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LX9211

Phase 2

Diabetic Peripheral Neuropathic Pain | Small molecule | Neurology |Lexicon Pharmaceuticals, Inc.|Last Updated: Oct 10, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment496
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06203002A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)PHASE2 COMPLETED 496 — — Nov 29, 2023Feb 24, 2025Oct 10, 2025108 United States
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Study Endpoints
Primary Endpoints
Change from Baseline to Week 8 in Average Daily Pain Score (ADPS)
Baseline, Week 8

ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\].

Secondary Endpoints
Change from Baseline to Week 8 in Burning Pain
Baseline, Week 8
Change from Baseline to Week 8 in Pain Interference on Sleep
Baseline, Week 8
Patient Global Impression of Change (PGIC) Score at Week 8
Week 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LX9211 Low DoseEXPERIMENTALLX9211 low dose, orally, once daily during a blinded treatment period.
LX9211 High DoseEXPERIMENTALLX9211 high dose, orally, once daily during a blinded treatment period.
LX9211 High Dose Followed by Low DoseEXPERIMENTALLX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period.
LX9211 PlaceboPLACEBO_COMPARATORLX9211 matching placebo, orally, once daily during a blinded treatment period.
Interventions
NameTypeDescription
Placebo (blinded)DRUGLX9211 matching placebo tablets
LX9211 (blinded)DRUGLX9211 (blinded) tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites108

Inclusion Criteria: 1. Participant has given written informed consent to participate in the study in accordance with local regulations 2. Adult male and female participants ≥18 years of age at the Screening Visit 3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening 4. ...

Countries:United States
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