{"id":"cr845","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Hyperkalemia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CR845 selectively antagonizes the bradykinin B1 receptor, which is upregulated in inflammatory conditions and plays a key role in itch sensation and inflammatory responses. By blocking this receptor, the drug reduces the transmission of itch signals and inflammatory mediators. This mechanism makes it particularly relevant for conditions characterized by chronic pruritus, especially in patients with kidney disease.","oneSentence":"CR845 is a selective kinin B1 receptor antagonist that blocks inflammatory signaling to reduce pruritus and other inflammatory symptoms.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:07:52.121Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate-to-severe pruritus in patients with chronic kidney disease on hemodialysis"},{"name":"Pruritus associated with atopic dermatitis (exploratory)"}]},"trialDetails":[{"nctId":"NCT05978063","phase":"PHASE2, PHASE3","title":"Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica","status":"TERMINATED","sponsor":"Cara Therapeutics, Inc.","startDate":"2023-08-01","conditions":"Pruritus, Notalgia Paresthetica","enrollment":214},{"nctId":"NCT05356403","phase":"PHASE3","title":"CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus","status":"TERMINATED","sponsor":"Cara Therapeutics, Inc.","startDate":"2022-08-26","conditions":"Chronic Kidney Diseases, Pruritus","enrollment":105},{"nctId":"NCT05342623","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus","status":"TERMINATED","sponsor":"Cara Therapeutics, Inc.","startDate":"2022-05-17","conditions":"Chronic Kidney Diseases, Pruritus","enrollment":286},{"nctId":"NCT05387707","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis","status":"TERMINATED","sponsor":"Cara Therapeutics, Inc.","startDate":"2022-08-16","conditions":"Pruritus, Atopic Dermatitis","enrollment":287},{"nctId":"NCT03617536","phase":"PHASE2","title":"A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2018-07-05","conditions":"Chronic Kidney Diseases, Pruritus","enrollment":269},{"nctId":"NCT03995212","phase":"PHASE2","title":"Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus","status":"TERMINATED","sponsor":"Cara Therapeutics, Inc.","startDate":"2019-06-25","conditions":"Cholestatic Pruritus","enrollment":14},{"nctId":"NCT04706975","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2021-01-11","conditions":"Pruritus, Notalgia Paresthetica","enrollment":126},{"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":"NCT05031546","phase":"","title":"Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin","status":"APPROVED_FOR_MARKETING","sponsor":"Cara Therapeutics, Inc.","startDate":"","conditions":"Uremic Pruritus","enrollment":""},{"nctId":"NCT03636269","phase":"PHASE3","title":"CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2018-07-17","conditions":"Uremic Pruritus","enrollment":473},{"nctId":"NCT03422653","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2018-02-20","conditions":"Uremic Pruritus","enrollment":378},{"nctId":"NCT04018027","phase":"PHASE2","title":"Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2019-06-29","conditions":"Pruritus, Atopic Dermatitis","enrollment":401},{"nctId":"NCT03998163","phase":"PHASE3","title":"CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2019-05-06","conditions":"Uremic Pruritus","enrollment":222},{"nctId":"NCT03281538","phase":"PHASE3","title":"Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2017-08-14","conditions":"Uremic Pruritus","enrollment":288},{"nctId":"NCT02944448","phase":"PHASE2","title":"A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2016-09","conditions":"Osteoarthritis, Hip, Osteoarthritis, Knee, Arthritis","enrollment":761},{"nctId":"NCT02858726","phase":"PHASE2, PHASE3","title":"Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2016-06","conditions":"Uremic Pruritus","enrollment":226},{"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},{"nctId":"NCT03947970","phase":"PHASE1","title":"Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2019-01-17","conditions":"Hemodialysis, Healthy","enrollment":12},{"nctId":"NCT02542384","phase":"PHASE2, PHASE3","title":"A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2015-09","conditions":"Post Abdominal Surgery Pain","enrollment":451},{"nctId":"NCT02524197","phase":"PHASE2","title":"A Study of the Safety and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or Knee","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2015-08","conditions":"Osteoarthritis","enrollment":81},{"nctId":"NCT02229929","phase":"PHASE2","title":"Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2014-07","conditions":"Pruritus, Uremic Pruritus","enrollment":89},{"nctId":"NCT00877799","phase":"PHASE2","title":"Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2009-03","conditions":"Acute Pain","enrollment":114},{"nctId":"NCT01789476","phase":"PHASE2","title":"A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2013-05","conditions":"Acute Pain","enrollment":51},{"nctId":"NCT01361568","phase":"PHASE2","title":"Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery","status":"COMPLETED","sponsor":"Cara Therapeutics, Inc.","startDate":"2011-07","conditions":"Postoperative Pain","enrollment":203}],"_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":["Cohort 1: CR845 0.024 mg/kg","Cohort 1: CR845 0.008 mg/kg","Cohort 2: CR845 0.040 mg/kg","Active treatment for post-operative pain","Preoperative Active Dose"],"phase":"phase_3","status":"active","brandName":"CR845","genericName":"CR845","companyName":"Cara Therapeutics, Inc.","companyId":"cara-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CR845 is a selective kinin B1 receptor antagonist that blocks inflammatory signaling to reduce pruritus and other inflammatory symptoms. Used for Moderate-to-severe pruritus in patients with chronic kidney disease on hemodialysis, Pruritus associated with atopic dermatitis (exploratory).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}