ONTAK
LOE ApproachingBLAVIALPriority Review
Approved
Feb 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONTAK is a biologic therapeutic approved in 1999 as a denileukin diftitox conjugate for treating cutaneous T-cell lymphoma and other T-cell malignancies. The drug functions as a fusion protein combining diphtheria toxin with interleukin-2, targeting IL-2 receptors on malignant T cells. It represents a pioneering approach in targeted cytotoxic immunotherapy.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30); commercial team likely focused on retention strategies and managed decline.
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 (15)
Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
Started Nov 2010
2 enrolled
Multiple Myeloma
A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer
Started Oct 2008
7 enrolled
Metastatic Pancreatic Cancer
Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak)
Started Jul 2008
21 enrolled
Peripheral T-Cell Lymphoma
Vaccination Plus Ontak in Patients With Metastatic Melanoma
Started Apr 2007
17 enrolled
Melanoma
A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma
Started Nov 2005
49 enrolled
Peripheral T-Cell Lymphoma
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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.