{"id":"gx-i7","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Injection site reaction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"It works by mimicking the action of FGF21, a hormone involved in glucose and lipid metabolism, to improve glycemic control and reduce body weight.","oneSentence":"GX-I7 is a recombinant human fibroblast growth factor 21 (FGF21) protein.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T02:40:26.458Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 2 diabetes"}]},"trialDetails":[{"nctId":"NCT05280457","phase":"PHASE2","title":"HPV 16-positive and/or HPV 18-positive Recurrent and/or For Patients With Metastatic Head and Neck Cancer to Evaluate GX-188E DNA Vaccination, GX-I7 and Nivolumab Combination Therapy","status":"RECRUITING","sponsor":"Yonsei University","startDate":"2022-04-15","conditions":"Head and Neck Squamous Cell Carcinoma","enrollment":21},{"nctId":"NCT05286060","phase":"PHASE2","title":"Trial of the Combination of GX-188E Vaccination, GX-I7 and Pembrolizumab in Patients With Advanced, Resectable HPV Type 16 and/or 18 Positive Head and Neck Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Yonsei University","startDate":"2022-03-01","conditions":"Head and Neck Squamous Cell Carcinoma","enrollment":56},{"nctId":"NCT05465954","phase":"PHASE2","title":"Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2023-01-24","conditions":"High Grade Astrocytic Tumor, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma","enrollment":54},{"nctId":"NCT04588038","phase":"PHASE1","title":"NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery","status":"TERMINATED","sponsor":"Hyunseok Kang, MD","startDate":"2021-03-12","conditions":"Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma","enrollment":4},{"nctId":"NCT04893018","phase":"PHASE1","title":"NT-I7 for Kaposi Sarcoma in Patients With or Without HIV","status":"TERMINATED","sponsor":"Fred Hutchinson Cancer Center","startDate":"2022-05-23","conditions":"AIDS-Related Kaposi Sarcoma, HIV Infection, Kaposi Sarcoma","enrollment":8},{"nctId":"NCT06344715","phase":"PHASE1","title":"Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC.","status":"RECRUITING","sponsor":"SL VAXiGEN","startDate":"2022-10-17","conditions":"Metastatic Castration-resistant Prostate Cancer (mCRPC)","enrollment":78},{"nctId":"NCT03752723","phase":"PHASE1, PHASE2","title":"Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)","status":"COMPLETED","sponsor":"Genexine, Inc.","startDate":"2019-03-27","conditions":"Triple Negative Breast Cancer","enrollment":84},{"nctId":"NCT05191784","phase":"PHASE2","title":"GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients","status":"UNKNOWN","sponsor":"Genexine, Inc.","startDate":"2022-01-26","conditions":"Recurrent Glioblastoma","enrollment":20},{"nctId":"NCT04730427","phase":"PHASE1","title":"Safety and Preliminary Efficacy Study of GX-I7 in Patients With COVID-19","status":"TERMINATED","sponsor":"Genexine, Inc.","startDate":"2021-03-24","conditions":"Covid19","enrollment":10},{"nctId":"NCT04065087","phase":"PHASE1, PHASE2","title":"Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma","status":"WITHDRAWN","sponsor":"Genexine, Inc.","startDate":"2019-08-22","conditions":"Newly Diagnosed Glioblastoma","enrollment":""},{"nctId":"NCT04289155","phase":"","title":"Individual Patient Compassionate Use of GX-I7","status":"NO_LONGER_AVAILABLE","sponsor":"Genexine, Inc.","startDate":"","conditions":"Glioblastoma, High Grade Glioma, Recurrent Glioblastoma","enrollment":""},{"nctId":"NCT04810637","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of GX-I7 in Elderly Patients With Asymptomatic or Mild Symptoms of COVID-19","status":"UNKNOWN","sponsor":"PT Kalbe Genexine Biologics","startDate":"2020-11-01","conditions":"Covid19","enrollment":210},{"nctId":"NCT03619239","phase":"PHASE1","title":"Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma","status":"COMPLETED","sponsor":"Genexine, Inc.","startDate":"2018-06-20","conditions":"Newly Diagnosed Glioblastoma","enrollment":15},{"nctId":"NCT03733587","phase":"PHASE1","title":"GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors","status":"COMPLETED","sponsor":"Genexine, Inc.","startDate":"2018-10-17","conditions":"Solid Tumor","enrollment":24},{"nctId":"NCT03478995","phase":"PHASE1","title":"Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors","status":"COMPLETED","sponsor":"Genexine, Inc.","startDate":"2018-03-05","conditions":"Locally Advanced or Metastatic Solid Tumors","enrollment":35},{"nctId":"NCT04283695","phase":"EARLY_PHASE1","title":"To Investigate the Absorption, Metabolism, Excretion, Absolute Bioavailability, and Immunogenicity of GX-I7 in Healthy Volunteers","status":"UNKNOWN","sponsor":"Seoul National University Hospital","startDate":"2019-07-03","conditions":"Leukopenia","enrollment":12},{"nctId":"NCT03144934","phase":"PHASE1","title":"Safety and Tolerability of GX-I7 in HPV-infected Female Volunteers","status":"COMPLETED","sponsor":"Genexine, Inc.","startDate":"2017-02-16","conditions":"Human Papillomavirus","enrollment":32},{"nctId":"NCT02860715","phase":"PHASE1","title":"Clinical Trial of GX-I7 in Healthy Volunteers","status":"COMPLETED","sponsor":"Genexine, Inc.","startDate":"2016-07-11","conditions":"Healthy","enrollment":30},{"nctId":"NCT03206138","phase":"NA","title":"Safety and Efficacy of GX-188E Administered Via EP Plus GX-I7 or Imiquimod.","status":"UNKNOWN","sponsor":"Seoul St. Mary's Hospital","startDate":"2017-05-30","conditions":"Cervical Intraepithelial Neoplasia 3","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["rhIL-7-hyFc","Efineptakin alfa","Efineptakin alfa NT-I7","NT-I7","TJ107"],"phase":"phase_2","status":"active","brandName":"GX-I7","genericName":"GX-I7","companyName":"Genexine, Inc.","companyId":"genexine-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"GX-I7 is a recombinant human fibroblast growth factor 21 (FGF21) protein. Used for Type 2 diabetes.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":10,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}