At a glance
- Difelikefalin is an FDA-approved drug, marketed as Korsuva, Difelikefalin (first approval: August 23, 2021).
- PubMed lists 133 publications mentioning it, including 12 randomized controlled trials and 6 animal-only studies.
- ClinicalTrials.gov lists 28 registered studies testing it (2 active).
- FDA's adverse event system (FAERS) holds 418 reports mentioning it; 299 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA214916 | KORSUVA | Approved, marketed | August 23, 2021 | VIFOR INTL |
| ANDA220919 | DIFELIKEFALIN ACETATE | Approved, marketed | August 31, 2026 | QILU PHARM HAINAN |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Efficacy and Safety of Switching from Nalfurafine to Difelikefalin in Hemodialysis Patients with Refractory Pruritus.
- The pharmacokinetics of a single intravenous dose of difelikefalin in adolescents aged 12 to 17 years on hemodialysis.
- Chronic Kidney Disease-Associated Pruritus in Danish Dialysis Patients: A Cross-Sectional Multicenter Study of Prevalence, Disease Burden, and Current Treatment Practices.
- Real-world effectiveness and safety of difelikefalin for chronic kidney disease-associated pruritus: a systematic review.
- Difelikefalin Treatment in Chronic Kidney Disease-Associated Pruritus: Modelling Infection-Related Hospitalisation Cost Offsets Using Trial and Real-World Data Across Seven European Countries.
- The neuroimmune architecture of uremic pruritus: mechanisms and therapeutic targeting.
- Pharmacology of pruritus (pathophysiology, therapeutic targets).
- Difelikefalin-associated adverse drug event signals: a real-world pharmacovigilance study from the FAERS database.
- JAAD Game Changer: A phase 2 study of oral difelikefalin in subjects with chronic kidney disease and moderate-to-severe pruritus.
- Development of a SMEDDS for oral delivery of hydrophilic peptide difelikefalin acetate: Preparation, characterization, and PK/PD evaluation.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 28
- Active
- 2
- With posted results
- 12
Conditions studied
Show 18 more studies
All 28 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 418
- Serious
- 299
- With death outcome
- 68
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.