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 33 indications[4].[1]

Inlyta is one of 559 small molecule programs targeting Collecting Duct Carcinoma. It is currently in Approved.

Indications

155

Total Trials

Active Trials

558

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Collecting Duct CarcinomaRecruiting

Hepatic FailureApproved

Colorectal CarcinomaApproved

Prostate AdenocarcinomaApproved

Clear Cell Renal CarcinomaApproved

ParagangliomaActive, not recruiting

Thyroid NeoplasmApproved

Kidney CancerNot yet recruiting

Nasopharyngeal NeoplasmApproved

Colorectal NeoplasmApproved

Collecting Duct CarcinomaPhase 2

Recruiting

Hepatic FailureApproved

Approved

Colorectal CarcinomaApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Clear Cell Renal CarcinomaApproved

Approved

ParagangliomaPhase 2

Active, not recruiting

Thyroid NeoplasmApproved

Approved

Kidney CancerPhase 3

Not yet recruiting

Nasopharyngeal NeoplasmApproved

Approved

Colorectal NeoplasmApproved

Approved

Showing 10 of 33 indications

Competition

Competitive Landscape

286 competitors in Advanced Solid Tumors

#DrugCompanyPhaseTrials

Inlyta

PPrism Pharmaceuticals

Approved

3 2

Keytruda

Merck & Co.

Phase 2

47 3

Avastin

Roche

Phase 2

12 4

Tecentriq

Roche

Phase 2

11 5

Imfinzi

AstraZeneca

Phase 2

10 6

Mektovi

Pfizer

Phase 2

3 7

Tarceva

OOSI Pharmaceuticals

Phase 2

6 8

Faslodex

FFresenius Kabi USA, LLC

Phase 2

3 9

Jemperli

GGlaxo Dba Glaxosmithkline

Phase 2

3 10

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Metastatic Renal Cell Carcinoma

NCT03595124

Phase 2Recruiting

Toripalimab

NCT06690697

Phase 2Active, not recruiting

Kidney Cancer

NCT03092856

Phase 3Active, not recruiting

Advanced Malignancies

NCT05059522

Q1 2027

Phase 2Recruiting

Trial

NCT03297606

Phase 2Active, not recruiting

Paraganglioma

NCT03839498

Clinical

Trials by Indication[1]

Renal Cell Carcinoma24 trials

Neoadjuvant Axitinib in Locally Advanced Renal Cell Carcinoma (RCC)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01263769·39 enrolled

Pembrolizumab and Axitinib as Neoadjuvant Therapy for Locally Advanced Non-metastatic Clear Cell Renal Cell Carcinoma

Unknown status·TTianjin Medical University Second Hospital·Phase 2·NCT04995016·18 enrolled

Neoadjuvant Pembrolizumab and Axitinib in Renal Cell Carcinoma With Inferior Vena Cava Tumor Thrombus

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT05969496·17 enrolled

Show 21 more trials

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

Recruiting·ZZHOU FANGJIAN·Phase 3·NCT05738694·298 enrolled

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

Recruiting·YYonsei University·Phase 2·NCT07469683·78 enrolled

A Phase II Study of Axitinib in Metastatic Non-clear Cell Renal Cell Carcinoma Patients Previously Treated With Temsirolimus

Completed·SSeoul National University Hospital·Phase 2·NCT01798446·41 enrolled

Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

Completed·RRenJi Hospital·Phase 2·NCT04118855·20 enrolled

Study of Patients With Metastatic and/or Advanced Renal Cell Carcinoma, Treated With Sunitinib/Axitinib.

