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Lexicon Pharmaceuticals (LXRX) FDA Events

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FDA Events for Lexicon Pharmaceuticals (LXRX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Lexicon Pharmaceuticals (LXRX). Over the past two years, Lexicon Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as LX9211, LX9851, and sotagliflozin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Lexicon Pharmaceuticals' Drugs in FDA Review

LX9211 - FDA Regulatory Timeline and Events

LX9211 is a drug developed by Lexicon Pharmaceuticals for the following indication: In Diabetic Peripheral Neuropathic Pain (DPNP). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LX9851 - FDA Regulatory Timeline and Events

LX9851 is a drug developed by Lexicon Pharmaceuticals for the following indication: For obesity and weight loss. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

sotagliflozin - FDA Regulatory Timeline and Events

sotagliflozin is a drug developed by Lexicon Pharmaceuticals for the following indication: INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Lexicon Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Lexicon Pharmaceuticals (LXRX) has reported FDA regulatory activity for the following drugs: sotagliflozin, LX9211 and LX9851.

The most recent FDA-related event for Lexicon Pharmaceuticals occurred on March 28, 2025, involving LX9851. The update was categorized as "Provided Update," with the company reporting: "Lexicon Pharmaceuticals, Inc announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders."

Current therapies from Lexicon Pharmaceuticals in review with the FDA target conditions such as:

  • INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). - sotagliflozin
  • In Diabetic Peripheral Neuropathic Pain (DPNP) - LX9211
  • For obesity and weight loss - LX9851

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:LXRX) was last updated on 7/10/2025 by MarketBeat.com Staff
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