Investigational status

“LB-102 is a novel, once-daily, orally administered investigational small molecule and potential first benzamide antipsychotic in the United States for the treatment of neuropsychiatric disorders.” (opens the source at this quote in a new tab)

“Currently, participation in one of our clinical trials is the only way to access our investigational products.” (opens the source at this quote in a new tab)

Current development phase

“LB-102 is currently in late-stage clinical development for schizophrenia (pivotal Phase 3 NOVA-2 trial) and bipolar depression (Phase 2 ILLUMINATE-1 trial).” (opens the source at this quote in a new tab)
“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)

Phase 2 NOVA-1 trial: completed, topline results January 2025, published in JAMA Psychiatry

“The topline results from the trial were announced in January 2025.” (opens the source at this quote in a new tab)
“We designed our Phase 2 acute schizophrenia trial to be potentially registrational by including a large sample size (n=359), robust statistical analyses, as well as numerous sensitivity analyses.” (opens the source at this quote in a new tab)

“Published results from the Phase 2 NOVA-1 trial of LB-102 in schizophrenia in JAMA Psychiatry.” (opens the source at this quote in a new tab)

Phase 3 NOVA-2 trial: initiated March 2026

“today announced the initiation of its pivotal Phase 3 trial (NOVA-2) evaluating the efficacy and safety of LB-102 as a treatment for schizophrenia.” (opens the source at this quote in a new tab)
“The trial is designed to enroll approximately 460 patients with acute exacerbation of schizophrenia at approximately 25 sites in the U.S.” (opens the source at this quote in a new tab)
“Patients will be randomized 1:1:1 to receive either 50 mg or 100 mg of LB-102 or placebo for six weeks.” (opens the source at this quote in a new tab)

“We initiated a six-week Phase 3 trial of LB-102 in patients with schizophrenia in March 2026.” (opens the source at this quote in a new tab)

Phase 3 NOVA-3 trial: 52-week open-label safety trial, enrolling

“The 52-week open-label safety and tolerability trial (NOVA-3), evaluating the long-term safety and tolerability of LB-102 in patients with stable schizophrenia, is enrolling eligible patients who have completed NOVA-2, as well as de novo patients.” (opens the source at this quote in a new tab)

“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” (opens the source at this quote in a new tab)

FDA end-of-phase 2 feedback on the registration package

“Based on positive end-of-Phase 2 feedback from the FDA, as well as historical precedent, we believe that our Phase 2 acute schizophrenia trial may serve as one of two pivotal trials required for approval of a new drug application, or NDA, in the United States.” (opens the source at this quote in a new tab)
“Based on recent positive feedback from the FDA, our current strategy is to utilize our recently completed Phase 2 trial in acute schizophrenia as one of two adequate and well-controlled trials required for FDA approval.” (opens the source at this quote in a new tab)

“FDA noted, in writing, that our Phase 2 trial appeared to have many of the characteristics of an adequate and well-controlled trial – providing an opportunity for approval with one successful Phase 3 trial” (opens the source at this quote in a new tab)
“Streamlined path to approval in SCZ with a single Phase 3 trial based on positive FDA feedback” (opens the source at this quote in a new tab)

“Based on positive results and prior FDA feedback, we believe NOVA-2, together with the open label extension trial, and data from our Phase 2 (NOVA-1) trial, will support the potential U.S. approval of LB-102 for the treatment of schizophrenia.” (opens the source at this quote in a new tab)

Status of NOVA-1 as one of two adequate and well-controlled trials: company caveats

“However, there is no guarantee that our Phase 2 trial will serve as one of the two pivotal trials required for FDA approval, and in such case, we may be required to conduct an additional pivotal trial in acute schizophrenia.” (opens the source at this quote in a new tab)
“The adequacy of our Phase 2 trial to support registration will be a matter of review by the FDA at the time of NDA submission and will depend on the totality of the data included in our submission, including the results of our planned Phase 3 trial.” (opens the source at this quote in a new tab)
“The FDA may also not agree with our determination that our Phase 2 acute schizophrenia trial may serve as one of the two pivotal trials required for approval of an NDA in the United States.” (opens the source at this quote in a new tab)

Safety database required to support an NDA

“In addition to our 6-week Phase 3 trial, the design of which we shared with the FDA as part of our end-of-Phase 2 interaction, we anticipate the FDA will require 1,500 patient exposures to support an approval in schizophrenia.” (opens the source at this quote in a new tab)
“To support approval, the safety population must include at least 1,500 cumulative patient exposures to LB-102, including at least 100 patients with greater than or equal to one year of exposure and 300 patients with greater than or equal to six months of exposure.” (opens the source at this quote in a new tab)
“As a result, we expect to enroll approximately 900 patients in our planned open label safety trial.” (opens the source at this quote in a new tab)

NOVA-2 topline timing: moved in July 2026 to the first half of 2027

“NEW YORK, July 22, 2026 (GLOBE NEWSWIRE)” (opens the source at this quote in a new tab)
“today announced that based on enrollment projections, it now expects to report topline results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in the first half of 2027 and to schedule a pre-NDA meeting with the FDA thereafter in the second half of 2027.” (opens the source at this quote in a new tab)
“Based on the pace of enrollment since initiating NOVA-2, we now expect to report topline results in the first half of 2027, ahead of our prior guidance of the second half of 2027, and to schedule a pre-NDA meeting soon thereafter in the second half of 2027,” (opens the source at this quote in a new tab)