Completed· Pfizer logo

Pfizer··NCT04033991·684 enrolled

To Examine the Effects of Axitinib Dose Reduction and Interruption for Adverse Event Management Among Patients Receiving Axitinib in for the Treatment of Advanced Renal Cell Carcinoma

Completed· Pfizer logo

Pfizer··NCT04682587·481 enrolled

Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma

Terminated·TTracon Pharmaceuticals Inc.·Phase 1/2·NCT01806064·173 enrolled

Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

Active, not recruiting·FFox Chase Cancer Center·Phase 1/2·NCT03172754·98 enrolled

A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma

Completed· Astellas logo

Astellas·Phase 2·NCT02639182·133 enrolled

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)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02853331·861 enrolled

PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

Terminated· Pfizer logo

Pfizer·Phase 2·NCT01441414·18 enrolled

Avelumab Plus Intermittent Axitinib in Previously Untreated Patients With Metastatic Renal Cell Carcinoma

Unknown status·CConsorzio Oncotech·Phase 2·NCT04698213·75 enrolled

NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma

Terminated·PPrECOG, LLC.·Phase 2·NCT01649180·3 enrolled

Toripalimab Combined With Axitinib as Neoadjuvant Therapy for Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma

Unknown status·WWest China Hospital·Phase 2·NCT04385654·40 enrolled

Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

Completed·KKidney Cancer Research Bureau·Phase 2·NCT02700568·21 enrolled

Postoperative Adjuvant Therapy for Non-clear Renal Cell Carcinoma With High-risk Recurrence Factors

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05768464·30 enrolled

A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04522323·67 enrolled

Trial of X4P-001 in Participants With Advanced Renal Cell Carcinoma

Completed·XX4 Pharmaceuticals·Phase 1/2·NCT02667886·74 enrolled

A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma

Recruiting·HHao Zeng·Phase 1/2·NCT05808608·33 enrolled

A Randomized Open Label Phase II Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma

Completed· Roche logo

Roche·Phase 2·NCT05805501·199 enrolled

Phase II Trial of Cadonilimab (AK104) Monotherapy or AK104 Plus Axitinib in Advanced/Metastatic Renal Cell Carcinoma (RCC)

Completed·AAkeso·Phase 2·NCT05256472·28 enrolled

Kidney Cancer8 trials

Clinical Study With Axitinib In Advanced Kidney Cancer, Who Have Failed First Line Treatment

No longer available· Pfizer logo

Pfizer··NCT01473043

Axitinib With or Without Anti-OX40 Antibody PF-04518600 in Treating Patients With Metastatic Kidney Cancer

Active, not recruiting·UUniversity of Southern California·Phase 2·NCT03092856·62 enrolled

Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT00835978·213 enrolled

Show 5 more trials

An Expanded Access Program to Axitinib is Available for Patients With Advanced Forms of Kidney Cancer (Ductal; Papillary; Chromophobic; Oncocytic) With Mutations in VHL, PBRM1 / BAP1, SETD2, VEGF)

No longer available·LLynkcell Europe··NCT05941637

Pembrolizumab With or Without Axitinib for Clear Cell Kidney Cancer in Patients Undergoing Surgery

Terminated·UUniversity of California, San Francisco·Phase 2·NCT04370509·6 enrolled

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer

Not yet recruiting·SSWOG Cancer Research Network·Phase 3·NCT07383441·718 enrolled

A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT04540705·30 enrolled

A Phase Ib/II Study of Talazoparib and Axitinib in Metastatic Renal Cell Carcinoma

Completed·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT04337970·23 enrolled

Melanoma7 trials

Study of the Anti-Angiogenesis Agent Axitinib in Patients With Stage III Malignant Melanoma

Completed·UUniversity of California, Irvine·Phase 2·NCT01321437·11 enrolled

A Two Arm Trial of Axitinib and Carboplatin/Paclitaxel in Melanoma

Completed·AAdil Daud·Phase 2·NCT01174238·40 enrolled

Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma

Completed·YYana Najjar·Phase 2·NCT04493203·31 enrolled

Show 4 more trials

Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT01533948·25 enrolled

A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma

Completed·NNanjing Leads Biolabs Co.,Ltd·Phase 1·NCT04640545·79 enrolled

Phase II Study in the Treatment of Patients With Advanced Mucinous Melanoma

Unknown status·PPeking University Cancer Hospital & Institute·Phase 2·NCT03941795·99 enrolled

Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT04996823·24 enrolled

Renal Cell Cancer5 trials

A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell Cancer

Unknown status·TTianjin Medical University Second Hospital·Phase 2·NCT04958473·40 enrolled

