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Denileukin diftitox

Generic Name
Denileukin diftitox
Drug Type
Biotech
CAS Number
173146-27-5
Unique Ingredient Identifier
25E79B5CTM

Overview

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). It is produced in an E. coli expression system.

Background

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). It is produced in an E. coli expression system.

Indication

For treatment of cutaneous T-cell lymphoma

Associated Conditions

  • Cutaneous T-Cell Lymphoma (CTCL)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
T-regulatory Cell Depletion with E7777 Combined with Pembrolizumab in Recurrent or Metastatic Solid Tumors
2022/01/20
NCT05200559
Phase 1
Recruiting
Alexander B Olawaiye, MD
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
2021/11/30
NCT05137847
N/A
Completed
Eisai Inc.
Study of E7777 Prior to Kymriah for R/R DLBCL
2021/04/22
NCT04855253
Phase 1
Recruiting
Masonic Cancer Center, University of Minnesota
Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma
2016/02/08
NCT02676778
Phase 2
Completed
Eisai Co., Ltd.
A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer
2013/01/23
NCT01773889
Phase 2
Terminated
The University of Texas Health Science Center at San Antonio
Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)
2011/09/13
NCT01432483
N/A
NO_LONGER_AVAILABLE
Eisai Inc.
A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma
2011/05/18
NCT01355783
Phase 3
Withdrawn
Eisai Inc.
Dose Escalation Trial of Denileukin Diftitox (Ontak) Post Autologous Transplantation
2010/12/02
NCT01251952
Phase 1
Terminated
Barbara Ann Karmanos Cancer Institute
Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma
2010/05/20
NCT01127451
Phase 2
Completed
Eisai Inc.
Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)
2010/04/20
NCT01106950
Phase 2
Terminated
Masonic Cancer Center, University of Minnesota

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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