“Discussion of the Phase 3 trial program in schizophrenia, its upcoming topline data readout expected in the first half of 2027, and ongoing pre-commercial planning activities” (opens the source at this quote in a new tab)

Pre-NDA meeting timing

“The Company expects to schedule a pre-NDA meeting with the FDA thereafter in the second half of 2027.” (opens the source at this quote in a new tab)

“Topline data expected 1H 2027” (opens the source at this quote in a new tab)
“Pre-NDA meeting expected 2H 2027” (opens the source at this quote in a new tab)

Pre-NDA meeting and NDA sequence stated in March 2026, before the July 2026 timing update

“If our Phase 3 trial is positive, we plan to hold a pre-NDA meeting with the FDA in the first quarter of 2028 to seek agreement from FDA on the suitability of our data to support an NDA submission for the treatment of schizophrenia with potential for submission of such NDA thereafter.” (opens the source at this quote in a new tab)

Regulatory submission

No evidence found.

Launch

No evidence found.

Fast track, breakthrough therapy, or priority review designation

No evidence found.

Planned NDA pathway under section 505(b)(1) or section 505(b)(2)

No evidence found.

New chemical entity status and regulatory exclusivity

“LB-102 is a new chemical entity and a methylated derivative of amisulpride, a second-generation antipsychotic drug approved in over 50 countries, not including the United States, because the development and regulatory requirements of the U.S. Food and Drug Administration, or FDA, for amisulpride were incompatible with patent coverage on the drug.” (opens the source at this quote in a new tab)
“The FDCA provides a five-year period of non-patent data exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity.” (opens the source at this quote in a new tab)

Patent protection: composition of matter expiry

“As of March 1, 2026, we owned approximately 43 patents and pending patent applications in the United States and foreign jurisdictions relating to LB-102, including five issued U.S. patents and thirteen issued foreign patents, three pending U.S. patent applications, twenty pending foreign applications, and two pending Patent Cooperation Treaty, or PCT, applications.” (opens the source at this quote in a new tab)
“The issued patents covering the composition of matter of LB-102 and method of treating schizophrenia are expected to expire in 2037, and any patents that may be issued from the pending patent applications are expected to expire between 2037 and 2047, in each case, without taking into account any possible patent term adjustment or extensions or terminal disclaimers and assuming payment of all appropriate maintenance, renewal, and annuity fees.” (opens the source at this quote in a new tab)
“We expect the patent term adjustment or extension to be up to five years.” (opens the source at this quote in a new tab)

“Robust IP portfolio with issued COM protection through ~2041 (including potential PTE)” (opens the source at this quote in a new tab)
“Includes estimated patent term extension (PTE), composition of matter (COM) IP expires 2037” (opens the source at this quote in a new tab)

Predominantly negative symptoms of schizophrenia: planned program

“On track to receive FDA feedback by end of 2026” (opens the source at this quote in a new tab)
“Exploring label-enabling Phase 3b trial designs” (opens the source at this quote in a new tab)

Pipeline in other indications: bipolar depression (ILLUMINATE-1) and adjunctive major depressive disorder

“today announced the initiation of a Phase 2 trial evaluating the efficacy and safety of LB-102 in patients with bipolar depression.” (opens the source at this quote in a new tab)
“The two-arm, six-week, outpatient trial is expected to enroll approximately 320 patients with bipolar 1 depression at approximately 30 sites in the U.S.” (opens the source at this quote in a new tab)

“The Phase 2 ILLUMINATE-1 trial evaluating the efficacy and safety of LB-102 in patients with bipolar 1 depression is enrolling patients, with topline data expected in the first quarter of 2028.” (opens the source at this quote in a new tab)
“Initiation of the Phase 2 trial in the adjunctive treatment of MDD is expected in early 2027, with topline data expected in the first half of 2029.” (opens the source at this quote in a new tab)
“The proceeds are intended to fund expansion of LB-102 into new indications, potentially including negative symptoms of schizophrenia and Alzheimer’s disease psychosis/agitation, and for general corporate purposes.” (opens the source at this quote in a new tab)

Long-acting injectable formulation in development

“We are also developing a long-acting injectable, or LAI, formulation of LB-102, which may improve compliance, a common issue in patients with schizophrenia and bipolar disorder.” (opens the source at this quote in a new tab)
“We have commenced LAI formulation development and expect to continue these efforts in 2026.” (opens the source at this quote in a new tab)
“We believe that the success of the 50 mg dose in our schizophrenia Phase 2 trial affords the opportunity to develop an LAI.” (opens the source at this quote in a new tab)

“LAI Formulation development in 2026” (opens the source at this quote in a new tab)

Development outside the United States

“We are conducting this trial entirely in the United States at approximately 25 sites, a similar number of sites as were utilized in our Phase 2 acute schizophrenia trial and there is a significant overlap between the sites utilized in our Phase 2 trial and those we are utilizing in the Phase 3 trial.” (opens the source at this quote in a new tab)
“While we are developing LB-102 for acute schizophrenia initially in the United States and potentially in other jurisdictions where amisulpride is not approved, we currently plan to develop LB-102 to treat bipolar depression and adjunctive MDD globally” (opens the source at this quote in a new tab)
“If approved for schizophrenia, we expect to commercialize the oral formulation of LB-102 in jurisdictions where amisulpride is unavailable as a generic, and we expect to commercialize an LAI form of LB-102 worldwide.” (opens the source at this quote in a new tab)

Marketing application, scientific advice, or designation from a regulator outside the United States

No evidence found.