{"id":"binetrakin","rwe":[{"pmid":"10627167","year":"1999","title":"USAN Council. List No. 422. New names. Binetrakin.","finding":"","journal":"Clinical pharmacology and therapeutics","studyType":"Clinical Study"}],"_fda":{"id":"2b563c1a-771f-eb3f-e063-6394a90a618f","set_id":"23886c49-5992-4a59-af52-e24eb3c9fbc5","openfda":{"nui":["N0000178328","N0000009391","M0011506","N0000175667","N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","N0000185015","N0000175541","M0011490"],"unii":["M89N0Q7EQR","751635Z921","37CQ2C7X93","7M867G6T1U","0MVO31Q3QS","92QVL9080Y","21K6M2I7AG","6WS4C399GB","2A88ZO081O","VP2CN2G7Y8","308LM01C72","7B69B0BD62"],"route":["ORAL"],"spl_id":["2b563c1a-771f-eb3f-e063-6394a90a618f"],"brand_name":["CITOMIX"],"spl_set_id":["23886c49-5992-4a59-af52-e24eb3c9fbc5"],"package_ndc":["17089-076-20"],"product_ndc":["17089-076"],"generic_name":["ALDESLEUKIN - BINETRAKIN - CANAKINUMAB - CENTELLA ASIATICA - CRANBERRY - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - LENOGRASTIM - PINEAPPLE - SUS SCROFA BONE MARROW - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA THYMUS -"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Interleukin-2 [CS]","Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]","Interferon-gamma [CS]"],"pharm_class_pe":["Increased Lymphocyte Activation [PE]","Increased Lymphocyte Cell Production [PE]","Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"substance_name":["ALDESLEUKIN","BINETRAKIN","CANAKINUMAB","CENTELLA ASIATICA","CRANBERRY","HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED)","INTERFERON GAMMA-1B","LENOGRASTIM","PINEAPPLE","SUS SCROFA BONE MARROW","SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE","SUS SCROFA THYMUS"],"pharm_class_epc":["Lymphocyte Growth Factor [EPC]","Non-Standardized Food Allergenic Extract [EPC]","Non-Standardized Plant Allergenic Extract [EPC]","Interferon gamma [EPC]"],"manufacturer_name":["Guna spa"],"is_original_packager":[true]},"purpose":["USES Immune Support during times of: seasonal colds and flu"],"version":"8","stop_use":["WARNINGS Stop use and ask doctor if symptoms persist more than 5 days or worsen."],"warnings":["Stop use and ask doctor if symptoms persist more than 5 days or worsen. If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children."],"questions":["QUESTIONS Questions?: info@gunainc.com tel. (484) 223-3500"],"when_using":["DIRECTIONS Turn tube upside down and rotate cap to release pellets into cap. Unscrew cap and without touching pellets tip them into the mouth under the tongue. Allow to dissolve Take 15 minutes before meals."],"effective_time":"20250110","active_ingredient":["ACTIVE INGREDIENTS/PURPOSE ANANASSA SATIVA 3X RELIEVES INFLAMMATION GCSF 4C, 9C, 15C, 30C, INTERFERON GAMMA 4C IMMUNE SUPPORT INTERLEUKIN 1 BETA 5C, INTERLEUKIN 2 5C, 7C, INTERLEUKIN 4 4C IMMUNE SUPPORT INTERLEUKIN 6 7C, 9C, 15C, THYMUS GLAND 4C IMMUNE SUPPORT HYDROCOTYLE ASIATICA 3X RELIEVES COLD SYMPTOMS LYMPHATIC VESSEL 4C, MOUNTAIN CRANBERRY 3X RELIEVES INFLAMMATION, SWELLING, RESPIRATORY CONGESTION MEDULLA OSSIS 4C RELIEVES NASAL CONGESTION"],"inactive_ingredient":["Inactive ingredient : Sucrose."],"indications_and_usage":["Immune support suring times of: Seasonal colds and flu"],"dosage_and_administration":["Take 15 minutes before meals Adults and children 12 years and older 5 pellets 3 times per day Children between 12 years and 6 years of age 3 pellets 3 times per day Children under 6 years 1 pellet 3 times per day to be disoolved into a little water"],"spl_product_data_elements":["CITOMIX ALDESLEUKIN - BINETRAKIN - CANAKINUMAB - CENTELLA ASIATICA - CRANBERRY - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - INTERFERON GAMMA-1B - LENOGRASTIM - PINEAPPLE - SUS SCROFA BONE MARROW - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - SUS SCROFA THYMUS - SUCROSE PINEAPPLE PINEAPPLE LENOGRASTIM LENOGRASTIM CENTELLA ASIATICA CENTELLA ASIATICA INTERFERON GAMMA-1B INTERFERON GAMMA-1B CANAKINUMAB CANAKINUMAB ALDESLEUKIN ALDESLEUKIN BINETRAKIN BINETRAKIN HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE SUS SCROFA BONE MARROW SUS SCROFA BONE MARROW CRANBERRY CRANBERRY SUS SCROFA THYMUS SUS SCROFA THYMUS white"],"pregnancy_or_breast_feeding":["PREGNANCY If pregnant or breast-feeding ask a health care professional before use."],"keep_out_of_reach_of_children":["WARNINGS Keep this and all medicines out of reach of children","Keep out of reach of children"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 5USCIT-E"]},"tags":[{"label":"Lymphocyte Growth Factor [EPC]","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Oral","category":"route"},{"label":"Active","category":"status"},{"label":"Seasonal colds","category":"indication"},{"label":"Guna spa","category":"company"}],"phase":"marketed","safety":{"boxedWarnings":[]},"trials":[],"aliases":[],"company":"Guna spa","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BINETRAKIN","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:15:46.956640+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:15:53.807100+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BINETRAKIN","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:15:54.714563+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":"2026-04-20T00:15:44.731077+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:15:44.731126+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:15:44.731136+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108412/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:15:55.179152+00:00"}},"allNames":"citomix","offLabel":[],"synonyms":["Citomix","ALDESLEUKIN"],"timeline":[],"approvals":[],"brandName":"Citomix","ecosystem":[],"mechanism":{"modality":"Small Molecule","drugClass":"Lymphocyte Growth Factor [EPC]","explanation":"","oneSentence":"","technicalDetail":"Citomix is a small molecule that acts as a Lymphocyte Growth Factor (EPC), stimulating the proliferation and differentiation of lymphocytes through an unknown mechanism of action."},"commercial":{},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"BINETRAKIN\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA Label"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=binetrakin","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=binetrakin","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-31T10:41:31.036807","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:15:57.877095+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"binetrakin","indications":{"approved":[{"name":"Seasonal colds","source":"OpenFDA Label","regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07398859","phase":"PHASE2","title":"Clinical Study on TQH2722 Injection Combined With Background Therapy for Seasonal Allergic Rhinitis","status":"RECRUITING","sponsor":"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","startDate":"2026-03-19","conditions":["Seasonal Allergic Rhinitis"],"enrollment":300,"completionDate":"2027-03"},{"nctId":"NCT06793085","phase":"","title":"Pro- and Anti-inflammatory Cytokines in PCOS","status":"RECRUITING","sponsor":"Jagiellonian University","startDate":"2025-01-20","conditions":["Reproductive Age","PCOS (Polycystic Ovary Syndrome)"],"enrollment":100,"completionDate":"2026-12-31"},{"nctId":"NCT05720325","phase":"PHASE2","title":"Dupilumab Effects Against Aeroallergen Challenge","status":"RECRUITING","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2023-03-29","conditions":["Asthma, Allergic"],"enrollment":88,"completionDate":"2027-11"},{"nctId":"NCT06173284","phase":"PHASE3","title":"Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis","status":"COMPLETED","sponsor":"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","startDate":"2024-01-22","conditions":["Dermatitis, Atopic"],"enrollment":519,"completionDate":"2025-11-20"},{"nctId":"NCT06324812","phase":"PHASE1,PHASE2","title":"Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","startDate":"2024-07-10","conditions":["Dermatitis, Atopic"],"enrollment":124,"completionDate":"2026-08"},{"nctId":"NCT06477653","phase":"PHASE2","title":"Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents","status":"RECRUITING","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2025-02-05","conditions":["Hypereosinophilic Syndrome"],"enrollment":30,"completionDate":"2027-03-30"},{"nctId":"NCT07042126","phase":"PHASE3","title":"Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis","status":"RECRUITING","sponsor":"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","startDate":"2025-08-05","conditions":["Dermatitis, Atopic"],"enrollment":180,"completionDate":"2027-09-30"},{"nctId":"NCT06495229","phase":"PHASE3","title":"Study of CM310 in Adolescent Subjects With Atopic Dermatis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Keymed Biosciences Co.Ltd","startDate":"2024-08-02","conditions":["Atopic Dermatitis"],"enrollment":180,"completionDate":"2026-08-30"},{"nctId":"NCT06277765","phase":"PHASE3","title":"Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis","status":"COMPLETED","sponsor":"Keymed Biosciences Co.Ltd","startDate":"2024-03-21","conditions":["Atopic Dermatitis"],"enrollment":180,"completionDate":"2025-01-23"},{"nctId":"NCT07199257","phase":"PHASE3","title":"A Study of GR1802 Injection in Patients With Seasonal Allergic Rhinitis.","status":"NOT_YET_RECRUITING","sponsor":"Genrix (Shanghai) Biopharmaceutical Co., Ltd.","startDate":"2025-09-25","conditions":["Allergic Rhinitis, Seasonal"],"enrollment":144,"completionDate":"2027-07-31"},{"nctId":"NCT06300203","phase":"PHASE2","title":"Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis","status":"RECRUITING","sponsor":"Beijing Tongren Hospital","startDate":"2024-03-18","conditions":["Seasonal Allergic Rhinitis"],"enrollment":120,"completionDate":"2026-06-30"},{"nctId":"NCT07154342","phase":"PHASE3","title":"A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis","status":"RECRUITING","sponsor":"Genrix (Shanghai) Biopharmaceutical Co., Ltd.","startDate":"2025-08-15","conditions":["Allergic Rhinitis, Seasonal"],"enrollment":150,"completionDate":"2026-07-31"},{"nctId":"NCT06760182","phase":"PHASE2","title":"Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","startDate":"2025-03-10","conditions":["Seasonal Allergic Rhinitis"],"enrollment":169,"completionDate":"2025-07-01"},{"nctId":"NCT06554847","phase":"PHASE3","title":"Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","startDate":"2024-09-23","conditions":["Dermatitis, Atopic","Eczema, Atopic"],"enrollment":400,"completionDate":"2026-08-16"},{"nctId":"NCT06315426","phase":"PHASE2","title":"A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR).","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genrix (Shanghai) Biopharmaceutical Co., Ltd.","startDate":"2024-03-24","conditions":["Allergic Rhinitis"],"enrollment":240,"completionDate":"2025-10"},{"nctId":"NCT05094570","phase":"PHASE4","title":"Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP","status":"RECRUITING","sponsor":"University of Virginia","startDate":"2022-09-01","conditions":["Nasal Polyps","Staphylococcus Aureus"],"enrollment":20,"completionDate":"2026-12-31"},{"nctId":"NCT06889506","phase":"NA","title":"Interleukin-4 in Pityriasis Lichenoides Chronica","status":"NOT_YET_RECRUITING","sponsor":"Cairo University","startDate":"2025-04-01","conditions":["Pityriasis Lichenoides"],"enrollment":50,"completionDate":"2025-07"},{"nctId":"NCT05100043","phase":"","title":"Interleukin 