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A second phase 3 registrational study of LX9211 in diabetic neuropathy

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Trial Profile

A second phase 3 registrational study of LX9211 in diabetic neuropathy

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2026

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At a glance

  • Drugs Pilavapadin (Primary)
  • Indications Diabetic neuropathies; Neuropathic pain
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 06 Feb 2026 New trial record
  • 21 Jan 2026 According to a Lexicon Pharmaceuticals media release, the company announced successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) for pilavapadin in diabetic peripheral neuropathic pain (DPNP). During the meeting, the FDA raised no objections to the advancement of pilavapadin into Phase 3 development, which would include two placebo-controlled, 12-week, two arm registrational studies comparing the 10 mg daily dose to placebo.

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