Last reviewed · How we verify
AG-013736
AG-013736 is a Multi-targeted tyrosine kinase inhibitor Small molecule drug developed by University of Wisconsin, Madison. It is currently in Phase 3 development for Renal cell carcinoma, Other solid tumors (in clinical development). Also known as: Axitinib, axitinib.
AG-013736 is a tyrosine kinase inhibitor that blocks multiple receptor tyrosine kinases involved in angiogenesis and tumor growth.
AG-013736 is a tyrosine kinase inhibitor that blocks multiple receptor tyrosine kinases involved in angiogenesis and tumor growth. Used for Renal cell carcinoma, Other solid tumors (in clinical development).
-
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 | AG-013736 |
|---|---|
| Also known as | Axitinib, axitinib |
| Sponsor | University of Wisconsin, Madison |
| Drug class | Multi-targeted tyrosine kinase inhibitor |
| Target | VEGFR (VEGF receptor), PDGFR, and other receptor tyrosine kinases |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AG-013736 inhibits VEGF receptors (VEGFR) and other receptor tyrosine kinases critical for tumor angiogenesis and vascular endothelial growth factor signaling. By blocking these pathways, the drug suppresses new blood vessel formation that tumors depend on for growth and metastasis. This multi-targeted approach aims to starve tumors of their blood supply while also directly inhibiting tumor cell proliferation.
Approved indications
- Renal cell carcinoma
- Other solid tumors (in clinical development)
Common side effects
- Hypertension
- Diarrhea
- Fatigue
- Nausea
- Anorexia
Key clinical trials
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (PHASE1)
- A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma (PHASE2)
- Drug Screening Using Novel IMD in Renal Cell Carcinoma (PHASE1)
- Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma (PHASE3)
- A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy (PHASE3)
- Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial (PHASE1)
- An Open-label, Randomized Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of the Combination Therapy of SLC-3010 and Axitinib Compared to Axitinib Monotherapy as a Second-line Treatment for Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma (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:
- AG-013736 CI brief — competitive landscape report
- AG-013736 updates RSS · CI watch RSS
- University of Wisconsin, Madison portfolio CI
Frequently asked questions about AG-013736
What is AG-013736?
How does AG-013736 work?
What is AG-013736 used for?
Who makes AG-013736?
Is AG-013736 also known as anything else?
What drug class is AG-013736 in?
What development phase is AG-013736 in?
What are the side effects of AG-013736?
What does AG-013736 target?
Related
- Drug class: All Multi-targeted tyrosine kinase inhibitor drugs
- Target: All drugs targeting VEGFR (VEGF receptor), PDGFR, and other receptor tyrosine kinases
- Manufacturer: University of Wisconsin, Madison — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Renal cell carcinoma
- Indication: Drugs for Other solid tumors (in clinical development)
- Also known as: Axitinib, axitinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing