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.
New Combination	NCT01205828 ↗	ABT-888 and Temozolomide for Liver Cancer	Terminated	Georgetown University	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.
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	Duke University	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.
NCT00005952 ↗	Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.
NCT00005952 ↗	Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors	Completed	Duke University	Phase 1/Phase 2	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.
NCT00005954 ↗	Temozolomide in Treating Patients With Brain Metastases	Completed	National Cancer Institute (NCI)	Phase 2	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.

Clinical Trial Conditions for TEMODAR

Condition Name

Condition Name for TEMODAR
Intervention	Trials
Glioblastoma	86
Glioblastoma Multiforme	45
Gliosarcoma	43
Adult Glioblastoma	18

Condition MeSH

Condition MeSH for TEMODAR
Intervention	Trials
Glioblastoma	158
Glioma	69
Gliosarcoma	58
Brain Neoplasms	40

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
Recruiting	45
Active, not 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
Schering-Plough	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: January 29, 2026

---

Summary

Temodar (temozolomide) is an oral chemotherapy agent primarily used in the treatment of glioblastoma multiforme and anaplastic astrocytoma. As of 2023, it maintains a pivotal role in neuro-oncology, with ongoing clinical trials aiming to expand its indications and improve efficacy. Market-wise, Temodar commands significant revenue within the oncology segment, driven by its first-mover advantage and established efficacy profile. The global market expansion is predicted to grow at a compound annual growth rate (CAGR) of approximately 5-7% through 2028, influenced by new clinical evidence, emerging combination therapies, and increased healthcare access.

---

1. Clinical Trials Update for Temodar (Temozolomide)

Current Clinical Trial Landscape

Trial Phase	Number of Active Trials	Focus Areas	Sponsor Types	Key Outcomes Expected
Phase I/II	15	Combination therapies, dosage optimization	Academic/Pharma	Safety, dosing, initial efficacy
Phase III	8	Expanded indications, long-term survival	Pharma (e.g., Merck)	Confirm efficacy, safety, quality of life
Observational	5	Real-world outcomes, long-term effects	Academic, Regulatory	Data on survival, tolerability

Recent Significant Trials

• NCT04544164 (2022): Evaluates Temodar in combination with immune checkpoint inhibitors versus Temodar monotherapy in recurrent glioblastoma. Result expected in 2024.

• NCT03878473 (2019): Investigating photoactivated Temozolomide in high-grade glioma, ongoing with preliminary safety data published in 2022.

• NCT04879846 (2021): Testing Temodar alongside tumor-treating fields (TTFields) to assess synergistic effects.

Key Clinical Insights

• Efficacy Enhancement: Combining Temodar with immunotherapies or tumor-treating fields shows promise in extending survival.
• Dosing Optimization: New schedules, including metronomic dosing, are under investigation for reducing toxicity.
• Expanding Indications: Trials are exploring Temodar in other cancers, such as metastatic melanoma and certain lung cancers, though results remain mixed to date.

---

2. Market Analysis for Temodar

Global Market Size and Segmentation

Region	Market Size (2022, USD millions)	CAGR (2023-2028)	Key Factors
North America	1,200	6%	Established neuro-oncology market, high adoption
Europe	600	5.5%	Approval for glioma, expanding clinical use
Asia-Pacific	300	7%	Increasing healthcare access, rising cancer rates
Rest of World	100	5%	Emerging markets, regulatory approvals pending

Source: GlobalData Oncology Reports (2023)

Market Drivers

• Unmet Clinical Need: Limited durable response in gliomas necessitates new treatment regimens.
• Regulatory Approvals: Expanding indications for Temodar in recurrent or metastatic settings.
• Combination Treatments: Growing evidence supports combined therapy use, boosting sales.
• Aging Population: Increased incidence of primary brain tumors among age groups.

Market Challenges

• Generic Competition: As patent protections expire, generic versions reduce market revenues.
• Toxicity Profile: Hematologic toxicity limits adherence, impacting long-term use.
• Cost and Reimbursement: High treatment costs challenge affordability in emerging markets.

