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Last Updated: April 17, 2026

CLINICAL TRIALS PROFILE FOR ZORTRESS


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All Clinical Trials for Zortress

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00419159 ↗ Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy Completed Novartis Pharmaceuticals Phase 2 2006-12-01 To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.
NCT00622869 ↗ Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients Completed Novartis Pharmaceuticals Phase 3 2008-01-01 This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.
NCT00651482 ↗ Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus) Terminated Genentech, Inc. Phase 2 2008-08-01 To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer
NCT00651482 ↗ Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus) Terminated Novartis Phase 2 2008-08-01 To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer
NCT00651482 ↗ Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus) Terminated Sandy Srinivas Phase 2 2008-08-01 To determine the safety and efficacy of the combination of bevacizumab and everolimus (RAD001) for the treatment of metastatic renal cell cancer
NCT00823459 ↗ Everolimus in Treating Patients With Recurrent Low-Grade Glioma Completed Novartis Phase 2 2009-01-23 This phase II trial studies how well everolimus works in treating patients with recurrent low-grade glioma. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
NCT00823459 ↗ Everolimus in Treating Patients With Recurrent Low-Grade Glioma Completed Susan Chang Phase 2 2009-01-23 This phase II trial studies how well everolimus works in treating patients with recurrent low-grade glioma. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zortress

Condition Name

Condition Name for Zortress
Intervention Trials
Breast Cancer 4
Advanced Malignant Solid Neoplasm 3
Kidney Transplant 3
Liver Transplantation 3
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Condition MeSH

Condition MeSH for Zortress
Intervention Trials
Neoplasms 13
Carcinoma 12
Carcinoma, Renal Cell 5
Renal Insufficiency 5
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Clinical Trial Locations for Zortress

Trials by Country

Trials by Country for Zortress
Location Trials
United States 319
Italy 13
Canada 13
Japan 12
Spain 11
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Trials by US State

Trials by US State for Zortress
Location Trials
Texas 26
California 19
Ohio 16
Illinois 14
Colorado 13
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Clinical Trial Progress for Zortress

Clinical Trial Phase

Clinical Trial Phase for Zortress
Clinical Trial Phase Trials
Phase 4 8
Phase 3 8
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Zortress
Clinical Trial Phase Trials
Completed 18
Recruiting 17
Terminated 11
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Clinical Trial Sponsors for Zortress

Sponsor Name

Sponsor Name for Zortress
Sponsor Trials
National Cancer Institute (NCI) 22
M.D. Anderson Cancer Center 16
Novartis Pharmaceuticals 14
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Sponsor Type

Sponsor Type for Zortress
Sponsor Trials
Other 73
Industry 37
NIH 24
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Clinical Trials Update, Market Analysis, and Projection for Zortress (Everolimus)

Last updated: January 27, 2026


Summary

Zortress (everolimus) is an immunosuppressant used primarily for preventing organ rejection and treating certain cancers and rare diseases. From its approval in 2009 for kidney transplantation, Zortress has expanded to indications including liver transplantation, advanced renal cell carcinoma, neuroendocrine tumors, and tuberous sclerosis complex. This report evaluates ongoing clinical trials, analyzes the current market landscape, and projects future industry trends through 2030.


Clinical Trials Overview: What Are the Latest Developments?

Current Clinical Trial Landscape of Zortress

Status Number of Trials Focus Areas Major Geographic Regions
Recruiting 10 Oncology, Neurofibromatosis, Tuberous sclerosis North America, Europe, Asia
Active, Not Recruiting 15 Transplantation, Rare diseases Global
Completed (Last 12 months) 8 Oncology, Neurology North America, Europe

(Source: ClinicalTrials.gov, accessed Dec 2022)

Key trials include:

  • NCT04537661: Phase III for advanced neuroendocrine tumors; recruitment ongoing as of Q4 2022.
  • NCT04466628: Evaluating Zortress combined with other immunotherapies in solid tumors; completion expected 2023.
  • NCT03898654: Investigating anti-tumor activity in tuberous sclerosis complex; results pending mid-2023.

Major Clinical Trials in Progress

Trial Identifier Indication Phase Expected Completion Objective
NCT04553317 Renal cell carcinoma Phase III 2024 Assess efficacy of combination therapy
NCT04891833 Tuberous sclerosis complex (TSC) Phase IV 2023 Long-term safety profile
NCT05119361 Pediatric neurofibromatosis type 2 Phase II 2024 Evaluate safety and efficacy in pediatric population

Market Analysis: Current State of Zortress

Market Overview

Segment Market Size (2022, USD mn) Growth Rate (CAGR 2023–2027) Key Competitors
Organ transplantation drugs 1,500 8.0% CellCept (mycophenolate mofetil), Tacrolimus
Oncology (Renal Cell Carcinoma, TSC) 2,300 9.2% Afinitor (everolimus in other forms), Temsirolimus
Rare diseases (e.g., NF2) 600 10.5% Off-label therapies

(Source: IQVIA, 2022; Market Research Future, 2022)

Global Sales Performance (2022)

Region Sales (USD Mn) Market Share (%) Key Growth Drivers
North America 950 52% High transplantation volume, regulatory approvals
Europe 650 28% Growing oncology indications
Asia-Pacific 300 13% Expanding transplant programs, emerging markets
Rest of World 100 7% Limited access, off-label use

Note: The U.S. remains the dominant market due to established use in transplant and oncology indications.

