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Inlyta (axitinib)
Inlyta works by blocking the activity of the mast/stem cell growth factor receptor Kit, which is involved in the growth and spread of cancer cells.
Inlyta (axitinib) is a small molecule kinase inhibitor that targets the mast/stem cell growth factor receptor Kit. It is a drug class of tyrosine kinase inhibitor used to treat renal cell carcinoma. Originally developed by Pfizer, it is now owned by Pf Prism Cv. Inlyta was FDA approved in 2012 and is still commercially available. Key safety considerations include its potential to cause hypertension and bleeding.
At a glance
| Generic name | axitinib |
|---|---|
| Sponsor | Pfizer |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Mast/stem cell growth factor receptor Kit |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2012 |
| Annual revenue | 923 |
Mechanism of action
Axitinib has been shown to inhibit receptor tyrosine kinases including vascular endothelial growth factor receptors (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. VEGF-mediated endothelial cell proliferation and survival were inhibited by axitinib in vitro and in mouse models. Axitinib was shown to inhibit tumor growth and phosphorylation of VEGFR-2 in tumor xenograft mouse models.
Approved indications
- Renal cell carcinoma
Common side effects
- Diarrhea
- Nausea
- Mucositis
- Hepatotoxicity
- Fatigue
- Hypertension
- Musculoskeletal pain
- Palmar-plantar erythrodysesthesia
- Dysphonia
- Decreased appetite
- Hypothyroidism
- Rash
Drug interactions
- boceprevir
- bosentan
- carbamazepine
- clarithromycin
- conivaptan
- dexamethasone
- dicycloverine
- efavirenz
- etravirine
- fosphenytoin
- indinavir
- itraconazole
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Inlyta CI brief — competitive landscape report
- Inlyta updates RSS · CI watch RSS
- Pfizer portfolio CI