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

Route and frequency

“LB-102 will be dosed orally once a day.” (opens the source at this quote in a new tab)

“Results from the study did suggest that once-a-day dosing of LB-102 could be effective in treating schizophrenia (amisulpride is typically dosed twice daily).” (opens the source at this quote in a new tab)

“Amisulpride can be administered once a day at oral doses up to 400mg, higher dose should be split into two separate doses.” (opens the source at this quote in a new tab)

NOVA-1: tablets administered per dose

“LB-102 tablets are 50 mg in strength.” (opens the source at this quote in a new tab)
“The placebo tablets will match the 50 mg tablets in appearance.” (opens the source at this quote in a new tab)
“Tablet-splitting procedures are outlined in the Pharmacy Manual.” (opens the source at this quote in a new tab)

Dose	Number of active tablets	Number of placebo tablets	Total number of tablets per dose
Placebo	“0”	“2.5”	“2.5”
50 mg	“1”	“1.5”	“2.5”
75 mg	“1.5”	“1”	“2.5”
100 mg	“2”	“0.5”	“2.5”

NOVA-2: oral tablets for six weeks

“LB-102 100 mg given orally for 6 weeks” (opens the source at this quote in a new tab)
“LB-102 oral tablet given for six weeks” (opens the source at this quote in a new tab)

Phase 1 PET study: capsule formulation, dosing time, and food

“a single dose of LB-102 was administered orally as a powder in capsule on day 1 of the study and in Cohort 4 once a day for four days” (opens the source at this quote in a new tab)
“Dose administration was scheduled for 8:00 AM (±1 h) each dosing day, following the collection of vital signs and a 12-lead ECG.” (opens the source at this quote in a new tab)
“The dose was given with water and subjects had the option to eat breakfast after dosing.” (opens the source at this quote in a new tab)

Setting: inpatient dosing in NOVA-1 and NOVA-2

“To facilitate enrollment of acutely ill patients and optimize treatment compliance, a 4-week inpatient hospitalization is required following the initial screening phase.” (opens the source at this quote in a new tab)

“Willing to be hospitalized for duration of the study” (opens the source at this quote in a new tab)

Setting: outpatient dosing in NOVA-3

“Concurrently with the Phase 3 NOVA-2 trial, we are enrolling an outpatient, open label trial (NOVA-3) to accrue the requisite safety population required to support NDA submission as well as other clinical trials and non-clinical studies typically required by FDA for an NDA approval.” (opens the source at this quote in a new tab)

Long-acting injectable formulation in development

“We are also developing an LAI formulation of LB-102, which may improve treatment adherence, a common issue in patients with schizophrenia and bipolar disorder.” (opens the source at this quote in a new tab)

Fasted or fed dosing conditions in NOVA-1, NOVA-2, and NOVA-3

No evidence found.

Missed dose instructions and administration with other medications

No evidence found.