Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05693935 | 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 | PHASE3 | COMPLETED | 675 | — | — | Jan 24, 2023 | Jan 27, 2025 | Mar 17, 2026 | 82 | United States, Bulgaria +3 |
| NCT06315283 | An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia | PHASE1 | COMPLETED | 153 | — | — | Mar 20, 2024 | Sep 4, 2025 | Jan 14, 2026 | 9 | United States, Croatia +2 |
| NCT06253546 | Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia | PHASE1 | COMPLETED | 24 | — | — | Mar 28, 2024 | Jun 12, 2025 | Aug 1, 2025 | 6 | China |
The PANSS is a 30-item scale used to evaluate positive and negative symptoms of schizophrenia. The PANSS was used to identify the presence and severity of psychopathology symptoms, the relationship of these symptoms to one another, and the global psychopathology. Each item was scored on a 7-point scale ranging from 1 (absent) to 7 (extreme). The positive symptom scale includes 7 items with a maximum score of 49; the negative symptom scale includes 7 items with a maximum score of 49; and the general psychopathology scale includes 16 items with a maximum score of 112. The total score was the sum of 30-item scale, ranging from 30 (absent) to 210 (extreme), with a higher score indicating greater severity of symptoms. Least square (LS) mean was calculated using a repeated measures model with treatment, study visit, treatment visit interaction, stratification variables (sex and geographic region), age, and PANSS total score at baseline as covariates.
| Arm | Type | Description |
|---|---|---|
| Double-blind Period: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to TV-44749 subcutaneously (SC) once monthly over 8 weeks in double-blind period. |
| Double-blind Period: TV-44749 318 mg | EXPERIMENTAL | Participants will receive TV-44749 extended-release injectable suspension at a dose of 318 milligrams (mg) SC once monthly over 8 weeks in double-blind period. |
| Double-blind Period: TV-44749 425 mg | EXPERIMENTAL | Participants will receive TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly over 8 weeks in double-blind period. |
| Double-blind Period: TV-44749 531 mg | EXPERIMENTAL | Participants will receive TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly over 8 weeks in double-blind period. |
| Open-label Period: Placebo to TV-44749 318 mg | EXPERIMENTAL | Participants who receive placebo during the double-blind period, will receive TV-44749 extended-release injectable suspension at a dose of 318 mg SC once monthly for up to 48 weeks in open-label period. |
| Open-label Period: Placebo to TV-44749 425 mg | EXPERIMENTAL | Participants who receive placebo during the double-blind period, will receive TV-44749 extended-release injectable suspension at a dose of 425 mg SC once monthly for up to 48 weeks in open-label period. |
| Open-label Period: Placebo to TV-44749 531 mg | EXPERIMENTAL | Participants who receive placebo during the double-blind period, will receive TV-44749 extended-release injectable suspension at a dose of 531 mg SC once monthly for up to 48 weeks in open-label period. |
| Oral olanzapine | ACTIVE_COMPARATOR | - |
| TV-44749 | EXPERIMENTAL | - |
| Olanzapine Dose 1 | EXPERIMENTAL | Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive subcutaneous (sc) injection of TV-44749 |
| Olanzapine Dose 2 | EXPERIMENTAL | Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749 |
| Olanzapine Dose 3 | EXPERIMENTAL | Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749 |
| Name | Type | Description |
|---|---|---|
| TV-44749 | DRUG | In Period 1, 2 monthly injections. In Period 2, up to 12 monthly injections |
| Placebo | DRUG | In Period 1, 2 monthly injections (Period 1 only) |
| Oral olanzapine | DRUG | Administered orally |
Inclusion Criteria: * The participant has a current confirmed diagnosis of schizophrenia according to the DSM-5, for \>1 year * The participant has exacerbation of schizophrenia that started ≤8 weeks prior to screening and would benefit from psychiatric hospitalization or continued hospitalization ...