INLYTA (axitinib)
INLYTA is indicated for the treatment of First-line treatment of advanced renal cell carcinoma in combination with avelumab; First-line treatment of advanced renal cell carcinoma in combination with pembrolizumab; Advanced renal cell carcinoma after failure of one prior systemic therapy.
How INLYTA Works
Axitinib functions by inhibiting specific receptor tyrosine kinases, specifically vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, and VEGFR-3. These receptors are involved in pathologic angiogenesis, tumor growth, and the progression of cancer. By blocking these targets, the drug inhibits the proliferation and survival of endothelial cells mediated by VEGF. This action results in the inhibition of tumor growth and the phosphorylation of VEGFR-2.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-01-27
- Patent Cliff
- 2037
- Revenue
- $220M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
INLYTA Approval History
What INLYTA Treats
3 indicationsINLYTA is approved for 3 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- First-line treatment of advanced renal cell carcinoma in combination with avelumab
- First-line treatment of advanced renal cell carcinoma in combination with pembrolizumab
- Advanced renal cell carcinoma after failure of one prior systemic therapy
INLYTA Target & Pathway
ProTarget
Receptors on blood vessel cells that respond to VEGF signals to form new blood vessels. Cancer cells exploit this pathway to ensure blood supply for tumor growth. Blocking VEGFRs prevents tumor angiogenesis and limits cancer progression.
Pathway Context
VEGFR on blood vessels is activated by VEGF to promote angiogenesis
A signaling protein that stimulates the formation of new blood vessels (angiogenesis). Tumors need blood supply to grow, so they secrete VEGF to create new vessels. Blocking VEGF starves tumors of oxygen and nutrients, inhibiting their growth.
INLYTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in INLYTA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INLYTA treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
99 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05805501 | BO43936 | Ph 2 | active not recruiting | A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma |
| NCT02535533 results posted | 201507716 | Ph 1, Ph 2 | completed | SLM + Axitinib for Clear Cell RCC |
| NCT05327686 SAMURAI | NRG-GU012 NCI-2022-02189, NRG-GU012 | Ph 2 | recruiting | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial |
| NCT01744249 results posted | AXI-IIG-02 2011-001550-29 | Ph 2, Ph 3 | completed | Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas |
| NCT04355156 AXMUS-C results posted | WS913975 2011-002598-49 | Ph 2 | completed | Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer |
| NCT05059522 | B9991046 2023-509466-38-00 | Ph 3 | active not recruiting | Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing |
| NCT05969496 NEOPAX | 22-1669.cc | Ph 2 | recruiting | Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus |
| NCT05808608 | AK104AXI-ssRCC | Ph 1, Ph 2 | active not recruiting | A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma |
| NCT03297606 CAPTUR | PM1 ESR-17-12831, CA209-9DL | Ph 2 | recruiting | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) |
| NCT05017012 | 3475A-C18 MK-3475A-C18, jRCT2031220507 | Ph 1 | active not recruiting | 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) |
| NCT07123090 SPARCC | 25-258 | Ph 2 | recruiting | A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma |
| NCT07469683 | 4-2024-1664 | Ph 2 | recruiting | 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 |
| NCT04693468 | 2020-0436 NCI-2020-06041, 2020-0436 | Ph 1 | recruiting | Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial |
| NCT06860386 | MCC-23473 | Ph 2 | suspended | Study of Adaptive Immunotherapy With VEGFR-TKI in Patients With Advanced RCC |
| NCT01409200 | 2011-0231 NCI-2015-01711, NCI-2011-02749 | Ph 2 | completed | Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis |
| NCT03839498 | AAAR5314 | Ph 2 | active not recruiting | Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma |
| NCT05384496 | 22-017 | Ph 2 | recruiting | Axitinib and Nivolumab for the Treatment of Mucosal Melanoma |
| NCT07383441 | S2419 NCI-2026-00080, S2419 | Ph 3 | not yet recruiting | Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer |
| NCT02853331 results posted | 3475-426 163460, MK-3475-426 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426) |
