Friday, July 10, 2026
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Drug profile · INN

temozolomide

APO-TEMOZOLOMIDE

temozolomide (APO-TEMOZOLOMIDE) is a dna inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01AX03
US status approved
Patents linked 20
Pipeline programs 41
News articles 0
Drug details — temozolomide
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
20
Programs
41
Data quality
0.89
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Quick answer

temozolomide (APO-TEMOZOLOMIDE) is a dna inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN temozolomide
Brand APO-TEMOZOLOMIDE
Mechanism DNA inhibitor
Target DNA
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01AX03
Originator Alphapharm Pty Ltd

Mechanism of action

DNA inhibitor

Primary target: DNA

Approval history

Authority Status Date
FDA approved —
EMA approved —
TGA approved —
NMPA clinical trials —

Pipeline programs

Search pipeline Sponsor programs
  1. 2019/2894 Phase 3 · George Institute for · Patients with High Risk Neuroblastoma
  2. EF-41/KEYNOTE D58 Phase 3 · Novo Nordisk A/S · Newly diagnosed Glioblastoma
  3. GCO-003 TARLANEC Phase 3 · CERo Therapeutics · Advanced pulmonary or gastroenteropancreatic poorly differen
  4. IFOM-CPT0092022PO008 Phase 3 · Telethon Foundation · Colon cancer
  5. MIN-003-1806 Phase 3 · Anaxis Pharma · Newly diagnosed primary glioblastoma multiforme (ndGBM)
  6. ONO-4059-17 Phase 3 · Anaxis Pharma · Relapsed/refractory primary central nervous system lymphoma
  7. Temozolomide Phase 3 · Adaptive Biotechnologies · Glioblastoma
  8. Temozolomide Phase 3 · GT Biopharma · Glioblastoma

Related & competitor drugs

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  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. acyclovir Human herpesvirus 1 DNA polymerase inhibitor
  3. acyclovir sodium Human herpesvirus 1 DNA polymerase inhibitor
  4. anagrelide Antineoplastic and immunomodulating agents (L01)
  5. apremilast Antineoplastic and immunomodulating agents (L04)
  6. arsenic trioxide Antineoplastic and immunomodulating agents (L01)

Related patents

Browse patents Alphapharm Pty Ltd patent hub

  1. US 12391663

    Isoindolinone compounds

    Expires Mon Aug 14 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 12378199

    Rigidified pentadentate chelating agents useful for the [Al18F]2+ labelling of biomolecules

    Expires Mon Jul 31 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 12263143

    Ionic channel modulation as a method for treating tumors through inflammasome activation

    Expires Mon Mar 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 12070628

    Low energy immune priming for treating cancer and metastasis

    Expires Mon Aug 22 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 12011619

    Low intensity focused ultrasound for treating cancer and metastasis

    Expires Mon Jun 13 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 11912682

    Isoindolinone compounds

    Expires Mon Feb 22 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 11344631

    Promoter for cell-specific gene expression and uses thereof

    Expires Mon May 26 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 11279922

    Delivery of therapeutic agents by a collagen binding protein

    Expires Mon Mar 17 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 11246858

    Immunoresponsive methods of treating tumors

    Expires Mon Feb 10 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 11001820

    Delivery of therapeutic agents by a collagen binding protein

    Expires Mon May 06 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 10974077

    Low intensity focused ultrasound for treating cancer and metastasis

    Expires Mon Apr 08 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. US 10772846

    Methods and compositions for treating and preventing arthritis

    Expires Mon Sep 10 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. US 10519138

    Modulators of SOCE, compositions, and uses thereof

    Expires Mon Dec 26 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  14. US 10213488

    Delivery of therapeutic agents by a collagen binding protein

    Expires Mon Feb 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  15. US 10104882

    Methods and compositions for preventing and treating electrophile-mediated toxicities

    Expires Mon Oct 18 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  16. US 9579273

    Delivery of therapeutic agents by a collagen binding protein

    Expires Mon Feb 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  17. US 9556438

    Gene vector

    Expires Mon Jan 26 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  18. US 9526765

    Delivery of therapeutic agents by a collagen binding protein

    Expires Mon Dec 22 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  19. US 9018251

    Method for treating brain cancer or reducing temozolomide-resistance of brain cancer cells

    Expires Mon Apr 23 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  20. US 8835510

    Methods and compositions for treating conditions mediated by oxidative stress or electrophilic environmental toxins

    Expires Mon Sep 11 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is temozolomide?

temozolomide (APO-TEMOZOLOMIDE) is a dna inhibitor. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for temozolomide?

APO-TEMOZOLOMIDE is a marketed brand name for temozolomide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of temozolomide?

temozolomide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.

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