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Difelikefalin Injection
Difelikefalin is a selective agonist of the peripheral kinin B1 receptor that reduces pruritus by modulating inflammatory pathways in patients with chronic kidney disease.
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.
At a glance
| Generic name | Difelikefalin Injection |
|---|---|
| Sponsor | Vifor Fresenius Medical Care Renal Pharma |
| Drug class | Kinin B1 receptor agonist |
| Target | Kinin B1 receptor (B1R) |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Moderate-to-severe pruritus in patients with chronic kidney disease on hemodialysis
Common side effects
- Hyperkalemia
- Hypotension
- Injection site reactions
- Headache
Key clinical trials
- Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus (PHASE3)
- Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis (PHASE1)
- CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients (PHASE1)
- Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects (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:
- Difelikefalin Injection CI brief — competitive landscape report
- Difelikefalin Injection updates RSS · CI watch RSS
- Vifor Fresenius Medical Care Renal Pharma portfolio CI