Name: LB-102 in Schizophrenia: Dosage
Published: 2026-10-08T10:27:28-04:00

Phase 1 single and multiple ascending dose study

“cohorts of six volunteers received doses ranging from 10 mg up to 200 mg” (opens the source at this quote in a new tab)
“In the multiple ascending dose, or MAD, portion of this trial, cohorts of six volunteers received doses of 50 mg to 100 mg twice-daily for one week.” (opens the source at this quote in a new tab)

“LB-102 75 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7)” (opens the source at this quote in a new tab)

“The MTD of LB-102 was identified as 150 mg per day as either 150 mg QD or 75 mg BID.” (opens the source at this quote in a new tab)

PET receptor occupancy study

“In Cohort 1, all four subjects were dosed with 50 mg LB-102. In Cohort 2, all subjects were dosed with 100 mg LB-102, and in Cohort 3 all subjects were dosed with 75 mg LB-102.” (opens the source at this quote in a new tab)

NOVA-1: fixed doses of 50 mg, 75 mg, and 100 mg once daily

“The randomization ratio was 3:3:3:1 to oral once-daily placebo; LB-102 50 mg; LB-102 75 mg; or LB-102 100 mg, with a smaller sample planned in the arm receiving 100 mg.” (opens the source at this quote in a new tab)

“Participants in each cohort received once-daily doses for four weeks.” (opens the source at this quote in a new tab)
“All patients started at the planned dose level without titration.” (opens the source at this quote in a new tab)

NOVA-1: dose rationale

“Based on the mechanism of action of LB-102 at dopamine D2 and 5HT7 receptors, data from animal models, and PET dopamine RO data, it is hypothesized that LB-102 will have antipsychotic effects at doses ranging from 50 mg/day to 100 mg/day.” (opens the source at this quote in a new tab)

“Because we were able to achieve 70% receptor occupancy under steady-state conditions with a once-daily dose of 50 mg of LB-102, we chose to advance this as the lowest dose in our Phase 2 trial (n=107 participants) while exploring the potential of higher doses at 75 mg (n=108 participants) and 100 mg (n=36 participants).” (opens the source at this quote in a new tab)
“Based on previous results, we believed that there was a potential for the 100 mg dose to result in receptor occupancy above 80%.” (opens the source at this quote in a new tab)

NOVA-2: fixed doses of 50 mg and 100 mg once daily

“This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, multicenter study designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of LB-102 100 mg once daily (QD) and LB-102 50 mg QD versus placebo QD for the treatment of adult patients with an acute exacerbation of schizophrenia” (opens the source at this quote in a new tab)

“To better inform potential future commercial use of LB-102, we are studying the effects of two doses, 50 mg LB-102 or 100 mg LB-102, versus placebo in this trial, and patients will be randomized in a 1:1:1 ratio across the three arms of the trial.” (opens the source at this quote in a new tab)
“All patients will start at their assigned dose level without titration.” (opens the source at this quote in a new tab)

NOVA-3: flexible dosing

“LB-102 flexible dosing 50 mg - 100 mg” (opens the source at this quote in a new tab)

Dose the company intends to commercialize

“Doses selected to inform use in commercial setting” (opens the source at this quote in a new tab)
“Simple QD dosing, starting therapeutic dose without titration” (opens the source at this quote in a new tab)

Comparison with the amisulpride dose

“The recommended dose of amisulpride for acute schizophrenia ranges from 400 mg to 800 mg per day, which may be increased up to 1,200 mg per day.” (opens the source at this quote in a new tab)
“The high doses of amisulpride increase systemic exposure to the drug, contribute to some of its side effects, and limit its ability to be formulated into an LAI” (opens the source at this quote in a new tab)

“Improved potency, lowering required dose and reducing systemic exposure – 50 mg LB-102 ≈ 400 mg amisulpride” (opens the source at this quote in a new tab)

“For acute psychotic episodes, oral doses between 400 mg/day and 800 mg/day are recommended.” (opens the source at this quote in a new tab)
“No specific titration is required when initiating the treatment.” (opens the source at this quote in a new tab)

Context: doses in the bipolar depression trial

“Dosing of LB-102 will start at 25 mg QD fixed dose for the first 3 weeks. At the start of Week 4, the dose of LB-102 may be increased to 50 mg QD based on the Clinical Global Impression Scale, Bipolar Version (CGI BP) improvement score.” (opens the source at this quote in a new tab)

Proposed labeled dose, maximum dose, and dose adjustment in renal or hepatic impairment

No evidence found.