DACOGEN
LOE ApproachingNDAINTRAVENOUSINJECTABLE
Approved
May 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DACOGEN is an intravenous injectable approved in 2006 by Otsuka for hematologic malignancies. The mechanism of action and specific indications are not specified in available data, limiting clinical context. As an NDA product with an approaching loss of exclusivity, it represents a mature asset in its commercial lifecycle.
LOE Approaching
Product faces approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team restructuring and emphasis on existing market defense rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Started Aug 2015
326 enrolled
Leukemia, Myeloid, Acute
A Study of Decitabine (DACOGEN) in Sequential Administration With Cytarabine in Children With Relapsed or Refractory Acute Myeloid Leukemia
Started Oct 2013
17 enrolled
Acute Myeloid Leukemia
An Open-Label, Phase I/II Study of Two Different Schedules of Dasatinib (Sprycel) and Decitabine (Dacogen) Used in Combination for Patients With Accelerated or Blastic Phase Chronic Myelogenous Leukemia (Protocol CA180357)
Started Jun 2012
32 enrolled
Leukemia
An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome
Started Dec 2010
156 enrolled
Myelodysplastic Syndromes
A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
Started Dec 2008
103 enrolled
Myelodysplastic Syndrome
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.