KORSUVA
Peakdifelikefalin
NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Aug 2021
Lifecycle
Peak
Competitive Pressure
15/100
Data completeness
5/8 — Partial
Priority Review
KORSUVA (difelikefalin) is (kor) agonist. Approved for moderate-to-severe pruritus associated with chronic kidney disease (ckd-ap) in adults undergoing hemodialysis (hd). First approved in 2021.
Drug data last refreshed 23h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KORSUVA (difelikefalin) is a kappa opioid receptor (KOR) agonist administered intravenously to treat moderate-to-severe pruritus (itching) associated with chronic kidney disease in hemodialysis patients. The precise mechanism by which KOR activation reduces pruritus remains unclear, though clinical benefit has been demonstrated in this specialized nephrology population.
LOE Approaching6.4 years to LOE
With patent expiry in late 2027 (~1.6 years remaining), the product is transitioning toward loss of exclusivity; commercial teams should expect modest-to-declining headcount and focus shifting to defensive strategies and pipeline transition planning.
Mechanism of Action
(KOR) agonist. The relevance of KOR activation to therapeutic effectiveness is not known.
Career Relevance
KORSUVA careers are concentrated in nephrology-focused commercial and medical affairs roles serving dialysis clinics and nephrologists. This represents a highly specialized niche career path with limited geographic footprint and narrowing opportunity as LOE approaches.
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.