Lexicon Pharmaceuticals, Inc. announced on September 17, 2025, the presentation of clinical data from its Phase 2b PROGRESS study for pilavapadin at the European Association for the Study of Diabetes (EASD) and NEUROdiab Annual Meetings. The presentations provided additional support for pilavapadin's profile and its potential as a new therapy for diabetic peripheral neuropathic pain (DPNP).
A post-hoc analysis of the PROGRESS data, excluding the 20 mg arm, showed nominally significant separation from placebo (p < 0.05) for the pilavapadin 10 mg dose arms. A clinically meaningful, two-point reduction from baseline in average daily pain scores (ADPS) was observed by week 11.
The pilavapadin 10 mg dose was well tolerated with minimal discontinuations, reinforcing Lexicon's decision to advance this dose into Phase 3 development. Pilavapadin has the potential to become the first non-opioid, oral medication approved for DPNP in over two decades.
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