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LB-102

Phase 3

Schizophrenia | Small molecule | Psychiatry |LB Pharmaceuticals Inc|Last Updated: May 15, 2026

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-BlindCONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment1,795
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT0736915452-week Open Label Safety-Tolerability StudyPHASE3 NOT YET_RECRUITING 900Apr 1, 2026Apr 1, 2029May 15, 202623 United States
NCT07363577Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute SchizophreniaPHASE3 RECRUITING 456Mar 25, 2026Oct 1, 2027May 6, 202613 United States
NCT06179108Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute SchizophreniaPHASE2 COMPLETED 359Nov 29, 2023Dec 4, 2024Oct 22, 202525 United States
NCT04588129Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy VolunteersPHASE1 COMPLETED 16Jan 5, 2021Nov 15, 2021May 4, 20221 United States
NCT04187560Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy AdultsPHASE1 COMPLETED 64Jan 22, 2020Nov 9, 2020Dec 10, 20201 United States
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Study Endpoints
Primary Endpoints
Evaluate long term safety and tolerability of LB-102 by evaluating the number of adverse event, incidence of treatment emergent events.
52 weeks

Overall adverse events, serious adverse events, incidence of treatment emergent events and adverse events which lead to study discontinuation

Change from baseline to Week 6 on the Positive and Negative Syndrome Scale
6 weeks

Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment

Change From Baseline to Week 4 in the PANSS Total Score
Baseline to Day 28 (4 weeks)

The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome

Brain Receptor Occupancy as Measured by Positron Emission Tomography
2.5 hours post LB-102 dose

PET scan of D2/D3 receptor occupancy using raclopride as a tracer

Percentage of participants who experience at least one treatment-emergent adverse event (TEAE)
Day 8 (Part A) or Day 15 (Part B)

A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.

Secondary Endpoints
Evaluate long term safety and tolerability
52 weeks
Assess the long-term effectiveness determined by Positive and Negative Syndrome Scale (PANSS)
52 weeks
Evaluate the Safety and Tolerability of LB-102
10 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LB-102OTHERAn open label study
LB-102 (50 mg tablet)EXPERIMENTAL• LB-102 50 mg given orally for 6 weeks
LB-102 (100 mg tablet)EXPERIMENTALLB-102 100 mg given orally for 6 weeks
PlaceboPLACEBO_COMPARATORPlacebo given orally for 6 weeks
LB-102, 50 mg QDEXPERIMENTALOral LB-102: 50 mg (n \~ 105)
LB-102, 75 mg QDEXPERIMENTALOral LB-102: 75 mg (n \~ 105)
LB-102, 100 mgEXPERIMENTALOral LB-102: 100 mg (n \~ 35)
Placebo comparatorPLACEBO_COMPARATORDrug: Placebo Matched placebo tablets
LB-102 50 mg, single dose Cohort 1EXPERIMENTALLB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects.
LB-102 100 mg, single dose Cohort 2EXPERIMENTALLB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects.
LB-102 75 mg, single dose Cohort 3EXPERIMENTALLB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects.
LB-102 100 & 50 mg, multiple dose Cohort 4EXPERIMENTALLB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for four days in 4 subjects: 2 subjects @ 100 mg and 2 subjects @ 50 mg.
Part A Cohort 1ACTIVE_COMPARATORLB-102 50 mg (n=6) or Matching Placebo (n=2) x 1 day
Part A Cohort 2ACTIVE_COMPARATORLB-102 15 mg (n=6) or Matching Placebo (n=2) x 1 day
Part A Cohort 3ACTIVE_COMPARATORLB-102 100 mg (n=6) or Matching Placebo (n=2) x 1 day
Part A Cohort 4ACTIVE_COMPARATORLB-102 200 mg (n=6) or Matching Placebo (n=2) x 1 day
Part A Cohort 5ACTIVE_COMPARATORLB-102 150 mg (n=6) or Matching Placebo (n-2) x 1 day
Part B Cohort 6ACTIVE_COMPARATORLB-102 50 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7)
Part B Cohort 7ACTIVE_COMPARATORLB-102 100 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7)
Part B Cohort 8ACTIVE_COMPARATORLB-102 75 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7)
Interventions
NameTypeDescription
LB-102DRUGLB-102 flexible dosing 50 mg - 100 mg
LB-102 (50 mg tablet)DRUGLB-102 oral tablet given for six weeks
LB-102 (100 mg tablet)DRUGLB-102 oral tablet given for six weeks
PlaceboOTHERPlacebo tablet given orally for six weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Provide ICF * Patients clinically stable PANSS \</= 70 at screening * CGI-S \</+ 3 at screening * Medically stable * BMI 18 -40 * Taking oral antipsychotic treatment for at least 30 days * Have stable living environment Exclusion Criteria: * Sexually active M/F patients not ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07363577Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07369154primaryCompletionDate: changed
LOWMay 24, 2026NCT07363577studyFirstPostDate: changed
LOWMay 24, 2026NCT07369154studyFirstPostDate: changed