Lexicon Pharmaceuticals, Inc.

The company is a biopharmaceutical company focused on developing and commercializing medicines. It primarily allocates resources to the research and development of its advanced drug candidates and the commercialization of its approved drug, INPEFA® (sotagliflozin). The company is developing sotagliflozin, an orally-delivered small molecule drug candidate, for hypertrophic cardiomyopathy (HCM) and is conducting the SONATA-HCM pivotal Phase 3 clinical trial for this indication. Separately, the company is seeking regulatory approval for ZYNQUISTA® (sotagliflozin) to treat type 1 diabetes. The U.S. Food and Drug Administration (FDA) issued complete response letters for the New Drug Application (NDA) for ZYNQUISTA in type 1 diabetes in March 2019 and December 2024. A public Notice of Opportunity for Hearing (NOOH) is ongoing regarding the NDA. The FDA has indicated that a third-party-funded, investigator-initiated study of sotagliflozin could provide evidence of diabetic ketoacidosis (DKA) incidence and safety data to support a resubmission of the NDA. The company is preparing for a potential resubmission if supported by patient exposure and safety data from this study. Additionally, the company is developing pilavapadin, an orally-delivered small molecule drug candidate, for neuropathic pain. It has completed two Phase 2 clinical trials evaluating pilavapadin for diabetic peripheral neuropathic pain (DPNP). Results from the PROGRESS Phase 2b clinical trial showed evidence of effect at the 10 mg dose, and the RELIEF-DPN-1 Phase 2a clinical trial yielded positive results. The FDA has granted Fast Track designation for pilavapadin in this indication, and the company is pursuing third-party collaboration for its further development and commercialization.