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
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 | 2021-12-15 |
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
No data
Clinical
Clinical Trials
27 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 | HP_0000989 | L29 | — | 4 | 3 | — | — | 7 |
Chronic renal insufficiency | D051436 | N18 | — | 1 | 2 | — | — | 3 | |
Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Acute pain | D059787 | R52 | — | 2 | — | — | — | 2 | |
Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | — | — | — | 1 |
Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | 1 | — | — | — | 1 |
Arthritis | D001168 | EFO_0005856 | 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 | ||
Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | — | 1 |
Postoperative pain | D010149 | G89.18 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
Renal dialysis | D006435 | EFO_0010690 | Z99.2 | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
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 analgesic opioid peptide used for the treatment of moderate to severe itching. It acts as a peripherally specific, 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
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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