Difelikefalin
As of the edition of 20 October 2026, Difelikefalin is a protein: marketed, first approved in 2021 (US); acts on OPRK1; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Protein
- Brand name
- Korsuva
- First approved
- 23 August 2021 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Vifor Fresenius Medical Care Renal Pharma; 2 holders in all
- Registered trials
- 21, 3 stopped early
- Disease areas
- Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive; Immune system; Inherited and neonatal
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by CSL Behring.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product7 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Difelikefalin.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OPRK1 | Kappa-type opioid receptor | P41145 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 7 | 6 | 1 | 0 |
| Phase 3 | 8 | 5 | 0 | 3 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cara Therapeutics | Originator and Lead sponsor of trials | 2019 to now |
| Vifor Fresenius Medical Care Renal Pharma | Applicant and Lead sponsor of trials | 2022 to now |
| CSL Behring | Acquired holder | 2025 to now |