Product Description
Difelikefalin is a medication used to treat and manage uremic pruritis and postoperative pain, affecting patients' quality of life. Difelikefalin is in the opioid class of drugs and works as a selective kappa-opioid receptor agonist; alternative names for difelikefalin include 4-amino-1-(D-phenylalanyl-D-phenylalanyl-D-leucyl-D-lysyl)piperidine-4-carboxylic acid, CKD-943, MR13A9, FE202845, and CR 845. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK574566/)
Mechanisms of Action: OPRK Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous, Oral
FDA Designation: *
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: None
Known Adverse Events: None
Company: Cara
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, Germany, Greece, Japan, Poland, Spain, United Kingdom
Active Clinical Trial Count: 9
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Cara presented P2 Pruritus results on 2024-06-12 for Difelikefalin
- Clinical Outcomes Reported - Cara announced they will present P3 Pruritus results in 3Q24 for Difelikefalin
- Clinical Outcomes Reported - Cara announced they will present P2 Notalgia Paresthetica results in 3Q24 for Difelikefalin
Highest Development Phases
Phase 3: Kidney Diseases|Pruritus
Phase 2: Kidney Failure, Chronic
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| KOR-PED-202 | P2 |
Recruiting |
Pruritus|Kidney Failure, Chronic |
2029-08-30 |
50% |
2025-03-18 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| KOR-PED-202 | P2 |
Not yet recruiting |
Pruritus|Kidney Diseases |
2029-08-30 |
2025-05-02 |
Treatments |
|
| Pharmacokinetics and Safety of Difelikefalin in Adolescents on Haemodialysis | P2 |
Active, not recruiting |
Kidney Diseases |
2021-10-08 |
2022-03-13 |
Treatments |
|
| KOR-CHINA-301 | P3 |
Completed |
Pruritus |
2024-09-25 |
31% |
2025-09-13 |
|
| 2022-000149-34 | P3 |
Active, not recruiting |
Kidney Diseases |
2024-08-16 |
|||
| CR845-310601 | P3 |
Completed |
Pruritus |
2024-06-12 |
2025-05-02 |
Treatments |
|
| CTR20220839 | P1 |
Completed |
Pruritus|Kidney Diseases |
2023-12-29 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
| jRCT2011200021 | P3 |
Active, not recruiting |
Pruritus |
2023-01-31 |
|||
| KOR-CHINA-101 | P1 |
Completed |
Kidney Failure, Chronic |
2023-10-09 |
23% |
2024-06-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/14/2025 |
News Article |
Cara Therapeutics Announces 1-for-3 Reverse Stock Split in Connection with the Proposed Merger with Tvardi Therapeutics |
|
12/27/2024 |
News Article |
Cara Therapeutics Announces Effective Date of 1-for-12 Reverse Stock Split |
|
12/18/2024 |
News Article |
Cara Therapeutics and Tvardi Therapeutics Announce Entry into Merger Agreement |
|
07/11/2024 |
News Article |
Cara Therapeutics Announces Exploration of Strategic Alternatives |