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Compound · clinical trials

Temsirolimus clinical trials

Also listed in trial records as CCI 779, CCI779
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 4 trials in our Canada, USA, Australia, Israel and Mexico registers that name Temsirolimus as an intervention. Synced 27 Sep 2026
4Current trials
1Recruiting now
3Lead sponsors
5Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Temsirolimus is named as an intervention in 4 current clinical trials in our Canada, USA, Australia, Israel and Mexico registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is National Cancer Institute (NCI) (2). The most-studied condition is Peripheral Artery Disease.

Where Temsirolimus is approved

All regulators →

Temsirolimus was first approved in the US on 30 May 2007. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
30 May 2007
Torisel
NDA022088 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
19 Nov 2007
Torisel
EMA product page
First centralised authorisation
CACanada (Health Canada)
21 Dec 2007
Torisel
Notice of Compliance 9263
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Trials by status

  • Recruiting125%
  • Active, closed375%

Trials by phase

  • Phase 3250%
  • Phase 2250%
01

Clinical trials of Temsirolimus

4 trials
StudyPhaseStatusLead sponsorRegisters
Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee
NCT04433572 · ClinicalTrials.gov ↗ · Peripheral Artery Disease, Critical Limb Ischemia
Phase 3 Recruiting Mercator MedSystems, Inc USA
Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
NCT02567435 · ClinicalTrials.gov ↗ · Alveolar Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma
Phase 3 Active, closed National Cancer Institute (NCI) Canada, Australia, Israel
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
NCT00977574 · ClinicalTrials.gov ↗ · Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma
Phase 2 Active, closed National Cancer Institute (NCI) Mexico
A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours
NCT01396408 · ClinicalTrials.gov ↗ · Advanced Rare Tumours
Phase 2 Active, closed Canadian Cancer Trials Group Canada

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Temsirolimus across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Temsirolimus on the HPRA medicines list.

  • Torisel 30 mg concentrate and solvent for solution for infusionPfizer Europe MA EEIG · EU/1/07/424/001
All 1 Irish product →

Supply shortages

No entry for Temsirolimus in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Temsirolimus

11 conditions
Peripheral Artery Disease1Critical Limb Ischemia1Advanced Rare Tumours1Alveolar Rhabdomyosarcoma1Botryoid-Type Embryonal Rhabdomyosarcoma1Embryonal Rhabdomyosarcoma1Rhabdomyosarcoma1Endometrial Adenocarcinoma1Endometrial Adenosquamous Carcinoma1Endometrial Clear Cell Adenocarcinoma1Endometrial Serous Adenocarcinoma1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
National Cancer Institute (NCI)2
Mercator MedSystems, Inc1
Canadian Cancer Trials Group1
05

By country register

RegisterTrialsRecruiting
Clinical trials in Canada20
Clinical trials in USA11
Clinical trials in Australia10
Clinical trials in Israel10
Clinical trials in Mexico10

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Temsirolimus trials

How many clinical trials are testing Temsirolimus?

4 current trials in our Canada, USA, Australia, Israel and Mexico registers name Temsirolimus (also registered as CCI 779) as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Temsirolimus trials recruiting patients?

Yes. 1 of the 4 trials is recruiting: 1 with sites in USA. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Temsirolimus clinical trials?

National Cancer Institute (NCI) (2), Mercator MedSystems, Inc (1) and Canadian Cancer Trials Group (1). The number in brackets is how many trials each organisation leads.

Is Temsirolimus licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Temsirolimus, for example Torisel 30 mg concentrate and solvent for solution for infusion (Pfizer Europe MA EEIG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Temsirolimus shortage?

Not in the lists we track: Temsirolimus has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Temsirolimus works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Temsirolimus works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Temsirolimus (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.