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Temsirolimus (CCI-779)
Temsirolimus (CCI-779) is a mTOR inhibitor Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Renal cell carcinoma, Soft tissue sarcoma. Also known as: Torisel.
Temsirolimus is a mTOR inhibitor that blocks the mTOR pathway, which is involved in cell growth and proliferation.
Temsirolimus, also known as CCI-779, is a small molecule inhibitor of the FKBP1A protein. It is used in clinical trials for various conditions, including triple-negative breast cancer, sepsis, and kidney transplant recipients.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Temsirolimus (CCI-779) |
|---|---|
| Also known as | Torisel |
| Sponsor | Pfizer |
| Drug class | mTOR inhibitor |
| Target | mTOR |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the mTOR pathway, temsirolimus reduces the growth and proliferation of cancer cells. This is achieved by blocking the activity of the mTOR protein, which is a key regulator of cell growth and metabolism. As a result, temsirolimus can help to slow down or stop the growth of cancer cells.
Approved indications
- Renal cell carcinoma
- Soft tissue sarcoma
Common side effects
- Fatigue
- Nausea
- Diarrhea
- Vomiting
- Anemia
- Thrombocytopenia
- Neutropenia
- Anorexia
- Hypertension
- Dyspnea
Key clinical trials
- A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations (PHASE2)
- Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors (PHASE2)
- Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial (PHASE2)
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
- SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations (PHASE3)
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer (PHASE1, PHASE2)
- A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Temsirolimus (CCI-779) CI brief — competitive landscape report
- Temsirolimus (CCI-779) updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Temsirolimus (CCI-779)
What is Temsirolimus (CCI-779)?
How does Temsirolimus (CCI-779) work?
What is Temsirolimus (CCI-779) used for?
Who makes Temsirolimus (CCI-779)?
Is Temsirolimus (CCI-779) also known as anything else?
What drug class is Temsirolimus (CCI-779) in?
What development phase is Temsirolimus (CCI-779) in?
What are the side effects of Temsirolimus (CCI-779)?
What does Temsirolimus (CCI-779) target?
Related
- Drug class: All mTOR inhibitor drugs
- Target: All drugs targeting mTOR
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Renal cell carcinoma
- Indication: Drugs for Soft tissue sarcoma
- Also known as: Torisel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing