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Lexicon Pharmaceuticals

Lexicon Pharmaceuticals logo
🇺🇸United States
Ownership
Public, Subsidiary
Established
1995-01-01
Employees
285
Market Cap
$621.7M
Website
http://www.lexpharma.com
Introduction

Lexicon Pharmaceuticals, Inc. engages in the discovery, development, and commercialization of pharmaceutical products for the treatment of human disease. Its drug candidates include: LX9211, an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain, and Sotagliflozin, a treatment for heart failure and type 1 diabetes. The company was founded by Brian P. Zambrowicz and Arthur T. Sands on July 7, 1995 and is headquartered in The Woodlands, TX.

Clinical Trials

61

Active:0
Completed:55

Trial Phases

3 Phases

Phase 1:27
Phase 2:16
Phase 3:18

Drug Approvals

3

FDA:3

Drug Approvals

INPEFA

Approval Date
Jan 15, 2024
FDA

Xermelo

Approval Date
Oct 25, 2022
FDA

Xermelo

Approval Date
Oct 25, 2022
FDA

Clinical Trials

Distribution across different clinical trial phases (61 trials with phase data)• Click on a phase to view related trials

Phase 1
27 (44.3%)
Phase 3
18 (29.5%)
Phase 2
16 (26.2%)

A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy

Phase 3
Recruiting
Conditions
Obstructive Cardiomyopathy, Hypertrophic
Non-obstructive Hypertrophic Cardiomyopathy
Interventions
Drug: Placebo
First Posted Date
2024-07-01
Last Posted Date
2025-08-08
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
500
Registration Number
NCT06481891
Locations
🇺🇸

Lexicon Investigational Site (4037), Scottsdale, Arizona, United States

🇺🇸

Lexicon Investigational Site (4012), Los Angeles, California, United States

🇺🇸

Lexicon Investigational Site (4035), Pomona, California, United States

and more 72 locations

A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Phase 2
Completed
Conditions
Diabetic Peripheral Neuropathic Pain
Interventions
Drug: LX9211 (blinded)
Drug: Placebo (blinded)
First Posted Date
2024-01-12
Last Posted Date
2025-05-11
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
496
Registration Number
NCT06203002
Locations
🇺🇸

Lexicon Investigational Site (128), Anniston, Alabama, United States

🇺🇸

Lexicon Investigational Site (222), Birmingham, Alabama, United States

🇺🇸

Lexicon Investigational Site (189), Daphne, Alabama, United States

and more 105 locations

Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia

Phase 2
Completed
Conditions
Postherpetic Neuralgia
Interventions
Drug: Placebo
First Posted Date
2020-12-10
Last Posted Date
2023-11-18
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
79
Registration Number
NCT04662281
Locations
🇺🇸

Lexicon Investigational Site, Kenosha, Wisconsin, United States

🇺🇸

Lexicon Investigational Site (113), Miami, Florida, United States

🇺🇸

Lexicon Investigational Site (147), Marietta, Georgia, United States

and more 11 locations

Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain

Phase 2
Completed
Conditions
Diabetic Peripheral Neuropathy
Diabetes
Interventions
Drug: LX9211 Matching Placebo
First Posted Date
2020-07-02
Last Posted Date
2025-06-25
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
319
Registration Number
NCT04455633
Locations
🇺🇸

Lexicon Investigational Site, Renton, Washington, United States

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

Phase 3
Terminated
Conditions
Type 2 Diabetes Mellitus
Heart Failure
Interventions
Drug: Placebo
First Posted Date
2018-05-11
Last Posted Date
2022-10-28
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
1222
Registration Number
NCT03521934
Locations
🇺🇸

Investigational Site Number 8400128, Alexander City, Alabama, United States

🇺🇸

Investigational Site Number 8400109, Cottonwood, Arizona, United States

🇺🇸

Investigational Site Number 8400032, Little Rock, Arkansas, United States

and more 463 locations
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News

Lexicon Pharmaceuticals Presents Patient-Reported Data on Diabetic Peripheral Neuropathic Pain at ASPN 2025

Lexicon Pharmaceuticals presented patient survey data on diabetic peripheral neuropathic pain (DPNP) at the 7th Annual Meeting of the American Society of Pain and Neuroscience to inform development of pilavapadin.

Lexicon's SONATA-HCM Phase 3 Trial Design Unveiled at European Cardiology Congress

Lexicon Pharmaceuticals has launched SONATA-HCM, the only ongoing Phase 3 trial evaluating sotagliflozin in both obstructive and non-obstructive hypertrophic cardiomyopathy, with enrollment active across 20 countries.

Lexicon's Non-Opioid Pain Drug Pilavapadin Misses Primary Endpoint in Phase IIb Diabetic Neuropathy Trial

Lexicon Pharmaceuticals' non-opioid painkiller pilavapadin failed to achieve statistical significance versus placebo in Phase IIb RELIEF-DPN-1 trial for diabetic neuropathy pain.

Sotagliflozin Shows Breakthrough 23% Reduction in Heart Attack and Stroke Risk for Diabetic Kidney Disease Patients

A landmark clinical trial led by Mount Sinai researchers demonstrates that sotagliflozin, a dual SGLT1/2 inhibitor, reduces heart attacks, strokes, and cardiovascular deaths by 23% in patients with type 2 diabetes and chronic kidney disease.

Lexicon's LX9211 Shows Promise for Diabetic Neuropathic Pain, Sotagliflozin Demonstrates Cardiovascular Benefits

Lexicon Pharmaceuticals' LX9211, a non-opioid therapy, completed Phase 2b trial for diabetic peripheral neuropathic pain, exceeding enrollment targets due to high interest.

Lexicon to Host Expert Panel on LX9211, Novel Non-Opioid Treatment for Diabetic Neuropathic Pain

Lexicon Pharmaceuticals will host a virtual webcast on January 28, 2025, featuring an in-depth discussion of LX9211, their investigational non-opioid treatment for diabetic peripheral neuropathic pain.

FDA Gears Up for Year-End Decisions on Novel Therapies for Rare Diseases and Cancer

• The FDA is set to decide on Ionis Pharmaceuticals' olezarsen for familial chylomicronemia syndrome (FCS), a rare genetic disease, by December 19, following positive Phase III results. • Lexicon Pharmaceuticals awaits the FDA's decision on sotagliflozin as an adjunct therapy for type 1 diabetes by December 20, despite concerns raised by an advisory committee. • AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC is under FDA review, with a decision expected by December 20, based on Phase III data showing progression-free survival benefits. • Neurocrine Biosciences anticipates FDA decisions on crinecerfont for congenital adrenal hyperplasia (CAH) by December 29 and 30, potentially marking the first new treatment in 70 years.

Lexicon Pharmaceuticals Completes Enrollment for Phase IIb Trial of LX9211 in Diabetic Peripheral Neuropathic Pain

Lexicon Pharmaceuticals has finished enrolling 494 subjects in its Phase IIb PROGRESS trial, exceeding the initial target by 20%, to evaluate LX9211 for diabetic peripheral neuropathic pain (DPNP).

Lexicon Pharmaceuticals Restructures, Cuts 60% of Staff After FDA Flags Zynquista Deficiencies

Lexicon Pharmaceuticals will lay off 60% of its workforce and disband its sales team to save $100 million, pivoting to focus on its research pipeline.

Lexicon's Sotagliflozin Faces Setback in Type 1 Diabetes Approval Bid After FDA Advisory Committee Vote

Lexicon Pharmaceuticals faces another hurdle for sotagliflozin as an FDA advisory committee votes against its approval for type 1 diabetes, despite prior EU approval.

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