Inlyta
(Axitinib)ApprovedSmall molecule
Axitinib is used to treat advanced kidney cancer and certain types of thyroid cancer by slowing or stopping the growth of cancer cells.[2] Inlyta is currently approved and in use across 47 indications[4].[1]
Inlyta is one of 896 small molecule programs targeting Collecting Duct Carcinoma. It is currently in Approved.
47
Indications
151
Total Trials
35
Active Trials
895
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
8
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 47 indications
Competition
Competitive Landscape
1639 competitors in Non-Small Cell Lung Cancer
#DrugCompanyPhaseTrials
1Inlyta
PPrism Pharmaceuticals
Approved
Yervoy
Bristol-Myers SquibbPreclinical
PORTRAZZA
Eli LillyPreclinical
Lenvima
EisaiPreclinical
Imjudo
AstraZenecaPreclinical
Gilotrif
Boehringer IngelheimPreclinical
Immunotherapy
Bristol-Myers SquibbPreclinical
PD-1 Inhibitor
Johnson & JohnsonPreclinical
Tyrosine Kinase Inhibitor
PfizerPreclinical
Aqupla
Jiangsu Simcere Pharmaceutical Co., Ltd.Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
Phase 1/2Active, not recruiting
Renal Cell Carcinoma
NCT03172754
Phase 2Active, not recruiting
Renal Cell Carcinoma
NCT05805501
Phase 2Active, not recruiting
Endometrial Cancer
NCT02912572
Phase 2Active, not recruiting
Metastatic Renal Cell Carcinoma
NCT03595124
Phase 1/2Active, not recruiting
Pembrolizumab
NCT05363631
Phase 2Recruiting
Toripalimab
NCT06690697
Clinical
Trials by Indication[1]
Renal Cell Carcinoma27 trials
Show 24 more trials
Kidney Cancer8 trials
Show 5 more trials
Melanoma7 trials
Show 4 more trials
Renal Cell Cancer5 trials
Non-Small Cell Lung Cancer4 trials
68 more indications
Metastatic Colorectal Cancer4 trials
Show 1 more trial
TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC)
Terminated·—·Phase 1·NCT04873895·5 enrolled
Metastatic Renal Cell Cancer4 trials
Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer
Completed·—·Phase 2·NCT02579811·40 enrolled
Clinical Trial4 trials
Show 1 more trial
Hepatocellular Carcinoma4 trials
Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib
Completed·—·Phase 2·NCT01352728·50 enrolled
Show 1 more trial
Patients With Advanced Solid Tumors3 trials
Advanced Solid Tumors3 trials
Trial3 trials
Pembrolizumab3 trials
Treatment3 trials
Glioblastoma3 trials
Advanced Solid Tumor2 trials
Prostate Cancer2 trials
Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer
Completed·—·Phase 2·NCT01385059·11 enrolled
Paraganglioma2 trials
Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Pheochromocytoma/Paraganglioma
Active, not recruiting·—·Phase 2·NCT03839498·6 enrolled
First Line Therapy2 trials
Adenoid Cystic Carcinoma2 trials
Endometrial Cancer2 trials
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
Active, not recruiting·—·Phase 2·NCT02912572·106 enrolled
Pembrolizumab With Axitinib in Recurrent Endometrial Cancer
Withdrawn·—·Phase 2·NCT04197219
Advanced2 trials
Metastatic Renal Cell Carcinoma2 trials
Neuroendocrine Carcinoma1 trial
Biliary Malignant Tumors1 trial
Salivary Gland Cancer1 trial
Soft Tissue Sarcoma1 trial
Metastasis1 trial
Maintenance Treatment1 trial
Axitinib as Maintenance Treatment in Patients With Metastatic CRC
Terminated·SSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)·Phase 2·NCT01483638·84 enrolled
NPC1 trial
NPC - AXEL Study : Axitinib-Avelumab
Completed·—·Phase 2·NCT04562441·13 enrolled
Vestibular schwannoma1 trial
Mantle Cell Lymphoma1 trial
Advanced or Metastatic Solid Tumors1 trial
Maximum Tolerated Dose1 trial
Endometriosis1 trial
Solid Malignancies1 trial
Alveolar Soft Part Sarcoma1 trial
Axitinib and Pembrolizumab in Subjects With Advanced Alveolar Soft Part Sarcoma and Other Soft Tissue Sarcomas
Completed·—·Phase 2·NCT02636725·33 enrolled
Recurrent or Refractory Solid Tumors1 trial
Papillary Renal Cell Carcinoma1 trial
Nivolumab1 trial
Glioblastoma Multiforme1 trial
Unresectable1 trial
Cervical Cancer1 trial
Myeloid Leukemia1 trial
Relapsed or Refractory1 trial
Nasopharyngeal Carcinoma1 trial
Nasopharyngeal Carcinoma (NPC) Axitinib
Completed·—·Phase 2·NCT01249547·37 enrolled
Renal Cancer1 trial
Nephrectomy1 trial
Malignant Mesothelioma1 trial
Gastric Cancer1 trial
Collecting Duct Carcinoma1 trial
Locally Advanced1 trial
Safety and Efficacy1 trial
Recurrent or Metastatic1 trial
Metastatic Head and Neck Cancer1 trial
Carcinoma, Renal Cell1 trial
Advanced Malignancies1 trial
Unspecified1 trial
Regulatory
FDA Approval Timeline[5]
Jan 27, 2012
INLYTA
NDA NDA202324
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Inlyta drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Axitinib. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Inlyta. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Vascular Endothelial Growth Factor Receptor Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- PPrism Pharmaceuticals
Patent Landscape[6]
Patent Cliff
Dec 14, 2030
Earliest patent expiration — generic entry possible after this date
Patent #Expires
8791140Dec 14, 2030
8791140*PEDJun 14, 2031
12534530Feb 3, 2035
10570202Feb 3, 2035
12534530*PEDAug 3, 2035