Wednesday, July 8, 2026

Drug profile · INN

azacitidine

azacitidine (AZACITIDINE ACCORD) is a dna (cytosine-5)-methyltransferase 3a inhibitor. Associated with Lacuna Pharma 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) L01BC07
US status approved
Patents linked 20
Pipeline programs 58
News articles 0
Congress events 2
Drug details — azacitidine
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
20
Programs
58
Data quality
0.89

Quick answer

azacitidine (AZACITIDINE ACCORD) is a dna (cytosine-5)-methyltransferase 3a inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN azacitidine
Brand AZACITIDINE ACCORD
Mechanism DNA (cytosine-5)-methyltransferase 3A inhibitor
Target DNA (cytosine-5)-methyltransferase 1
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation POWDER
ATC code L01BC07

Mechanism of action

DNA (cytosine-5)-methyltransferase 3A inhibitor

Primary target: DNA (cytosine-5)-methyltransferase 1

Approval history

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

Congress & event coverage

  • Presentation
    DIA

    1 presentation · regulatory

  • Presentation
    THMA Pharmacy Growth

    1 presentation · cardiology

Pipeline programs

  1. 09 Phase 3 · First People's Hospital · Acute Myeloid Leukaemia
  2. 2215-CL-0201 Phase 3 · Astellas Pharma · Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in
  3. 75276617AML3001 Phase 3 · Janssen-Cilag International N.V · Acute Myeloid Luekemia
  4. AG120-C-009 Phase 3 · George Institute for · Previously Untreated Acute Myeloid Leukemia with an IDH1 Mut
  5. APG2575AG301 Phase 3 · Anaxis Pharma · Acute myeloid leukemia
  6. APG2575MG301 Phase 3 · Anaxis Pharma · Newly Diagnosed Higher Risk Myelodysplastic Syndrome
  7. APR-246 + azacitidine Phase 3 · Aprea Therapeutics · MDS
  8. ASTX030-01 Phase 3 · Taiho Pharma Canada · Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leuk

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azathioprine Antineoplastic and immunomodulating agents (L04)
  1. US 12428406

    Methods and compounds for restoring mutant p53 function

    Expires Mon Sep 25 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12419880

    Companion diagnostic tool for mutant p53 reactivating compounds

    Expires Mon Sep 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. WO 2025027051

    INHIBITEURS DE SPHINGOSINE-1-PHOSPHATE LYASE DESTINÉS À ÊTRE UTILISÉS DANS LE TRAITEMENT DE MALADIES NEURODÉGÉNÉRATIVES

    Expires Wed Feb 01 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. WO 2024211523

    SCHÉMAS POSOLOGIQUES DESTINÉS À ÊTRE UTILISÉS DANS LA PRÉVENTION DE LA RECHUTE DE LA LEUCÉMIE MYÉLOÏDE AIGUË APRÈS UNE TRANSPLANTATION DE CELLULES SOUCHES HÉMATOPOÏÉTIQUES ALLOGÉNIQUES AVEC DU VÉNÉTOCLAX EN COMBINAISON AVEC DE L'AZACITIDINE

    Expires Wed Oct 05 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. WO 2024175803

    COMPOSÉS POUR LE TRAITEMENT DE MALADIES MYÉLOÏDES AVEC DES ANOMALIES CHROMOSOMIQUES

    Expires Wed Aug 24 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. WO 2024146923

    INHIBITEURS DE POLYMÉRISATION DE TUBULINE

    Expires Wed Jul 06 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11963953

    Deuterated compounds for restoring mutant p53 function

    Expires Mon Apr 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11926632

    Methods and compounds for restoring mutant p53 function

    Expires Mon Mar 07 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11814373

    Methods and compounds for restoring mutant p53 function

    Expires Mon Nov 09 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11807644

    Methods and compounds for restoring mutant p53 function

    Expires Mon Nov 02 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 11731953

    Methods and compounds for restoring mutant p53 function

    Expires Mon Aug 17 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. WO 2022234069

    NOUVEAUX DÉRIVÉS DE 2-AMINOOXAZOLE ET LEUR UTILISATION POUR LE TRAITEMENT DE MALADIES INFECTIEUSES

    Expires Wed Nov 05 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 11339141

    Methods and compounds for restoring mutant p53 function

    Expires Mon May 19 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. EP 3708579

    CLAUDIN-6-SPEZIFISCHE IMMUNREZPTOREN UND T-ZELL-EPITOPE

    Expires Tue Sep 11 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. WO 2020095183

    COMBINAISON POUR LE TRAITEMENT DU CANCER

    Expires Wed May 09 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 10640485

    Methods and compounds for restoring mutant p53 function

    Expires Mon Apr 30 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 10138219

    Methods and compounds for restoring mutant p53 function

    Expires Mon Nov 22 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. EP 3144307

    NEUE OXAZOL DERIVATEN ALS SYK KINASEHEMMER

    Expires Tue Mar 17 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. EP 3027208

    DIAGNOSE UND THERAPIE VON KREBS MIT KREBSSTAMMZELLEN

    Expires Tue Jun 03 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. WO 2016085391

    DÉRIVÉS DE BIS (SULFONAMIDE) ETLEUR UTILISATION COMME INHIBITEURS DE MPGES

    Expires Wed May 28 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is azacitidine?

azacitidine (AZACITIDINE ACCORD) is a dna (cytosine-5)-methyltransferase 3a inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for azacitidine?

AZACITIDINE ACCORD is a marketed brand name for azacitidine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of azacitidine?

azacitidine 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.