Drug intelligence / Profile preview

Ceplene + aldesleukin

Development stage
Phase 3
Lead developer
Viatris
Modality
Cytokines & Interferons → Recombinant Proteins and Enzymes, Small Molecules
Administration
Subcutaneous
01

Overview

Ceplene + aldesleukin is a fixed combination therapy used as maintenance treatment in adults with acute myeloid leukaemia (AML) who are in remission after consolidation therapy. Ceplene contains histamine dihydrochloride, an immune modulator that inhibits NADPH oxidase-mediated production of reactive oxygen species (ROS) by phagocytes. By reducing ROS, Ceplene protects IL-2–activated natural killer (NK) cells and T cells from oxidative stress-induced dysfunction and apoptosis. Aldesleukin is recombinant human interleukin-2 (IL-2), a cytokine that stimulates the proliferation and activation of lymphocytes including NK cells and cytotoxic T lymphocytes. The combination aims to optimize anti-leukaemic immune responses by enhancing the activity of IL-2 while preventing ROS-mediated suppression of effector lymphocytes[1][2][6]. This regimen is specifically indicated for prolonging remission in AML patients; it has not shown benefit for patients in second or later remissions[2]. The most common side effects include flushing, headache, fatigue, fever, and injection site reactions[1][2].

Brand names
Ceplene + Proleukin
Other names
histamine dihydrochloride + aldesleukinhistamine dihydrochloride + interleukin-2Ceplene + interleukin-2
02

Targets

IL-2R (Interleukin-2/interleukin-15 receptor complex)NOX4 (NADPH oxidase 4)

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