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LB-102

Phase 3

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

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials5
Total Enrollment1,795
FDA Designations
No designations recorded
Clinical trial landscape

LB-102 · 6 trials · 2 indications

Phase 3 2Phase 2 2Phase 1 2
NCT0736915452-week Open Label Safety-Tolerability StudySchizophrenia
NOT YET_RECRUITING900 Analytics
NCT07363577Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute SchizophreniaSchizophrenia
RECRUITING456 Analytics
PHASE3NOT YET_RECRUITING
52-week Open Label Safety-Tolerability Study
SchizophreniaUnlock trial analytics
PHASE3RECRUITING
Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
SchizophreniaUnlock trial analytics
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 in Montgomery Åsberg Depression Rating -10 core symptom scale (MADRS-10)
Baseline to Day 42

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.

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 to 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, 2026NCT07494305primaryCompletionDate: changed
LOWMay 26, 2026NCT07363577Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07369154primaryCompletionDate: changed
LOWMay 24, 2026NCT07494305studyFirstPostDate: changed
LOWMay 24, 2026NCT07363577studyFirstPostDate: changed
LOWMay 24, 2026NCT07369154studyFirstPostDate: changed