Afinitor

(everolimus)

ApprovedSmall molecule

Everolimus is used to treat certain cancers (including kidney cancer and breast cancer) and to prevent organ rejection after transplant. It works by slowing down the growth of cancer cells and suppressing the immune system.[2] Afinitor is currently approved and in use across 117 indications[4].[1]

Afinitor is one of 1441 small molecule programs targeting Breast Cancer. It is currently in Approved.

117

Indications

567

Total Trials

Active Trials

1,440

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Breast CancerActive, not recruiting

MeningiomaRecruiting

Kidney CancerCompleted

Colorectal CancerNot yet recruiting

Tuberous SclerosisCompleted

CancerActive, not recruiting

Heart TransplantNot yet recruiting

Atypical Endometrial HyperplasiaActive, not recruiting

Renal AngiomyolipomaActive, not recruiting

AstrocytomaActive, not recruiting

Breast CancerPhase 3

Active, not recruiting

MeningiomaPhase 2

Recruiting

Kidney CancerPhase 3

Completed

Colorectal CancerPhase 2

Not yet recruiting

Tuberous SclerosisApproved

Completed

CancerPhase 2

Active, not recruiting

Heart TransplantApproved

Not yet recruiting

Atypical Endometrial HyperplasiaPhase 2

Active, not recruiting

Renal AngiomyolipomaApproved

Active, not recruiting

AstrocytomaApproved

Active, not recruiting

Showing 10 of 117 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Afinitor

Novartis

Approved

62 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Spravato

WWim Janssens

Preclinical

2 4

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 5

Duragesic

CCephalon

Preclinical

1 6

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 7

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 8

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 9

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 10

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Breast Cancer

NCT05594095

Phase 1Active, not recruiting

Breast Cancer

NCT02057133

Phase 2Not yet recruiting

Colorectal Cancer

NCT06301386

Phase 1Active, not recruiting

Non-Small Cell Lung Cancer

NCT02321501

Q1 2027

Phase 3Active, not recruiting

Renal Cell Carcinoma

NCT02811861

Q4 2027

Phase 1Recruiting

Glioblastoma

NCT05432518

Clinical

Trials by Indication[1]

Breast Cancer20 trials

Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 2·NCT00930930·145 enrolled

Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping

Not yet recruiting·FFudan University·Phase 2·NCT06561022·260 enrolled

A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT01305941·32 enrolled

Show 17 more trials

SNF Platform Study of HR+/ HER2-advanced Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05594095·620 enrolled

The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT03659136·103 enrolled

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT02057133·198 enrolled

Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT00680758·18 enrolled

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

Completed· Novartis logo

Novartis·Phase 3·NCT00863655·724 enrolled

Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 3·NCT05429684·120 enrolled

S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer

Active, not recruiting·SSWOG Cancer Research Network·Phase 3·NCT01674140·1,939 enrolled

S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer

Terminated·SSWOG Cancer Research Network·Phase 3·NCT02137837·37 enrolled

Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Active, not recruiting· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 1·NCT05293964·214 enrolled

Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer

Completed· Bayer logo

Bayer·Phase 2·NCT02258451·283 enrolled

Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00915603·113 enrolled

Study of Combined Fulvestrant and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure

Completed·MMara Chambers·Phase 2·NCT00570921·33 enrolled

Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer

Completed·—·Phase 1/2·NCT00458237·11 enrolled

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT03176238·235 enrolled

Eribulin Mesylate and Everolimus in Treating Patients With Triple-Negative Metastatic Breast Cancer

Completed·—·Phase 1·NCT02120469·27 enrolled

Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer

Unknown status·OOrganisation for Oncology and Translational Research·Phase 2·NCT02025712·35 enrolled

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

Recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 3·NCT07024173·240 enrolled

Renal Cell Carcinoma13 trials

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Active, not recruiting· Eisai logo

Eisai·Phase 3·NCT02811861·1,069 enrolled

Everolimus Versus Sunitinib in Non-Clear Cell Renal Cell Carcinoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01185366·73 enrolled

Study of Lenvatinib in Combination With Everolimus in Participants With Unresectable Advanced or Metastatic Renal Cell Carcinoma (RCC)

Completed· Eisai logo

Eisai·Phase 1·NCT02454478·7 enrolled

Show 10 more trials

Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus

Completed·AAssociation Pour La Recherche des Thérapeutiques Innovantes en Cancérologie·Phase 2·NCT01715935·25 enrolled

Efficacy and Safety Comparison of RAD001 Versus Sunitinib in the First-line and Second-line Treatment of Patients With Metastatic Renal Cell Carcinoma

Completed· Novartis logo

Novartis·Phase 2·NCT00903175·471 enrolled

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04195750·755 enrolled

Everolimus in Patients With Metastatic Renal Cell Carcinoma Following Progression on Prior Bevacizumab Treatment

Completed·KKidney Cancer Research Bureau·Phase 4·NCT02056587·37 enrolled

MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma

Completed· Takeda logo

Takeda·Phase 2·NCT02724020·96 enrolled

Biomarker Trial of Everolimus in Patients With Advanced Renal Cell Carcinoma

Completed·—·Phase 2·NCT00827359·25 enrolled

Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma

Completed· Eisai logo

Eisai·Phase 2·NCT03173560·343 enrolled

A Phase Ib Study of Rad001 and Sutent to Treat Renal Cell Carcinoma

Completed·—·Phase 1·NCT00788060·5 enrolled

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

Completed·EExelixis·Phase 3·NCT01865747·658 enrolled

Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib

Completed· Novartis logo

Novartis·Phase 4·NCT01514448·29 enrolled

Liver Transplant11 trials

Efficacy and Safety of CertiroBell® Tablet Plus Tacrolimus in Primary Living Donor Liver Transplant Recipients

Unknown status· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 4·NCT04867720·112 enrolled

De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study

Withdrawn·RRennes University Hospital·Phase 3·NCT02909335

REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy

Completed· Novartis logo

Novartis·Phase 3·NCT02115113·78 enrolled

Show 8 more trials

Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02188719·15 enrolled

Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant

Completed·UUniversity of California, San Francisco·Phase 4·NCT02429869·10 enrolled

Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

Unknown status·AAzienda Ospedaliera di Padova·Phase 2·NCT01423708·117 enrolled

Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection

Terminated· Novartis logo

Novartis·Phase 2·NCT00582738·43 enrolled

Everolimus Monotherapy as Immunosuppression After Liver Transplant

Terminated·IIndiana University·Phase 3·NCT04063865·14 enrolled

Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.

Completed·MMilton S. Hershey Medical Center·N/A·NCT01936519·24 enrolled

Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT01150097·284 enrolled

Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT00622869·719 enrolled

Kidney Transplant7 trials

Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate

Completed·HHospital do Rim e Hipertensão·Phase 4·NCT01354301·300 enrolled

Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

Completed·HHospital do Rim e Hipertensão·Phase 4·NCT03468478·1,209 enrolled

Envarsus® Once Daily With Everolimus in Elderly Kidney Transplant Recipients: Pharmacokinetic and Clinical Study

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 2·NCT02970630·28 enrolled

Show 4 more trials

Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia.

Completed·UUniversity Hospital, Strasbourg, France·Phase 4·NCT03216967·130 enrolled

A Prospective, Open Label Study of CERtican in KIdney Transplantation

Completed· Novartis logo

Novartis·Phase 4·NCT01594268·54 enrolled

Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients

Completed·UUniversity of California, San Francisco·Phase 4·NCT01624948·40 enrolled

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient

Recruiting·KKing Chulalongkorn Memorial Hospital·N/A·NCT04542733·50 enrolled

Lymphoma5 trials

Everolimus and Bortezomib in Treating Patients With Relapsed or Refractory Lymphoma

Terminated·—·Phase 1·NCT00671112·30 enrolled

Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment

Completed·MMayo Clinic·Phase 2·NCT00436618·277 enrolled

Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01665768·56 enrolled

Show 2 more trials

Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

Completed·MMayo Clinic·Phase 1/2·NCT01075321·58 enrolled

Everolimus Plus Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma

Completed·MMassachusetts General Hospital·Phase 2·NCT00869999·26 enrolled

108 more indications

Neuroendocrine Tumors5 trials

Phase 1 TheraSphere + Everolimus With Neuroendocrine Tumors (NETs) + Liver Only or Liver Dominant Disease

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT01864070

Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT02315625·16 enrolled

Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

Recruiting·GGrupo Espanol de Tumores Neuroendocrinos·Phase 3·NCT05918302·120 enrolled

Show 2 more trials

Treatment of Neuroendocrine Tumors (NETs) With Combination of Everolimus and Radiolabeled Somatostatin Analogue

Unknown status·KKing Faisal Specialist Hospital & Research Center·Phase 1/2·NCT03629847·30 enrolled

A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03070301·21 enrolled

Glioma4 trials

A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT03632317

Everolimus in Treating Patients With Recurrent Low-Grade Glioma

Completed·SSusan Chang·Phase 2·NCT00823459·58 enrolled

A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection

Completed·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 1·NCT03834740·27 enrolled

Show 1 more trial

Everolimus (RAD001) for Children With Chemotherapy-Refractory Progressive or Recurrent Low-Grade Gliomas

Completed·—·Phase 2·NCT00782626·23 enrolled

Thyroid Cancer4 trials

Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT02143726·35 enrolled

Pasireotide & Everolimus in Adult Patients With Radioiodine-Refractory Differentiated & Medullary Thyroid Cancer

Completed·EEmory University·Phase 2·NCT01270321·42 enrolled

Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone

Unknown status·TThomas Jefferson University·Phase 2·NCT01263951·35 enrolled

Show 1 more trial

UPCC 36315 A Phase II Study Of Everolimus (RAD001) And Lenvatinib (E7080) In Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Lenvatinib Alone

Suspended·TThomas Jefferson University·Phase 2·NCT03139747·5 enrolled

Efficacy and Safety4 trials

Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection

Completed· Novartis logo

Novartis·Phase 3·NCT00300274·721 enrolled

A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies

Not yet recruiting·YYonsei University·Phase 2·NCT07477548·67 enrolled

Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

Completed· Novartis logo

Novartis·Phase 4·NCT00170820·20 enrolled

Show 1 more trial

Efficacy and Safety of Precision Therapy in Refractory Tumor

Unknown status·BBaodong Qin·Phase 2·NCT03239015·300 enrolled

Renal Transplant3 trials

Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00170833·80 enrolled

Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids

Completed· Novartis logo

Novartis·Phase 3·NCT00658320·122 enrolled

Cytokines Evaluation in Early Calcineurin Inhibitors Withdrawn on Renal Transplant

Completed·AAndre Barreto Pereira·Phase 4·NCT01239472·30 enrolled

Metastatic Colorectal Cancer3 trials

Expanded Cohort for Metastatic Colorectal Cancer (MCRC) Using Bevacizumab + Everolimus

Completed·HHerbert Hurwitz·Phase 2·NCT00597506·50 enrolled

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy

Completed· Novartis logo

Novartis·Phase 2·NCT00419159·199 enrolled

Renal Transplant Recipients3 trials

Study of Everolimus in de Novo Renal Transplant Recipients

Terminated·—·N/A·NCT01609673·1 enrolled

Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT01114529·828 enrolled

Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT00965094·36 enrolled

Advanced Solid Tumors2 trials

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT04185883·610 enrolled

Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT00954512·15 enrolled

Metastatic Melanoma2 trials

Study of Everolimus With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT01014351·70 enrolled

RAD001 Plus Bevacizumab in Metastatic Melanoma

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00591734·57 enrolled

Cancer2 trials

A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

Active, not recruiting·UUppsala University Hospital·Phase 2·NCT04185831·167 enrolled

Everolimus for Cancer With TSC1 or TSC2 Mutation

Completed·—·Phase 2·NCT02201212·30 enrolled

Hepatocellular Carcinoma2 trials

Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01642186·28 enrolled

Global Study Looking at the Combination of RAD001 Plus Best Supportive Care (BSC) and Placebo Plus BSC to Treat Patients With Advanced Hepatocellular Carcinoma.

Completed· Novartis logo

Novartis·Phase 3·NCT01035229·546 enrolled

Heart Transplant2 trials

Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant

Unknown status·FFundacion Investigacion y Desarrollo·Phase 4·NCT00695344·52 enrolled

Safe Renal Function In Long Term Heart Transplanted Patients

Unknown status·AA.O. Ospedale Papa Giovanni XXIII·Phase 4·NCT00505102·200 enrolled

Trial2 trials

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Phase I Trial of VS-6766 Alone and in Combination With Everolimus

Completed·RRoyal Marsden NHS Foundation Trust·Phase 1·NCT02407509·104 enrolled

Colorectal Cancer2 trials

Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients

Not yet recruiting·FFudan University·Phase 2·NCT06301386·25 enrolled

Safety Study of the Combination of Panitumumab, Irinotecan and Everolimus in the Treatment of Advanced Colorectal Cancer

Completed·TThe Queen Elizabeth Hospital·Phase 1/2·NCT01139138·49 enrolled

Left Ventricular Hypertrophy2 trials

Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study

Unknown status·IInstituto de Urologia e Nefrologia·Phase 4·NCT02493465·50 enrolled

Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants

Completed·EEdoardo Melilli·Phase 4·NCT03415750·20 enrolled

Pancreatic Neuroendocrine Tumor2 trials

Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01229943·150 enrolled

VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Everolimus for Treating Patients With Pancreatic Neuroendocrine Tumors

Terminated·WWashington University School of Medicine·Phase 1/2·NCT01784861·23 enrolled

Melanoma2 trials

Everolimus in Treating Patients With Stage IV Melanoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00098553·53 enrolled

Temozolomide and Everolimus in Treating Patients With Stage IV Melanoma That Cannot be Removed by Surgery

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00521001·49 enrolled

Prostate Cancer2 trials

Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer

Completed·SSCRI Development Innovations, LLC·Phase 1·NCT02125084·38 enrolled

Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

Completed·SSwiss Cancer Institute·Phase 2·NCT00976755·37 enrolled

Endometrial Cancer2 trials

Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

Completed·AARCAGY/ GINECO GROUP·Phase 2·NCT00870337·44 enrolled

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Completed·GGOG Foundation·Phase 2·NCT02228681·74 enrolled

Renal Transplantation2 trials

Renal Transplantation in the Elderly - nEverOld Study

Unknown status·UUniversity of Sao Paulo General Hospital·Phase 4·NCT01631058·90 enrolled

Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)

Unknown status·UUniversity of Cincinnati·Phase 4·NCT04849533·120 enrolled

Glioblastoma Multiforme2 trials

AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma Multiforme

Completed· Novartis logo

Novartis·Phase 1/2·NCT00107237·16 enrolled

Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme

Completed·NNCIC Clinical Trials Group·Phase 1·NCT00387400·32 enrolled

Safety and Efficacy2 trials

Phase IV Study of the Safety and Efficacy of Everolimus in Adult Patients With Progressive pNET in China

Completed· Novartis logo

Novartis·Phase 4·NCT02842749·61 enrolled

A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys

Terminated·MMatthew Cooper·Phase 2/3·NCT01878786·25 enrolled

Cardiac Transplant2 trials

Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy

Completed· Novartis logo

Novartis·Phase 3·NCT00097968

Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.

Completed· Novartis logo

Novartis·Phase 3·NCT00170794

Malignancies1 trial

Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast

Completed·—·Phase 1·NCT03154281·14 enrolled

Gastrointestinal Stromal Tumor1 trial

Expanded Access to Everolimus, for an Individual Patient With GIST (Gastrointestinal Stromal Tumors)(CTMS#18-0019)

No longer available·TThe University of Texas Health Science Center at San Antonio··NCT03493152

Refractory Solid Tumors1 trial

Study to Evaluate the Safety and Efficacy of Everolimus, in Subjects With PIK3CA Amplification, PTEN Loss and PIK3CA Mutation Refractory Solid Tumors

Completed·SSamsung Medical Center·Phase 2·NCT02449538·10 enrolled

Metformin1 trial

Exemestane-RAD001-Metformin

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01627067·23 enrolled

Lung Cancer1 trial

Safety of Everolimus and Pemetrexed in Lung Cancer Patients

Completed· Novartis logo

Novartis·Phase 1·NCT00434174·48 enrolled

Oral Mucositis1 trial

Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT

Completed·CComprehensive Support Project for Oncology Research·Phase 3·NCT02376985·174 enrolled

Phase II1 trial

Phase II Study of Everolimus Beyond Progression

Terminated·EEmory University·Phase 2·NCT02269670·3 enrolled

Advanced Cancer1 trial

Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01596140·27 enrolled

Stomatitis1 trial

Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

Terminated·AAlliance for Clinical Trials in Oncology·Phase 3·NCT03839940·39 enrolled

Tacrolimus1 trial

Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium

Completed·GGaetano Ciancio·Phase 3·NCT01680861·32 enrolled

Maintenance Therapy1 trial

Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin

Unknown status·GGruppo Oncologico Italiano di Ricerca Clinica·Phase 2·NCT02687958·30 enrolled

Gallbladder Carcinoma1 trial

Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT02836847·152 enrolled

Gastric Cancer1 trial

Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)

Completed· Novartis logo

Novartis·Phase 3·NCT00879333·656 enrolled

Multiple Myeloma1 trial

Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Completed·MMayo Clinic·Phase 2·NCT00618345·35 enrolled

Primary Peritoneal Cavity Cancer1 trial

Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Completed·MMayo Clinic·Phase 2·NCT02283658·20 enrolled

Patients With Advanced Solid Tumors1 trial

Cisplatin and Everolimus in Treating Patients With Advanced Solid Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00423865·30 enrolled

Resistance1 trial

Rotating Pazopanib and Everolimus to Avoid Resistance

Completed·NNetherlands Working Group on Immunotherapy of Oncology·Phase 2·NCT01408004·101 enrolled

Intracranial Meningioma1 trial

Trial of the Combination of Bevacizumab and Everolimus in Patients With Refractory, Progressive Intracranial Meningioma

Terminated·SSCRI Development Innovations, LLC·Phase 2·NCT00972335·18 enrolled

Transplantation1 trial

Single-centre Study of Everolimus as GvHD Prophylaxis After Post-Transplantation Cyclophosphamide After Allogeneic SCT

Completed·UUniversity of Cologne·Phase 2·NCT02812940·19 enrolled

Pediatric Patients1 trial

Selecting Patient-Specific Biologically Targeted Therapy for Pediatric Patients With Refractory Or Recurrent Brain Tumors

Unknown status·SSeattle Children's Hospital·N/A·NCT02015728·20 enrolled

Advanced Solid Malignancies1 trial

A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies

Completed·EEmory University·Phase 1·NCT01470209·43 enrolled

ADPKD1 trial

Everolimus on CKD Progression in ADPKD Patients

Terminated·—·Phase 2/3·NCT01009957·71 enrolled

HER21 trial

Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02152943·37 enrolled

Marginal Zone B-Cell Lymphoma1 trial

Multicenter Phase II Study to Evaluate the Clinical Activity and the Safety Profile of Everolimus in Marginal Zone B-cell Lymphomas (MZL)

Completed·IInternational Extranodal Lymphoma Study Group (IELSG)·Phase 2·NCT01164267·30 enrolled

Graft Versus Host Disease1 trial

Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease

Terminated·UUniversity Hospital Tuebingen·Phase 1·NCT00373815·10 enrolled

Intestinal Cancer1 trial

A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study

Unknown status·SSun Yat-sen University·N/A·NCT02013089·50 enrolled

Plexiform Neurofibroma1 trial

Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1)

Terminated· Novartis logo

Novartis·Phase 2·NCT01365468·9 enrolled

Metastatic Head and Neck Cancer1 trial

Everolimus and Docetaxel in Treating Patients With Recurrent, Locally Advanced, or Metastatic Head and Neck Cancer

Terminated·UUniversity College, London·Phase 1/2·NCT01313390·4 enrolled

Chronic Myelogenous Leukemia1 trial

Everolimus and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission After Previous Imatinib Mesylate

Completed· Novartis logo

Novartis·Phase 1/2·NCT00093639

Phase IB1 trial

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

Recruiting·FForward Pharmaceuticals Co., Ltd.·Phase 1/2·NCT07002177·196 enrolled

Sturge-Weber syndrome1 trial

Adjunctive Everolimus (RAD 001) Therapy for Epilepsy in Children With Sturge-Weber Syndrome (SWS)

Withdrawn·—·Phase 2·NCT01997255

Neuroendocrine Carcinoma1 trial

Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01204476·27 enrolled

Metastatic Cancer1 trial

Tamoxifen-RAD001 Versus Tamoxifen Alone in Patients With Anti-aromatase Resistant Breast Metastatic Cancer

