Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Nov;81(16):1937-1944.
doi: 10.1007/s40265-021-01619-6.

Difelikefalin: First Approval

Emma D Deeks  1
Affiliations
Review

Difelikefalin: First Approval

Emma D Deeks. Drugs. 2021 Nov.

Abstract

Difelikefalin (Korsuva™) is a synthetic peptide agonist of the kappa opioid receptor being developed by Cara Therapeutics for the treatment of pruritus. In August 2021, intravenous difelikefalin was approved in the USA for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing haemodialysis. Intravenous difelikefalin has also been evaluated for CKD-associated pruritus in patients undergoing haemodialysis in various other countries, with Marketing Authorization Application under regulatory review in the EU and a phase III trial ongoing in Japan. Clinical studies of an oral formulation of difelikefalin have also been completed or are underway in pruritus indications, including pruritus associated with atopic dermatitis, notalgia paraesthetica or primary biliary cholangitis. This article summarizes the milestones in the development of difelikefalin leading to this first approval for CKD-associated pruritus in adults undergoing haemodialysis.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Phan NQ, Lotts T, Antal A, et al. Systemic kappa opioid receptor agonists in the treatment of chronic pruritus: a literature review. Acta Derm Venereol. 2012;92(5):555–60. - DOI
    1. Aldrich JV, McLaughlin JP. Opioid peptides: potential for drug development. Drug Discov Today Technol. 2011;9(1):e23–31. - DOI
    1. Albert-Vartanian A, Boyd MR, Hall AL, et al. Will peripherally restricted kappa-opioid receptor agonists (pKORAs) relieve pain with less opioid adverse effects and abuse potential? J Clin Pharm Ther. 2016;41(4):371–82. - DOI
    1. Vadivelu N, Huang Y, Mirante B, et al. Patient considerations in the use of tapentadol for moderate to severe pain. Drug Healthc Patient Saf. 2013;5:151–9. - DOI
    1. Pattinson KT. Opioids and the control of respiration. Br J Anaesth. 2008;100(6):747–58. - DOI

LinkOut - more resources