4 and Interferon Gamma Predictors of Human Papillomavirus Immunotherapy in Warts","status":"COMPLETED","sponsor":"Zagazig University","startDate":"2020-01-03","conditions":["Warts Hand","Wart, Genital"],"enrollment":80,"completionDate":"2021-03-02"},{"nctId":"NCT02922998","phase":"","title":"CD64 and Antibiotics in Human Sepsis","status":"COMPLETED","sponsor":"University of Ulm","startDate":"2016-09","conditions":["Antibiotic Resistant Infection","Critical Illness","SIRS","Sepsis"],"enrollment":64,"completionDate":"2021-06-30"},{"nctId":"NCT06385236","phase":"PHASE4","title":"Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping","status":"RECRUITING","sponsor":"University of California, San Diego","startDate":"2024-02-19","conditions":["Moderate to Severe Asthma"],"enrollment":120,"completionDate":"2028-01-31"},{"nctId":"NCT06552520","phase":"PHASE3","title":"To Evaluate the Phase III Clinical Trial of TQH2722 Injection in the Treatment of Moderate to Severe Atopic Dermatitis","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.","startDate":"2024-09","conditions":["Atopic Dermatitis"],"enrollment":500,"completionDate":"2026-06"},{"nctId":"NCT05470647","phase":"PHASE2","title":"A Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Beijing Tongren Hospital","startDate":"2022-08-17","conditions":["Allergic Rhinitis"],"enrollment":93,"completionDate":"2022-12-28"},{"nctId":"NCT06028490","phase":"PHASE2","title":"A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.","status":"UNKNOWN","sponsor":"Zheng Liu ENT","startDate":"2023-09-07","conditions":["Allergic Rhinitis"],"enrollment":90,"completionDate":"2023-11"},{"nctId":"NCT05783544","phase":"NA","title":"Impact of A. Lumbricoides on Pulmonary Aspergillosis Development","status":"UNKNOWN","sponsor":"Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan","startDate":"2015-05-01","conditions":["COPD Exacerbation Acute","Ascaris Lumbricoides Infection","Chronic Pulmonary Aspergillosis"],"enrollment":200,"completionDate":"2025-12-31"},{"nctId":"NCT02858895","phase":"PHASE2","title":"Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma","status":"COMPLETED","sponsor":"Medicenna Therapeutics, Inc.","startDate":"2017-04-11","conditions":["Glioblastoma","Grade IV Astrocytoma","Glioblastoma Multiforme","Grade IV Glioma"],"enrollment":47,"completionDate":"2019-10-31"},{"nctId":"NCT00000769","phase":"PHASE1","title":"A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":["Sarcoma, Kaposi","HIV Infections"],"enrollment":48,"completionDate":"1998-04"},{"nctId":"NCT00001564","phase":"PHASE2","title":"A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1996-12-23","conditions":["Ewing's Sarcoma","Rhabdomyosarcoma"],"enrollment":30,"completionDate":"2007-10-25"},{"nctId":"NCT04018131","phase":"PHASE3","title":"The Efficacy of Cimetidin for Acute - Extrinsic Atopic Dermatitis Treated With Standard Therapy","status":"UNKNOWN","sponsor":"Fakultas Kedokteran Universitas Indonesia","startDate":"2018-03-26","conditions":["Atopic Dermatitis","Immunoglobulin E Concentration, Serum"],"enrollment":26,"completionDate":"2020-06-30"},{"nctId":"NCT00923910","phase":"PHASE1,PHASE2","title":"Wilm's Tumor 1 Protein Vaccine to Treat Cancers of the Blood","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2008-02-22","conditions":["Leukemia, Acute Myelogenous (AML)","Leukemia, Acute Lymphocytic (ALL)","Leukemia, Chronic Myelogenous (CML)","Myelodysplastic Syndrome (MDS)","Non-Hodgkin's Lymphoma (NHL)"],"enrollment":10,"completionDate":"2016-11-15"},{"nctId":"NCT00017693","phase":"PHASE2","title":"Recombinant Human IL-4 Receptor Used in Treatment of Asthma","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"1998-05","conditions":["Asthma"],"enrollment":62,"completionDate":"2000-02"},{"nctId":"NCT02496273","phase":"PHASE1","title":"Phase