Completed·AARCAGY/ GINECO GROUP·Phase 2·NCT01298713·111 enrolled

Stent Implantation1 trial

Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation

Unknown status·GGerman Heart Institute·Phase 3·NCT00426049·484 enrolled

Advanced Urothelial Cancer1 trial

Expanded Phase I Pazopanib and Everolimus in Advanced Solid Tumors and Previously Treated Advanced Urothelial Cancer

Completed·—·Phase 1·NCT01184326·23 enrolled

Kidney Cancer1 trial

Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy

Terminated·NNational Cancer Institute (NCI)·Phase 3·NCT01198158·77 enrolled

Esophageal Cancer1 trial

Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer

Completed·TTranslational Oncology Research International·Phase 2·NCT00985192·49 enrolled

Clear Cell Renal Cancer1 trial

Efficacy Study of Sunitinib and Everolimus (Rotational vs Sequential Arm) in Pats. With m Clear Cell Renal Cancer

Terminated·AAssociació per a la Recerca Oncologica, Spain·Phase 2·NCT01784978·41 enrolled

Acute Myeloid Leukemia1 trial

Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia

Unknown status·IInstitut de Recherche Clinique sur les Cancers et le Sang·Phase 1·NCT00544999·21 enrolled

Chronic Lymphocytic Leukemia1 trial

Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed·MMayo Clinic·Phase 1/2·NCT00935792·28 enrolled

Acute Coronary Syndrome1 trial

Controlled Level EVERolimus in Acute Coronary Syndromes

Completed·UUniversity of Zurich·Phase 1/2·NCT01529554·150 enrolled

Pancreatic Adenocarcinoma1 trial

LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy

Active, not recruiting·GGeorgetown University·Phase 1/2·NCT02985125·44 enrolled

Cognitive Function1 trial

Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus

Completed·UUniversity of Kansas Medical Center··NCT03413722·30 enrolled

Growth1 trial

Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus

Completed· Novartis logo

Novartis·Phase 4·NCT02338609·15 enrolled

Arteriosclerosis1 trial

Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

Terminated·DDianet Dialysis Centers·Phase 4·NCT01276834·13 enrolled

Patient Preference1 trial

Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab

Completed·IiOMEDICO AG·Phase 4·NCT02248571·85 enrolled

Autosomal Dominant Polycystic Kidney Disease1 trial

Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease

Completed· Novartis logo

Novartis·Phase 4·NCT00414440·431 enrolled

Withdrawal1 trial

Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.

Completed· Novartis logo

Novartis·Phase 3·NCT01023815·330 enrolled

Gemcitabine1 trial

Treatment of Patients Suffering From a Progressive Pancreas Carcinoma With Everolimus (RAD001) and Gemcitabine

Completed· Novartis logo

Novartis·Phase 1/2·NCT00560963·21 enrolled

Ovarian Cancer1 trial

Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

Terminated·UUniversity of Utah·Phase 1/2·NCT01149434·19 enrolled

Locally Advanced1 trial

A Study of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for Locally Advanced Cervix Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT01217177·14 enrolled

Myelodysplastic Syndromes1 trial

RAD001(Everolimus) in Treating Patients With Myelodysplastic Syndromes

Terminated·—·Phase 2·NCT00809185·7 enrolled

Fluorouracil1 trial

Everolimus, Fluorouracil, Leucovorin, Panitumumab, and Oxaliplatin in Treating Patients With Tumors That Did Not Respond to Treatment

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT00610948·74 enrolled

RCC1 trial

Study of the Combination of CM082 With Everolimus in Patients With mRCC

Unknown status·AAnewPharma·Phase 1·NCT02577458·18 enrolled

Metabolism1 trial

Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise

Terminated·JJosep m Cruzado·Phase 4·NCT01561404·3 enrolled

Diffuse Intrinsic Pontine Glioma1 trial

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication

Unknown status·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT02233049·250 enrolled

Chronic Renal Failure1 trial

Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure

Completed·HHospices Civils de Lyon·Phase 4·NCT00716573·120 enrolled

Epilepsy1 trial

Adjunctive Everolimus Treatment of Refractory Epilepsy

Unknown status·NNational Institute on Drug Dependence, China·Phase 2·NCT05613166·108 enrolled