| NCT04585815 results posted | B8011011 2020-002829-28 | Ph 1, Ph 2 | terminated | Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) |
| NCT03092856 | 4K-16-5 NCI-2017-00223, 4K-16-5 | Ph 2 | active not recruiting | Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer |
| NCT05363631 | 202104398 | Ph 1, Ph 2 | active not recruiting | Seleno-L Methionine (SLM)-Axitinib-Pembrolizumab |
| NCT04996823 | MCC-21112 63403991 | Ph 2 | recruiting | Axitinib + Ipilimumab in Advanced Melanoma |
| NCT03595124 results posted | NCI-2018-01489 NCI-2018-01489, AREN1721 | Ph 2 | active not recruiting | A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC) |
| NCT06962787 | BL-B01D1-204-13 | Ph 2 | recruiting | A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer |
| NCT03172754 | GU-102 17-1009 | Ph 1, Ph 2 | active not recruiting | Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma |
| NCT04258956 AXAGIST | AXAGIST | Ph 2 | completed | A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy |
| NCT04458259 | C4201002 2021-004270-59, ARRAY-067-102 | Ph 1 | terminated | Study of PF-07265807 in Participants With Metastatic Solid Tumors. |
| NCT05949632 | INCB99280-201 2023-510281-27-00, 2022-003663-13 | Ph 1, Ph 2 | terminated | A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors |
| NCT04341181 ProTarget | ProTarget | Ph 2 | recruiting | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling |
| NCT04522323 | D7980C00003 2023-509604-15-00, 2019-004338-41 | Ph 1 | active not recruiting | A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma |
| NCT06161558 | 10001657 001657-C | Ph 1 | withdrawn | Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors |
| NCT04493203 results posted | HCC 20-101 | Ph 2 | completed | Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma |
| NCT02912572 results posted | 16-322 | Ph 2 | active not recruiting | Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer |
| NCT04337970 | 20-001 | Ph 1, Ph 2 | completed | Talazoparib and Axitinib for People With Previously Treated Advanced Kidney Cancer |
| NCT02597322 AXIPAN | P110209 | Ph 2 | completed | Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN) |
| NCT05256472 | AK104-213 | Ph 2 | active not recruiting | A Study of AK104 Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma |
| NCT06364631 CARE1 | 2023-503317-29-00 2023/3764 | Ph 3 | recruiting | CARE1 Pragmatic Clinical Trial |
| NCT04562441 | NPC 033 | Ph 2 | completed | NPC - AXEL Study : Axitinib-Avelumab |
| NCT05097599 StrataPATH | STR-004-001 KEYNOTE-F04 | Ph 2 | terminated | StrataPATH™ (Precision Indications for Approved Therapies) |
| NCT05904730 | A6334536 | Ph 1 | completed | Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations |
| NCT06211114 | FD-001-II-RCC | Ph 2 | recruiting | Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma |
| NCT01693822 A-PREDICT results posted | ICR-CTSU/2011/10033 | Ph 2 | completed | A Phase II Study of Axitinib in Patients With Metastatic Renal Cell Cancer Unsuitable for Nephrectomy |
| NCT02639182 results posted | AGS-16C3F-15-3 | Ph 2 | completed | A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma |
| NCT06690697 | 2411091-1 | Ph 2 | recruiting | Combination of Toripalimab and JS004 Therapy for ccRCC |
| NCT03990571 results posted | 2019-0107 NCI-2019-03704, 2019-0107 | Ph 2 | completed | Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma |
| NCT02667886 results posted | X4P-001-RCCA | Ph 1, Ph 2 | completed | Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma |
| NCT01263769 results posted | 2010-0072 NCI-2011-00279 | Ph 2 | completed | Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC) |
| NCT02636725 results posted | 20150932 | Ph 2 | completed | Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas |
| NCT02859012 AxitinibACC | Axitinib in ACC | Ph 2 | completed | Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma |
Showing 50 of 99 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INLYTA FDA Label Details
Indications & Usage
FDA Label (PDF)INLYTA is indicated for the treatment of First-line treatment of advanced renal cell carcinoma in combination with avelumab; First-line treatment of advanced renal cell carcinoma in combination with pembrolizumab; Advanced renal cell carcinoma after failure of one prior systemic therapy.
INLYTA Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for INLYTA
Revenue Insights
- • Q4-2025: $220M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 36 active patents
Trial Analysis
- • 106 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment