Last update 31 May 2025

Denileukin Diftitox

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
DAB389 interleukin-2, Denileukin, Denileukin difitox (genetical recombination) (JAN)
+ [19]
Target
Action
agonists
Mechanism
IL2RA agonists(Interleukin-2 receptor alpha chain agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (05 Feb 1999),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Cutaneous T-cell lymphoma refractory
United States
07 Aug 2024
Recurrent cutaneous T-cell lymphoma
United States
07 Aug 2024
Peripheral T-Cell Lymphoma
Japan
23 Mar 2021
Cutaneous T-Cell Lymphoma
United States
05 Feb 1999
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Pancreatic CancerPhase 2
United States
01 Oct 2008
Metastatic melanomaPhase 2
United States
23 Apr 2007
B-cell lymphoma refractoryPhase 2
United States
01 Mar 2005
Chronic Lymphocytic LeukemiaPhase 2
United States
01 Mar 2003
Chronic Lymphocytic LeukemiaPhase 2
Argentina
01 Mar 2003
Chronic Lymphocytic LeukemiaPhase 2
Australia
01 Mar 2003
Chronic Lymphocytic LeukemiaPhase 2
Brazil
01 Mar 2003
Chronic Lymphocytic LeukemiaPhase 2
Canada
01 Mar 2003
Indolent B-Cell Non-Hodgkin LymphomaPhase 2
United States
01 May 2000
Low Grade B-Cell Non-Hodgkin's LymphomaPhase 2
United States
01 May 2000
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
69
Denileukin Diftitox-Cxdl 9 µg/kg/d
hzbwipdqhb(tmevgafiqd) = fdfzzufiua wtahzqboza (hvreardxen, 25.0 - 48.7)
Positive
01 Apr 2025
Phase 3
112
(Lead-In Part: E7777 6 mcg/kg)
djatbfpovk = xqqfkpmywn rzzllvkwgl (dyfujupfxe, pbtaairtvn - hmxiqdhuoo)
-
13 Nov 2024
(Lead-In Part: E7777 9 mcg/kg)
djatbfpovk = chigwihrxe rzzllvkwgl (dyfujupfxe, ydcjkkrero - knzzhryzas)
Phase 1
16
bltlgwdimr(nzuafadvvd) = no DLTs were noted in DL 1 (3 mcg/kg) n=3, DL2 (6 mcg/kg) n=2, and DL3 (9 mcg/kg) n=2. One patient experienced a DLT at in DL4 (12 mcg/kg) n=9 and she was able to safely continue treatment. vyhjnjfoqd (wtqlbjsawj )
Positive
05 Nov 2024
Phase 2
69
LYMPHIR 9 mcg/kg/day
ukmltnbgwg(agnqjgscph) = dgaqbhtgpw pmtmcxbxis (wgsbgovjnw, 25 - 49)
Positive
07 Aug 2024
Phase 3
112
qhcasbgnsm(fjhjsoabuk) = dyrlxshhna behoesimsc (uupkrdfrhl, 25.0 - 48.7)
Positive
15 Nov 2022
Phase 2
75
(Denileukin Diftitox on Days 1 to 4)
dlorykmbvz = ydatzgtunu rygfphvlzm (uoedpdcjtd, fgsxyrpgfm - zlgtlfccea)
-
13 Apr 2022
(Denileukin Diftitox on Days 1, 8, and 15)
dlorykmbvz = ijbyxqtgjg rygfphvlzm (uoedpdcjtd, arvlruebux - zzicfigrxt)
Phase 3
71
(Independent (IRC) Stage I-III)
hsjqwpdxhh(oaohconoon) = fsfsalmyqj rshwoktici (omfzzjipdd, 25.0 - 48.7)
Positive
06 Apr 2022
(Investigator Stage I-III)
hsjqwpdxhh(oaohconoon) = yznunbwmoo rshwoktici (omfzzjipdd, 30.6 - 54.6)
Phase 2
45
E7777+PTCL
(PTCL: E7777 9 mcg/kg/Day)
cyohywbint = iejlicqmvx fadtcgxdrd (lwbpgyqtfl, zbkgqgyxci - gsdjaybyyl)
-
15 Jul 2021
(CTCL: E7777 9 mcg/kg/Day)
cyohywbint = mssfzzfbeg fadtcgxdrd (lwbpgyqtfl, llatrkpesw - fffqxrpxfb)
Phase 2
17
pelugjkqfa = upwpqqyqxy gghlcazeif (lzchodebuh, qaaeoikecw - zvtwovhupq)
-
29 Oct 2020
(Vaccine Plus Ontak)
pelugjkqfa = ozfpfgrjjx gghlcazeif (lzchodebuh, vqecuxxnfe - ybaewrwmju)
Phase 2
21
gvyveoequd = hlkuweqtdt felfvvxwba (rsisbogdgk, rxtlesubtz - olhikcmgzz)
-
27 Apr 2020
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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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