Last reviewed · How we verify
Korsuva (DIFELIKEFALIN)
Korsuva works by activating the kappa-type opioid receptor, which helps to reduce itching.
Korsuva (DIFELIKEFALIN) is a small molecule kappa opioid receptor agonist developed by CARA THERAPEUTICS INC and currently owned by Vifor Intl. It was FDA approved in 2021 for the treatment of pruritus associated with chronic kidney disease (CKD-aP). Korsuva works by activating the kappa-type opioid receptor, providing relief from itching. It is a patented medication with no generic manufacturers available. Key safety considerations include its mechanism of action, which may have implications for patients with a history of substance abuse.
At a glance
| Generic name | DIFELIKEFALIN |
|---|---|
| Sponsor | Vifor Intl |
| Drug class | Kappa Opioid Receptor Agonist |
| Target | Kappa-type opioid receptor |
| Modality | Recombinant protein |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2021 |
Mechanism of action
KORSUVA is kappa opioid receptor (KOR) agonist. The relevance of KOR activation to therapeutic effectiveness is not known.
Approved indications
- Pruritus associated with chronic kidney disease (CKD-aP)
Common side effects
- Diarrhea
- Dizziness
- Nausea
- Gait Disturbances
- Hyperkalemia
- Somnolence
- Mental Status Change
- Headache
- Falls
- Confusional state
Key clinical trials
- Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus (PHASE2)
- 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)
- 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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Korsuva CI brief — competitive landscape report
- Korsuva updates RSS · CI watch RSS
- Vifor Intl portfolio CI