Temozolomide

Alkylating Drug — ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Temozolomide is an ofp drug in the Alkylating Drug class catalogued in DrugCentral. It was first approved by the EMA in 1999. Its mechanism of action is classified as Alkylating Activity. Recorded indications include Astrocytoma, anaplastic, Ewing's sarcoma, Glioblastoma multiforme of brain and Glioma, malignant.

• Approval status: ofp (first approved 1999 by the EMA).
• Drug class: Alkylating Drug.
• Mechanism of action: Alkylating Activity.
• Indications: Astrocytoma, anaplastic, Ewing's sarcoma, Glioblastoma multiforme of brain and Glioma, malignant.
• ATC code: L01AX03 (Other alkylating agents).
• Molecular formula: C6H6N6O2; molecular weight 194.15 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (4)

• Astrocytoma, anaplastic
• Ewing's sarcoma
• Glioblastoma multiforme of brain
• Glioma, malignant

Off-label uses (2)

• Metastatic malignant melanoma
• Pancreatic Neuroendocrine Tumor

Contraindications (13)

• Acute nephropathy
• Anemia
• Aplastic anemia
• Bone marrow depression
• Breastfeeding (mother)
• Hepatic failure
• Lymphocytopenia
• Myelodysplastic syndrome
• Neutropenic disorder
• Pancytopenia
• Pneumocystosis jiroveci pneumonia
• Pregnancy, function
• Thrombocytopenic disorder

Mechanism & targets

• Mechanism of action (MoA): Alkylating Activity
• Established pharmacologic class: Alkylating Drug

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2007-07-26	PMDA	—	Schering-Plough K.K.
1999-08-11	FDA	—	MERCK SHARP DOHME	Yes
1999-01-26	EMA	—	MERCK SHARP & DOHME B.V.

ATC classification

ATC code	Therapeutic hierarchy
L01AX03	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › ALKYLATING AGENTS › Other alkylating agents

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Disease progression	2624.1
Thrombocytopenia	1705.4
Product use in unapproved indication	1370.7
Malignant neoplasm progression	1225.2
Hypermutation	882.2
Tumour pseudoprogression	823.5
Neoplasm progression	657.1
Lymphopenia	654.8
Death	619.2
Neutropenia	555.4
Seizure	531.9
Myelosuppression	482.7

Chemical structure

Full physicochemical, ADMET and 3D-structure analysis of Temozolomide is on its molecule page.

• Molecular formula: C₆H₆N₆O₂
• Molecular weight: 194.15 g/mol
• CAS number: 85622-93-1
• InChIKey: BPEGJWRSRHCHSN-UHFFFAOYSA-N
• PubChem CID: 5394

CN1N=NC2=C(N=CN2C1=O)C(N)=O

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Temozolomide used for?

DrugCentral lists the following indications for Temozolomide: Astrocytoma, anaplastic, Ewing's sarcoma, Glioblastoma multiforme of brain and Glioma, malignant.

How does Temozolomide work?

Temozolomide is classified as Alkylating Activity.

When was Temozolomide first approved?

Temozolomide was first approved by the EMA in 1999.

What drug class does Temozolomide belong to?

Temozolomide is in the Alkylating Drug class.

What is the chemical formula of Temozolomide?

Temozolomide has the molecular formula C6H6N6O2 and a molecular weight of 194.15 g/mol.

Sources

• DrugCentral drug card 2589 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL810 — compound record and bioactivity
• PubChem CID 5394 — chemical identifiers
• DrugBank DB00853 — drug record
• FDA UNII YF1K15M17Y — substance identity
• DailyMed: FDA labels for Temozolomide — current prescribing information (label search)
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.