{"id":"difelikefalin-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperkalemia"},{"rate":null,"effect":"Hypotension"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL3989915","moleculeType":"Protein","molecularWeight":"679.86"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Difelikefalin activates the B1 receptor on sensory nerves and immune cells, leading to anti-inflammatory signaling that alleviates itching associated with uremia. The drug works peripherally without significant central nervous system penetration, making it suitable for injection in dialysis patients. By targeting the kinin-kallikrein system, it addresses the underlying inflammatory mechanisms driving pruritus in chronic kidney disease.","oneSentence":"Difelikefalin is a selective agonist of the peripheral kinin B1 receptor that reduces pruritus by modulating inflammatory pathways in patients with chronic kidney disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:09:24.524Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate-to-severe pruritus in patients with chronic kidney disease on hemodialysis"}]},"trialDetails":[{"nctId":"NCT05885737","phase":"PHASE3","title":"Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus","status":"COMPLETED","sponsor":"Vifor Fresenius Medical Care Renal Pharma","startDate":"2023-05-18","conditions":"Uremic Pruritus","enrollment":260},{"nctId":"NCT05885763","phase":"PHASE1","title":"Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis","status":"COMPLETED","sponsor":"Vifor Fresenius Medical Care Renal Pharma","startDate":"2023-06-26","conditions":"End Stage Renal Disease on Hemodialysis","enrollment":30},{"nctId":"NCT05533008","phase":"PHASE1","title":"CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2019-12-31","conditions":"Hemodialysis","enrollment":35},{"nctId":"NCT04019574","phase":"PHASE1","title":"Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2019-06-20","conditions":"Healthy","enrollment":57}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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":"Difelikefalin Injection","genericName":"Difelikefalin Injection","companyName":"Vifor Fresenius Medical Care Renal Pharma","companyId":"vifor-fresenius-medical-care-renal-pharma","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Difelikefalin is a selective agonist of the peripheral kinin B1 receptor that reduces pruritus by modulating inflammatory pathways in patients with chronic kidney disease. Used for Moderate-to-severe pruritus in patients with chronic kidney disease on hemodialysis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}