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

Product information and disease description Product description Product information

Indication

4 evidence topics · 4 sources

Indication under development

“Our lead product candidate, LB‑102, is a Phase 3 oral small molecule in development for the treatment of schizophrenia.” (opens the source at this quote in a new tab)
“Our ongoing Phase 3 trial (NOVA-2) is enrolling individuals with acute schizophrenia, defined as a sudden and severe worsening of psychotic symptoms such as hallucinations, delusions, and other positive symptoms.” (opens the source at this quote in a new tab)

Population studied in the phase 3 NOVA-2 trial

“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)
“Diagnosis of schizophrenia as defined by DSM-5” (opens the source at this quote in a new tab)
“18 Years to 65 Years” (opens the source at this quote in a new tab)

Population studied in the phase 2 NOVA-1 trial

“Male and female patients 18 to 55 years of age inclusive at the time of informed consent with a diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by the MINI 7.0.2 .” (opens the source at this quote in a new tab)
“Must be willing to be hospitalized for the duration of the inpatient period of the study.” (opens the source at this quote in a new tab)

Population studied in the open-label NOVA-3 trial

“Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia who are experiencing inadequate response or who are having issues with side effects, general tolerability, or overall effectiveness of their current antipsychotic medication and desire to change medications, or who have completed their participation in current LB-102 clinical studies” (opens the source at this quote in a new tab)

Proposed labeled indication submitted to a regulator

No evidence found.