denileukin diftitox

Trade name: ontak

Recombinant proteinapprovedOrphan Drug ^FDA

Approved

Feb 5, 1999

Denileukin diftitox, sold under the brand name Ontak among others, is an anti-cancer medication used for the treatment of adults with T-cell lymphoma. It is an IL2-receptor-directed cytotoxin. It is an engineered protein combining interleukin-2 and diphtheria toxin. — Wikipedia

Clinical trial activity

39 trials · 34 clinical orgs · 3 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jun 1, 1995 (NCT00050999)

Timeline

1990s

Aug 21, 1996
Orphan Drug Designation
Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
Feb 5, 1999
Seragen — Earliest FDA Approval
Feb 5, 1999
Eisai — Marketing Organization
Feb 5, 1999
Seragen — NDA Organization
Feb 5, 1999
Eisai — NDA Secondary Org

2000s

Jan 1, 2002
Earliest Phase 1 Sponsor(trial)

2020s

Aug 7, 2024
Citius Pharmaceuticals — Marketing Organization

Indications

Approved for

Lymphoma, T-Cell, Cutaneous

Studied for

Mechanism of action

Interleukin-21BINDING AGENT
IL21 binding agent
- Interleukin-21 (IL21) ↗
Interleukin-2 receptorBINDING AGENT
Interleukin-2 receptor binding agent
targets toxin to cell
Binding site involves alpha and beta subunits
Elongation factor 2INHIBITOR
EEF2 inhibitor
- Elongation factor 2 (EEF2) ↗

Approval history

approvedAcceleratedFeb 5, 1999

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Multi-specific: No
Payload: diphtheria toxin

Oral

Parenteral

Yes

Topical

Black box warning

Sources

Also known as

dab(389)-il-2
dab(389)il-2
dab389 il2
dab389-il-2
dab(389)-interleukin 2
denileukin diftitox
denileukin diftitox
denileukin diftitox
denileukin diftitox
denileukin diftitox
denileukin diftitox
denileukin diftitox
denileukin diftitox
denileukin diftitox
diphtheria toxin precursor
dt
dt
ly-335348
nad(+--diphthamide adp- ribosyltransferase)
ontak
ontak
ontak
ontak
ontak

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT01432483	N/A	Sep 7, 2011	Eisai
NCT01401530	Phase 1	Jul 1, 2011	Eisai
NCT01251952	Phase 1	Nov 1, 2010	Eisai, Wayne State University
NCT01106950	Phase 2	Jul 1, 2010	University of Minnesota
NCT01127451	Phase 2	Jun 1, 2010	Eisai, IQVIA, PharmaBio Development Inc.
NCT00945269	Phase 1/Phase 2 (Phase 2)	Jul 1, 2009	National Cancer Institute (NCI), University of Washington
NCT01773889	Phase 2	Jun 1, 2009	University of Texas, San Antonio
NCT00801918	Phase 2	Dec 1, 2008	Columbia University
NCT00726037	Phase 2	Oct 1, 2008	Eisai, Loyola University, Riveria Country Club Organization
NCT00703105	Phase 2	Oct 1, 2008	Loyola University
NCT00460109	Phase 2	Apr 1, 2008	Mayo Clinic, National Cancer Institute (NCI)
NCT00515528	Phase 2	Apr 1, 2007	Eisai, University of Chicago
NCT00880360	Phase 2	Feb 1, 2007	University of Texas, San Antonio
NCT00513188	N/A	Feb 1, 2007	University of Miami
NCT00299689	Phase 2	Mar 1, 2006	James Graham Brown Cancer Center, University of Louisville
NCT00337987	Phase 2	Nov 1, 2005	Eisai, Yale University
NCT00224354	Phase 1	Sep 1, 2005	Baylor University, Methodist Cancer Center, Houston, Texas
NCT00224874	Phase 2	Sep 1, 2005	Blood and Marrow Transplant Clinical Trials Network, Center for International Blood and Marrow Transplant Research, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
NCT00128622	Phase 1	Sep 1, 2005	Duke University, National Cancer Institute (NCI)
NCT00425672	Phase 1/Phase 2 (Phase 2)	Sep 1, 2005	National Cancer Institute (NCI), University of Washington

Showing 20 of 39 trials

Page 1 / 2

Organizations

Research & Development (34)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Eisai	For profit	14	10	4	1995
National Cancer Institute (NCI)	Government	14	3	3	1999
Ligand Pharmaceuticals	For profit	6	1	2	1995
University of Washington	Academic/Hospital	4	4	2	2003
Yale University	Academic/Hospital	3	1	2	2001
Loyola University	Academic/Hospital	2	2	1	2008
National Institutes of Health (NIH)	Government	2	0	1	2004
Northwestern University	Academic/Hospital	2	1	2	1999
University of Texas, San Antonio	Academic/Hospital	2	2	1	2007
Baylor University	Academic/Hospital	1	1	1	2005
Blood and Marrow Transplant Clinical Trials Network	Academic/Hospital	1	0	1	2005
Center for International Blood and Marrow Transplant Research	Government	1	0	1	2005
Columbia University	Academic/Hospital	1	1	1	2008
Duke University	Academic/Hospital	1	1	1	2005
Eastern Cooperative Oncology Group	Academic/Hospital	1	1	1	1999
IQVIA	For profit	1	0	1	2010
James Graham Brown Cancer Center	Academic/Hospital	1	1	1	2006
Mayo Clinic	Academic/Hospital	1	0	1	2008
Methodist Cancer Center, Houston, Texas	Academic/Hospital	1	0	1	2005
National Heart, Lung, and Blood Institute (NHLBI)	Government	1	1	1	2005

34 organizations

Page 1 / 2

Marketing (4)

Organization	Org type	Relationship	Date
Citius Pharmaceuticals	For profit	MKTG	Aug 7, 2024
Eisai	For profit	MKTG	Feb 5, 1999
Eisai	For profit	NDA2	Feb 5, 1999
Seragen	For profit	NDA	Feb 5, 1999