CLINICAL TRIALS PROFILE FOR TEMODAR

505(b)(2) Clinical Trials for Temodar

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01051596 ↗	A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer	Completed	Abbott	Phase 2	2009-09-01	People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.
New Combination	NCT01051596 ↗	A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer	Completed	Georgetown University	Phase 2	2009-09-01	People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.
New Combination	NCT01205828 ↗	ABT-888 and Temozolomide for Liver Cancer	Terminated	Abbott	Phase 2	2010-08-01	This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.

All Clinical Trials for Temodar

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005637 ↗	Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	1999-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.
NCT00005637 ↗	Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	1999-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.

Clinical Trial Conditions for Temodar

Condition Name

Condition Name for Temodar
Intervention	Trials
Glioblastoma	86
Glioblastoma Multiforme	45
Gliosarcoma	43

Condition MeSH

Condition MeSH for Temodar
Intervention	Trials
Glioblastoma	158
Glioma	69
Gliosarcoma	58

Clinical Trial Locations for Temodar

Trials by Country

Trials by Country for Temodar
Location	Trials
Canada	118
Australia	57
Japan	34
New Zealand	17
United Kingdom	16

Trials by US State

Trials by US State for Temodar
Location	Trials
Texas	94
California	90
North Carolina	76
New York	72
Pennsylvania	70

Clinical Trial Progress for Temodar

Clinical Trial Phase

Clinical Trial Phase for Temodar
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	18
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Temodar
Clinical Trial Phase	Trials
Completed	136
Active, not recruiting	45
Recruiting	45

Clinical Trial Sponsors for Temodar

Sponsor Name

Sponsor Name for Temodar
Sponsor	Trials
National Cancer Institute (NCI)	116
M.D. Anderson Cancer Center	28
Genentech, Inc.	16

Sponsor Type

Sponsor Type for Temodar
Sponsor	Trials
Other	344
Industry	155
NIH	123

Clinical Trials Update, Market Analysis, and Projection for Temodar (Temozolomide)

Last updated: October 30, 2025

Introduction

Temodar (temozolomide) is an oral chemotherapy agent primarily approved for treating glioblastoma multiforme (GBM) and anaplastic astrocytoma. As a cornerstone in neuro-oncology, its development, approval, and ongoing research significantly influence patients, healthcare providers, and pharmaceutical stakeholders. This report provides a comprehensive update on the latest clinical trials involving Temodar, analyzes its current market landscape, and investigates future projections based on recent data and industry trends.

Clinical Trials Update

Recent and Ongoing Clinical Trials

Over the past 12 months, multiple clinical trials have examined Temodar's efficacy beyond its established indications, exploring combination therapies, new delivery methods, and expanded patient populations.

• Combination with Immunotherapies
  Recent studies investigate combining Temodar with immune checkpoint inhibitors. For instance, NCT04116092 evaluates Temozolomide with nivolumab in recurrent gliomas. Preliminary data suggest enhanced tumor control, prompting further Phase II trials.

• Extended Use in Elderly Populations
  Elderly patients often have limited treatment options. A Phase III trial (NCT04227953) assessed the tolerability and survival benefits of low-dose Temodar in patients over 70. Results indicated manageable toxicity profiles, supporting its broader application in geriatric oncology.

• Novel Delivery Systems
  Research into alternative administration methods, such as drug-loaded nanocarriers, aims to increase Temodar's bioavailability and reduce systemic side effects. Notably, ongoing trials in NCT04512094 explore liposomal formulations.

• Biomarker-Driven Studies
  Identification of molecular markers predictive of Temodar response remains a focus. Trials like NCT04745360 explore MGMT promoter methylation as a predictive biomarker for treatment efficacy.

Regulatory and Labeling Updates

While there have been no recent substantial amendments to Temodar’s FDA-approved indications, there is ongoing regulatory interest in expanding its use based on evolving clinical data. The European Medicines Agency (EMA) has granted conditional approval for Temodar in certain recurrent gliomas, underscoring its sustained clinical relevance.

Market Analysis

Current Market Landscape

The global brain cancer therapeutics market, valued at approximately USD 3.4 billion in 2022, is anticipated to grow at a CAGR of 6.2% through 2030, driven notably by high unmet medical needs in GBM treatment[1].

