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Data updated: May 26, 2026

AFINITOR DISPERZ (everolimus)

Protein Kinase Inhibitors Genetically Validated
Oncology Approved 2012-08-29

AFINITOR DISPERZ is indicated for the treatment of Breast Cancer; Neuroendocrine Tumors; Renal Cell Carcinoma; Renal Angiomyolipoma; Tuberous Sclerosis Complex; Subependymal Giant Cell Astrocytoma; Partial-Onset Seizures.

Source: FDA Label • Novartis • Kinase Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How AFINITOR DISPERZ Works

Everolimus is an inhibitor of the mammalian target of rapamycin (mTOR), specifically targeting the mTORC1 complex. It acts as a downstream effector of the PI3

Source: FDA Label
4
Indications
--
Phase 3 Trials
1
Priority Reviews
13
Years on Market

Details

Status
Prescription
First Approved
2012-08-29
Routes
ORAL
Dosage Forms
TABLET, FOR SUSPENSION

Companies

Novartis
Active Ingredient: EVEROLIMUS

AFINITOR DISPERZ Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
51 FDA actions from 2012 to 2024 · 3 indication expansions
Mar 2024 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Feb 2022 SUPPL
Label · Labeling
FDA Letter Label
Apr 2021 SUPPL
Label · Labeling
FDA Letter Label

What AFINITOR DISPERZ Treats

7 indications

AFINITOR DISPERZ is approved for 7 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Breast Cancer
  • Neuroendocrine Tumors
  • Renal Cell Carcinoma
  • Renal Angiomyolipoma
  • Tuberous Sclerosis Complex
  • Subependymal Giant Cell Astrocytoma
  • Partial-Onset Seizures
Source: FDA Label

AFINITOR DISPERZ Target & Pathway

Pro

Target

HER2 (Human Epidermal Growth Factor Receptor 2) Growth Factor Receptor

A receptor tyrosine kinase that promotes cell growth and division. Approximately 20% of breast cancers overexpress HER2, leading to aggressive tumor growth. Targeting HER2 blocks these growth signals and can trigger immune-mediated destruction of cancer cells.

Pathway Context

HER2 forms dimers with other HER family members to activate growth signaling

HER3 (Human Epidermal Growth Factor Receptor 3)
EGFR (Epidermal Growth Factor Receptor) receptor

A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.

AFINITOR DISPERZ Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

2

Same target(s) AND same indication — head-to-head.

TEMSIROLIMUS
GLAND
2018 1 indic.
TORISEL
PF PRISM
2007 1 indic.

MoA expansion candidates

7

Same target(s), different indications — where else is this mechanism being explored?

FYARRO
AADI
2021 1 indic.
ENVARSUS XR
VELOXIS PHARMS
2015 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

FAVLYXA
AVYXA HOLDINGS
2026 3 indic.
OZILTUS
AMNEAL PHARMS
2025 4 indic.
Unlock 13 more competitors across all three rings.
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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 AFINITOR DISPERZ's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AFINITOR DISPERZ treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to AFINITOR DISPERZ

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AFINITOR
EVEROLIMUS
6 shared
Novartis
Shared indications:
Breast CancerNeuroendocrine TumorsRenal Cell Carcinoma +3 more
AN-SULFUR COLLOID
TECHNETIUM TC-99M SULFUR COLLOID KIT
1 shared
Sun Pharma
Shared indications:
Breast Cancer
APTIOM
ESLICARBAZEPINE ACETATE
1 shared
SUMITOMO PHARMA AM
Shared indications:
Partial-Onset Seizures
View all 20 similar drugs Pro
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Clinical Trial Registry

