NDAINTRAVENOUSPOWDER
Approved
Feb 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
TEMODAR (temozolomide) by Merck & Co. is alkylating activity [moa]. Approved for alkylating drug [epc]. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TEMODAR (temozolomide) is an intravenous alkylating agent chemotherapy drug approved by the FDA in 2009 for treating certain cancers. It works by alkylating DNA, causing strand breaks and cell death in rapidly dividing malignant cells. The drug is administered as an intravenous powder formulation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team restructuring and shift toward lifecycle extension or pipeline support roles.
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)
Testing Addition of an Anti-cancer Drug, Vorasidenib to Temozolomide, After Radiation for Advanced Brain Cancer
Started Jul 2026
408 enrolled
Astrocytoma, IDH-Mutant, Grade 3
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Started Jun 2026
132 enrolled
Relapsed/Refractory Primary Central Nervous System Lymphoma
Testing the Addition of an Anti-Cancer Drug, Mycophenolate Mofetil, to the Usual Treatment (Radiation Therapy and Temozolomide) for Advanced Brain Cancer
Started Jun 2026
422 enrolled
Advanced Glioblastoma
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Started May 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
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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.