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
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Difelikefalin acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KORSUVA | Cara Therapeutics | N-214916 RX | 2021-08-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| korsuva | New Drug Application | 2024-08-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pruritus | HP_0000989 | D011537 | L29 |
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
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pruritus | D011537 | HP_0000989 | L29 | — | 9 | 11 | — | 1 | 19 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 2 | 2 | — | — | 5 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 2 | 2 | — | — | 4 |
| Back pain | D001416 | HP_0003418 | M54 | — | 2 | 1 | — | — | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | 1 | — | — | 2 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | 1 | 1 | — | — | 2 |
| Dermatitis | D003872 | HP_0011123 | 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 | HP_0001369 | M05-M14 | — | 1 | — | — | — | 1 |
| Rheumatic diseases | D012216 | — | M79.0 | — | 1 | — | — | — | 1 |
| Joint diseases | D007592 | HP_0003040 | 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 | N18.9 | 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) |
Target
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Trends
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Additional graphs summarizing 229 documents
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Safety
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Adverse Events
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201 adverse events reported
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