368 trials
Trial Sponsor ID Phase Status Title
NCT05773274 NCI-2023-00118 NCI-2023-00118, CCTG-NE1 Ph 2 recruiting Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
NCT04665739 NCI-2020-12905 NCI-2020-12905, A021901 Ph 2 recruiting Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
NCT07405164 6482-043 U1111-1325-4582, 2025-524160-38-00 Ph 3 recruiting Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
NCT05918302 LEVEL GETNE-T2217 2022-502154-13-00 Ph 3 recruiting Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.
NCT04802759 CO42867 2020-004889-19, 2023-507495-48-00 Ph 1, Ph 2 recruiting A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
NCT03577431 LITTMUS-MGH DAIT ITN073ST Ph 1, Ph 2 active not recruiting Liver Transplantation With Tregs at MGH
NCT07062965 C4551002 2025-520566-22-00 Ph 3 recruiting A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
NCT06280950 ELIMINATE DAIT CTOT-43 Ph 2 recruiting Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
NCT05306340 ML43171 2022-000199-20, 2023-506821-12-00 Ph 3 active not recruiting A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
NCT06428396 6482-029 MK-6482-029, LITESPARK-029 Ph 2 recruiting Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
NCT07165886 HB1901-010 Ph 2, Ph 3 recruiting Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors
NCT05843253 CONNECT TarGeT-A R01FD008167 Ph 2 recruiting Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
NCT06943755 STELLAR-311 XL092-311 2025-521043-20-00, 1011801 Ph 2, Ph 3 recruiting Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
NCT04485559 190819 NCI-2020-04097 Ph 1 suspended Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)
NCT02985125 results posted 2016-0232 Ph 1, Ph 2 completed LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy
NCT01167530 RAD001 IGR 1269 Ph 1 completed Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer
NCT07191353 StrongBone 2024-520372-10-00 Ph 2 recruiting Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
NCT06832189 EVEREST DAIT ITN101ST Ph 1 recruiting EVR and EPO for Liver Transplant Tolerance
NCT03049189 COMPETE results posted ITM-LET-01 Ph 3 active not recruiting Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
NCT06382948 ADELA MedOPP545 2024-512926-27-00 Ph 3 recruiting Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
NCT05252585 CRAD001M2402 Ph 4 active not recruiting A Phase IV Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)
NCT02962414 CRAD001M2X02B 2024-516746-19-00 Ph 3 active not recruiting Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment
NCT05477576 ACTION-1 RYZ101-301 Ph 3 recruiting Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
NCT05573126 EP0062-101 Ph 1, Ph 2 recruiting Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
NCT03950609 2018-0253 NCI-2019-02051, 2018-0253 Ph 2 active not recruiting Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors
NCT07477548 4-2025-1169 Ph 2 not yet recruiting A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies
NCT05012371 2021-0400 NCI-2021-07429, 2021-0400 Ph 2 active not recruiting Lenvatinib With Everolimus Versus Cabozantinib for Second-Line or Third-Line Treatment of Metastatic Renal Cell Cancer
NCT07426484 25-743 Ph 4 not yet recruiting Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy
NCT02811861 CLEAR results posted E7080-G000-307 KEYNOTE-581, 2016-000916-14 Ph 3 active not recruiting Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma
NCT06105632 C4391022 2023-506487-13-00 Ph 2 active not recruiting A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
NCT02397083 LEVER 2014-0944 NCI-2015-00919, 2014-0944 Ph 2 active not recruiting Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer
NCT02143726 results posted A091302 U10CA180821, NCI-2014-00623 Ph 2 active not recruiting Sorafenib Tosylate With or Without Everolimus in Treating Patients With Advanced, Radioactive Iodine Refractory Hurthle Cell Thyroid Cancer
NCT03008408 2015-0961 NCI-2018-01284, 2015-0961 Ph 2 active not recruiting A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma
NCT01674140 e3 results posted S1207 S1207, U10CA032102 Ph 3 active not recruiting S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
NCT05949658 2023-0275 1U01AG081482-01, SMPH/MEDICINE/GER-AD DEV Ph 1 recruiting Rapalog Pharmacology (RAP PAC) Study
NCT02520063 results posted F150701004 (UAB 1514) UAB1514 Ph 1, Ph 2 completed Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
NCT05476939 BIOMEDE 2 2014/2126 2014-001929-32, 2023-506027-29-00 Ph 3 recruiting Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
NCT01217931 2010-0085 NCI-2011-00256 Ph 2 active not recruiting Sequential Two-agent Assessment in Renal Cell Carcinoma Therapy: The START Trial
NCT02407509 RAF/MEK CCR3808 2012-001040-22 Ph 1 completed Phase I Trial of VS-6766 Alone and in Combination With Everolimus
NCT02081755 013-307 Ph 4 enrolling by invitation Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer
NCT02057133 15252 I3Y-MC-JPBH Ph 1 active not recruiting A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread
NCT05933395 GERTRUDE STUDY02001800 NCI-2024-09317 Ph 2 recruiting Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
NCT01087554 2009-0729 NCI-2011-00562 Ph 1 active not recruiting Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer
NCT02813135 ESMART 2016-000133-40 2016/2396, 2024-514791-40-00 Ph 1, Ph 2 recruiting European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
NCT03065387 2016-0430 NCI-2018-01218, 2016-0430 Ph 1 active not recruiting Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation
NCT05563220 ELEVATE STML-ELA-0222 Ph 1, Ph 2 recruiting Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
NCT07318324 2025-1174 NCI-2025-09476 Ph 1 not yet recruiting Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer
NCT00799188 CERTICOEUR 2007.489/32 Ph 3 completed CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial
NCT03284957 AMEERA-1 results posted TED14856 U1111-1189-4896, 2024-512997-89 Ph 1, Ph 2 terminated Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
NCT03740334 18-328 Ph 1 active not recruiting Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL

Showing 50 of 368 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

AFINITOR DISPERZ FDA Label Details

Indications & Usage

FDA Label (PDF)

AFINITOR DISPERZ is indicated for the treatment of Breast Cancer; Neuroendocrine Tumors; Renal Cell Carcinoma; Renal Angiomyolipoma; Tuberous Sclerosis Complex; Subependymal Giant Cell Astrocytoma; Partial-Onset Seizures.

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Data Sources

FDA Approval: NDA203985 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.