Dacogen (decitabine)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Decitabine wherever you encounter it, plus the key facts at a glance.
- Generic name
- Decitabine
- Brand name
- Dacogen
- Development code
- 5-aza-2'-deoxycytidine
- Drug class
- Hypomethylating agent (nucleoside metabolic inhibitor)
- Manufacturer
- Generic manufacturers (Dacogen brand, Otsuka, discontinued)
- How it's taken
- IV infusion, 5 days of each 28-day cycle
An IV infusion given on 5 days of each 28-day cycle, used with Venclexta as an alternative to azacitidine in older or unfit adults with AML. Its own label covers myelodysplastic syndromes, not AML, so the AML use is off label for decitabine itself; the Venclexta label names it as an approved partner. The brand Dacogen is discontinued and only generics are sold.
We'll email you when new trials for Acute Myeloid Leukemia open and when the FDA acts on a treatment for it. Unsubscribe anytime.
You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Acute Myeloid Leukemia. Turn any of these off from the link in every email.
Where Decitabine fits
An alternative to azacitidine as the hypomethylating partner for venetoclax; the oral combination Inqovi (decitabine with cedazuridine) was approved for the same AML use with venetoclax in May 2026.
How Decitabine works
Decitabine is incorporated into DNA during cell division and locks up DNA methyltransferase, so the methyl tags that keep tumor suppressor genes silent are lost over successive divisions and the genes come back on[1].
Mechanism: Hypomethylating agent: a deoxycytidine analog that blocks DNA methyltransferase
Side effects and safety
The decitabine label has no boxed warning. It warns of myelosuppression (neutropenia, thrombocytopenia and anemia, with counts checked before each cycle and cycles delayed until recovery) and harm to an unborn baby[1]. The most common side effects in its MDS trials were neutropenia, thrombocytopenia, anemia, fatigue, fever, nausea, cough, petechiae, constipation, diarrhea and high blood sugar[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Decitabine
In the Venclexta regimen decitabine is given at 20 mg/m2 by IV infusion over 1 hour once a day on days 1 to 5 of each 28-day cycle, with Venclexta 400 mg daily[2]. Infusions are given at an infusion center.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Clinical trial results
Venclexta's accelerated approval included a decitabine cohort from the Phase 1b study M14-358, and the Venclexta label lists decitabine as a partner on that basis; the large randomized VIALE-A trial used azacitidine[2]. Decitabine's own approval rests on randomized MDS trials described in its label[1].
Development history
Dacogen was approved on May 2, 2006 for MDS. The brand is listed as discontinued in Drugs@FDA; generic decitabine for injection remains on the market[3].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Decitabine
▸What is Decitabine (Dacogen)?
An IV infusion given on 5 days of each 28-day cycle, used with Venclexta as an alternative to azacitidine in older or unfit adults with AML. Its own label covers myelodysplastic syndromes, not AML, so the AML use is off label for decitabine itself; the Venclexta label names it as an approved partner. The brand Dacogen is discontinued and only generics are sold.
▸How does Decitabine work?
Decitabine is incorporated into DNA during cell division and locks up DNA methyltransferase, so the methyl tags that keep tumor suppressor genes silent are lost over successive divisions and the genes come back on[1].
▸What are the side effects of Decitabine?
The decitabine label has no boxed warning. It warns of myelosuppression (neutropenia, thrombocytopenia and anemia, with counts checked before each cycle and cycles delayed until recovery) and harm to an unborn baby[1]. The most common side effects in its MDS trials were neutropenia, thrombocytopenia, anemia, fatigue, fever, nausea, cough, petechiae, constipation, diarrhea and high blood sugar[1].
▸How is Decitabine taken?
In the Venclexta regimen decitabine is given at 20 mg/m2 by IV infusion over 1 hour once a day on days 1 to 5 of each 28-day cycle, with Venclexta 400 mg daily[2]. Infusions are given at an infusion center.
▸Is Decitabine FDA approved?
Yes, Decitabine (Dacogen) is FDA approved (2006) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- openFDA · 2025-08-05. Decitabine for injection prescribing information (BluePoint Laboratories). https://api.fda.gov/drug/label.json?search=set_id:%2200caa305-fef4-471b-b9c3-4bcf5fe7b244%22
- AbbVie Inc. via openFDA · 2026-05-20. Venclexta (venetoclax tablets) prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%22b118a40d-6b56-cee3-10f6-ded821a97018%22
- FDA. Dacogen approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021790