Triple-Negative Breast Cancer1 trial

Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer

Completed·AAmy Tiersten·Phase 2·NCT02531932·64 enrolled

Endometrial Carcinoma1 trial

A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03008408·90 enrolled

Lung Transplant Recipient1 trial

Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT01404325·130 enrolled

Neurofibromatosis1 trial

Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02332902·24 enrolled

Hormone Receptor Positive1 trial

Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01197170·277 enrolled

Glioblastoma1 trial

Pilot Trial for Treatment of Recurrent Glioblastoma

Recruiting·AAHS Cancer Control Alberta·Phase 1·NCT05432518·10 enrolled

Non-Small Cell Lung Cancer1 trial

Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT02321501·37 enrolled

Temozolomide1 trial

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

Recruiting·NNationwide Children's Hospital·Phase 2·NCT05843253·120 enrolled

Macroglobulinemia1 trial

Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia

Terminated·—·Phase 1/2·NCT01125293·46 enrolled

Squamous Cell Carcinoma1 trial

Study in Locally Advanced Squamous Cell Carcinoma of Head and Neck

Terminated·UUniversity of Chicago·Phase 2·NCT01133678·50 enrolled

Transplant Recipient1 trial

Everolimus in de Novo Heart Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT01017029·182 enrolled

Metastatic1 trial

RAMSETE: RAD001 in Advanced and Metastatic Silent Neuro-endocrine Tumors in Europe

Completed· Novartis logo

Novartis·Phase 2·NCT00688623·73 enrolled

Mantle Cell Lymphoma1 trial

Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy

Terminated·TTechnical University of Munich·Phase 2·NCT00727207·35 enrolled

Malignant Pleural Mesothelioma1 trial

Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01024946·11 enrolled

Recurrent or Refractory1 trial

Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT00187174·41 enrolled

Locally Advanced Head and Neck Cancer1 trial

Everolimus in Restoring Salivary Gland Function in Participants With Locally Advanced Head and Neck Cancer Treated With Radiation Therapy

Terminated·UUniversity of Arizona·Phase 1·NCT03578432·2 enrolled

Testicular Germ Cell Cancer1 trial

Everolimus in Refractory Testicular Germ Cell Cancer

Completed·NNational Cancer Institute, Slovakia·Phase 2·NCT01466231·15 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

Completed· Novartis logo

Novartis·Phase 1·NCT01854606·31 enrolled

Uveitis1 trial

Everolimus for the Treatment of Uveitis Unresponsive to Cyclosporine A

Completed·CCarsten Heinz·Phase 2·NCT00803816·12 enrolled

Metastasis1 trial

An Open Label, Single-Centre, Pilot Study of Everolimus With EBRT for the Treatment of mNET Liver Metastasis

Completed·SSunnybrook Health Sciences Centre·Phase 1/2·NCT02205515·17 enrolled

Tuberous Sclerosis1 trial

A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous Sclerosis

Unknown status·—·Phase 2·NCT01954693·48 enrolled

Lymphangioleiomyomatosis1 trial

Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

Completed· Novartis logo

Novartis·Phase 3·NCT00790400·118 enrolled

Carcinoma1 trial

Addition of Everolimus to Standard of Care in Carcinoma Gallbladder

Recruiting·—·Phase 2/3·NCT05833815·56 enrolled

TED1 trial

TB Host Directed Therapy

Unknown status·TThe Aurum Institute NPC·Phase 2·NCT02968927·200 enrolled

Primary Aldosteronism1 trial

Open-label Study on Treatment of Primary Aldosteronism With Everolimus

Completed·UUniversity Hospital, Basel, Switzerland·Phase 2·NCT03174171·12 enrolled

Head and Neck Cancer1 trial

Phase II Study of RAD001 Head and Neck Cancer

Terminated·—·Phase 2·NCT01051791·13 enrolled

Unspecified2 trials

A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

Completed· Novartis logo

Novartis·Phase 1·NCT02890069·298 enrolled

Rapalog Pharmacology (RAP PAC) Study

Recruiting·UUniversity of Wisconsin, Madison·Phase 1·NCT05949658·72 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 30, 2009

AFINITOR

NDA NDA022334

Apr 20, 2010

ZORTRESS

NDA NDA021560

Jul 9, 2010

AFINITOR

NDA NDA022334

Jul 9, 2010

AFINITOR

NDA NDA022334

Jul 9, 2010

AFINITOR

NDA NDA022334

Oct 29, 2010

AFINITOR

NDA NDA022334

May 5, 2011

AFINITOR

NDA NDA022334

May 5, 2011

AFINITOR

NDA NDA022334

Mar 30, 2012

AFINITOR

NDA NDA022334

Mar 30, 2012

AFINITOR

NDA NDA022334

Apr 26, 2012

AFINITOR

NDA NDA022334

Jul 20, 2012

AFINITOR

NDA NDA022334

Aug 29, 2012

AFINITOR DISPERZ

NDA NDA203985

Aug 29, 2012

AFINITOR

NDA NDA022334

Aug 29, 2012

AFINITOR DISPERZ

NDA NDA203985

Mar 26, 2013

AFINITOR

NDA NDA022334

Jun 21, 2013

AFINITOR

NDA NDA022334

Nov 6, 2013

AFINITOR DISPERZ

NDA NDA203985

Nov 6, 2013

AFINITOR

NDA NDA022334

Feb 20, 2014

AFINITOR DISPERZ

NDA NDA203985

Feb 20, 2014

AFINITOR

NDA NDA022334

Feb 20, 2014

AFINITOR DISPERZ

NDA NDA203985

Feb 20, 2014

AFINITOR

NDA NDA022334

Feb 20, 2014

AFINITOR DISPERZ

NDA NDA203985

Feb 20, 2014

AFINITOR

NDA NDA022334

Jul 1, 2014

AFINITOR

NDA NDA022334

Jul 1, 2014

AFINITOR DISPERZ

NDA NDA203985

Sep 12, 2014

AFINITOR

NDA NDA022334

Oct 20, 2014

AFINITOR

NDA NDA022334

Dec 18, 2014

AFINITOR

NDA NDA022334

Jan 23, 2015

AFINITOR DISPERZ

NDA NDA203985

Jan 23, 2015

AFINITOR

NDA NDA022334

May 22, 2015

AFINITOR

NDA NDA022334

Jul 1, 2015

AFINITOR DISPERZ

NDA NDA203985

Aug 24, 2015

AFINITOR DISPERZ

NDA NDA203985

Sep 18, 2015

AFINITOR

NDA NDA022334

Jan 29, 2016

AFINITOR

NDA NDA022334

Jan 29, 2016

AFINITOR DISPERZ

NDA NDA203985

Feb 4, 2016

AFINITOR

NDA NDA022334

Feb 18, 2016

AFINITOR

NDA NDA022334

Feb 26, 2016

AFINITOR

NDA NDA022334

Jun 14, 2016

AFINITOR

NDA NDA022334

Sep 26, 2017

AFINITOR

NDA NDA022334

Apr 10, 2018

AFINITOR

NDA NDA022334

Apr 10, 2018

AFINITOR DISPERZ

NDA NDA203985

Jan 22, 2020

AFINITOR

NDA NDA022334

Jan 22, 2020

AFINITOR DISPERZ

NDA NDA203985

Feb 13, 2020

AFINITOR

NDA NDA022334

Feb 13, 2020

AFINITOR DISPERZ

NDA NDA203985

Apr 16, 2021

AFINITOR DISPERZ

NDA NDA203985

Apr 16, 2021

AFINITOR

NDA NDA022334

Dec 30, 2021

AFINITOR

NDA NDA022334

Feb 1, 2022

AFINITOR DISPERZ

NDA NDA203985

Feb 1, 2022

AFINITOR

NDA NDA022334

Mar 11, 2024

AFINITOR DISPERZ

NDA NDA203985

Jun 1, 2026

AFINITOR DISPERZ

NDA NDA203985

Jun 1, 2026

AFINITOR

NDA NDA022334

Sources

References

[1]
ClinicalTrials.gov — 567 trial records for everolimus. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Afinitor drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — everolimus compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for everolimus. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA203985). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Afinitor. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FK506-Binding Protein 1a Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Jul 1, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8410131Nov 1, 2025

8410131*PEDMay 1, 2026

9006224Jul 1, 2028