Denileukin Diftitox

Sold as Ontak. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Denileukin Diftitox (sold as Ontak), first approved Feb 5, 1999, with 1 new use approved and 0 published complete response letters.

First approved: Feb 5, 1999
Applications: 1
New uses approved: 1
Complete response letters: 0
First approved in Japan: Mar 23, 2021

Orphan Designations (FDA)

4 designations, 2 approved for the designated use; see all orphan designations

Treatment of cutaneous T-cell lymphomaCitius Oncology, Inc. · designated Jul 12, 2013 · approved Aug 7, 2024
treatment of peripheral T-cell lymphoma (PTCL)Citius Oncology, Inc. · designated Jun 29, 2011
Treatment of peripheral T-cell lymphomaEisai, Inc. · designated Apr 30, 2010
Treatment of patients with cutaneous T-cell lymphomaEisai, Inc. · designated Aug 21, 1996 · approved Feb 5, 1999

Approvals in Japan (PMDA)

First approved in Japan 266 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Remitoro, new ingredientA drug with a new active ingredient indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma and relapsed or refractory cutaneous… · Eisai Co., Ltd. · Mar 23, 2021

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Phase I Trial of Subcutaneous VDJ010 In Healthy Subjects and Patients With Ulcerative ColitisUlcerative Colitis (UC) · Beijing VDJBio Co., LTD.	Phase 1	Recruiting	Nov 12, 2026
HCW9302 (Interleukin-2 Fusion Protein) for Alopecia AreataAlopecia Areata(AA) · HCW Biologics	Phase 1	Recruiting	Jul 3, 2025
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive LifileucelUnresectable Melanoma, Metastatic Melanoma · Iovance Biotherapeutics, Inc.	Phase 1 / Phase 2	Recruiting	Apr 23, 2025
T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid TumorsEpithelial Ovarian Cancer · Alexander B Olawaiye, MD	Phase 1 / Phase 2	Active, not recruiting	Jan 20, 2022

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Feb 5, 1999	OntakBLA 103767 · New molecular entity	Eisai Inc	5	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA