NDAORALCAPSULEPriority Review
Approved
Aug 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
TEMODAR (temozolomide) by Merck & Co. is alkylating activity [moa]. First approved in 1999.
Drug data last refreshed 3d ago
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Started Apr 2026
132 enrolled
Relapsed/Refractory Primary Central Nervous System Lymphoma
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Started Apr 2026
162 enrolled
Glioblastoma (GBM)Newly Diagnosed GlioblastomaGBM+4 more
Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma
Started Jan 2026
103 enrolled
GlioblastomaGBM
Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma
Started Dec 2025
190 enrolled
GlioblastomaBrain CancerGlioblastoma Multiforme+4 more
Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
Started Nov 2025
70 enrolled
GliomaCNS Tumor, AdultCNS Tumor, Childhood
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.