Difelikefalin
Also referenced as: Korsuva
A peripherally selective kappa-opioid receptor agonist used for a defined chronic-kidney-disease itch indication.
- Evidence grade
- AStrong Clinical Evidence
Strong Clinical Evidence
- Regulatory status
- FDA Approved for Specific Indication
Korsuva is FDA-approved for moderate-to-severe CKD-associated pruritus in adults undergoing hemodialysis.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A peripherally selective kappa-opioid receptor agonist used for a defined chronic-kidney-disease itch indication.
Korsuva is FDA-approved for moderate-to-severe CKD-associated pruritus in adults undergoing hemodialysis.
The indication does not cover every cause of itching or all kidney-disease populations.
Why It's Being Studied
- CKD-associated pruritus
- Peripheral itch signalling
Mechanism of Action
It activates peripheral kappa-opioid receptors to reduce itch-related signalling rather than acting as an ordinary cosmetic skin peptide.
It activates peripheral kappa-opioid receptors to reduce itch-related signalling rather than acting as an ordinary cosmetic skin peptide. The indication does not cover every cause of itching or all kidney-disease populations.
From molecular target to clinical evidence
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Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- CKD-associated pruritus
- Peripheral itch signalling
- Intravenous approved medicine in hemodialysis
Evidence Summary
Human trials support moderate-to-severe CKD-associated pruritus in adults receiving hemodialysis.
Higher tiers carry more weight. Filled tiers have evidence for Difelikefalin; tap to read it.
- Human trials support moderate-to-severe CKD-associated pruritus in adults receiving hemodialysis.
1 cited sources.
- Prescribing label1
Human clinical evidence
- Human trials support moderate-to-severe CKD-associated pruritus in adults receiving hemodialysis.
Reported Adverse Events in Research
- Dizziness, somnolence, altered mental status and falls are significant adverse effects.
Limitations of Current Evidence
- The indication does not cover every cause of itching or all kidney-disease populations.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Difelikefalin | Trofinetide | |
|---|---|---|
| Evidence grade | A — Strong Clinical Evidence | B — Moderate Human Evidence |
| Regulatory status | FDA Approved for Specific Indication | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Intravenous approved medicine in hemodialysis | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Prescribing label
Difelikefalin — prescribing label