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CR845
CR845 is a selective kinin B1 receptor antagonist that blocks inflammatory signaling to reduce pruritus and other inflammatory symptoms.
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).
At a glance
| Generic name | CR845 |
|---|---|
| Also known as | 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 |
| Sponsor | Cara Therapeutics, Inc. |
| Drug class | Kinin B1 receptor antagonist |
| Target | Bradykinin B1 receptor |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Nephrology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Moderate-to-severe pruritus in patients with chronic kidney disease on hemodialysis
- Pruritus associated with atopic dermatitis (exploratory)
Common side effects
- Headache
- Diarrhea
- Nausea
- Hyperkalemia
Key clinical trials
- Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (PHASE2, PHASE3)
- CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus (PHASE3)
- 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 (PHASE3)
- A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus (PHASE2)
- Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus (PHASE2)
- Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT) (PHASE2)
- CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CR845 CI brief — competitive landscape report
- CR845 updates RSS · CI watch RSS
- Cara Therapeutics, Inc. portfolio CI