Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

decitabine

DACOGEN

decitabine (DACOGEN) is a dna (cytosine-5)-methyltransferase 1 inhibitor. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved EMA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01BC08
US status approved
Patents linked 16
Pipeline programs 26
News articles 0
Drug details — decitabine
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INTRAVENOUS
Patents
16
Programs
26
Data quality
0.84
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Quick answer

decitabine (DACOGEN) is a dna (cytosine-5)-methyltransferase 1 inhibitor. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN decitabine
Brand DACOGEN
Mechanism DNA (cytosine-5)-methyltransferase 1 inhibitor
Target DNA (cytosine-5)-methyltransferase 1
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INTRAVENOUS
Formulation INJECTABLE
ATC code L01BC08

Mechanism of action

DNA (cytosine-5)-methyltransferase 1 inhibitor

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

Approval history

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

Pipeline programs

Search pipeline
  1. DAC-HAAG-02 Phase 3 · Hospital Authority · Acute Myeloid Leukemia
  2. Decitabine Phase 3 · Chinese Academy of · Myelodysplastic Syndrome
  3. Decitabine Phase 3 · First People's Hospital · Acute Myeloid Leukemia
  4. Decitabine Phase 3 · First People's Hospital · Acute Myeloid Leukemia, Adult
  5. Decitabine Phase 3 · First People's Hospital · Thrombocytopenia
  6. Decitabine plus HAAG regimen Phase 3 · First People's Hospital · Acute Myeloid Leukemia
  7. Experimental: Venetoclax in combination with Decitabine (+-sorafenib) Phase 3 · Kunming Hope of · Elderly AML Patients
  8. IRST204.07 Phase 3 · Istituto Gentili Italia · Acute myeloid leukemia

Related & competitor drugs

Browse all 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. azacitidine Antineoplastic and immunomodulating agents (L01)

Related patents

Browse patents

  1. US 12391686

    Compounds and uses thereof

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

    granted

  2. US 12383555

    Methods of treating cancers

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 12383560

    Compounds and uses thereof

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 12384776

    Compounds and uses thereof

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 12351579

    Compounds and uses thereof

    Expires Mon Jul 03 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 12139487

    Compounds and uses thereof

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

    granted

  7. US 11851445

    Compounds and uses thereof

    Expires Mon Dec 21 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 11793825

    Biomarkers for predicting responsiveness to decitabine therapy

    Expires Mon Oct 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 11787800

    BRD9 degraders and uses thereof

    Expires Mon Oct 12 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 11773085

    Methods and compounds for treating disorders

    Expires Mon Sep 28 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 11767330

    Citrate salt, pharmaceutical compositions, and methods of making and using the same

    Expires Mon Sep 21 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. US 11560381

    Compounds and uses thereof

    Expires Mon Jan 19 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  13. US 11497752

    Compounds and uses thereof

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

    granted

  14. US 11485732

    Compounds and uses thereof

    Expires Mon Oct 27 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  15. US 11414416

    Compounds and uses thereof

    Expires Mon Aug 11 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  16. US 10940160

    Biomarkers for predicting responsiveness to decitabine therapy

    Expires Mon Mar 04 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is decitabine?

decitabine (DACOGEN) is a dna (cytosine-5)-methyltransferase 1 inhibitor. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for decitabine?

DACOGEN is a marketed brand name for decitabine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of decitabine?

decitabine 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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