Torisel
(Temsirolimus)ApprovedSmall molecule
Temsirolimus is used to treat advanced kidney cancer and a type of blood cancer called mantle cell lymphoma. It works by slowing down the growth of cancer cells in the body.[2] Torisel is currently approved and in use across 67 indications[4].[1]
Torisel is one of 1322 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Approved.
67
Indications
174
Total Trials
17
Active Trials
1,321
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
4
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 67 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Torisel
PPrism Pharmaceuticals
Approved
Avastin
BBio-Thera Solutions
Preclinical
Voltaren
NovartisPreclinical
Lupron
EEastern Cooperative Oncology Group
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Zinecard
CChildren's Oncology Group
Preclinical
Chirocaine
PPurdue Pharma LP
Preclinical
Chantix
PPrism Pharmaceuticals
Preclinical
Fentanyl Citrate
IINSYS Therapeutics Inc
Preclinical
Metfomin
UUniversity of Texas Southwestern Medical Center
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Lymphoma12 trials
Show 9 more trials
Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)
Withdrawn·—·Phase 1/2·NCT01170052·20 enrolled
Temsirolimus in Recurrent Primary Central Nervous System (CNS) Lymphoma
Unknown status·—·Phase 2·NCT00942747·37 enrolled
Renal Cell Carcinoma7 trials
Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
Completed·—·Phase 2·NCT00782275·41 enrolled
Show 4 more trials
Prostate Cancer6 trials
Mantle Cell Lymphoma5 trials
Patients With Solid Tumors5 trials
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence
Recruiting·—·Phase 1·NCT02446431·20 enrolled
77 more indications
Patients With Advanced Solid Tumors5 trials
CCI-779 in Treating Patients With Advanced Solid Tumors
Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT00003712·15 enrolled
Advanced Cancer5 trials
Solid Tumors4 trials
Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors
Completed·—·Phase 1·NCT00998036·9 enrolled
Metastatic Prostate Cancer4 trials
Temsirolimus and Bevacizumab in Hormone-Resistant Metastatic Prostate Cancer That Did Not Respond to Chemotherapy
Completed·—·Phase 1/2·NCT01083368·22 enrolled
Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology In Men With Castration Resistant Metastatic Prostate Cancer
Terminated·—·Phase 2·NCT00887640·11 enrolled
Metastatic Solid Tumors4 trials
Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment
Completed·—·Phase 1·NCT00909831·40 enrolled
Non-Small Cell Lung Cancer4 trials
Melanoma4 trials
Glioblastoma Multiforme4 trials
Malignant Glioma4 trials
Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas
Completed·—·Phase 1·NCT02238496·10 enrolled
Show 1 more trial
CCI-779 in Treating Patients With Malignant Glioma
Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT00022724·49 enrolled
Squamous Cell Carcinoma3 trials
Bevacizumab3 trials
Endometrial Cancer3 trials
Multiple Myeloma3 trials
Soft Tissue Sarcoma3 trials
Acute Lymphoblastic Leukemia3 trials
Breast Cancer3 trials
Trial2 trials
Second-line Therapy2 trials
Outcome2 trials
Solid Malignancies2 trials
Lenalidomide2 trials
Endometrial Carcinoma2 trials
Metastatic Cancer2 trials
Drug2 trials
Glioblastoma2 trials
Kidney Cancer2 trials
Neuroblastoma2 trials
Brain Tumors2 trials
Refractory Solid Tumors2 trials
Pancreatic Cancer2 trials
Chronic Lymphocytic Leukemia2 trials
Rhabdomyosarcoma2 trials
Ovarian Cancer2 trials
Renal Cell Cancer2 trials
Recurrent or Refractory1 trial
Advanced Rare Tumours1 trial
Tics1 trial
Cervical Cancer1 trial
Colorectal Cancer1 trial
Temsirolimus (CCI-770, Torisel) Combined With Cetuximab in Cetuximab-Refractory Colorectal Cancer
Completed·—·Phase 1·NCT00593060·35 enrolled
Small Cell Lung Cancer1 trial
Gastrointestinal Stromal Tumor1 trial
Metastatic Colorectal Cancer1 trial
Leukemia1 trial
Phase II1 trial
Phase II Study of Alternating Sunitinib and Temsirolimus
Completed·—·Phase 2·NCT01517243·37 enrolled
Hepatocellular Carcinoma1 trial
Chronic Myelogenous Leukemia1 trial
Acute Myeloid Leukemia1 trial
Advanced Stage Cancer1 trial
Advanced Gynecological Malignancies1 trial
AZD2171 and Temsirolimus in Patients With Advanced Gynecological Malignancies
Completed·—·Phase 1·NCT01065662·11 enrolled
Dexamethasone1 trial
First Line Therapy1 trial
Gemcitabine Hydrochloride, Cisplatin, and Temsirolimus as First-Line Therapy in Treating Patients With Locally Advanced and/or Metastatic Transitional Cell Cancer of the Urothelium
Completed·—·Phase 1/2·NCT01090466·15 enrolled
Metastatic Melanoma1 trial
CCI-779 in Treating Patients With Metastatic Melanoma
Completed·—·Phase 2·NCT00022464
Bladder Cancer1 trial
Primary Peritoneal Cancer1 trial
Neuroendocrine Carcinoma1 trial
Desmoplastic Small Round Cell Tumor1 trial
Recurrent Sarcoma1 trial
Advanced or Metastatic Solid Tumors1 trial
Clear Cell Renal Carcinoma1 trial
Protein Kinase Inhibitors1 trial
Endometrial Adenocarcinoma1 trial
Hepatoblastoma1 trial
Unspecified2 trials
Regulatory
FDA Approval Timeline[5]
May 30, 2007
TORISEL
NDA NDA022088
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Torisel drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Temsirolimus. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- FK506-Binding Protein 1a Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- PPrism Pharmaceuticals
Patent Landscape[6]
Patent Cliff
Jul 20, 2026
Earliest patent expiration — generic entry possible after this date