Data updated: May 26, 2026
TEMSIROLIMUS
Genetically Validated
Trial Activity: Declining 14 active trials
Oncology
Approved 2018-07-30
Temsirolimus is a kinase inhibitor used for patients with advanced renal cell carcinoma. This medication helps patients with this specific type of kidney cancer by targeting proteins that regulate how tumor cells grow and divide. It is typically prescribed to slow the progression of the disease when it has reached an advanced stage.
Source: FDA Label • GLAND
How TEMSIROLIMUS Works
Temsirolimus works by binding to an intracellular protein to inhibit mTOR, which is a primary regulator of cell division. This inhibition causes tumor cells to stop growing and blocks the signaling pathways used for protein synthesis. It also reduces the levels of vascular endothelial growth factor and hypoxia-inducible factors within the tumor environment.
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)
2
Indications
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2018-07-30
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
TEMSIROLIMUS Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2018 to 2025
What TEMSIROLIMUS Treats
1 indicationsTEMSIROLIMUS is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Renal Cell Carcinoma
Source: FDA Label
TEMSIROLIMUS Target & Pathway
ProTarget
TEMSIROLIMUS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
2
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
8
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 14 more competitors across all three rings.
Upgrade to Pro 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 TEMSIROLIMUS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TEMSIROLIMUS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TEMSIROLIMUS
3 of 15FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
113 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 113 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
TEMSIROLIMUS FDA Label Details
Indications & Usage
TEMSIROLIMUS is indicated for the treatment of Renal Cell Carcinoma.
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TORISEL
Full clinical data, patents, trials, and competitive landscape for temsirolimus.
Data Sources
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