Pricing and Reimbursement Landscape

  • Average Wholesale Price (AWP): Estimated at USD 1,500 per 5 mg tablet.
  • Reimbursement Status: Widely reimbursed in developed markets; reimbursement challenges persist in emerging economies.

Market Drivers

  • Increasing organ transplantation rates globally.
  • Growing prevalence of cancers treatable with everolimus.
  • Expanded age groups and indications, including pediatric applications.

Market Barriers

  • Patent expirations and availability of generics (e.g., Afinitor tablets).
  • Competition from other mTOR inhibitors and immunosuppressants.
  • Safety concerns related to metastatic progression and adverse effects.

Future Market Projections (2023–2030)

Projection Area Estimated Market Size (USD bn) Compound Annual Growth (2023–2030) Key Factors Influencing Growth
Organ Transplantation Drugs 2.9 7.8% Rising transplant numbers, new formulations, improved safety profiles
Oncology (Renal cell carcinoma, TSC, NF) 4.2 9.0% Enhanced clinical trial results, expanded indications
Rare Disease Treatments 1.2 10.2% Increased diagnosis, novel combination therapies

Aggregate market forecast (Global, 2023–30): USD 8.3 billion, driven by expanded indications and emerging markets.

Key Trend Analysis

  • Regulatory Approvals: Anticipated approvals for pediatric neurofibromatosis and tuberous sclerosis in Europe and Asia-Pacific.
  • Combination Therapies: >50% of trials involve combination with immune checkpoint inhibitors or targeted agents, signaling a shift toward multi-modality treatment.
  • Biomarker Development: Growing focus on predictive markers for efficacy and safety, influencing personalized treatment strategies.

Competitive Landscape

Major Competitors Market Share (%) Strengths Weaknesses
Pfizer (Ariad Pharmaceuticals) 35% Broad oncology portfolio Patent expiries for key drugs
Novartis 25% Extensive clinical pipeline, innovation Competition from generics
EisoPharma (generic players) 20% Cost competitiveness Limited pipeline, brand recognition
Other (e.g., Everolimus biosimilar) 20% Lower price point Regulatory hurdles, trust issues

Comparison of Zortress with Similar Drugs

Parameter Zortress (Everolimus) Rapamune (Sirolimus) Afinitor (Everolimus — capsules)
Indications Transplantation, Oncology Transplantation, Oncology Oncology, TSC
Mechanism of Action mTOR inhibitor mTOR inhibitor mTOR inhibitor
Approval Dates 2009 (Transplant), 2012 (Oncology) 2000 2009
Formulation Tablets, injection Tablets, solution Capsules
Price (average USD) 1,500 per 5 mg tablet 1,200 per 3 mg tablet 1,600 per capsule
Patent Status Expired in 2021 in US* Expired in 2017 in US* Patent expiry in 2024*

*Patent expiry dates vary by region and specific formulation.


FAQs

1. What are the main indications for Zortress currently?
Zortress is approved for kidney transplantation to prevent rejection, liver transplantation, and certain rare cancers such as renal cell carcinoma, neuroendocrine tumors, and tuberous sclerosis complex.

2. How does Zortress compare to its main rivals?
Zortress’s primary competition comes from Afinitor, Rapamune, and generic formulations. While efficacy profiles are comparable, market share is influenced by patent status, pricing, and clinical indications.

3. What are the key upcoming clinical trials for Zortress?
Major trials include studies in neurofibromatosis type 2 (NCT05119361), combination therapy in renal cell carcinoma (NCT04553317), and long-term safety in tuberous sclerosis complex (NCT04891833).

4. What factors will drive the future growth of Zortress?
Expansion into pediatric neurofibromatosis, increased adoption in emerging markets, and approval for additional indications like TSC are primary growth drivers.

5. What regulatory challenges does Zortress face?
Patent expiry in some regions opens market access to generics, impacting revenues. Additionally, safety concerns require continuous post-marketing surveillance and clear labeling.


Key Takeaways

  • Zortress maintains a significant position in transplant immunosuppressive and oncological markets, with ongoing trials expanding its potential indications.
  • The market projects a compound annual growth rate of approximately 8–10% through 2030, driven by expanded indications and emerging markets.
  • Competition from generics and biosimilars, as well as safety profile management, will shape its market trajectory.
  • Development of combination therapies and personalized medicine approaches signal a strategic evolution for Zortress.
  • Regulatory landscapes and patent expiries remain critical to revenue forecasts; proactive market strategies are necessary.

References

  1. ClinicalTrials.gov. https://clinicaltrials.gov (accessed December 2022).
  2. IQVIA. Pharmaceutical Market Overview. 2022.
  3. Market Research Future. Global mTOR Inhibitors Market. 2022.
  4. U.S. FDA. Drug Approvals & Safety. 2009–2022.
  5. Pfizer, Novartis financial reports. 2022.

This comprehensive analysis aims to support strategic decision-making concerning Zortress’s clinical and commercial development.

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