{"id":"smofkabiven","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Hypertriglyceridemia"},{"rate":null,"effect":"Phlebitis or catheter-related complications"},{"rate":null,"effect":"Electrolyte imbalances"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SmofKabiven is an all-in-one intravenous nutrition formulation combining soybean oil-based lipid emulsion, amino acids, dextrose, and added vitamins and trace elements. It is designed for total parenteral nutrition (TPN) support in hospitalized or home-care patients with gastrointestinal dysfunction, malabsorption, or inability to maintain adequate oral intake. The formulation provides essential fatty acids, nitrogen, and energy substrates to maintain anabolism and prevent malnutrition.","oneSentence":"SmofKabiven is a parenteral nutrition emulsion that provides balanced macronutrients (lipids, amino acids, carbohydrates) and micronutrients to support metabolic needs in patients unable to eat orally.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:08:21.250Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Total parenteral nutrition in patients with gastrointestinal dysfunction or inability to maintain adequate oral intake"},{"name":"Nutritional support in post-operative or critically ill patients"}]},"trialDetails":[{"nctId":"NCT07010068","phase":"NA","title":"Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study","status":"NOT_YET_RECRUITING","sponsor":"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","startDate":"2025-06-01","conditions":"Malnutrition (Calorie), Stem Cell Transplant Complications","enrollment":214},{"nctId":"NCT06089551","phase":"PHASE4","title":"Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery","status":"UNKNOWN","sponsor":"Copenhagen University Hospital at Herlev","startDate":"2023-10-18","conditions":"Laparotomy, Bowel Obstruction, Ischemia, Mesenteric","enrollment":342},{"nctId":"NCT05257031","phase":"PHASE3","title":"Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care","status":"COMPLETED","sponsor":"Fresenius Kabi","startDate":"2022-02-12","conditions":"Nutrition Therapy, Critical Illness","enrollment":56},{"nctId":"NCT04479254","phase":"NA","title":"The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)","status":"COMPLETED","sponsor":"International Islamic University Malaysia","startDate":"2019-09-25","conditions":"Critical Illness","enrollment":60},{"nctId":"NCT03792087","phase":"PHASE3","title":"Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion","status":"COMPLETED","sponsor":"Fresenius Kabi","startDate":"2017-12-21","conditions":"Parenteral Feeding, Surgery","enrollment":272},{"nctId":"NCT03792100","phase":"PHASE3","title":"Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded \"All in One\" for Parenteral Nutrition","status":"COMPLETED","sponsor":"Fresenius Kabi","startDate":"2019-01-03","conditions":"Parenteral Nutrition, Surgery","enrollment":273},{"nctId":"NCT04425642","phase":"NA","title":"Effects of Parenteral Nutrition in HSCT","status":"COMPLETED","sponsor":"St. Petersburg State Pavlov Medical University","startDate":"2020-02-01","conditions":"Hematologic Malignancy","enrollment":120},{"nctId":"NCT03992716","phase":"PHASE4","title":"Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness","status":"TERMINATED","sponsor":"Fresenius Kabi","startDate":"2019-11-26","conditions":"Critical Illness","enrollment":7},{"nctId":"NCT03355079","phase":"PHASE4","title":"Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy","status":"TERMINATED","sponsor":"Fresenius Kabi","startDate":"2018-02-28","conditions":"Cancer-related Malnutrition","enrollment":2},{"nctId":"NCT01362582","phase":"PHASE3","title":"Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer","status":"TERMINATED","sponsor":"National Center for Tumor Diseases, Heidelberg","startDate":"2010-03","conditions":"Pancreatic Cancer","enrollment":32},{"nctId":"NCT02238886","phase":"NA","title":"Radical Cystectomy, Nutrition and Convalescence","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","startDate":"2012-05","conditions":"Urinary Bladder Neoplasms, Cystectomy, Bladder Cancer","enrollment":36},{"nctId":"NCT01533298","phase":"PHASE3","title":"A Safety, Efficacy Study of CombiflexOmega Peri Versus SmofKabiven Peripheral in Patients With Parenteral Nutrition","status":"COMPLETED","sponsor":"JW Life Science","startDate":"2011-07","conditions":"Parent","enrollment":50},{"nctId":"NCT01533766","phase":"PHASE3","title":"A Safety, Efficacy Study of CombiflexOmega Versus SmofKabiven in Patients With Parenteral Nutrition","status":"COMPLETED","sponsor":"JW Life Science","startDate":"2011-08","conditions":"Parent","enrollment":50}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["SmofKabiven Perifer"],"phase":"marketed","status":"active","brandName":"SmofKabiven","genericName":"SmofKabiven","companyName":"JW Life Science","companyId":"jw-life-science","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SmofKabiven is a parenteral nutrition emulsion that provides balanced macronutrients (lipids, amino acids, carbohydrates) and micronutrients to support metabolic needs in patients unable to eat orally. Used for Total parenteral nutrition in patients with gastrointestinal dysfunction or inability to maintain adequate oral intake, Nutritional support in post-operative or critically ill patients.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}