A Dose Finding Study To Evaluate Safety, Drug Interaction, Tumor Markers Of Axitinib In Combination With MK-3475 In Adult Patients With Previously Untreated Advanced Renal Cell Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT02133742·52 enrolled

A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

Completed· Pfizer logo

Pfizer·Phase 1·NCT02493751·55 enrolled

Show 2 more trials

Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02560012·4 enrolled

A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)

Completed· Pfizer logo

Pfizer·Phase 3·NCT02684006·886 enrolled

Clinical Trial4 trials

Continuing Access to Axitinib (A406- AG- 013736 ) For Patients Previously Receiving AG 013736 In Clinical Trials

Completed· Pfizer logo

Pfizer·N/A·NCT00828919·52 enrolled

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Recruiting·UUlrik Lassen·Phase 2·NCT04341181·300 enrolled

Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations

Completed·LLynkcell Europe·Phase 1·NCT05904730·10 enrolled

Show 1 more trial

CARE1 Pragmatic Clinical Trial

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT06364631·1,250 enrolled

75 more indications

Metastatic Colorectal Cancer4 trials

Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer

Completed·IImperial College London·Phase 2·NCT04355156·52 enrolled

Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer

Completed·GGustave Roussy, Cancer Campus, Grand Paris·N/A·NCT01486251·27 enrolled

TACE Plus Axitinib and Hydroxychlorquine for Liver-Dominant Metastatic Colorectal Cancer (CRC)

Terminated·—·Phase 1·NCT04873895·5 enrolled

Show 1 more trial

A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT01490866·70 enrolled

Non-Small Cell Lung Cancer4 trials

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT04585815·34 enrolled

A Study of Avelumab in Combination With Axitinib In Non-Small Cell Lung Cancer (NSCLC) or Urothelial Cancer (Javelin Medley VEGF)

Terminated· Pfizer logo

Pfizer·Phase 2·NCT03472560·61 enrolled

Anti-angiogenesis Agent AG-013736 in Patients With Advanced Non-Small Cell Lung Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT00094094·32 enrolled

Show 1 more trial

Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

Completed· Pfizer logo

Pfizer·Phase 1/2·NCT00768755·180 enrolled

Hepatocellular Carcinoma4 trials

Hepatocellular Carcinoma (HCC) Transarterial Chemoembolisation (TACE) +Axitinib

Completed·—·Phase 2·NCT01352728·50 enrolled

Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT05249569·1 enrolled

Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma

Completed· Pfizer logo

Pfizer·Phase 2·NCT01210495·224 enrolled

Show 1 more trial

Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

Completed·UUniversity Health Network, Toronto·Phase 2·NCT01334112·30 enrolled

Metastatic Renal Cell Cancer4 trials

Axitinib Given on an Individualized Schedule for Metastatic Renal Cell Cancer

Completed·—·Phase 2·NCT02579811·40 enrolled

Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT00678392·723 enrolled

Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT00920816·492 enrolled

Show 1 more trial

A Phase II Study of Axitinib in Patients With Metastatic Renal Cell Cancer Unsuitable for Nephrectomy

Completed·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT01693822·65 enrolled

Metastatic Renal Cell Carcinoma4 trials

Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Recruiting·NNRG Oncology·Phase 2·NCT05327686·240 enrolled

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03595124·15 enrolled

Application of 18F-FDG PET/CT in Evaluating Treatment Response to Targeted Therapy Plus Immunotherapy in Patients With Metastatic Renal Cell Carcinoma: A Single-Center Retrospective Clinical Study

Completed·FFirst Affiliated Hospital of Fujian Medical University··NCT07827482·228 enrolled

Show 1 more trial

A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC

Recruiting·SStephanie Berg·Phase 2·NCT07123090·25 enrolled

Trial3 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Open Label Continuation Study of TRC105 for Patients Who Have Completed a Prior TRC105 Trial

No longer available·TTracon Pharmaceuticals Inc.··NCT02354612

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03297606·720 enrolled

Patients With Advanced Solid Tumors3 trials

A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT01999972·50 enrolled

Study Of AG-013736 (Axitinib) In Patients With Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT00447005·12 enrolled

Erlotinib in Combination With Select Tyrosine Kinase Inhibitors in Adult Patients With Advanced Solid Tumors

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT06161558

Advanced Solid Tumors3 trials

Study of the Combination of Axitinib Plus Everolimus in Patients With Malignant Advanced Solid Tumors

Completed·UUniversity Hospital, Bordeaux·Phase 1·NCT01334073·19 enrolled

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)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1·NCT05017012·72 enrolled

A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

Terminated· Incyte logo

Incyte·Phase 1/2·NCT05949632·5 enrolled

Treatment3 trials

Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries

Completed· Pfizer logo

Pfizer··NCT04669366·1,205 enrolled

An Observational Chart Review Study To Describe The Real-World Outcomes And Use Of Avelumab In Combination With Axitinib For Treatment Of Patients With aRCC In The UK

Completed· Pfizer logo

Pfizer··NCT05394493·130 enrolled

Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England

Completed· Ipsen logo

Ipsen··NCT04637204·1,540 enrolled

Glioblastoma3 trials

A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma

Completed·BBart Neyns·Phase 2·NCT01562197·56 enrolled

Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma

Withdrawn·CCenter Trials & Treatment·Phase 1·NCT03275558

Clinical Trial on the Combination of Avelumab and Axitinib for the Treatment of Patients With Recurrent Glioblastoma

Completed·UUniversitair Ziekenhuis Brussel·Phase 2·NCT03291314·52 enrolled

Advanced Solid Tumor2 trials

Investigational Agent AG-013736 In Combinations With Standard Of Care Treatments For Patient's With Advanced Solid Tumor

Completed· Pfizer logo

Pfizer·Phase 1·NCT00454649·102 enrolled

A Study In Patients With Advanced Solid Tumor

Completed· Pfizer logo

Pfizer·Phase 1·NCT00726752·6 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

Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-pathway in Metastatic, Recurrent or Primary Unresectable Pheochromocytoma/Paraganglioma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01967576·14 enrolled

Pembrolizumab2 trials

Optimizing Pembrolizumab Therapy With Timing and Intensification With Axitinib

Withdrawn·UUniversity of Oklahoma·Phase 2·NCT05263609

Axitinib +/- Pembrolizumab in First Line Treatment of mPRCC

Recruiting·CCentre Leon Berard·Phase 2·NCT05096390·72 enrolled

Adenoid Cystic Carcinoma2 trials

Study of Axitinib in Patients With Recurred or Metastatic Adenoid Cystic Carcinoma

Completed·SSeoul National University Hospital·Phase 2·NCT02859012·60 enrolled

Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03990571·40 enrolled

First Line Therapy2 trials

Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

Completed· Merck & Co. logo

Merck & Co.··NCT05650164·171 enrolled

Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART)

Completed· Pfizer logo

Pfizer··NCT05012865·48 enrolled

Advanced2 trials

Avelumab, Palbociclib and Axitinib in Advanced RCC

Withdrawn·—·Phase 2·NCT05176288

A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)

Completed· Pfizer logo

Pfizer·Phase 1·NCT03289533·22 enrolled

Clear Cell Renal Cell Carcinoma2 trials

Phase I/II Study of Seleno-L Methionine (SLM) in Sequential Combination With Fixed Doses and Schedules of Axitinib and Pembrolizumab (SAP) in Locally Advanced and Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

Completed·MMohammed Milhem·Preclinical·NCT05363631·15 enrolled

A Prospective, Single-Center, Single-Arm, Phase II Clinical Study of Stereotactic Ablative Radiotherapy Combined With Axitinib and Toripalimab in the Treatment of Oligometastatic Clear Cell Renal Cell Carcinoma

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT07744932·48 enrolled

Prostate Cancer1 trial

Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01409200·73 enrolled

Metastasis1 trial

Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis

Unknown status·PPeking University Cancer Hospital & Institute·Phase 1·NCT05070221·30 enrolled

Carcinoid Tumor1 trial

A Study of Axitinib in Advanced Carcinoid Tumors

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT01435122·30 enrolled

Glioblastoma Multiforme1 trial

Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

Terminated·UUniversity of Cincinnati·Phase 2·NCT01508117·1 enrolled

High Risk Patients1 trial

Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients

Terminated·SSFJ Pharma Ltd. II·Phase 3·NCT01599754·724 enrolled

Biliary Malignant Tumors1 trial

Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors

Unknown status·PPeking Union Medical College Hospital·Phase 2·NCT04010071·60 enrolled

Solid Tumors1 trial

Study of Axitinib and Temsirolimus in Solid Tumors

Completed·EEmory University·Phase 1·NCT01529138·13 enrolled

Nivolumab1 trial

Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients

Recruiting·CConsorzio Oncotech·Phase 2·NCT05817903·118 enrolled

Unresectable1 trial

Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01255137·13 enrolled

Cervical Cancer1 trial

Avelumab With Axitinib in Persistent or Recurrent Cervical Cancer After Platinum-based Chemotherapy

Completed·TThe University of Hong Kong·N/A·NCT03826589·23 enrolled

Completed·MMohammed Milhem·Phase 1·NCT02535533·46 enrolled

NPC1 trial

NPC - AXEL Study : Axitinib-Avelumab

Completed·—·Phase 2·NCT04562441·13 enrolled

Mantle Cell Lymphoma1 trial

Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]

Completed· Pfizer logo

Pfizer··NCT00700258·1,520 enrolled

Vestibular schwannoma1 trial

Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas

Completed·NNYU Langone Health·Phase 2·NCT02129647·13 enrolled

Gastrointestinal Stromal Tumor1 trial

A Study of Avelumab In Combination With Axitinib in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumor After Failure of Standard Therapy

Completed·MMaria Sklodowska-Curie National Research Institute of Oncology·Phase 2·NCT04258956·58 enrolled

Mucosal Melanoma1 trial

Axitinib and Nivolumab for the Treatment of Mucosal Melanoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05384496·20 enrolled

Malignant Mesothelioma1 trial

Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

Completed·TThe Netherlands Cancer Institute·Phase 1/2·NCT01211275·32 enrolled

Myeloid Leukemia1 trial

Axitinib and Bosutinib in Treating Patients With Chronic, Accelerated, or Blastic Phase Chronic Myeloid Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT02782403·4 enrolled

Relapsed or Refractory1 trial

Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy

Unknown status·SSamsung Medical Center·Phase 2·NCT02638428·90 enrolled

Survival1 trial

Survival Prolongation by Rationale Innovative Genomics

Terminated·WWorldwide Innovative Network Association·Phase 1/2·NCT03386929·15 enrolled

Safety and Efficacy1 trial

Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea

Completed· Pfizer logo

Pfizer··NCT02156895·111 enrolled

Neoadjuvant1 trial

Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC

Unknown status·TThe Netherlands Cancer Institute·Phase 2·NCT03341845·40 enrolled

Toripalimab1 trial

Combination of Toripalimab and JS004 Therapy for ccRCC

Recruiting·FFudan University·Phase 2·NCT06690697·80 enrolled

Endometriosis1 trial

Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis

Withdrawn·BBioGene Pharmaceutical Ltd.·Phase 1/2·NCT03481842

Nasopharyngeal Carcinoma1 trial

Nasopharyngeal Carcinoma (NPC) Axitinib

Completed·—·Phase 2·NCT01249547·37 enrolled

Nephrectomy1 trial

Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT02597322·21 enrolled

Endometrial Cancer1 trial

Pembrolizumab With Axitinib in Recurrent Endometrial Cancer

Withdrawn·—·Phase 2·NCT04197219

Gastric Cancer1 trial

Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT00842244·22 enrolled

Collecting Duct Carcinoma1 trial

Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma

Recruiting·PPeking University Cancer Hospital & Institute·Phase 2·NCT06211114·30 enrolled

Locally Advanced1 trial

A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06962787·260 enrolled

Recurrent or Metastatic1 trial

SABR Combined with Axitinib and Toripalimab in Recurrent or Metastatic RCC

Recruiting·PPeking University First Hospital·Phase 2·NCT06889649·30 enrolled

Metastatic Melanoma1 trial

Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

Completed· Pfizer logo

Pfizer·Phase 2·NCT00094107·32 enrolled

Surgery1 trial

Prior Axitinib as a Determinant of Outcome of Renal Surgery

Active, not recruiting·UUniversity of California, San Diego·Phase 2·NCT03438708·22 enrolled

Metastatic Head and Neck Cancer1 trial

Phase II Trial Evaluating Axitinib In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT01469546·42 enrolled

Renal Cancer1 trial

Study of Axitinib for Reducing Extent of Venous Tumour Thrombus in Renal Cancer With Venous Invasion

Completed·SScottish Clinical Trials Research Unit·Phase 2·NCT03494816·24 enrolled

Head and Neck Cancer1 trial

Expansion Trial for Axitinib In Head And Neck Cancer

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT02762513·29 enrolled

Maximum Tolerated Dose1 trial

The Safety and Maximum Tolerated Dose of Axitinib in Combination With Radiotherapy for HCC

Completed·SShin Kong Wu Ho-Su Memorial Hospital·Phase 1·NCT02814461·9 enrolled

Metastatic Solid Tumors1 trial

Study of PF-07265807 in Participants With Metastatic Solid Tumors.

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04458259·88 enrolled

Solid Malignancies1 trial

Pharmacodynamic Study With FLT-PET/CT in Patients With Prostate/Other Solid Malignancies Treated With High Dose Axitinib

Completed·UUniversity of Wisconsin, Madison·Phase 1·NCT01540526·24 enrolled

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

VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors

Completed·CChildren's Oncology Group·Phase 1·NCT02164838·51 enrolled

Papillary Renal Cell Carcinoma1 trial

Axitinib in1st Line Treatment for Patients With Advanced or Metastatic Papillary Renal Cell Carcinoma

Completed·CCentre Leon Berard·Phase 2·NCT02489695·44 enrolled

Neuroendocrine Carcinoma1 trial

Sandostatin LAR and Axitinib vs Pbo in Pnts With Advanced Well-differentiated Non-pancreatic Neuroendocrine Carcinomas

Unknown status·GGrupo Espanol de Tumores Neuroendocrinos·Phase 2/3·NCT01744249·255 enrolled

Salivary Gland Cancer1 trial

Axitinib in R/M Salivary Gland Cancers of the Upper Aerodigestive Tract - SGC-AX14

Completed·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano·Phase 2·NCT02857712·26 enrolled

Soft Tissue Sarcoma1 trial

A Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas

Completed·SSheffield Teaching Hospitals NHS Foundation Trust·Phase 2·NCT01140737·145 enrolled

Stage III Prostate Cancer1 trial

A Randomized, Phase II Study Assessing Axitinib as Pre-Surgical Therapy in Patients With High Risk Prostate Cancer

Completed·CCity of Hope Medical Center·Phase 2·NCT01385059·11 enrolled

Immune Checkpoint Inhibitors1 trial

Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma

Active, not recruiting·RRenJi Hospital·Phase 2·NCT06279403·21 enrolled

Advanced Renal Cell Carcinoma1 trial

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (FRUSICA-2)

Completed·HHutchmed·Preclinical·NCT05522231·265 enrolled

Advanced Malignancies1 trial

AVELUMAB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED AVELUMAB CLINICAL STUDIES.

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05059522·77 enrolled

Carcinoma, Renal Cell1 trial

AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

Recruiting· Pfizer logo

Pfizer·Preclinical·NCT07227415·224 enrolled

Advanced Malignant Solid Neoplasm1 trial

Modular Phase 1B Hypothesis-Testing, Biomarker-Driven, Talazoparib Combination Trial (TalaCom)

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04693468·111 enrolled

Non-Clear Cell Renal Cell Carcinoma1 trial

Microenvironment and Nephrectomy After Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell Renal Carcinomas, Including SMARCB1-Deficient Renal Medullary Carcinoma: The MANTIS-RCC Phase II Study

Not yet recruiting·FFudan University·Phase 2·NCT07816770·30 enrolled

Metastatic Clear Cell Renal Cell Carcinoma1 trial

Toripalimab Plus Axitinib Induction Therapy With Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma: A Prospective, Single-Arm, Phase II Study (TACTIC-RCC)

