A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia

Inclusion Criteria:

• The participant has a current confirmed diagnosis of schizophrenia according to theDSM-5, for >1 year

• The participant has exacerbation of schizophrenia that started ≤8 weeks prior toscreening and would benefit from psychiatric hospitalization or continuedhospitalization for symptoms of schizophrenia.

• Participants who have received an antipsychotic treatment (other than clozapine) inthe past year must have been responsive based on the investigator's judgment (andbased on discussions with family members, caregivers, or healthcare professionals,as applicable).

• Body mass index between 18.0 and 40.0 kg/m2, inclusive, at the time of screening

• Women may be included only if they have a negative beta-human chorionic gonadotropin (β-HCG) test at screening and baseline

• Women of childbearing potential must agree not to try to become pregnant, and,unless they have exclusively same-sex partners, must agree to use a highly effectivemethod of contraception prior to the first administration of IMP, and agree tocontinue the use of this method for the duration of the study, and for 70 days afterthe last dose of IMP

• The participant is in adequate health as determined by medical and psychiatrichistory, medical examination, electrocardiogram (ECG), serum chemistry, hematology,coagulation urinalysis, and serology.

• NOTE- Additional criteria apply, please contact the investigator for moreinformation

Exclusion Criteria:

• The participant has a current clinically significant DSM-5 diagnosis other thanschizophrenia (has a primary current diagnosis other than schizophrenia or acomorbid diagnosis that is primarily responsible for the current symptoms andfunctional impairment).

• The participant has a known history of the following: (a) borderline personalitydisorder, antisocial personality disorder, or bipolar disorder; (b) traumatic braininjury causing ongoing cognitive difficulties, Alzheimer's disease, or another formof dementia, or any chronic organic disease of the central nervous system; and (c)intellectual disability of a severity that would impact ability to participate inthe study.

• The participant was hospitalized for >14 days (with the exception of social oradministrative hospitalization) in the current exacerbation episode prior toscreening.

• The participant has a significant risk of violent behavior based on theparticipant's medical history or investigator's judgment.

• The participant has a significant risk of committing suicide based on theparticipant's medical history or C-SSRS, and the investigator's judgment.

• The participant is currently using an LAI antipsychotic or is still under thecoverage period of the specific LAI at time of screening.

• The participant has taken clozapine or has received electroconvulsive therapy withinthe last 12 months prior to screening.

• The participant is currently receiving daily oral olanzapine at a dose >20 mg/day.

• The participant has current or a history of known hypersensitivity to olanzapine orany of the excipients of TV-44749 or the oral formulation of olanzapine.

• The participant has had a significant sedation or delirium after antipsychotictreatment according to medical and psychiatric history and as judged by theinvestigator or suffered from delirium due to a medical condition.

• The participant has a non-fasting glucose level of ≥200 mg/dL at screening

• The participant meets criteria for moderate to severe substance use disorder (basedon DSM-5 criteria) within the past 6 months (excluding those related to caffeine ornicotine)

• NOTE- Additional criteria apply, please contact the investigator for moreinformation