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Drug

Aldesleukin

Established medicine
ClassInterleukin-2 receptor agonistResearchOngoing clinical research
Also known as 125-L-Serine-2-133-interleukin 2, 125-L-serine-2-133-interleukin 2 (human reduced), Interleukin-2 aldesleukin, Interleukin-2(2-133),125-ser+5 more

125-L-Serine-2-133-interleukin 2, 125-L-serine-2-133-interleukin 2 (human reduced), Interleukin-2 aldesleukin, Interleukin-2(2-133),125-ser, Proleukin, rhIL-2, Aldesleukina, Recombinant human interleukin-2, Recombinant interleukin-2 human.

RxNorm70223ChEMBLCHEMBL1201438ATCL03AC01UNIIM89N0Q7EQR
1
Research papers
21
Active clinical trials
3
Protein targets
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers

Clinical trial2026-09-01Primary completion · ClinicalTrials.gov

Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma

Clinical trial2026-08-31Results expected Q3 2031 · ClinicalTrials.gov

A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab

Clinical trial2026-08-24Results expected Q4 2028 · ClinicalTrials.gov

A Phase I Study of Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Other Hematologic Malignancies

Clinical trial2026-08-17Results expected Q2 2029 · ClinicalTrials.gov

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer

Clinical trial2026-08-14Results expected Q1 2029 · ClinicalTrials.gov

Phase I/II Study of High Dose Interleukin 2, Aldesleukin, in Combination With the Histone Deacetylase Inhibitor Entinostat in Patients With Metastatic Renal Cell Carcinoma

Clinical trial2026-08-13Results posted · ClinicalTrials.gov

Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD

Clinical trial2026-07-22Status changed to Active, not recruiting · ClinicalTrials.gov

A Modular, Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Efficacy of AZD4045, an Allogeneic Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma

Clinical trial2026-07-02Results expected Q4 2029 · ClinicalTrials.gov

A Phase 2 Study to Evaluate the Efficacy and Safety of Adoptive Transfer of Autologous Tumor Infiltrating Lymphocytes in Patients With Unresectable, Recurrent, or Metastatic Gastrointestinal Stromal Tumors

Clinical trial2026-06-15Results expected Q4 2027 · ClinicalTrials.gov

A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers

Clinical trial2026-06-12Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers

Clinical trial2026-06-12Results expected Q1 2027 · ClinicalTrials.gov

Clinical and immunologic effects of intranodal autologous tumor lysate-dendritic cell vaccine with Aldesleukin (Interleukin 2) and IFN-{alpha}2a therapy in metastatic renal cell carcinoma patients.

Research2009-07-21Clinical cancer research : an official journal of the American Association for Cancer Research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Aldesleukin
Aliases & brands
125-L-Serine-2-133-interleukin 2125-L-serine-2-133-interleukin 2 (human reduced)Interleukin-2 aldesleukinInterleukin-2(2-133),125-serProleukinrhIL-2AldesleukinaRecombinant human interleukin-2Recombinant interleukin-2 human
RxNorm CUI
70223
ChEMBL ID
CHEMBL1201438
ATC codes
L03AC01
UNII
M89N0Q7EQR
Primary mechanism
Interleukin-2 receptor agonist

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-2 receptor subunit alpha
IL2RA · P01589
AGONISTInterleukin-2 receptor agonist
Cytokine receptor common subunit gamma
IL2RG · P31785
AGONISTInterleukin-2 receptor agonist
Interleukin-2 receptor subunit beta
IL2RB · P14784
AGONISTInterleukin-2 receptor agonist

Clinical trials

200 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
200
registered trials across all phases
LATEST COMPLETION 2026
21
Active studies
15
Recruiting
26
Late-stage (III+)
116
Completed
63
Discontinued
PHASE DISTRIBUTIONn = 200
Early Phase 12Phase 158Phase 1 / 234Phase 280Phase 2 / 33Phase 316Phase 41Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies

CompletedPH IVNovartis Pharmaceuticalsn=262010

High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)

RecruitingPH IIIKey trialSt. Anna Kinderkrebsforschungn=3,3002026

Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

CompletedPH IIIKey trialNational Cancer Institute (NCI)n=1,4492025

Short-term Efficacy of Low-dose Interleukin-2 Treatment in Chrornic Spontaneous Urticaria: a Randomized, Controlled, Single-center Clinical Trial

Unknown statusPH II/IIISecond Xiangya Hospital of Central South Universityn=562022

Prospective-randomized Adaptive Study, With Active Control to Evaluate the Efficacy and Safety of Interleukin (IL)-17 Inhibitor Treatment Versus Low Doses of IL-2 Versus Indirect IL-6 Inhibitor in Hospitalized Patients With Severe Forms of COVID-19

CompletedPH IIIUniversity of Sao Paulon=602021

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I/II Trial in Patients With Metastatic Gastrointestinal Epithelial Cancer Administering Tumor-Infiltrating Lymphocytes in Which the Gene Encoding CISH Was Inactivated Using the CRISPR/Cas9 System

CompletedPH I/IIIntima Bioscience, Inc.n=232026

Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

CompletedPH IIIKey trialNational Cancer Institute (NCI)n=1,4492025

Autologous Bone Marrow Transplantation for Non-M3 Acute Myeloid Leukemia (AML) in First Remission in Patients </=60 Years of Age Using Busulfan/Fractionated Total Body Irradiation (FTBI) and VP16 as the Preparative Regimen

CompletedPH IICity of Hope Medical Centern=602025

Phase II Study of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cells and Anti-CTLA4 for Patients With Metastatic Melanoma

CompletedPH IIM.D. Anderson Cancer Centern=162024

Phase I/Ib Study of Adoptive Cellular Therapy Using Autologous IL-21-Primed CD8+ Tumor Antigen-Specific T Cells in Combination With Utomilumab (PF-05082566) in Patients With Platinum Resistant Ovarian Cancer

CompletedPH I/IIM.D. Anderson Cancer Centern=52023

Multi-center, Open Label, Phase Ib Clinical Trial to Evaluate Safety, Tolerance and Efficacy of TASO(TGF-β2 Targeting Anti-sense Oligonucleotide)-001 in Combination With Recombinant Interleukin-2 in Advanced or Metastatic Solid Tumor

CompletedPH IAutotelicbion=92023

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
Leading researchers
  • Barth RJ Jr1
  • Cole BF1
  • Crocenzi TS1
  • Crosby NA1
  • Ernstoff MS1
  • Fisher JL1
  • Foster C1
  • Harris RD1
Leading institutions
free-text, unnormalised
  • Dartmouth-Hitchcock Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials