# Histamine dihydrochloride

Source: https://onco.cc/drugs/histamine-dihydrochloride/  
OnCo record `histamine-dihydrochloride` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Ceplene is a twice-daily injection of histamine given alongside low-dose interleukin-2 as maintenance treatment for adults with acute myeloid leukaemia in first remission, to help immune cells prevent relapse. It is authorised in Europe only.

## Summary

Histamine dihydrochloride was authorised in the EU in October 2008 under exceptional circumstances, with low-dose interleukin-2, as maintenance therapy for adults with acute myeloid leukaemia in first complete remission, on a phase 3 trial of 320 patients in which the combination improved leukaemia-free survival compared with no maintenance; the label notes efficacy is not fully established over age 60 and an FDA application was not approvable in 2000. It is one of the very few approved maintenance immunotherapies in AML, though oral azacitidine (Onureg) and FLT3 inhibitors now fill that space, and it is little used. Flushing, headache, hypotension and injection-site reactions occur with each histamine dose.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-24
- Tags: ema-list
- Brand: Ceplene
- Modality: Immunomodulator (H2 receptor agonist) given with interleukin-2
- Mechanism: Inhibits NADPH oxidase in monocytes and macrophages via H2 receptors, reducing the reactive oxygen species that inactivate NK and T cells and thereby protecting IL-2-activated lymphocytes in the leukaemic microenvironment.
- Approvals: EU 2008: Maintenance with interleukin-2 for adults with AML in first remission (exceptional circumstances)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Histamine_dihydrochloride
- Study 0201 (Blood 2006): https://doi.org/10.1182/blood-2005-10-4073
- EPAR (EMA): https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene

## Connected records

- drugs: [Aldesleukin (high-dose IL-2)](https://onco.cc/drugs/aldesleukin/)
- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- technologies: [Cytokines & engineered cytokines](https://onco.cc/technologies/cytokine-therapy/)
- trials: [Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer](https://onco.cc/trials/nct05810792/), [Study 0201](https://onco.cc/trials/study-0201/)
- key papers: [Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial](https://onco.cc/key-papers/paper-study-0201-blood-2006/)

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