2246 (PHASE3)
- A Comparative Study of KW-2246 (PHASE3)
- Clinical Study of KW-2246 in Patients With Cancer Pain (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:
- KW-2246 CI brief — competitive landscape report
- KW-2246 updates RSS · CI watch RSS
- Kyowa Kirin Co., Ltd. portfolio CI
Frequently asked questions about KW-2246
What is KW-2246?
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What does KW-2246 target?
Related
- Drug class: All OX40 agonist monoclonal antibody drugs
- Target: All drugs targeting OX40
- Manufacturer: Kyowa Kirin Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors (Phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing