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Research Report
Aldesleukin (Proleukin): A Comprehensive Monograph on a Foundational High-Dose Cytokine Immunotherapy
Executive Summary
Aldesleukin, a recombinant form of interleukin-2, represents a paradigm of high-risk, high-reward immunotherapy. As a potent cytokine, it non-specifically activates a broad and powerful anti-tumor immune response, leading to durable, complete remissions in a small but significant subset of patients with metastatic melanoma and renal cell carcinoma. This efficacy, however, is inextricably linked to a profile of severe, life-threatening toxicities, most notably Capillary Leak Syndrome, which necessitates administration in a specialized inpatient setting with intensive care support. This monograph provides an exhaustive analysis of Aldesleukin's complex pharmacology, its established and emerging clinical roles, the rigorous demands of its administration and safety management, and its regulatory history. It positions Aldesleukin not as an obsolete agent in the era of targeted therapies and checkpoint inhibitors, but as a formidable, albeit niche, therapeutic option whose unique mechanism continues to offer the potential for a cure in select patients.
Section 1: Introduction to Aldesleukin – A Recombinant Cytokine
1.1. Overview and Classification
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/10 | Phase 1 | Completed | |||
2023/09/29 | Phase 3 | Completed | |||
2023/05/12 | Phase 1 | Completed | |||
2021/11/16 | Phase 2 | Active, not recruiting | |||
2021/06/09 | Phase 1 | Completed | |||
2021/01/14 | Phase 1 | Completed | |||
2020/11/12 | Phase 1 | Completed | |||
2020/05/06 | Phase 1 | Completed | |||
2018/12/28 | Phase 3 | Completed | |||
2018/01/10 | Phase 1 | Completed |
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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