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Drug

Temsirolimus

Approved · EMA
Emerging researchLate-stage developmentSteady momentum

Also known as Torisel.

RxNorm657797ChEMBLCHEMBL1201182UNII624KN6GM2T
4
Research papers
14
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC #704865), Paclitaxel/Carboplatin/Temsirolimus (NSC #683864) and Ixabepilone (NSC #710428)/Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Clinical trial2026-07-31Results posted · ClinicalTrials.gov

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

Clinical trial2026-06-30Results posted · ClinicalTrials.gov

A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Clinical trial2026-06-17Results posted · ClinicalTrials.gov

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Clinical trial2026-05-29Results expected Q4 2027 · ClinicalTrials.gov

A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination With Valproic Acid, or Cetuximab in Patients With Advanced Malignancy and Other Indications

Clinical trial2026-05-08Terminated · ClinicalTrials.gov

Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer

Clinical trial2026-04-30Primary completion · ClinicalTrials.gov

Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer.

Research2018-02-17BMC cancer

Phase 2 Study of Bevacizumab and Temsirolimus After VEGFR TKI in Metastatic Renal Cell Carcinoma.

Research2016-02-23Clinical genitourinary cancer

Drug Safety Update: Temsirolimus: severe hypersensitivity reactions during infusion

Regulatory2014-12-11MHRA

MicroRNAs induced in melanoma treated with combination targeted therapy of Temsirolimus and Bevacizumab.

Research2013-09-18Journal of translational medicine

Clinical activity and safety of combination therapy with temsirolimus and bevacizumab for advanced melanoma: a phase II trial (CTEP 7190/Mel47).

Research2013-04-25Clinical cancer research : an official journal of the American Association for Cancer Research

Approval: Torisel (EMA)

Regulatory2007-11-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Temsirolimus
Aliases & brands
Torisel
RxNorm CUI
657797
ChEMBL ID
CHEMBL1201182
UNII
624KN6GM2T
Regulatory jurisdictions
emamhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-11-19
Latest approval
2007-11-19
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2007-11-19Approval
Approval: Torisel (EMA)
Indication: Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk… Show full indication

Renal-cell carcinoma Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors. Mantle-cell lymphoma Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Temsirolimus: severe hypersensitivity reactions during infusion
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

174 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
174
registered trials across all phases
LATEST COMPLETION 2026
14
Active studies
5
Recruiting
13
Late-stage (III+)
122
Completed
38
Discontinued
PHASE DISTRIBUTIONn = 174
Early Phase 13Phase 163Phase 1 / 222Phase 273Phase 37Phase 41Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A RANDOMIZED PHASE 4 STUDY COMPARING 2 INTRAVENOUS TEMSIROLIMUS (TEMSR) REGIMENS IN SUBJECTS WITH RELAPSED, REFRACTORY MANTLE CELL LYMPHOMA

CompletedPH IVPfizern=1012018

Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the Incidence of Ischemia-Driven Major Amputation, Clinically Driven Target Lesion Revascularization, and Clinically Relevant Target Lesion Occlusion After Revascularization of Lesions Below the Knee in Patients With Symptomatic Rutherford 3-5 Peripheral Artery Disease

RecruitingPH IIIMercator MedSystems, Inc.n=2502032

A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Active, not recruitingPH IIINational Cancer Institute (NCI)n=3252026

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

CompletedPH IIINational Cancer Institute (NCI)n=2362026

A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

CompletedPH IIIJanssen Research & Development, LLCn=2802016

Recent completions

Trials that read out recently, adding to the completed evidence base.

Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus (NSC#683864) Added to High Risk Stratum Treatment

CompletedPH IIINational Cancer Institute (NCI)n=2362026

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors

CompletedPH IAstraZenecan=1402025

A Phase I Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) With Temsirolimus in Children With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma (DIPG)

CompletedPH IM.D. Anderson Cancer Centern=182025

Umbrella Protocol for Phase I/IIa Trials of Molecularly Matched Targeted Therapies Plus Radiotherapy in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation: NCT Neuro Master Match - N²M² (NOA-20)

CompletedPH I/IIUniversity Hospital Heidelbergn=2282023

A Phase II Randomized Trial of Irinotecan/Temozolomide With Temsirolimus (NSC# 683864) or Chimeric 14.18 Antibody (Ch14.18) (NSC# 764038) in Children With Refractory, Relapsed or Progressive Neuroblastoma

CompletedPH IINational Cancer Institute (NCI)n=732022

A Randomized Phase I/II Study of Bortezomib, Rituximab, Dexamethasone and Temsirolimus in Patients With Relapsed Waldenstrom Macroglobulinemia and Relapsed/Refractory Mantle Cell, Follicular, Marginal Zone or Small Lymphocytic Lymphomas (Phase I), and Untreated/Relapsed Waldenstrom Macroglobulinemia (Phase II)

CompletedPH I/IINational Cancer Institute (NCI)n=92021

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132018
Major research themes2
Gene Expression Regulation, Neoplastic1Molecular Targeted Therapy1
Journals, researchers & institutions
Top journals
  • BMC cancer1
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Clinical genitourinary cancer1
  • Journal of translational medicine1
Leading researchers
  • Molhoek KR2
  • Slingluff CL Jr2
  • Wagenseller AG2
  • Atkins MB1
  • Bellera C1
  • Bhatt RS1
  • Brautigan DL1
  • Carvo I1
Leading institutions
free-text, unnormalised
  • Bergonié Institute1
  • Beth Israel Deaconess Medical Center1
  • Brigham and Women's Hospital1
  • Clinical and Epidemiology Department & Clinical Investigation Center INSERM CIC 14011
  • Dana-Farber Cancer Institute1
  • François Baclesse Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.