{"id":"aldesleukin","rwe":[{"pmid":"41409530","year":"2025","title":"Immune Cell-Targeting Biologics for Alopecia Areata: A New Paradigm in Precision Medicine.","finding":"","journal":"Skin appendage disorders","studyType":"Clinical Study"},{"pmid":"40590904","year":"2025","title":"[(68)Ga]Ga-interleukin-2 for imaging activated T-lymphocytes: biochemical characterization and phase I study in normal subjects.","finding":"","journal":"European journal of nuclear medicine and molecular imaging","studyType":"Clinical Study"},{"pmid":"40315882","year":"2025","title":"Targeting the intracellular immune checkpoint CISH with CRISPR-Cas9-edited T cells in patients with metastatic colorectal cancer: a first-in-human, single-centre, phase 1 trial.","finding":"","journal":"The Lancet. Oncology","studyType":"Clinical Study"},{"pmid":"39913410","year":"2025","title":"Drug-induced autoimmune-like hepatitis: A disproportionality analysis based on the FAERS database.","finding":"","journal":"PloS one","studyType":"Clinical Study"},{"pmid":"39837618","year":"2025","title":"Art of TIL immunotherapy: SITC's perspective on demystifying a complex treatment.","finding":"","journal":"Journal for immunotherapy of cancer","studyType":"Clinical Study"}],"_fda":{"id":"ed8137f8-9931-234c-e053-2a95a90a5769","set_id":"0619f291-207a-4e01-96bd-b882726665e2","openfda":{"nui":["N0000178328","N0000009391","M0011506","N0000175667"],"upc":["0317089380184"],"unii":["M89N0Q7EQR"],"route":["ORAL"],"spl_id":["ed8137f8-9931-234c-e053-2a95a90a5769"],"brand_name":["GUNA-IL 2"],"spl_set_id":["0619f291-207a-4e01-96bd-b882726665e2"],"package_ndc":["17089-380-18"],"product_ndc":["17089-380"],"generic_name":["ALDESLEUKIN"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Interleukin-2 [CS]"],"pharm_class_pe":["Increased Lymphocyte Activation [PE]","Increased Lymphocyte Cell Production [PE]"],"substance_name":["ALDESLEUKIN"],"pharm_class_epc":["Lymphocyte Growth Factor [EPC]"],"manufacturer_name":["Guna spa"],"is_original_packager":[true]},"purpose":["USES IMMUNE SYSTEM SUPPORT"],"version":"5","warnings":["WARNINGS Stop use and ask doctor if symptoms worsen or persist more than 5 days"],"questions":["QUESTIONS Questions? : info@gunainc.com Tel. (484) 223-3500"],"effective_time":"20221115","active_ingredient":["ACTIVE INGREDIENTS/PURPOSE INTERLEUKIN 2 4C IMMUNE SYSTEM SUPPORT"],"inactive_ingredient":["Inactive ingredient: Ethyl alcohol 30%."],"indications_and_usage":["Take 15 minutes before meals"],"dosage_and_administration":["DIRECTIONS Take 15 minutes before meals. Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children under 6 years 5 drops twice a day in a glass of water."],"spl_product_data_elements":["GUNA-IL 2 ALDESLEUKIN ALCOHOL ALDESLEUKIN ALDESLEUKIN"],"pregnancy_or_breast_feeding":["PREGNANCY If pregnant or breast-feeding ask a doctor before use"],"keep_out_of_reach_of_children":["WARNINGS Keep this and all medicines out of reach of children"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL image of box label"]},"tags":[{"label":"Lymphocyte Growth Factor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Interleukin-2 receptor","category":"target"},{"label":"IL2RA","category":"gene"},{"label":"IL2RB","category":"gene"},{"label":"IL2RG","category":"gene"},{"label":"L03AC01","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Acute myeloid leukemia, disease","category":"indication"},{"label":"Metastatic malignant melanoma","category":"indication"},{"label":"Metastatic renal cell carcinoma","category":"indication"},{"label":"Chiron","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Anti-HIV Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Anti-Retroviral Agents","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"143 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"109 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"82 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"81 reports"},{"date":"","signal":"THROMBOCYTOPENIA","source":"FDA FAERS","actionTaken":"80 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"71 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"66 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"64 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"62 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"59 reports"}],"commonSideEffects":[{"effect":"Hypotension","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Hyperbilirubinemia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Dyspnea","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Rash","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Diarrhea","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Oliguria","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Chills","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Thrombocytopenia","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Confusional state","drugRate":"30%","severity":"common","organSystem":""},{"effect":"Increased creatinine","drugRate":"30%","severity":"common","organSystem":""}],"specialPopulations":{"Pregnancy":"Proleukin has been shown to have embryolethal effects in rats when given in doses at 27 to 36 times the human dose (scaled by body weight). Significant maternal toxicities were observed in pregnant rats administered Proleukin by IV injection at doses 2.1 to 36 times higher than the human dose during critical period of organogenesis. No evidence of teratogenicity was observed other than that attributed to maternal toxicity. There are no adequate well-controlled studies in pregnant women. Use in pregnant women only if clearly needed.","Geriatric use":"There were small number of patients aged 65 and over in clinical trials of Proleukin; experience is limited to 27 patients, eight with metastatic melanoma and nineteen with metastatic renal cell carcinoma. The response rates were similar in patients 65 years and over as compared to those less than 65 years of age. The median number of courses and the median number of doses per course were similar between older and younger patients.","Paediatric use":"Safety and effectiveness in children under 18 years of age have not been established."},"seriousAdverseEvents":[{"effect":"Fatal adverse reactions","drugRate":"4%","severity":"serious"},{"effect":"Fatal adverse reactions","drugRate":"2%","severity":"serious"},{"effect":"Cardiac arrest","drugRate":"1%","severity":"serious"},{"effect":"Myocardial infarction","drugRate":"1%","severity":"serious"},{"effect":"Pulmonary embolism","drugRate":"1%","severity":"serious"},{"effect":"Cerebrovascular accident","drugRate":"1%","severity":"serious"},{"effect":"Hepatic failure","drugRate":"1%","severity":"serious"},{"effect":"Renal failure","drugRate":"1%","severity":"serious"},{"effect":"Pulmonary edema","drugRate":"1%","severity":"serious"},{"effect":"Respiratory failure","drugRate":"1%","severity":"serious"}]},"trials":[],"aliases":[],"company":"Chiron","patents":[],"pricing":[],"_fixedAt":"2026-03-30T16:30:10.640284","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ALDESLEUKIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:31:50.018402+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Aldesleukin","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:31:58.105291+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:31:56.685097+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T03:31:48.655119+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALDESLEUKIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:31:57.536235+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:47.576548+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:47.576601+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:47.576613+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T03:31:59.136071+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Interleukin-2 receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:31:58.104919+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201438/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:31:58.014686+00:00"}},"allNames":"proleukin","offLabel":[],"synonyms":["BAY 50-4798","aldesleukin","proleukin","aldesleukine"],"timeline":[{"date":"1992-05-05","type":"positive","source":"DrugCentral","milestone":"FDA approval (Chiron)"}],"aiSummary":"Proleukin (Aldesleukin) is a lymphocyte growth factor that targets the interleukin-2 receptor. It is a small molecule modality that was originally developed by Chiron and is currently owned by the same company. Proleukin was FDA-approved in 1992 for the treatment of metastatic malignant melanoma, metastatic renal cell carcinoma, and acute myeloid leukemia. The commercial status of Proleukin is patented, and it is not yet available as a generic. Key safety considerations include potential severe side effects such as flu-like symptoms, rash, and cardiovascular issues.","brandName":"Proleukin","ecosystem":[{"indication":"Acute myeloid leukemia, disease","otherDrugs":[{"name":"azacitidine","slug":"azacitidine","company":"Celgene"},{"name":"cytarabine","slug":"cytarabine","company":""},{"name":"daunorubicin","slug":"daunorubicin","company":""},{"name":"decitabine","slug":"decitabine","company":"Astex Pharmaceuticals, Inc."}],"globalPrevalence":800000},{"indication":"Metastatic malignant melanoma","otherDrugs":[{"name":"binimetinib","slug":"binimetinib","company":"Array Biopharma Inc"},{"name":"cobimetinib","slug":"cobimetinib","company":"Genentech Inc"},{"name":"dabrafenib","slug":"dabrafenib","company":"Novartis Pharms Corp"},{"name":"dacarbazine","slug":"dacarbazine","company":"Bayer Hlthcare"}],"globalPrevalence":330000},{"indication":"Metastatic renal cell carcinoma","otherDrugs":[{"name":"bevacizumab","slug":"bevacizumab","company":"Genentech"},{"name":"cabozantinib","slug":"cabozantinib","company":"Exelixis"},{"name":"nivolumab","slug":"nivolumab","company":"Bristol Myers Squibb"},{"name":"pembrolizumab","slug":"pembrolizumab","company":"Merck Sharp Dohme"}],"globalPrevalence":3360000}],"mechanism":{"target":"Interleukin-2 receptor","novelty":"First-in-class","targets":[{"gene":"IL2RA","source":"DrugCentral","target":"Interleukin-2 receptor","protein":"Interleukin-2 receptor subunit alpha"},{"gene":"IL2RB","source":"DrugCentral","target":"Interleukin-2 receptor","protein":"Interleukin-2 receptor subunit beta"},{"gene":"IL2RG","source":"DrugCentral","target":"Interleukin-2 receptor","protein":"Cytokine receptor common subunit gamma"}],"modality":"Small Molecule","drugClass":"Lymphocyte Growth Factor [EPC]","explanation":"","oneSentence":"","technicalDetail":"Proleukin (Aldesleukin) is a recombinant form of interleukin-2 (IL-2) that selectively binds to the IL-2 receptor, triggering a cascade of intracellular signaling events that lead to the activation, proliferation, and differentiation of lymphocytes, particularly T cells and natural killer cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Interleukin_2","title":"Interleukin 2","extract":"\nInterleukin-2 (IL-2) is an interleukin, which is a type of cytokine signaling molecule forming part of the immune system. It regulates the activities of white blood cells (leukocytes, often lymphocytes) that are responsible for immunity. IL-2 is part of the body's natural response to microbial infection, and in discriminating between foreign (\"non-self\") and \"self\". IL-2 mediates its effects by binding to IL-2 receptors, which are expressed by lymphocytes. The major sources of IL-2 are activated CD4+ T cells and activated CD8+ T cells. Put shortly, the function of IL-2 is to stimulate the growth of helper, cytotoxic and regulatory T cells.","wiki_history":"== History==\n\nAccording to an immunology textbook: \"IL-2 is particularly important historically, as it is the first type I cytokine that was cloned, the first type I cytokine for which a receptor component was cloned, and was the first short-chain type I cytokine whose receptor structure was solved. Many general principles have been derived from studies of this cytokine including its being the first cytokine demonstrated to act in a growth factor–like fashion through specific high-affinity receptors, analogous to the growth factors being studied by endocrinologists and biochemists\". In the mid-1970s, it was discovered that T-cells could be selectively proliferated when normal human bone marrow cells were cultured in conditioned medium obtained from phytohemagglutinin-stimulated normal human lymphocytes. The key factor was isolated from cultured mouse cells in 1979 and from cultured human cells in 1980. The gene for human IL-2 was cloned in 1982 after an intense competition.\n\nCommercial activity to bring an IL-2 drug to market was intense in the 1980s and 1990s. By 1983, Cetus Corporation had created a proprietary recombinant version of IL-2 (Aldesleukin, later branded as Proleukin), with the alanine removed from its N-terminal and residue 125 replaced with serine. The failure led to the collapse of Cetus, and in 1991 the company was sold to Chiron Corporation. Chiron continued the development of IL-2, which was finally approved by the FDA as Proleukin for metastatic renal carcinoma in 1992.\n\nBy 1993 aldesleukin was the only approved version of IL-2, but Roche was also developing a proprietary, modified, recombinant IL-2 called teceleukin, with a methionine added at is N-terminal, and Glaxo was developing a version called bioleukin, with a methionine added at is N-terminal and residue 125 replaced with alanine. Dozens of clinical trials had been conducted of recombinant or purified IL-2, alone, in combination with other drugs, or using cell therapies, in which cells "},"commercial":{"launchDate":"1992","_launchSource":"DrugCentral (FDA 1992-05-05, CHIRON)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5011","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ALDESLEUKIN","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ALDESLEUKIN","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Interleukin_2","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T08:34:50.664981","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:32:00.858982+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[{"form":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","route":"INTRAVENOUS","company":"Clinigen Group PLC","brandName":"Proleukin","isOriginal":false,"marketingStatus":"BLA"}],"competitors":[{"drugName":"oprelvekin","drugSlug":"oprelvekin","fdaApproval":"1997-11-25","relationship":"same-class"}],"genericName":"aldesleukin","indications":{"approved":[{"name":"Acute myeloid leukemia, disease","source":"DrugCentral","snomedId":91861009,"regulator":"FDA","usPrevalence":null,"globalPrevalence":800000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency 2018[INST])"},{"name":"Metastatic malignant melanoma","source":"DrugCentral","snomedId":443493003,"regulator":"FDA","eligibility":"ECOG performance status (ECOG PS 0), ECOG PS >1 is extremely limited","usPrevalence":100000,"globalPrevalence":330000,"prevalenceMethod":"curated","prevalenceSource":"IARC GLOBOCAN, 2022"},{"name":"Metastatic renal cell carcinoma","source":"DrugCentral","snomedId":702392008,"regulator":"FDA","eligibility":null,"usPrevalence":null,"globalPrevalence":3360000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (European Medicines Agency 2010[INST])"}],"offLabel":[],"pipeline":[]},"_fixedFields":["pubmed(113)"],"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"oprelvekin","brandName":"oprelvekin","genericName":"oprelvekin","approvalYear":"1997","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01038778","phase":"PHASE1,PHASE2","title":"Entinostat in Combination With Aldesleukin in Treating Patients With Metastatic Kidney Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2009-10-29","conditions":["Clear Cell Renal Cell Carcinoma","Metastatic Kidney Carcinoma","Stage III Renal Cell Cancer AJCC v7","Stage IV Renal Cell Cancer AJCC 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