PROLEUKIN (aldesleukin)
Proleukin (aldesleukin) is a lymphocyte growth factor used in the treatment of advanced malignancies in adult patients. It is specifically indicated for the management of metastatic renal cell carcinoma and metastatic melanoma. The drug serves as a therapeutic intervention to stimulate the immune system's response against these specific types of metastatic cancer.
How PROLEUKIN Works
Aldesleukin functions as an interleukin-2 lymphocyte growth factor that activates cellular immunity and produces multiple dose-dependent immunological effects. It enhances lymphocyte mitogenesis and cytotoxicity while inducing the activity of natural killer and lymphokine-activated killer cells. Additionally, the drug stimulates the production of various cytokines, including interferon gamma, tumor necrosis factor, and interleukin-1, to inhibit tumor growth.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1992-05-05
- Patent Cliff
- 2005
- Routes
- N/A
- Dosage Forms
- VIAL
PROLEUKIN Approval History
What PROLEUKIN Treats
2 indicationsPROLEUKIN is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Renal Cell Carcinoma
- Melanoma
PROLEUKIN Boxed Warning
CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment. Administer Proleukin in a hospital setting with an intensive care facility. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Contraindications (4) , W...
WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and hepatic impairment. Administer Proleukin in a hospital setting with an intensive care facility. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.1) ] . Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . Serious Infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat pre-existing bacterial infections prior to initiation of Proleukin therapy and withhold Proleukin as recommended [see Dosage and Administration (2.4) , Warnings and Precautions (5.3) ] . WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITY, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS) including life-threatening or fatal reactions, has occurred in patients treated with Proleukin. Administer Proleukin in a hospital setting with an intensive care unit. Withhold or discontinue Proleukin as recommended. ( 2.4 , 4 , 5.1 ) Neurologic toxicities, which may be life-threatening or result in coma or permanent neurological deficits, have occurred in patients treated with Proleukin. Withhold or discontinue Proleukin as recommended. ( 2.4 , 5.2 ) Serious infections including sepsis and bacterial endocarditis have occurred in patients treated with Proleukin. Treat preexisting bacterial infections prior to initiating Proleukin and withhold Proleukin as recommended. ( 2.4 , 5.3 )
PROLEUKIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PROLEUKIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PROLEUKIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PROLEUKIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
163 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06904066 | 10002088 002088-C | Ph 1 | recruiting | Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies |
| NCT02133196 | 140104 14-C-0104 | Ph 2 | recruiting | T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer |
| NCT06253520 | 10001662 001662-C | Ph 1 | active not recruiting | 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 |
| NCT01174121 | 100166 10-C-0166 | Ph 2 | recruiting | Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer |
| NCT03412877 | 180049 18-C-0049 | Ph 2 | recruiting | Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer |
| NCT02621021 | 160027 16-C-0027 | Ph 2 | recruiting | A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab |
| NCT05155033 | 10000354 000354-C | Ph 2 | recruiting | Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma |
| NCT06158828 ABCD-NK | 202401147 | Ph 1, Ph 2 | recruiting | Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML |
| NCT03190941 | 170113 17-C-0113 | Ph 1, Ph 2 | recruiting | Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients |
| NCT01955460 | 2012-0758 NCI-2014-01211, RP110553-P4 | Ph 1 | active not recruiting | Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma |
| NCT01038778 results posted | NCI-2012-02900 NCI-2012-02900, CDR0000662915 | Ph 1, Ph 2 | active not recruiting | Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer |
| NCT03017131 | i 283616 NCI-2016-01477, i 283616 | Ph 1 | active not recruiting | Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT02830724 | 160131 16-C-0131 | Ph 1, Ph 2 | recruiting | Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers |
| NCT00574652 | ANRS HC 21 VASCU IL-2 2006-004039-31 | Ph 1, Ph 2 | completed | Evaluation of Clinical Efficacy and Immunologic Response After IL-2 Therapy in HCV-related Vasculitis Patients |
| NCT06236425 | MCC-23098 | Ph 1 | active not recruiting | TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC |
| NCT05267626 | CP-AU-007-01 | Ph 1, Ph 2 | recruiting | Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer |
| NCT04629729 | FT819-101 | Ph 1 | active not recruiting | FT819 in Subjects With B-cell Malignancies |
| NCT03745326 results posted | 190017 19-C-0017 | Ph 1, Ph 2 | terminated | Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients |
| NCT04347616 NK4AML | HEMAML42 2019-001929-27 | Ph 1, Ph 2 | terminated | Natural Killer-cell Therapy for Acute Myeloid Leukemia |
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT05639972 | 192104 Pro2022000437 | Ph 1, Ph 2 | recruiting | E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers |
| NCT05686226 | 192204 U01CA287904, NCI-2023-02813 | Ph 2 | recruiting | E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers |
| NCT05566223 CheckCell-2 | 2022LC001 | Ph 1, Ph 2 | withdrawn | CISH Inactivated TILs in the Treatment of NSCLC |
| NCT04426669 | 2019LS002 | Ph 1, Ph 2 | completed | A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering |
| NCT07389239 | IRB25-1721 | Ph 1, Ph 2 | not yet recruiting | A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies. |
| NCT03666000 | PBCAR0191-01 | Ph 1 | recruiting | Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT03474497 results posted | 1166212 | Ph 1, Ph 2 | active not recruiting | UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade |
| NCT00923806 | 090047 09-C-0047 | Ph 1 | terminated | Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer |
| NCT05357027 | TC-E202-CC-PI | Ph 1, Ph 2 | terminated | HPV16 E6 TCR T Cells for Cervical Carcinoma |
| NCT05989828 | 1B-23-1 NCI-2023-04697, 1B-23-1 | Ph 1 | recruiting | A2-ESO-1 TCR-Engineered T Cells for Relapsed/Refractory Advanced or Metastatic NY-ESO-1 Overexpression Positive Triple Negative Breast Cancer |
| NCT06255028 CALiPSO-1 | CNTY-101-151-01 2024-518797-13 | Ph 1 | active not recruiting | A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases |
| NCT06626256 | 24231 NCI-2024-08121, 24231 | Ph 1 | withdrawn | STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma |
| NCT04155710 | IOV-CLL-01 | Ph 1 | completed | Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL |
| NCT01319565 results posted | 110123 11-C-0123 | Ph 2 | completed | Prospective Randomized Study of Cell Transfer Therapy for Metastatic Melanoma Using Tumor Infiltrating Lymphocytes Plus IL-2 Following Non-Myeloablative Lymphocyte Depleting Chemo Regimen Alone or in Conjunction With 12Gy Total Body Irradiation (TBI... |
| NCT05802056 | MC220404 NCI-2023-02250, MC220404 | Ph 1 | recruiting | Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis |
| NCT05336409 ELiPSE-1 | CNTY-101-111-01 (ELiPSE-1) | Ph 1 | terminated | A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies |
| NCT03260504 results posted | 9611 NCI-2017-01416, RG1717068 | Ph 1 | terminated | Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer |
| NCT03039673 MIROCALS | H2020/PHRC-N/2014/GB-01 2015-005347-14 | Ph 2 | completed | MIROCALS: Modifying Immune Response and OutComes in ALS |
| NCT01697527 | 12-000153 NCI-2012-01548 | Ph 2 | active not recruiting | Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies |
| NCT03449108 | 2017-0672 NCI-2018-00918, 2017-0672 | Ph 2 | active not recruiting | LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas |
| NCT05400122 | CASE6Y21 | Ph 1 | suspended | Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer |
| NCT03782636 ITAD | 13341 | Ph 2 | active not recruiting | Interleukin-2 Therapy of Autoimmunity in Diabetes (ITAD) |
| NCT05296564 | 0752-20-HMO | Ph 1, Ph 2 | recruiting | Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers |
| NCT06690281 | 10001870 001870-C | Ph 2 | withdrawn | A Phase II Study of Adjuvant Immunotherapy Targeting KRAS G12D, KRAS G12V, or TP53 R175H for Participants With Advanced Gastrointestinal Malignancies |
| NCT06204991 ADP-TILIL7 | MM2319 | Ph 1 | recruiting | To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma |
| NCT02775292 NYM | 15-001433 NCI-2016-00201, R35CA197633 | Ph 1 | completed | Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1 |
| NCT05881525 | TC-N201-ST | Ph 1 | recruiting | NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors |
| NCT07063875 SILVER | SILVER Trial | Ph 1, Ph 2 | recruiting | Adding IL-2 to Tebentafusp to Eradicate Cancer Progression |
| NCT04625205 | NTC-001 2019-003908-13, 2023-508524-35-00 | Ph 1 | terminated | A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma |
| NCT05483491 | 192004 NCI-2022-07699, Pro2022002198 | Ph 1 | recruiting | KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer |
Showing 50 of 163 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROLEUKIN FDA Label Details
Indications & Usage
FDA Label (PDF)PROLEUKIN is indicated for the treatment of Renal Cell Carcinoma; Melanoma.
WARNING: CAPILLARY LEAK SYNDROME (CLS), NEUROLOGIC TOXICITIES and SERIOUS INFECTIONS Capillary leak syndrome (CLS), including life threatening or fatal reactions, has occurred in patients treated with Proleukin. Do not administer Proleukin to patients with significant cardiac, pulmonary, renal, and ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment