Upcoming FDA Events for LB Pharmaceuticals
LB Pharmaceuticals (LBRX) has upcoming FDA regulatory milestones for LB-102. The table below outlines estimated target dates and event types for these pending regulatory actions.
LB Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by LB Pharmaceuticals (LBRX).
Over the past two years, LB Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LB-102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LB-102 FDA Regulatory Timeline and Events
LB-102 is a drug developed by LB Pharmaceuticals for the following indication: In Patients With Bipolar Depression.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LB-102
- Announced Date:
- April 22, 2026
- Indication:
- In Patients With Bipolar Depression
Announcement
LB Pharmaceuticals Inc announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial."
AI Summary
LB Pharmaceuticals announced that the Journal of the American Medical Association (JAMA) Psychiatry has published its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial." The paper presents the Phase 2 randomized trial findings evaluating the efficacy and safety of LB-102 in adults with acute schizophrenia, offering peer-reviewed data on the drug’s clinical profile.
LB-102 is now being tested in the pivotal Phase 3 NOVA-2 study, a six-week, double-blind, placebo-controlled trial planned to enroll about 460 patients at roughly 25 U.S. sites. Topline results from NOVA-2 are expected in the second half of 2027. If the Phase 3 data are positive, LB-102 could become the first benzamide approved for schizophrenia in the United States.
Read Announcement- Drug:
- LB-102
- Announced Date:
- March 27, 2026
- Indication:
- In Patients With Bipolar Depression
Announcement
- LB Pharmaceuticals Inc announced the presentation of new data further evaluating the effects of LB-102 on cognitive performance in the Phase 2 NOVA-1 clinical trial in patients with acute schizophrenia.
AI Summary
LB Pharmaceuticals announced it will present new data that further evaluates the effects of LB-102 on cognitive performance in the Phase 2 NOVA‑1 clinical trial. The trial enrolled patients experiencing acute schizophrenia and is focused on assessing whether LB-102 can affect thinking skills that are often impaired in this condition.
The company said the new data add to the trial’s findings by specifically looking at cognition. While the announcement did not detail specific results or statistics, the presentation is meant to show how LB-102 performs on measures of cognitive functioning within the NOVA‑1 study population.
These data are intended to inform LB Pharmaceuticals’ next steps in development and to help clinicians and researchers better understand LB-102’s effects on cognitive symptoms in acute schizophrenia. The company is expected to share additional details as they become available.Read Announcement
- Drug:
- LB-102
- Announced Date:
- March 25, 2026
- Target Action Date:
- H2 2027
- Estimated Target Date Range:
- July 1, 2027 - December 31, 2027
- Indication:
- In Patients With Bipolar Depression
Announcement
LB Pharmaceuticals Inc announced that the Topline data expected in 2H 2027
AI Summary
LB Pharmaceuticals announced that topline data from its Phase 3 NOVA-2 trial of LB-102 are expected in the second half of 2027. NOVA-2 will enroll about 460 patients and the primary endpoint is change in PANSS total score at week 6. Secondary endpoints include measures of negative symptoms, cognitive performance, and assessments of safety and tolerability.
LB-102 has the potential to be the first benzamide approved for schizophrenia in the U.S. The company also plans an open-label extension of about 900 patients, open to NOVA-2 completers and new enrollees, to characterize long-term safety and further study effects on negative symptoms and cognition. Investors and clinicians will watch the 2027 readout for clues about LB-102’s real-world potential and next steps.
Read Announcement- Drug:
- LB-102
- Announced Date:
- March 25, 2026
- Indication:
- In Patients With Bipolar Depression
Announcement
LB Pharmaceuticals Inc announced the initiation of its pivotal Phase 3 trial (NOVA-2) evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia.
AI Summary
LB Pharmaceuticals announced the start of its pivotal Phase 3 NOVA-2 trial to test LB-102 as a treatment for schizophrenia. The trial will enroll about 460 patients and could lead to the first benzamide approved for schizophrenia in the U.S. The primary endpoint is change from baseline in PANSS total score at week 6. Secondary endpoints will assess negative symptoms, cognitive performance, and safety and tolerability.
The company also plans an open-label extension of roughly 900 patients, allowing NOVA-2 completers and new patients to continue treatment while gathering long-term safety data and more information on negative symptoms and cognition. Topline results from NOVA-2 are expected in the second half of 2027. If data are positive, LB Pharmaceuticals expects to pursue regulatory discussions with the FDA toward potential approval.
Read Announcement- Drug:
- LB-102
- Announced Date:
- January 26, 2026
- Indication:
- In Patients With Bipolar Depression
Announcement
LB Pharmaceuticals Inc announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar depression. L
AI Summary
LB Pharmaceuticals has started a Phase 2 trial to test the efficacy and safety of LB-102 in patients with bipolar depression. LB-102 is a once-daily oral investigational drug, a methylated derivative of amisulpride, that selectively blocks D2, D3 and 5HT7 receptors. The company positions it as a potential benzamide antipsychotic with limited off-target effects and a focus on tolerability.
The ILLUMINATE-1 trial is a multicenter, randomized, double-blind, placebo-controlled study with fixed- and flexible-dose elements. About 320 adults with bipolar I depression will be enrolled at roughly 30 U.S. sites. Patients will be randomized 1:1 to LB-102 (25 mg or 50 mg once daily) or placebo for six weeks. The primary endpoint is the MADRS-10 score at week six, with the main analysis pooling both LB-102 doses versus placebo. Secondary measures include MADRS-6, CGI-BP, cognition, anhedonia, and safety/tolerability.
Topline results are expected in the first quarter of 2028. The trial aims to address unmet needs such as faster onset, fewer side effects like sedation and EPS, and improving anhedonia and cognitive symptoms.
Read Announcement
LB Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, LB Pharmaceuticals (LBRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, LB Pharmaceuticals (LBRX) has reported FDA regulatory activity for LB-102.
The most recent FDA-related event for LB Pharmaceuticals occurred on April 22, 2026, involving LB-102. The update was categorized as "Publication," with the company reporting: "LB Pharmaceuticals Inc announced the publication in the Journal of the American Medical Association (JAMA) Psychiatry of its manuscript titled "Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults with Acute Schizophrenia: A Phase 2 Randomized Clinical Trial.""
Currently, LB Pharmaceuticals has one therapy (LB-102) targeting the following condition: In Patients With Bipolar Depression.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:LBRX last updated on 4/22/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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