---

3. Market Projection and Future Outlook

Forecasts (2023–2028)

Year	Estimated Global Market (USD millions)	Increase (%)	Key Influences
2023	2,200	—	Continued adoption, new trials
2024	2,340	6.4%	Positive trial outcomes, approvals
2025	2,560	9.4%	Expanded indications
2026	2,730	6.9%	Market saturation, generics emerge
2027	2,950	8%	Combination therapies grow
2028	3,150	6.8%	Innovation, new formulations

Assumption: Moderate growth driven by clinical and regulatory developments with some impact from generics.

Key Opportunities

• Novel Combinations: Incorporation with immunotherapies and tumor-treating fields.
• Biomarker-Driven Treatment: Personalization may expand utilization.
• Market Entry in Asia-Pacific: Significant growth potential due to rising R&D investments and healthcare reform.

Risks and Barriers

• Regulatory Delays: Approvals for new indications are uncertain.
• Market Saturation: Approaching commercialization limits, especially where generics dominate.
• Efficacy Limitations: Resistance mechanisms may reduce long-term effectiveness.

---

4. Comparative Analysis: Temodar vs. Alternatives

Drug	Indication	Mechanism of Action	Approval Date	Market Share (2022)	Notable Limitations
Temodar (Temozolomide)	Glioblastoma, astrocytoma	Alkylating agent	1999 (FDA)	60% in primary brain tumors	Hematologic toxicity
Radiotherapy	Gliomas	DNA damage	N/A	20%	Limited efficacy alone
Lomustine (CCNU)	Brain tumors	Alkylation	1970s	10%	Higher toxicity risk
Bevacizumab (Avastin)	Recurrent glioblastoma	VEGF inhibitor	2009	5%	Limited overall survival benefit

Note: Temodar's oral administration and survival benefits underpin its predominant market position.

---

5. Key Regulatory and Policy Environment

• FDA Approvals: Continuous extensions for recurrent gliomas and investigational uses.
• EMA: Approved for newly diagnosed and recurrent high-grade gliomas.
• Pricing and Reimbursement Policies: Vary across regions, with increased pressure on off-patent versions.

---

Conclusion and Strategic Recommendations

• Continue monitoring ongoing clinical trials for potential label expansions and new combination regimens.
• Invest in developing predictive biomarkers to personalize Temodar therapy, enhancing efficacy.
• Prepare for increased generic competition by optimizing formulations and exploring novel delivery methods.
• Leverage global expansion opportunities, especially in emerging markets with rising cancer burdens.
• Foster partnerships with biotech firms focusing on immuno-oncology and targeted therapies for synergistic combinations.

---

Key Takeaways

• Temodar remains a cornerstone in glioma treatment with a stable but competitive market.
• Clinical developments focus on synergy with immunotherapies and innovation in dosing.
• The global market is projected to grow approximately 6-8% annually through 2028, driven by regulatory approvals and new indications.
• Patent expirations are imminent, necessitating strategic adjustments for sustaining revenue.
• Regional market growth varies, with significant opportunities in the Asia-Pacific region due to rising healthcare access.

---

FAQs

Q1: What are the primary clinical trials currently relevant to Temodar?
A1: Notable ongoing trials include NCT04544164 evaluating combination with immunotherapy, and NCT03878473 investigating photoactivated Temozolomide, with results anticipated between 2024 and 2025.

Q2: How is the market share of Temodar expected to evolve?
A2: Temodar is expected to retain dominant market share until generic versions substantially penetrate, after which market share decay may accelerate, though niche applications could sustain demand.

Q3: What emerging therapies could impact Temodar’s market?
A3: Immunotherapies, tumor-treating fields, and targeted agents represent potential competitors, especially if they demonstrate superior efficacy or safety.

Q4: What are the main challenges facing Temodar’s market growth?
A4: Key challenges include generic competition, toxicity limitations, high treatment costs, and regulatory hurdles for new indications.

Q5: How do global regulatory policies influence Temodar’s market outlook?
A5: Approvals by FDA and EMA bolster confidence and usage, but regional disparities and reimbursement policies can limit access and expansion in certain markets.

---

References

1. GlobalData Oncology Reports (2023)
2. ClinicalTrials.gov (2023)
3. FDA and EMA approval summaries (1999–2023)
4. Market research analyses from IQVIA, EvaluatePharma (2023)
5. Published clinical trial results and peer-reviewed journals (2022–2023)