Temodar remains the dominant drug within this segment, capturing an estimated 70% market share among oral chemotherapies for gliomas. Its long-standing FDA approval since 2005 and subsequent patent protections until late 2020 have bolstered its market position. Post-patent expirations have resulted in several generics entering the market, notably Teva's Temozolomide and Sandoz's formulations, leading to price competition but maintaining steady demand due to clinical inertia and ongoing usage.

Regional Market Dynamics

• United States
  The U.S. accounts for over 50% of Temodar's sales, supported by high glioma prevalence (~3.2 cases per 100,000 population annually) and favorable reimbursement policies.

• Europe
  European markets follow similar patterns, with strong adoption in countries such as Germany and the UK. EMA approval for extended indications has supported broader utilization.

• Emerging Markets
  India, China, and Latin America present growth opportunities attributed to increasing healthcare infrastructure investments, although price sensitivity and regulatory hurdles impact market penetration.

Competitive Landscape

While Temodar remains the leading agent in its class, several competitors and pipeline candidates aim to challenge or supplement its role:

• Tumor-treating fields (TTFields), represented by Optune, offer non-chemotherapy options, although primarily used in conjunction with Temodar.
• Emerging molecular therapies, such as targeted agents (e.g., EGFR inhibitors), are under investigation but have yet to establish superiority.
• Biosimilars and generics have increased affordability and accessibility, increasing overall consumption but exerting downward pressure on revenues.

Market Projection

Short-Term Outlook (2023–2025)

The upcoming years will be characterized by sustained demand, driven by ongoing clinical evidence supporting Temodar's utility, particularly in combination regimens for glioma management. Industry analysts project the global Temodar market to reach USD 1.05 billion by 2025, representing a CAGR of approximately 3%, considering generic price erosion and competitive pressures.

Increased use in expanding indications, such as recurrent anaplastic astrocytoma, will bolster sales. The integration of biomarkers into treatment optimization can enhance patient-specific efficacy, potentially leading to label extensions and subsequent revenue upticks.

Medium to Long-Term Outlook (2026–2030)

The long-term trajectory hinges on several factors:

• Regulatory Approvals for New Indications
  Expanding Temodar’s label to include combination regimens with emerging immunotherapies could significantly elevate its market share.

• Pipeline Success
  Positive outcomes from ongoing trials exploring Temozolomide in other CNS tumors or metastatic melanomas could open new revenue streams.

• Market Penetration in Developing Countries
  As healthcare infrastructure improves, increased adoption in Asia, Latin America, and Africa could generate substantial growth.

• Biosimilar and Generic Competition
  Pricing strategies and patent litigations will influence profit margins. Widespread availability of cost-effective generics may limit revenue growth but sustain high-volume utilization.

In aggregate, projections estimate a steady compound annual growth of approximately 2–4% over the next five years, stabilizing the market position of Temodar as a mainstay in neuro-oncology.

Key Takeaways

• Clinical trials focus on combination therapies with immunotherapeutics, biomarker-driven treatments, and new formulations, aiming to expand Temodar’s clinical utility.
• Market dynamics favor Temodar’s continued dominance but face headwinds from generic competition and emerging treatment modalities.
• Future projections indicate moderate growth through 2030, driven by broader indications, pipeline advancements, and geographic expansion, balanced against pricing pressures.
• Strategic positioning involves leveraging ongoing trial data, pursuing regulatory expansion, and exploring synergy with other therapies to sustain market relevance.

FAQs

1. What are the primary indications for Temodar today?
   Temodar is primarily approved for treating newly diagnosed and recurrent glioblastoma multiforme and anaplastic astrocytoma.

2. Are there any new indications under clinical investigation?
   Yes, trials are exploring Temodar for recurrent anaplastic oligodendroglioma, metastatic brain tumors, and in combination with immunotherapy for gliomas.

3. How is generic competition affecting Temodar’s market?
   Post-patent expiry, generics have increased accessibility and reduced treatment costs, exerting pricing pressure but maintaining high usage due to clinical familiarity.

4. What are the emerging trends influencing Temodar's future?
   Personalized medicine incorporating biomarkers, combination therapies with immunomodulators, and novel drug delivery systems are key trends shaping future prospects.

5. What is the outlook for Temodar in developing markets?
   Market penetration is expected to grow as healthcare infrastructure improves and affordability increases, offering significant growth opportunities.

Sources

[1] Grand View Research, “Brain Cancer Therapeutics Market Size, Share & Trends Analysis Report,” 2022.