I Trial of CEA Specific AAV-DC-CTL Treatment in Stage IV Gastric Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"The First People's Hospital of Changzhou","startDate":"2016-01","conditions":["Gastric Cancer"],"enrollment":60,"completionDate":"2030-12"},{"nctId":"NCT01921374","phase":"NA","title":"Mother-caregivers of Children With Duchenne Muscular Dystrophy","status":"COMPLETED","sponsor":"Monica Levy Andersen","startDate":"2013-08","conditions":["Other Diseases or Conditions"],"enrollment":60,"completionDate":"2014-07"},{"nctId":"NCT00256035","phase":"NA","title":"Interleukin-4 (IL-4) as a Marker of Atherosclerosis","status":"WITHDRAWN","sponsor":"Melbourne Health","startDate":"","conditions":["Atherosclerosis","Ischemic Heart Disease"],"enrollment":0,"completionDate":""},{"nctId":"NCT00006113","phase":"PHASE2","title":"Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma","status":"TERMINATED","sponsor":"University of Southern California","startDate":"1999-06","conditions":["Melanoma (Skin)"],"enrollment":25,"completionDate":"2006-04"},{"nctId":"NCT00003842","phase":"PHASE1","title":"IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma","status":"UNKNOWN","sponsor":"Barrett Cancer Center","startDate":"1999-03","conditions":["Brain and Central Nervous System Tumors"],"enrollment":30,"completionDate":""},{"nctId":"NCT00039052","phase":"PHASE1","title":"Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer","status":"COMPLETED","sponsor":"Neurocrine Biosciences","startDate":"2002-01","conditions":["Breast Cancer","Kidney Cancer","Lung Cancer"],"enrollment":0,"completionDate":"2008-07"},{"nctId":"NCT00014677","phase":"PHASE2","title":"NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme","status":"COMPLETED","sponsor":"Neurocrine Biosciences","startDate":"2001-03","conditions":["Brain and Central Nervous System Tumors"],"enrollment":0,"completionDate":"2008-07"},{"nctId":"NCT00785668","phase":"PHASE1","title":"A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects","status":"COMPLETED","sponsor":"Aerovance, Inc.","startDate":"2007-11","conditions":["Asthma"],"enrollment":10,"completionDate":"2008-02"},{"nctId":"NCT00001909","phase":"PHASE2","title":"Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"1999-05","conditions":["Asthma","Hypersensitivity"],"enrollment":40,"completionDate":"2000-05"},{"nctId":"NCT00535028","phase":"PHASE2","title":"A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)","status":"COMPLETED","sponsor":"Aerovance, Inc.","startDate":"2005-01","conditions":["Allergic Asthma"],"enrollment":24,"completionDate":"2005-05"},{"nctId":"NCT00535431","phase":"PHASE2","title":"Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatics","status":"COMPLETED","sponsor":"Aerovance, Inc.","startDate":"2005-12","conditions":["Allergic Asthma"],"enrollment":32,"completionDate":"2006-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Oral"},"crossReferences":{"UNII":"M89N0Q7EQR","SPL_ID":"2b563c1a-771f-eb3f-e063-6394a90a618f","chemblId":"CHEMBL2108412"},"formularyStatus":[],"_enricherVersion":"v2-openfda","developmentCodes":[],"ownershipHistory":[{"period":"","companyName":"Guna spa","relationship":"Original Developer"}],"publicationCount":1,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"originalDeveloper":"Guna spa","recentPublications":[{"date":"1999 Dec","pmid":"10627167","title":"USAN Council. List No. 422. New names. Binetrakin.","journal":"Clinical pharmacology and therapeutics"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Guna spa","companyId":"guna-spa","modality":"Recombinant protein","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:15:57.877095+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}