TheraRadar
Data updated: May 26, 2026

TORISEL (temsirolimus)

Genetically Validated Trial Activity: Declining 14 active trials
Oncology Approved 2007-05-30

TORISEL is indicated for the treatment of Renal Cell Carcinoma.

Source: FDA Label • PF PRISM CV
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How TORISEL Works

Temsirolimus is an inhibitor of mTOR (mammalian target of rapamycin). It forms a complex with the intracellular protein FKBP-12, which then inhibits mTOR activity, a key regulator of cell division. This inhibition results in a G1 growth arrest in tumor cells. Furthermore, blocking mTOR prevents the phosphorylation of downstream effectors (p70S6k and S6 ribosomal protein) in the PI3K/AKT pathway and leads to reduced levels of hypoxia-inducible factors (HIF-1 and HIF-2 alpha) and vascular endothelial growth factor (VEGF).

Source: FDA Label

Development Insights

National Cancer Institute (NCI) conducting 33 trials (28%)
376 indications explored (Broad Platform)
→ advanced cancer (6 trials)
→ kidney cancer (5 trials)
→ recurrent adult soft tissue sarcoma (4 trials)
4
Indications
--
Phase 3 Trials
1
Priority Reviews
18
Years on Market

Details

Status
Prescription
First Approved
2007-05-30
Patent Cliff
2032

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

PF PRISM CV
Active Ingredient: TEMSIROLIMUS

TORISEL Approval History

2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2007 to 2018 · 3 indication expansions
Mar 2018 SUPPL
Label · Labeling
FDA Letter Label
May 2017 SUPPL
Label · Labeling
FDA Letter Label
Jul 2016 SUPPL
Label · Labeling
FDA Letter Label

What TORISEL Treats

1 indications

TORISEL is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Renal Cell Carcinoma
Source: FDA Label

TORISEL Target & Pathway

Pro

Target

MTOR (Mechanistic Target of Rapamycin) Intracellular Kinase

TORISEL 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.

AFINITOR DISPERZ
Novartis
2012 7 indic.
AFINITOR
Novartis
2009 7 indic.

MoA expansion candidates

8

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.
JOBEVNE
BIOCON BIOLOGICS
2025 8 indic.
Unlock 14 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 TORISEL's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TORISEL 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 TORISEL

3 of 15

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

AFINITOR
EVEROLIMUS
1 shared
Novartis
Shared indications:
Renal Cell Carcinoma
AFINITOR DISPERZ
EVEROLIMUS
1 shared
Novartis
Shared indications:
Renal Cell Carcinoma
AVZIVI
BEVACIZUMAB-TNJN
1 shared
BIO-THERA SOLUTIONS LTD
Shared indications:
Renal Cell Carcinoma
View all 15 similar drugs Pro
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Clinical Trial Registry

115 trials
Trial Sponsor ID Phase Status Title
NCT00980460 results posted NCI-2011-01975 NCI-2011-01975, AHEP0731 Ph 3 active not recruiting Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer
NCT02567435 results posted NCI-2015-01644 NCI-2015-01644, ARST1431 Ph 3 active not recruiting Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
NCT00977574 results posted NCI-2011-01969 NCI-2011-01969, GOG-0086P Ph 2 active not recruiting Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
NCT01552434 2012-0061 NCI-2012-00347, 2012-0061 Ph 1 terminated Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
NCT01187199 2010-0486 NCI-2012-01788 Ph 1 active not recruiting Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer
NCT01375829 NCI-2012-02907 NCI-2012-02907, NCI-2012-01136 Ph 1 active not recruiting Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
NCT02693535 TAPUR Pro00014171 Ph 2 recruiting TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
NCT03297606 CAPTUR PM1 ESR-17-12831, CA209-9DL Ph 2 recruiting Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT01396408 I206 Ph 2 active not recruiting A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours
NCT02215720 TORERO 2010-012275-88 2010/1626 Ph 1 completed Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors
NCT02389309 2014-0692 NCI-2015-00524, 2014-0692 Ph 1 active not recruiting Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors
NCT03203525 2014-0357 NCI-2018-01597, 2014-0357 Ph 1 active not recruiting Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer
NCT01946529 results posted ESFT13 NCI-2013-01657 Ph 2 active not recruiting Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors
NCT01087554 2009-0729 NCI-2011-00562 Ph 1 active not recruiting Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer
NCT04433572 TANGO-3 CIP0216 Ph 3 recruiting Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
NCT02420613 2014-0135 NCI-2015-00817, 2014-0135 Ph 1 completed Vorinostat and Temsirolimus With or Without Radiation Therapy in Treating Younger Patients With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma
NCT01529593 2011-0923 NCI-2012-00216 Ph 1 terminated Temsirolimus in Combination With Metformin in Patients With Advanced Cancers
NCT00838955 201170 Ph 2 terminated Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma
NCT03942601 TAP-DANCE CIP0215 Ph 2 terminated Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
NCT03158389 N²M² NCT-2014-0235/N2M2 2015-002752-27 Ph 1, Ph 2 completed NCT Neuro Master Match - N²M² (NOA-20)
NCT01517243 results posted D1011 Ph 2 completed Phase II Study of Alternating Sunitinib and Temsirolimus
NCT02343718 I218 Ph 1 completed Vinblastine and Temsirolimus in Pediatrics With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
NCT01614197 results posted T2014-001 Ph 1 completed A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma
NCT02238496 AAAM3801 Ph 1 completed Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas
NCT01611116 TOR-AML 3066K1-1165 Ph 2 completed Study With Temsirolimus Added to Standard Chemotherapy for Patients Over 60 Years With Acute Myeloblastic Leukemia
NCT01767194 results posted NCI-2012-03125 NCI-2012-03125, CDR0000745188 Ph 2 completed Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma
NCT01174199 RPCI I 150709 NCI-2009-01537 Ph 1 terminated Temsirolimus and Vorinostat in Treating Patients With Metastatic Prostate Cancer
NCT01381692 results posted NCI-2011-02650 NCI-2011-02650, CDR0000701362 Ph 1, Ph 2 completed Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
NCT01392183 results posted 2011-0358 NCI-2011-01277 Ph 2 completed Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)
NCT01051557 results posted NCI-2011-01409 NCI-2011-01409, 09-058 Ph 1, Ph 2 completed Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma
NCT01827943 VESTOR results posted IB2009-08 Ph 2 completed Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer
NCT01065662 09-397 Ph 1 completed AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
NCT01687673 results posted 124511 NCI-2012-02021 Ph 2 completed Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma
NCT02093598 POEM LLO-TEM-2011-01/TEM IIG-4 2011-005031-96 Ph 2 completed POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus
NCT01596140 2012-0153 NCI-2012-00789 Ph 1 completed Vemurafenib in Combination With Everolimus or Temsirolimus With Advanced Cancer
NCT01281917 results posted HO10407 H-2010-0393, NCI-2011-00647 Ph 2 completed Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma
NCT01712828 CC-5013-CP-011 Ph 1 completed Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males
NCT01076543 results posted NCI-2011-01456 NCI-2011-01456, 09-443-A Ph 1, Ph 2 completed Lenalidomide and Temsirolimus in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma
NCT01083368 results posted CASE7808 NCI-2010-00308, CASE7808 Ph 1, Ph 2 completed Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy
NCT01196429 results posted NCI-2011-02653 NCI-2011-02653, CDR0000684262 Ph 2 completed Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer
NCT00723255 results posted NCI-2009-00598 NCI-2009-00598, CDR0000601291 Ph 2 completed Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer
NCT00729586 results posted NCI-2009-01085 NCI-2009-01085, GOG-0248 Ph 2 completed Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer
NCT01026623 results posted NCI-2011-01406 NCI-2011-01406, CDR0000659064 Ph 1, Ph 2 completed Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer
NCT01180049 results posted 3066K1-4438 B1771007, 2009-015498-11 Ph 4 completed Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma
NCT00909831 CDR0000643294 UPCC-08908, 807931 Ph 1 completed Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment
NCT00761644 2008-0384 NCI-2012-01665 Ph 1 completed Doxil, Bevacizumab and Temsirolimus Trial
NCT01010126 results posted NCI-2012-02086 NCI-2012-02086, NCI-2011-02504 Ph 2 completed Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
NCT01614795 results posted NCI-2012-01971 NCI-2012-01971, ADVL1221 Ph 2 completed Cixutumumab and Temsirolimus in Treating Younger Patients With Recurrent or Refractory Sarcoma
NCT02560012 results posted GU-14-102 HSC-14-0665 Ph 2 terminated Personalized Targeted Inhibitors Treatment in Renal Cell Cancer
NCT01111825 results posted 10-005 Ph 1, Ph 2 completed Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

Showing 50 of 115 trials

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Active Pipeline

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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.

TORISEL FDA Label Details

Indications & Usage

FDA Label (PDF)

TORISEL is indicated for the treatment of Renal Cell Carcinoma.

View full patent landscape →
4 OB patents · 2 families · 98 international docs across 34 countries

TORISEL Patents & Exclusivity

Latest Patent: Nov 2032

Patents (4 active)

US8791097*PED Expires Nov 10, 2032
US8791097 Expires May 10, 2032
US8026276*PED Expires Jul 20, 2026
US8026276 Expires Jan 20, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TORISEL

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2032
  • • 5 active patents

Trial Analysis

  • • 116 total trials
  • • Stage: Declining

Competitive Landscape

  • • 15 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA022088 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment