Korsuva, Kapruvia(difelikefalin)
Kapruvia, Korsuva (difelikefalin) is a protein pharmaceutical. Difelikefalin was first approved as Korsuva on 2021-08-23. It is used to treat pruritus in the USA. It has been approved in Europe to treat pruritus. The pharmaceutical is active against kappa-type opioid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Korsuva
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| korsuva | New Drug Application | 2025-08-26 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DIFELIKEFALIN ACETATE, KORSUVA, CARA THERAP | |||
| 2026-08-23 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Difelikefalin Acetate, Korsuva, Cara Therap | |||
| 7402564 | 2027-11-12 | DS, DP | U-3204 |
| 7713937 | 2027-11-12 | DS, DP | U-3204 |
| 7727963 | 2027-11-12 | DS, DP | U-3204 |
| 8217007 | 2027-11-12 | U-3204 | |
| 8236766 | 2027-11-12 | U-3204 | |
| 8486894 | 2027-11-12 | U-3204 | |
| 8536131 | 2027-11-12 | DS, DP | U-3204 |
| 9334305 | 2027-11-12 | U-3204 | |
| 9359399 | 2027-11-12 | U-3204 | |
| 10017536 | 2027-11-12 | DP | U-3204 |
| 10138270 | 2027-11-12 | U-3204 | |
| 10793596 | 2027-11-12 | DS, DP | U-3204 |
HCPCS
Code | Description |
|---|---|
| J0879 | Injection, difelikefalin, 0.1 microgram, (for esrd on dialysis) |
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pruritus | D011537 | — | L29 | — | 9 | 9 | — | 1 | 17 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 2 | 2 | — | — | 5 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 2 | 2 | — | — | 4 |
| Back pain | D001416 | — | M54 | — | 2 | 1 | — | — | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | 1 | — | — | 2 |
| Eczema | D004485 | — | L30.9 | — | 1 | 1 | — | — | 2 |
| Dermatitis | D003872 | — | L30.9 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | 2 | — | — | — | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 2 | — | — | — | 2 |
| Acute pain | D059787 | — | R52 | — | 2 | — | — | — | 2 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | — | — | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | 1 | — | — | — | 1 |
| Rheumatic diseases | D012216 | — | M79.0 | — | 1 | — | — | — | 1 |
| Joint diseases | D007592 | — | M12.9 | — | 1 | — | — | — | 1 |
| Musculoskeletal diseases | D009140 | — | — | — | 1 | — | — | — | 1 |
| Collagen diseases | D003095 | — | — | — | 1 | — | — | — | 1 |
| Biliary liver cirrhosis | D008105 | — | K74.3 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 2 | — | — | — | — | 2 |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | 2 | — | — | — | — | 2 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Difelikefalin |
| INN | difelikefalin |
| Description | Difelikefalin, sold under the brand name Korsuva, is an opioid peptide used for the treatment of moderate to severe itch. It acts as a peripherally-restricted, highly selective agonist of the κ-opioid receptor (KOR).
|
| Classification | Protein |
| Drug class | enkephalin agonists (various indications) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)C[C@@H](NC(=O)[C@@H](Cc1ccccc1)NC(=O)[C@H](N)Cc1ccccc1)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(C(=O)O)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 1024828-77-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989915 |
| ChEBI ID | — |
| PubChem CID | 24794466 |
| DrugBank | DB11938 |
| UNII ID | NA1U919MRO (ChemIDplus, GSRS) |
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Safety
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344 adverse events reported
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