{"id":929212,"date":"2026-01-21T08:34:32","date_gmt":"2026-01-21T13:34:32","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/"},"modified":"2026-01-21T08:34:32","modified_gmt":"2026-01-21T13:34:32","slug":"lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/","title":{"rendered":"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain"},"content":{"rendered":"<h2>\n\u2013 No objections raised by FDA to advancement of pilavapadin into Phase 3 development utilizing two-arm registrational studies of 10 mg daily dose compared to placebo \u2013<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"left\">THE WOODLANDS, Texas, Jan.  21, 2026  (GLOBE NEWSWIRE) &#8212; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=L_MVr-RRKuH8GqeHJ3cLpW4mlOn__jvQF2QGSOWCzs0ijzv4fxDMNR8gZ4BMxzjx9EmId3nLE-c9W5gEim2NVy9aucF_gx9h7sJpd_2RfJviOqvoaNC3dTGUNqC_XIf1\" rel=\"nofollow\" target=\"_blank\"><u>Lexicon Pharmaceuticals, Inc.<\/u><\/a>\u00a0(Nasdaq: LXRX) today announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration\u00a0(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. The primary endpoint of the Phase 3 studies will be the change in average daily pain score (ADPS) from baseline to Week 12.<\/p>\n<p>\u201cOur End-of-Phase 2 meeting with FDA was productive and provided Lexicon with the insights needed to design a robust Phase 3 program, with the goal of making the first non-opioid DPNP medicine available to patients in over two decades,\u201d said Mike Exton, Ph.D., chief executive officer and director of Lexicon. \u201cFurthermore, the FDA did not require any unanticipated preclinical or clinical studies that would be expected to complicate or delay the advancement of this program into Phase 3 development and a potential regulatory submission.\u201d<\/p>\n<p>\n        <strong>About Pilavapadin<\/strong><br \/>\n        <br \/>Discovered using Lexicon\u2019s unique approach to gene science, pilavapadin is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1, a novel target for neuropathic pain which inhibits reuptake and recycling of neurotransmitters involved in pain signaling without affecting opiate pathways. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of pilavapadin demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways.<\/p>\n<p>\n        <strong>About Lexicon Pharmaceuticals\u202f\u00a0<\/strong>\u00a0<br \/>Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients\u2019 lives. Through the Genome5000\u2122 program, Lexicon\u2019s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications.\u00a0For additional information, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=jiWdp2HVn5kMOFETyUFXBr1cnuglT3Wlv2swgje_KA5bMKn1L4C4eY5Z4kIc-M4_J9mW2tzlOJvRnMOHy6ScEUqQZGqyqhMH_IkkdfAHRlc=\" rel=\"nofollow\" target=\"_blank\"><u>www.lexpharma.com.<\/u><\/a>\u00a0\u00a0<\/p>\n<p>\n        <strong>Safe Harbor Statement\u202f\u202f<\/strong>\u00a0<br \/><em>This press release\u00a0contains\u00a0\u201cforward-looking statements,\u201d including statements relating to Lexicon\u2019s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development\u00a0of,\u00a0regulatory filings for, and potential therapeutic and commercial potential of its drug candidates. In addition, this press release also\u00a0contains\u00a0forward looking statements relating to Lexicon\u2019s growth and future operating results, discovery, development and commercialization of products, strategic\u00a0alliances\u00a0and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management\u2019s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon\u2019s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon\u2019s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information\u00a0identifying\u00a0such\u00a0important factors\u00a0is contained under \u201cRisk Factors\u201d in Lexicon\u2019s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission.\u00a0Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.\u202f\u202f\u202f\u00a0<\/em>\u00a0<\/p>\n<p>\n        <strong>For Investor and Media Inquiries<\/strong>:<br \/>Lisa DeFrancesco\u202f\u202f\u00a0<br \/>Lexicon Pharmaceuticals, Inc.\u202f\u00a0<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=kuO80x84412iJzPrCxiTUpP9LetgGjI0zTpZDfZ9Q2LVdYfogNTJSoCdcLCOjdjBd152QINRWfT9P9CMqyG0w0g1uRrlulZvCVrFcRtIro4=\" rel=\"nofollow\" target=\"_blank\"><u>lexinvest@lexpharma.com<\/u><\/a>\u00a0<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYyOTM5NiM3MzcyMDk3IzIwMDM5Njc=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/MjgyN2JjMmUtYzdhMi00MWRmLWFiZjctNWU0Nzg2NDg1YThmLTEwMTU1NDAtMjAyNi0wMS0yMS1lbg==\/tiny\/Lexicon-Pharmaceuticals-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u2013 No objections raised by FDA to advancement of pilavapadin into Phase 3 development utilizing two-arm registrational studies of 10 mg daily dose compared to placebo \u2013 THE WOODLANDS, Texas, Jan. 21, 2026 (GLOBE NEWSWIRE) &#8212; Lexicon Pharmaceuticals, Inc.\u00a0(Nasdaq: LXRX) today announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration\u00a0(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. The primary endpoint of the Phase 3 studies will be the change in average daily pain score (ADPS) from &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-929212","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"\u2013 No objections raised by FDA to advancement of pilavapadin into Phase 3 development utilizing two-arm registrational studies of 10 mg daily dose compared to placebo \u2013 THE WOODLANDS, Texas, Jan. 21, 2026 (GLOBE NEWSWIRE) &#8212; Lexicon Pharmaceuticals, Inc.\u00a0(Nasdaq: LXRX) today announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration\u00a0(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. The primary endpoint of the Phase 3 studies will be the change in average daily pain score (ADPS) from &hellip; Continue reading &quot;Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-21T13:34:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYyOTM5NiM3MzcyMDk3IzIwMDM5Njc=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain\",\"datePublished\":\"2026-01-21T13:34:32+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\\\/\"},\"wordCount\":694,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTYyOTM5NiM3MzcyMDk3IzIwMDM5Njc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\\\/\",\"name\":\"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/","og_locale":"en_US","og_type":"article","og_title":"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain - Market Newsdesk","og_description":"\u2013 No objections raised by FDA to advancement of pilavapadin into Phase 3 development utilizing two-arm registrational studies of 10 mg daily dose compared to placebo \u2013 THE WOODLANDS, Texas, Jan. 21, 2026 (GLOBE NEWSWIRE) &#8212; Lexicon Pharmaceuticals, Inc.\u00a0(Nasdaq: LXRX) today announced the successful completion of the End-of-Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration\u00a0(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. The primary endpoint of the Phase 3 studies will be the change in average daily pain score (ADPS) from &hellip; Continue reading \"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/","og_site_name":"Market Newsdesk","article_published_time":"2026-01-21T13:34:32+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYyOTM5NiM3MzcyMDk3IzIwMDM5Njc=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain","datePublished":"2026-01-21T13:34:32+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/"},"wordCount":694,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYyOTM5NiM3MzcyMDk3IzIwMDM5Njc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/lexicon-pharmaceuticals-announces-successful-end-of-phase-2-meeting-with-fda-for-pilavapadin-in-the-treatment-of-diabetic-peripheral-neuropathic-pain\/","name":"Lexicon Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA For Pilavapadin in the Treatment of Diabetic Peripheral Neuropathic Pain - 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