Difelikefalin is under clinical development by Cara Therapeutics and currently in Phase III for Pruritus. According to GlobalData, Phase III drugs for Pruritus have a 60% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Difelikefalin’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Difelikefalin overview

Difelikefalin Acetate (Korsuva, Kapruvia) is a antipruritic agent. It is formulated as solution for intravenous route of administration. It is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.

Difelikefalin is under development for the treatment of acute postoperative pain in Hallux valgus (Bunion), pruritis associated with atopic dermatitis and chronic kidney disease, chronic and acute pain, somato-visceral inflammatory pain, osteoarthritis pain, chronic, acute inflammatory pain and neuropathic pain and primary biliary cholangitis (PBC) associated with moderate-to-severe pruritus. The drug candidate is administered through intravenous and oral route. The drug candidate is a new chemical entity (NCE) and a hydrophilic tetrapeptide. It acts by targeting kappa opioid receptor. The drug candidate is based on DimerScreen technology.

Cara Therapeutics overview

Cara Therapeutics is a biotechnology company. It develops and commercializes chemical entities. The company offers kappa opioid receptor agonists in the therapeutic areas of acute pain, chronic pain, neuropathic pain and pruritus. Its lead product candidate includes KORSUVA injection, under phase-II clinical trial to treat patients with chronic kidney disease that is associated with pruritus undergoing hemodialysis; chronic liver disease-associated pruritus and pruritus associated with atopic dermatitis. The company’s other product candidate includes CR845 / IV Difelikefalin, which peripherally modulates kappa receptor signals without opioid receptors’ activation in CNS. Cara Therapeutics is headquartered in Stamford, Connecticut, the US.

For a complete picture of Difelikefalin’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.