{"id":"duloxetine-hydrochloride-enteric-capsules","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Nausea"},{"rate":"10-15","effect":"Dizziness"},{"rate":"10-15","effect":"Somnolence"},{"rate":"10-15","effect":"Dry mouth"},{"rate":"10-15","effect":"Constipation"},{"rate":"8-12","effect":"Fatigue"},{"rate":"10-15","effect":"Headache"},{"rate":"8-12","effect":"Insomnia"},{"rate":"5-10","effect":"Sexual dysfunction"}]},"_chembl":{"chemblId":"CHEMBL1200328","moleculeType":"Small molecule","molecularWeight":"333.88"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting the reuptake of both serotonin and norepinephrine, duloxetine increases the concentration of these neurotransmitters in synaptic spaces, enhancing their signaling. This dual mechanism is thought to improve mood regulation and pain perception. The enteric coating formulation delays release until the drug reaches the small intestine, potentially improving tolerability and reducing gastrointestinal side effects.","oneSentence":"Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases levels of serotonin and norepinephrine in the central nervous system by blocking their reuptake at the presynaptic membrane.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:10:19.676Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Major depressive disorder"},{"name":"Generalized anxiety disorder"},{"name":"Diabetic peripheral neuropathic pain"},{"name":"Fibromyalgia"},{"name":"Chronic musculoskeletal pain"}]},"trialDetails":[{"nctId":"NCT06842992","phase":"PHASE2","title":"A Phase II Study to Evaluate NH102 for Depression","status":"COMPLETED","sponsor":"Jiangsu Nhwa Pharmaceutical Co., Ltd.","startDate":"2024-12-04","conditions":"Major Depressive Disorder (MDD)","enrollment":243},{"nctId":"NCT07253207","phase":"PHASE3","title":"Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder","status":"COMPLETED","sponsor":"Zhejiang Huahai Pharmaceutical Co., Ltd.","startDate":"2024-10-17","conditions":"Major Depressive Disorder (MDD)","enrollment":392},{"nctId":"NCT06259526","phase":"PHASE2","title":"A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression","status":"COMPLETED","sponsor":"Tasly Pharmaceutical Group Co., Ltd","startDate":"2023-12-26","conditions":"Depression","enrollment":267},{"nctId":"NCT04364997","phase":"PHASE3","title":"Study of Desvenlafaxine in Treating Major Depressive Disorder.","status":"COMPLETED","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2020-06-18","conditions":"Major Depressive Disorder","enrollment":420},{"nctId":"NCT05018013","phase":"PHASE2","title":"Study of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression","status":"UNKNOWN","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2021-08-21","conditions":"Major Depressive Disorder (MDD)","enrollment":240},{"nctId":"NCT04751318","phase":"PHASE1","title":"Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions","status":"COMPLETED","sponsor":"Laboratorios Andromaco S.A.","startDate":"2021-02-27","conditions":"Bioequivalence","enrollment":36},{"nctId":"NCT04723238","phase":"PHASE1","title":"Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions","status":"COMPLETED","sponsor":"Laboratorios Andromaco S.A.","startDate":"2021-01-23","conditions":"Bioequivalence","enrollment":36}],"_emaApprovals":[],"_faersSignals":[],"_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":[],"phase":"phase_3","status":"active","brandName":"Duloxetine Hydrochloride Enteric Capsules","genericName":"Duloxetine Hydrochloride Enteric Capsules","companyName":"Zhejiang Huahai Pharmaceutical Co., Ltd.","companyId":"zhejiang-huahai-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) that increases levels of serotonin and norepinephrine in the central nervous system by blocking their reuptake at the presynaptic membrane. Used for Major depressive disorder, Generalized anxiety disorder, Diabetic peripheral neuropathic pain.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}