NDAINTRAVENOUSSOLUTIONPriority Review
Approved
May 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
TORISEL (temsirolimus) by Pfizer is (mammalian target of rapamycin). Approved for advanced renal cell carcinoma. First approved in 2007.
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TORISEL (temsirolimus) is an intravenous mTOR inhibitor approved in 2007 for advanced renal cell carcinoma. It works by binding to FKBP-12 and blocking mTOR activity, which halts tumor cell division and reduces expression of HIF-1, HIF-2α, and VEGF. This mechanism addresses a key driver of RCC progression and angiogenesis.
Peak6.5 years to LOE
TORISEL remains in peak commercial phase with stable market position; teams are mid-sized and focused on maintaining share in a competitive oncology space.
Mechanism of Action
(mammalian target of rapamycin). Temsirolimus binds to an intracellular protein (FKBP-12), and the protein-drug complex inhibits the activity of mTOR that controls cell division. Inhibition of mTOR activity resulted in a G1 growth arrest in treated tumor cells. When mTOR was inhibited, its ability…
Indications (1)
Clinical Trials (20)
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
Started Jul 2025
250 enrolled
Peripheral Artery DiseaseCritical Limb Ischemia
Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
Started Oct 2019
10 enrolled
Peripheral Arterial Disease
Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO)
Started Mar 2017
100 enrolled
Chronic Limb Ischemia
A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma
Started Jul 2015
16 enrolled
Lymphoblastic Leukemia, Acute, ChildhoodLymphoblastic LymphomaPeripheral T-cell Lymphoma
Vinblastine and Temsirolimus in Pediatrics With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
Started Jun 2015
7 enrolled
Recurrent LymphomaRefractory LymphomaSolid Tumours+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.