{"id":"octreotide-microspheres","safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal pain/discomfort"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Hyperglycemia"},{"rate":null,"effect":"Cholelithiasis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Octreotide is a synthetic somatostatin analog that activates somatostatin receptors (particularly SSTR2 and SSTR5) on neuroendocrine tumor cells and hormone-secreting cells. The microsphere formulation provides sustained release over weeks to months, allowing for less frequent dosing while maintaining therapeutic levels. This mechanism suppresses excessive hormone secretion (such as growth hormone, insulin, and vasoactive peptides) and directly inhibits tumor cell proliferation in neuroendocrine malignancies.","oneSentence":"Octreotide microspheres are a long-acting formulation of the somatostatin analog octreotide that binds somatostatin receptors to inhibit hormone secretion and tumor growth.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:47:18.258Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Neuroendocrine tumors (carcinoid syndrome, acromegaly, gastroenteropancreatic neuroendocrine tumors)"},{"name":"Variceal bleeding in portal hypertension"}]},"trialDetails":[{"nctId":"NCT07479784","phase":"PHASE3","title":"Octreotide Microspheres for Preventing Pancreatic Fistula","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2026-04-01","conditions":"Pancreatic Fistula","enrollment":230},{"nctId":"NCT06505395","phase":"PHASE2","title":"A Trial to Assess Efficacy, Safety, Pharmacokinetics of Octreotide Subcutaneous Injection in Patients With Gastroentero-pancreatic Neuroendocrine Tumor (GEP-NET)","status":"RECRUITING","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2024-07-30","conditions":"Gastrointestinal Neuroendocrine Pancreatic Tumor","enrollment":90},{"nctId":"NCT06300216","phase":"","title":"A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors","status":"NOT_YET_RECRUITING","sponsor":"Qilu Hospital of Shandong University","startDate":"2024-03-26","conditions":"Neuroendocrine Tumors","enrollment":500},{"nctId":"NCT06254235","phase":"PHASE1","title":"Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers","status":"COMPLETED","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2021-06-16","conditions":"Healthy Volunteers","enrollment":240},{"nctId":"NCT05761431","phase":"PHASE1","title":"A Single-dose Study of Octreotide Injection in Healthy Adult Subjects","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2023-03-02","conditions":"Acromegaly","enrollment":56},{"nctId":"NCT02294786","phase":"PHASE2","title":"Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2014-12-17","conditions":"Cancer","enrollment":62},{"nctId":"NCT00466856","phase":"PHASE2","title":"Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors","status":"TERMINATED","sponsor":"Vanderbilt-Ingram Cancer Center","startDate":"2003-12","conditions":"Head and Neck Cancer, Islet Cell Tumor, Metastatic Cancer","enrollment":10},{"nctId":"NCT00248157","phase":"PHASE3","title":"Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-11","conditions":"Diabetic Retinopathy","enrollment":105},{"nctId":"NCT00248131","phase":"PHASE3","title":"Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2005-11","conditions":"Diabetic Retinopathy","enrollment":260},{"nctId":"NCT00130845","phase":"PHASE3","title":"Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy","status":"COMPLETED","sponsor":"Novartis","startDate":"2000-02","conditions":"Diabetic Retinopathy","enrollment":312},{"nctId":"NCT00131144","phase":"PHASE3","title":"Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy","status":"COMPLETED","sponsor":"Novartis","startDate":"1999-11","conditions":"Diabetic Retinopathy","enrollment":583}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Octreotide Microspheres","genericName":"Octreotide Microspheres","companyName":"Shanghai Zhongshan Hospital","companyId":"shanghai-zhongshan-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Octreotide microspheres are a long-acting formulation of the somatostatin analog octreotide that binds somatostatin receptors to inhibit hormone secretion and tumor growth. Used for Neuroendocrine tumors (carcinoid syndrome, acromegaly, gastroenteropancreatic neuroendocrine tumors), Variceal bleeding in portal hypertension.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}