Developer · LBRX · United States
LB Pharmaceuticals Inc.
A clinical-stage biopharmaceutical company developing novel therapies for schizophrenia, bipolar depression, and other neuropsychiatric diseases. Its lead candidate, LB-102 (N-methylamisulpride), is a benzamide antipsychotic in Phase 3 development.
Pipeline (1)
- SchizophreniaPhase 3Active
- Bipolar depressionPhase 2Recruiting
- Major depressive disorderUnknownActive
Catalysts · 3 upcoming · 1 reported
- 2H 2027Anticipated
LB-102 (N-methylamisulpride)forSchizophreniaTopline data
Pivotal Phase 3 NOVA-2 topline (PANSS total at Week 6) anticipated in 2H 2027.
- 1Q 2028Anticipated
LB-102 (N-methylamisulpride)forBipolar depressionTopline data
Phase 2 ILLUMINATE-1 topline (MADRS-10 change at Week 6) in bipolar I depression anticipated in 1Q 2028.
- 1H 2029Anticipated
LB-102 (N-methylamisulpride)forMajor depressive disorderTopline data
LB Pharmaceuticals plans to initiate a Phase 2 adjunctive-MDD trial of LB-102 in early 2027, with topline data expected in 1H 2029.
Recently reported
- 2025-01-08met
LB-102 (N-methylamisulpride)forSchizophreniaTopline data
Phase 2 NOVA-1 met its primary endpoint: significant PANSS total reduction at Week 4 at all LB-102 doses vs placebo, with favorable short-term safety.
Recent activity
- Mar 25, 2026Phase changeLB-102 (N-methylamisulpride)·SchizophreniaPhase 3Pivotal Phase 3 NOVA-2 (NCT07363577) initiated and recruiting: ~456 patients with acute schizophrenia at ~25 U.S. sites; 50 mg / 100 mg / placebo over 6 weeks; primary endpoint PANSS total change at Week 6; topline expected 2H 2027.source ↗
- Jan 23, 2026Phase changeLB-102 (N-methylamisulpride)·Bipolar depressionPhase 2Phase 2 ILLUMINATE-1 (NCT07494305) initiated in bipolar I depression, expanding the LB-102 development program beyond schizophrenia. ~320 patients with bipolar I depression at ~30 U.S. sites; once-daily LB-102 (25 mg/50 mg fixed-flexible) vs placebo 1:1 over 6 weeks; primary endpoint MADRS-10 change at Week 6; topline anticipated 1Q 2028. CT.gov actual start date 2026-01-23; initiation announced by the company 2026-01-26.source ↗
- Jan 8, 2025ReadoutLB-102 (N-methylamisulpride)·SchizophreniametPhase 2 NOVA-1 met its primary endpoint: significant PANSS total reduction at Week 4 at all LB-102 doses vs placebo, with favorable short-term safety.source ↗
Trials recruiting · 2 recruiting of 3 sponsored
- Phase 3LB-102 (N-methylamisulpride)
A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Acute Schizophrenia (NOVA-2)
- Phase 2LB-102 (N-methylamisulpride)
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With Major Depressive Episodes Associated With Bipolar I Disorder (ILLUMINATE-1)
Competitive landscape
Other companies developing against LB Pharmaceuticals Inc.'s targets or indications.
- Alto Neuroscience, Inc.4 compoundsSchizophreniaBipolar depressionMajor depressive disorder
- Intra-Cellular Therapies, Inc.1 compoundSchizophreniaBipolar depressionMajor depressive disorder
- Alkermes plc1 compoundD2Schizophrenia
- Autobahn Therapeutics, Inc.1 compoundBipolar depressionMajor depressive disorder
- Boehringer Ingelheim International GmbH3 compoundsSchizophreniaMajor depressive disorder
- Cerevel Therapeutics Holdings, Inc.2 compoundsSchizophreniaMajor depressive disorder
- Engrail Therapeutics, Inc.1 compoundD2Major depressive disorder
- Neurocrine Biosciences, Inc.5 compoundsSchizophreniaMajor depressive disorder
- Otsuka Pharmaceutical Co., Ltd.3 compoundsD2Major depressive disorder
- Reviva Pharmaceuticals Holdings, Inc.1 compoundD2Schizophrenia
- Teva Pharmaceutical Industries Ltd.1 compoundD2Schizophrenia
- Vanda Pharmaceuticals Inc.2 compoundsSchizophreniaMajor depressive disorder