Not yet recruiting·FFudan University·Phase 2·NCT07776717·30 enrolled

Metastatic Endometrial Cancer1 trial

A Phase 2, Two-Group, Two-Stage, Open-Label Study of Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer, Avelumab / Talazoparib in Patients With MSS Recurrent or Persistent Endometrial Cancer, and Avelumab / Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT02912572·106 enrolled

Unspecified1 trial

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 27, 2012

INLYTA

NDA NDA202324

Sep 16, 2013

INLYTA

NDA NDA202324

Aug 1, 2014

INLYTA

NDA NDA202324

Dec 29, 2014

INLYTA

NDA NDA202324

Mar 30, 2016

INLYTA

NDA NDA202324

Jun 16, 2016

INLYTA

NDA NDA202324

Aug 10, 2018

INLYTA

NDA NDA202324

Jan 23, 2020

INLYTA

NDA NDA202324

Jun 4, 2020

INLYTA

NDA NDA202324

Sep 22, 2022

INLYTA

NDA NDA202324

Jul 16, 2024

INLYTA

NDA NDA202324

Sources

References

[1]
ClinicalTrials.gov — 155 trial records for Axitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Inlyta drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Axitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Axitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA202324). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Inlyta. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

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

3 more patents

10570202*PEDAug 3, 2035

10869924Jan 12, 2037

10869924*PEDJul 12, 2037

Inlyta

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Renal Cell Carcinoma24 trials

Kidney Cancer8 trials

Melanoma7 trials

Renal Cell Cancer5 trials

Clinical Trial4 trials

Metastatic Colorectal Cancer4 trials

Non-Small Cell Lung Cancer4 trials

Hepatocellular Carcinoma4 trials

Metastatic Renal Cell Cancer4 trials

Metastatic Renal Cell Carcinoma4 trials

Trial3 trials

Patients With Advanced Solid Tumors3 trials

Advanced Solid Tumors3 trials

Treatment3 trials

Glioblastoma3 trials

Advanced Solid Tumor2 trials

Paraganglioma2 trials

Pembrolizumab2 trials

Adenoid Cystic Carcinoma2 trials

First Line Therapy2 trials

Advanced2 trials

Clear Cell Renal Cell Carcinoma2 trials

Prostate Cancer1 trial

Metastasis1 trial

Carcinoid Tumor1 trial

Glioblastoma Multiforme1 trial

High Risk Patients1 trial

Biliary Malignant Tumors1 trial

Solid Tumors1 trial

Nivolumab1 trial

Unresectable1 trial

Cervical Cancer1 trial

Solitary Fibrous Tumor1 trial

Immunotherapy1 trial

Maintenance Treatment1 trial

CLE1 trial

NPC1 trial

Mantle Cell Lymphoma1 trial

Vestibular schwannoma1 trial

Gastrointestinal Stromal Tumor1 trial

Mucosal Melanoma1 trial

Malignant Mesothelioma1 trial

Myeloid Leukemia1 trial

Relapsed or Refractory1 trial

Survival1 trial

Safety and Efficacy1 trial

Neoadjuvant1 trial

Toripalimab1 trial

Endometriosis1 trial

Nasopharyngeal Carcinoma1 trial

Nephrectomy1 trial

Endometrial Cancer1 trial

Gastric Cancer1 trial

Collecting Duct Carcinoma1 trial

Locally Advanced1 trial

Recurrent or Metastatic1 trial

Metastatic Melanoma1 trial

Surgery1 trial

Metastatic Head and Neck Cancer1 trial

Renal Cancer1 trial

Head and Neck Cancer1 trial

Maximum Tolerated Dose1 trial

Metastatic Solid Tumors1 trial

Solid Malignancies1 trial

Alveolar Soft Part Sarcoma1 trial

Recurrent or Refractory Solid Tumors1 trial

Papillary Renal Cell Carcinoma1 trial

Neuroendocrine Carcinoma1 trial

Salivary Gland Cancer1 trial

Soft Tissue Sarcoma1 trial

Stage III Prostate Cancer1 trial

Immune Checkpoint Inhibitors1 trial

Advanced Renal Cell Carcinoma1 trial