kappa opioid receptor agonist
Difelikefalin
Answer
Difelikefalin is authorised or registered in the US, the EU, the UK, Canada, Australia, Switzerland and Singapore: 7 of the 10 registers read. Highest trial phase: Phase 3 (1 phase 3 trial, 0 with posted results). It has 25 registered trials, 2 of them running. Brand names on the FDA label register: Korsuva.
RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03
Not medical, legal or regulatory advice.
25 trials by status
Trial registerClinicalTrials.gov and EU CTIS · read 2026-10-03 · 2 trials have posted results
Trials first submitted per year
Trial registerClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 2026 is not complete. 2 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).
Status by jurisdiction
World map| Where | Status | Register | Read |
|---|---|---|---|
| United States | FDA-approved | FDA, openfda | 2026-10-03 |
| European Union | Authorised | EMA, ema | 2026-10-03 |
| United Kingdom | Authorised | MHRA, uk-mhra | 2026-10-03 |
| Canada | Authorised | Health Canada, ca-dpd | 2026-10-03 |
| Australia | Registered | TGA, au-artg | 2026-10-03 |
| Switzerland | Authorised | Swissmedic, ch-swissmedic | 2026-10-03 |
| Brazil | Not on the register | ANVISA, br-anvisa | 2026-09-03 |
| Serbia | Not on the register | ALIMS, rs-alims | 2026-09-03 |
| Singapore | Registered | HSA, sg-hsa | 2026-09-03 |
| Turkey | Not on the register | TITCK, tr-titck | 2026-09-03 |
An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.
Side effects
Trial registerCHANGE ALERTS
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One email when the status of Difelikefalin changes on the register. You confirm your address first.
REGISTERED TRIALS
Newest 10 of 25 trials
| NCT06593392 | Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus currently recruiting participants · register updated 2026-09-01 |
|---|---|
| 2023-509909-74-00 | An Open-label, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 no status recorded · register updated 2026-08-24 |
| NCT07526324 | Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease not yet recruiting participants · register updated 2026-04-13 |
| NCT05885737 | Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus completed · register updated 2025-09-12 |
| NCT05885763 | Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis completed · register updated 2025-02-14 |
| NCT05978063 | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthe terminated before completion · register updated 2024-06-21 |
| NCT05342623 | A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe P terminated before completion · register updated 2024-05-07 |
| NCT05356403 | CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Modera terminated before completion · register updated 2024-05-07 |
| 2023-503957-36-00 | A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Se no status recorded · register updated 2024-04-29 |
| NCT05387707 | Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Sev terminated before completion · register updated 2024-02-22 |
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New trials, approvals and enforcement actions. One email a week.