ONTAK (denileukin diftitox) · EISAI INC
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-02-05
- Patent Cliff
- 2006
- Routes
- N/A
- Dosage Forms
- VIAL
ONTAK Approval History
What ONTAK Treats
2 FDA approvalsOriginally approved for its first indication in 1999 . Covers 2 distinct patient populations.
- Other (2)
ONTAK Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
EISAI INC's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00945269 | 2271.00 NCI-2010-00738, K12CA076930 | Ph 1, Ph 2 | terminated | Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma |
| NCT01127451 results posted | E7272-701 | Ph 2 | completed | Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma |
| NCT00632827 results posted | 072518 NCI-2011-01285 | Ph 2 | terminated | Treatment of PTCL With Aggressive Induction Therapy Followed by Autologous SCT Using Denileukin Diftitox (Ontak) |
| NCT01106950 results posted | 2010LS010 MT2010-02, 1003M79954 | Ph 2 | terminated | Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML) |
| NCT00460109 results posted | NCCTG-N0682 NCI-2009-00662, CDR0000539551 | Ph 2 | completed | Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma |
| NCT00726037 results posted | 200732 | Ph 2 | terminated | A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer |
| NCT00801918 | AAAC8963 | Ph 2 | withdrawn | Denileukine Diftitox for Relapsed ALCL |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ONTAK FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment