Drug Profile

Denileukin diftitox - Citius Oncology/Eisai

Alternative Names: DAB389IL-2; DAB₃₈₉ interleukin-2; E7272; E7777; I/ONTAK; Interleukin-2 fusion toxin; LY 335348; LYMPHIR; ONTAK; Remitoro

Latest Information Update: 29 Oct 2025

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At a glance

Originator Ajinomoto; Japanese Foundation for Cancer Research
Developer Citius Oncology; Eisai Co Ltd
Class ADP ribose transferases; Anti-inflammatories; Antineoplastics; Antipsoriatics; Antiretrovirals; Antirheumatics; Bacterial toxins; Interleukins; Recombinant fusion proteins; Skin disorder therapies
Mechanism of Action Protein synthesis inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Peripheral T-cell lymphoma; Cutaneous T-cell lymphoma
New Molecular Entity Yes

Marketed Cutaneous T-cell lymphoma; Peripheral T-cell lymphoma
Phase II Malignant melanoma
Phase I/II Diffuse large B cell lymphoma
Discontinued Alopecia; Atopic dermatitis; HIV infections; Inflammatory bowel diseases; Multiple sclerosis; Psoriasis; Rheumatoid arthritis; Transplant rejection

20 Oct 2025 Citius Oncology enters into a distribution services agreement with McKesson Corporation in USA
20 Oct 2025 Citius Pharmaceuticals plans to launch denileukin diftitox for Cutaneous T-cell lymphoma in USA, in the fourth quarter of 2025
07 Oct 2025 Citius Oncology enters into distribution agreement with Integris Pharma for Denileukin diftitox in Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia

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