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Denileukin diftitox - Eisai

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Drug Profile

Denileukin diftitox - Eisai

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

Latest Information Update: 23 Jun 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 - Cutaneous T-cell lymphoma; Peripheral T-cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • 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

Most Recent Events

  • 17 Jun 2025 Citius Pharmaceuticals plans to launch denileukin diftitox for Cutaneous T-cell lymphoma (Second-line therapy or greater) in the USA in the H2 of 2025
  • 12 Feb 2025 9435474 - no updates
  • 12 Aug 2024 Citius Pharmaceuticals completes the spin-off of denileukin diftitox into its majority-owned oncology company, Citius Oncology

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