Product Description
Difelikefalin is a peripherally restricted and selective agonist of kappa opioid receptors that are considered to be important in modulating pruritus in conditions such as chronic kidney disease.
Mechanisms of Action: OPRK Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous,Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Hungary | Iceland | Ireland | Italy | Lithuania | Norway | Poland | Portugal | Singapore | Slovakia | Sweden | United Arab Emirates | United Kingdom | United States
Approved Indications: Pruritus | Kidney Diseases
Known Adverse Events: Dizziness | Headache | Hyperkalemia | Diarrhea
Company: Cara
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, China, Japan, United States
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Kidney Diseases|Pruritus
Phase 2: Back Pain|Kidney Failure, Chronic
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| KOR-PED-202 | P2 |
Not yet recruiting |
Kidney Failure, Chronic|Pruritus |
2029-08-30 |
|
| KOR-CHINA-301 | P3 |
Active, not recruiting |
Pruritus |
2025-07-01 |
86% |
| 2022-000149-34 | P3 |
Active, not recruiting |
Kidney Diseases |
2024-08-16 |
|
| KOR-CHINA-101 | P1 |
Completed |
Kidney Failure, Chronic |
2023-10-09 |
21% |