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BAY73-4506
BAY73-4506 is a Kinase inhibitor Small molecule drug developed by Bayer. It is currently in Phase 2 development.
BAY73-4506 is believed to be a kinase inhibitor, though its specific molecular target has not been publicly disclosed.
BAY73-4506 is a small molecule used in clinical trials for various cancer indications, including Hepatocellular Carcinoma, Cancer of the Bile Duct, and Colorectal Cancer. It has been studied in combination with other treatments such as HAIC, Bevacizumab, and ICIs in trials like NCT05713994.
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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). -
Big-pharma sponsor
+3.0pp
Bayer 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 | BAY73-4506 |
|---|---|
| Sponsor | Bayer |
| Drug class | Kinase inhibitor |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
As a kinase inhibitor developed by Bayer, BAY73-4506 likely works by blocking specific protein kinases involved in cancer cell growth and survival. However, the exact molecular target and binding mechanism have not been publicly characterized in available scientific literature.
Approved indications
Common side effects
Key clinical trials
- Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma (PHASE2)
- Regorafenib in Patients With Refractory Primary Bone Tumors (PHASE1, PHASE2)
- A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies (PHASE2)
- TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (PHASE2)
- Phase II Study of Regorafenib as Maintenance Therapy (PHASE2)
- Regorafenib in Metastatic Colorectal Cancer : a Cohort Study in the Real-life Setting
- Phase II Study of Regorafenib in Metastatic Soft Tissue Sarcoma (PHASE2)
- Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7 (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:
- BAY73-4506 CI brief — competitive landscape report
- BAY73-4506 updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about BAY73-4506
What is BAY73-4506?
How does BAY73-4506 work?
Who makes BAY73-4506?
What drug class is BAY73-4506 in?
What development phase is BAY73-4506 in?
Related
- Drug class: All Kinase inhibitor drugs
- Manufacturer: Bayer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing