Drug · Small Molecule
Histamine
CI-DRUG-00000788Explore in graph →CHEMBL90 Approved
Regulatory
Approvals (1)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
emaProvenance
- Source
- EMA — European public assessment reports (centrally authorised medicines)
- Dataset
- EMA medicines data (xlsx)
- Version
- ema-medicines-2026-09-11T06:00
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- EMA copyright — reproduction and distribution permitted for non-commercial and commercial purposes provided EMA is acknowledged as the source (https://www.ema.europa.eu/en/about-us/legal-notice)
- Run
- ING-EMA-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| EU EMA | Acute Myeloid Leukemia | Ceplene maintenance therapy is indicated for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2 (IL-2). The efficacy of Ceplene has not been fully demonstrated in patients older than age 60. | approved | Oct 7, 2008 | ema |
Data updated 5 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 1 | 0 | 2 | 4 | 1 | EU | Oct 7, 2008 | 1998-07 |
| Leukemia | Approved | Phase 3 | 0 | 0 | 1 | 1 | 1 | EU | Oct 7, 2008 | 1998-07 |
| Malignant Pancreatic Neoplasm | Phase2 | Phase 2 | 1 | 0 | 0 | 1 | 0 | — | — | Apr 1, 2024 |
| Malignant Kidney Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 1 | 0 | — |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
No curated evidence item mentions this therapy yet.
Clinical trials
Trials with this intervention (4)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT05810792 | Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer(PANCEP-1) | not yet recruiting | Phase 2 | 50 | Sahlgrenska University HospitalOTHER | 0 | Nov 22, 2023 | clinicaltrials |
| NCT00039234 | Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver |