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histamine dihydrochloride and IL-2
This combination therapy stimulates immune cells through histamine receptor signaling and IL-2-mediated T-cell activation to enhance anti-tumor immunity.
This combination therapy stimulates immune cells through histamine receptor signaling and IL-2-mediated T-cell activation to enhance anti-tumor immunity. Used for Metastatic melanoma, Renal cell carcinoma.
At a glance
| Generic name | histamine dihydrochloride and IL-2 |
|---|---|
| Also known as | Ceplene, Proleukin, IL-2, interleukin-2, histamine |
| Sponsor | Cytovia, Inc. |
| Drug class | Immunomodulator combination |
| Target | Histamine receptors (H1, H2, H3, H4) and IL-2 receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Histamine dihydrochloride acts as an immunomodulator that enhances immune cell function, while IL-2 (interleukin-2) is a cytokine that promotes T-cell proliferation and activation. Together, they work synergistically to boost the body's natural anti-tumor immune response by increasing lymphocyte activity and cytokine production.
Approved indications
- Metastatic melanoma
- Renal cell carcinoma
Common side effects
- Fever
- Chills
- Fatigue
- Nausea
- Hypotension
- Tachycardia
Key clinical trials
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ TILS (PHASE1, PHASE2)
- Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer (PHASE2)
- Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial (PHASE1)
- Maintenance Therapy With Histamine Dihydrochloride and Interleukin-2 in Adult Acute Myeloid Leukemia (AML) Patients With Measurable Minimal Residual Disease (MRD)- a Non-interventional Study (NIS)
- A Study of HDC/IL-2 Treatment in Chronic Myelomonocytic Leukemia (CMML) (PHASE1, PHASE2)
- Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia (PHASE4)
- Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- histamine dihydrochloride and IL-2 CI brief — competitive landscape report
- histamine dihydrochloride and IL-2 updates RSS · CI watch RSS
- Cytovia, Inc. portfolio CI