{"id":"sucrosomial-iron","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances (nausea, constipation, abdominal discomfort)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL1200823","moleculeType":"Small molecule","molecularWeight":"398.14"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The sucrosomal formulation protects iron from interaction with food components and gastric pH, allowing more efficient absorption in the small intestine while minimizing local irritation. This novel delivery system enhances bioavailability compared to conventional iron salts and reduces the incidence of gastrointestinal adverse events associated with standard iron supplementation.","oneSentence":"Sucrosomial iron delivers iron as a ferric hydroxide complex encapsulated in a sucrose-based matrix to improve absorption and reduce gastrointestinal side effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:09:55.990Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Iron deficiency anemia"}]},"trialDetails":[{"nctId":"NCT07308769","phase":"PHASE4","title":"Efficacy and Tolerability of Sucrosomial® Iron vs Ferric Maltol in Iron Deficient Women","status":"RECRUITING","sponsor":"Pharmanutra S.p.a.","startDate":"2025-12-11","conditions":"Anemia, Iron Deficiency Anemia (IDA)","enrollment":146},{"nctId":"NCT07287371","phase":"PHASE4","title":"Sucrosomial Vs Intravenous Iron for Preoperative Anemia","status":"NOT_YET_RECRUITING","sponsor":"University of Rochester","startDate":"2025-12-31","conditions":"Anemia, Iron Deficiency Anemia","enrollment":75},{"nctId":"NCT06270498","phase":"PHASE4","title":"Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure","status":"RECRUITING","sponsor":"Raffaele De Caterina","startDate":"2024-03-14","conditions":"Chronic Heart Failure, Iron-deficiency, Left Ventricular Systolic Dysfunction","enrollment":60},{"nctId":"NCT04250298","phase":"NA","title":"Sucrosom5al Iron Supplementation in Blood Donors","status":"COMPLETED","sponsor":"Medical University of Graz","startDate":"2019-11-13","conditions":"Iron-deficiency","enrollment":50},{"nctId":"NCT07163390","phase":"NA","title":"Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy","status":"NOT_YET_RECRUITING","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2025-09-15","conditions":"Anemia, Iron Deficiency, Pregnancy Anemia","enrollment":82},{"nctId":"NCT06970925","phase":"EARLY_PHASE1","title":"Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac Surgery","status":"RECRUITING","sponsor":"Englewood Hospital and Medical Center","startDate":"2025-06-30","conditions":"Cardiac Surgery","enrollment":40},{"nctId":"NCT07038330","phase":"PHASE4","title":"DOSE FINDING PROSPECTIVE ANALYSIS AFTER HEART SURGERY for Sucrosomial Iron","status":"NOT_YET_RECRUITING","sponsor":"Cardiochirurgia E.H.","startDate":"2025-06-23","conditions":"Anemia","enrollment":150},{"nctId":"NCT03833336","phase":"PHASE3","title":"Effects of Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)","status":"COMPLETED","sponsor":"Institut de Recerca Biomèdica de Lleida","startDate":"2017-08-23","conditions":"Heart Failure With Normal Ejection Fraction, Ferropenic Anemia","enrollment":72},{"nctId":"NCT05678647","phase":"NA","title":"Sucrosomial Iron and Iron Sulphate to Blood Donors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Uppsala University Hospital","startDate":"2023-01-31","conditions":"Blood Donation","enrollment":120},{"nctId":"NCT05985070","phase":"NA","title":"Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"Liaquat University of Medical & Health Sciences","startDate":"2023-07-17","conditions":"Iron Deficiency, Iron Deficiency Anemia","enrollment":59},{"nctId":"NCT05989984","phase":"NA","title":"Efficacy Evaluation of an ODF Iron Supplement Vs an Iron Supplement in Capsules in Subjects with Mild Anemia","status":"COMPLETED","sponsor":"IBSA Farmaceutici Italia Srl","startDate":"2023-07-29","conditions":"Iron Deficiencies","enrollment":23},{"nctId":"NCT06279429","phase":"NA","title":"Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia","status":"UNKNOWN","sponsor":"Kuang Tien General Hospital","startDate":"2022-05-31","conditions":"CKD, Sleep Disorder","enrollment":100},{"nctId":"NCT05225545","phase":"PHASE3","title":"Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis","status":"UNKNOWN","sponsor":"American University of Beirut Medical Center","startDate":"2019-11-04","conditions":"Anemia, Iron Deficiency, Ulcerative Colitis","enrollment":30},{"nctId":"NCT05702970","phase":"PHASE4","title":"Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency","status":"UNKNOWN","sponsor":"University of Padova","startDate":"2024-01-15","conditions":"Heart Failure, Iron-deficiency, Heart Failure, Systolic","enrollment":258},{"nctId":"NCT04078880","phase":"NA","title":"Iron Supplementation in Hip/Knee Surgery","status":"COMPLETED","sponsor":"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","startDate":"2018-12-04","conditions":"Orthopedic Disorder, Hip Arthropathy, Knee Arthropathy","enrollment":82},{"nctId":"NCT05660200","phase":"NA","title":"Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of an ODF Iron Supplement vs an Iron Supplement in Capsules","status":"COMPLETED","sponsor":"IBSA Farmaceutici Italia Srl","startDate":"2022-11-25","conditions":"Iron-deficiency","enrollment":9},{"nctId":"NCT04587141","phase":"PHASE3","title":"Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial","status":"UNKNOWN","sponsor":"Fondazione IRCCS Policlinico San Matteo di Pavia","startDate":"2020-01-01","conditions":"Iron Deficiency Anemia, Inflammatory Bowel Diseases","enrollment":300},{"nctId":"NCT03560687","phase":"NA","title":"CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation Before Heart Surgery","status":"COMPLETED","sponsor":"Cardiochirurgia E.H.","startDate":"2018-10-15","conditions":"Anemia","enrollment":1023},{"nctId":"NCT02916654","phase":"NA","title":"Sucrosomial Iron in Patients With Celiac Disease and IDA","status":"UNKNOWN","sponsor":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","startDate":"2015-04","conditions":"Celiac Disease, Iron Deficiency Anemia","enrollment":20}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"COVID-19"}],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["CardioSideral","Sideral Forte","SiderAl Forte","Sideral","SiderAl Forte®"],"phase":"marketed","status":"active","brandName":"Sucrosomial Iron","genericName":"Sucrosomial Iron","companyName":"Cardiochirurgia E.H.","companyId":"cardiochirurgia-e-h","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sucrosomial iron delivers iron as a ferric hydroxide complex encapsulated in a sucrose-based matrix to improve absorption and reduce gastrointestinal side effects. Used for Iron deficiency anemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}