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Lexicon’s ‘Get set go’ attitude after entering Phase 3

Lexicon Pharmaceuticals is moving its non-opioid pain drug pilavapadin into Phase 3 trials for diabetic nerve pain after positive discussions with the FDA.

Category: Health Published Date: 28 January 2026
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Introduction

Lexicon Pharmaceuticals entered the competition in 1995 with its excellent small molecule drugs harnessed with gene knockout technology. The main target of the company is chronic issues in oncology, neurology and cardiometabolism. Its popular products like LX9211 and INPEFA are a boon to the healthcare sector and a profitable area for the company as well.

Lexicon’s exclusive Genome5000™ program includes the study of around 5,000 genes to address around 100 therapeutic areas. Lexicon is dedicated and committed to most of the valuable partnerships to keep on upgrading its small molecule space and sharpen its strategy skills consistently.

Announcement

Lexicon Pharmaceuticals, after its successful meeting with the FDA regarding its completion of the Phase 2 study, is now excited and prepared to begin the Phase 3 study for its non-opioid analgesic pilavapadin. Apart from this, Lexicon recently finished its trading session at $1.56, nearly a 19% profit from its closing price.

Jefferies analyst analysis

According to Jefferies analysts, regulators can support the pilavapadin’s development by also promoting the use of non-opioid and other options in chronic pain indications. In an interaction with the investors, the analyst pointed out the published draft guidance, which is a huge support to the drugmakers to discover new non-opioid alternatives for chronic pain. And Lexicon is ready to double its clinical strength with this regulatory flexibility.

Analyst added, “The regulatory environment in chronic pain is seen to ease the pathway because the FDA is partnering with the sponsors on the options for non-addictive solutions. Lexicon is on its way, unaware of what it may earn by advancing pilavapadin for diabetic peripheral neuropathic pain (DPNP). This advancement may hit the profit above $1 billion in the near future.

Sigh of relief

The meeting with the FDA regarding the completion of the phase 2 and this advancement decision went really smooth and Lexicon’s excellent design of the trial was also seen meeting the FDA standards to the core. This undisruptive meeting was a relief to the company. Literally unbothered attitude from the agency’s end reflected their confidence in the company’s efforts.

Lexicon CEO, Mike Exton, said, “If we receive an approval, pilavapadin will be the first ever non-opioid therapy for DPNP.” Lexicon has tried really very hard to bring pilavapadin to late-stage development, showcasing its immense potential volume in chronic pain. This thoroughness and dedication might attract BD collaboration.

Author

Chandni Pathak

Chandni Pathak

Holding M.Pharm in Pharmaceutical Chemistry, Chandni crafts cutting-edge, research-driven healthcare news for Towards Healthcare, combining scientific depth with innovative storytelling to simplify complex topics for global readers.