Cara Therapeutics

Cara Therapeutics is a biopharmaceutical company focused on developing and commercializing treatments for pruritus (itching) by selectively targeting peripheral kappa opioid receptors (KORs). The company was founded in 2004 by Dr. Derek T. Chalmers, Dr. Michael E. Lewis, and Dr. Frédérique Menzaghi. Dr. Chalmers, who has a background in pharmacology, co-founded Arena Pharmaceuticals before establishing Cara Therapeutics. The company initially focused on developing therapeutics for pain and inflammation but shifted its focus to pruritus after its lead drug candidate showed promise in alleviating itch.

The company's lead product is KORSUVA™ (difelikefalin), a first-in-class KOR agonist. In August 2021, the U.S. Food and Drug Administration (FDA) approved the intravenous (IV) formulation of KORSUVA™ for treating moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing hemodialysis. This was the first and only therapy approved by the FDA for this specific condition. The approval was based on positive data from two Phase III trials, KALM-1 and KALM-2, which demonstrated significant reductions in itch intensity and improvements in quality of life. The drug works by activating KORs on peripheral sensory neurons and immune cells, which helps to reduce the transmission of itch signals and inflammation without causing the central nervous system side effects associated with typical opioids. Cara Therapeutics has also been developing an oral formulation of difelikefalin for other conditions, including atopic dermatitis and notalgia paresthetica.

Cara Therapeutics generates revenue through collaborations, commercial supply, and royalties from its partnerships. It has licensing agreements with Vifor Pharma (now CSL Vifor) and Fresenius Medical Care for the commercialization of IV KORSUVA™ globally, excluding the U.S., Japan, and South Korea, under various profit-sharing arrangements. It also has agreements with Maruishi Pharmaceutical for Japan and Chong Kun Dang Pharmaceutical for South Korea.

In late 2024, facing financial difficulties, Cara Therapeutics announced a reverse merger agreement with Tvardi Therapeutics, a Houston-based biopharmaceutical firm. The merger, expected to close in 2025, will result in the combined company operating under the Tvardi Therapeutics name and trading under the ticker symbol “TVRD”. The new entity will focus on advancing Tvardi's pipeline, which is centered on treatments for fibrosis-driven diseases.

Keywords: pruritus, difelikefalin, KORSUVA, kappa opioid receptor agonist, chronic kidney disease, hemodialysis, biopharmaceutical, antipruritic, CKD-aP, peripheral nervous system, Vifor Pharma, CSL Vifor, Fresenius Medical Care, notalgia paresthetica, atopic dermatitis, reverse merger, Tvardi Therapeutics, drug development, clinical trials, FDA approval