Temozolomide: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Temozolomide appears in the FDA drug-label database. Marketed as temozolomide.
- Drug class
- Alkylating Drug (FDA established pharmacologic class)
- Mechanism of action
- Alkylating Activity (as stated on the FDA label)
- Boxed warning
- The FDA label for Temozolomide carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Temozolomide capsules, USP is an alkylating drug indicated for the treatment of adult patients with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. (1.1) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2) 1.1 Newly Diagnosed Glioblastoma Temozolomide capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1.2 Refractory Anaplastic Astrocytoma Temozolomide capsules, USP is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing — Rising Pharma Holding, Inc. | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2026-03-03 |
| CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. — Deva Holding AS - Cerkezkoy Subesi | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-07-16 |
| CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. — Deva Holding AS - Cerkezkoy Subesi | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-07-16 |
| CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. — Deva Holding AS - Cerkezkoy Subesi | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-07-16 |
| CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. — Deva Holding AS - Cerkezkoy Subesi | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-07-16 |
Phase breakdown
Conditions being studied
Recruiting trials involving Temozolomide
- 5FU/LV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer.
- A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
- Glutamate Inhibitors in Glioblastoma
- Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain
- Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
- Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal Cancer
- SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
- Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer
- Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer
- Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
- Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Common questions
Is Temozolomide FDA-approved?
Yes, marketed as temozolomide. Its FDA label carries a boxed warning.
How many recruiting trials involve Temozolomide?
11 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.