Denileukin diftitox is under clinical development by Citius Pharmaceuticals and currently in Pre-Registration for Sezary Syndrome. According to GlobalData, Pre-Registration drugs for Sezary Syndrome have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Denileukin diftitox’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Denileukin diftitox overview

Denileukin diftitox (Ontak, Remitoro) is a recombinant DNA-derived cytotoxic protein, composed of the amino acid sequences for diphtheria toxin fragments A and B (Met 1-Thr 387)-His followed by the sequences for interleukin-2 (IL-2; Ala 1-Thr 133), produced in an E. coli expression system, acts as anti-neoplastic agent. It is formulated as solution and powder for solution for intravenous and intravenous drip route of administration. Ontak is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. Remitoro is indicated for the treatment of relapsed or refractory Peripheral T-cell Lymphoma (PTCL) and relapsed or refractory Cutaneous T-cell Lymphoma (CTCL).

Ontak (denileukin diftitox, E7272, E7777) is under development for the treatment of peripheral and cutaneous T-cell lymphoma including mycosis fungoides [MF] or Sezary Syndrome, solid tumors including cutaneous melanoma, non-small cell lung cancer, renal cell carcinoma, endometrial cancer and epithelial ovarian cancer. The drug candidate was also under development for the treatment of metastatic malignant melanoma, B-cell chronic lymphocytic leukemia (CLL), pancreatic cancer, post autologous transplantation, B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, small lymphocytic lymphoma and transformed B-cell lymphoma.

Citius Pharmaceuticals overview

Citius Pharmaceuticals (Citius) is a specialty pharmaceutical company that focuses on the development and commercialization of anti-infective products in adjunct cancer care and critical care drug products. The company’s proprietary product candidates include Mino-Lok, an antibiotic lock solution intended for the treatment of patients with catheter-related bloodstream infections and Hydro-Lido, a topical formulation of hydrocortisone and lidocaine intended to provide anti-inflammatory and anesthetic relief to patients suffering from Grade I and II hemorrhoids. Citius is headquartered in Cranford, New Jersey, the US

For a complete picture of Denileukin diftitox’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.