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TV-44749 · 3 trials · 1 indication
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 ...
TV-44749 is an investigational small molecule being developed for the treatment of schizophrenia in adults. It is a psychiatry therapeutic currently in Phase 3 clinical development. The drug is being studied in randomized, double-blind, controlled trials to evaluate its efficacy and safety in patients with schizophrenia.
TV-44749 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is an investigational small molecule for schizophrenia and is currently in Phase 3 clinical development.
TV-44749 is in Phase 3 clinical development for schizophrenia. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 program includes a completed randomized, double-blind, placebo-controlled study with an open-label long-term safety phase.
TV-44749 has been studied in three completed clinical trials. The pivotal Phase 3 trial is NCT05693935, a randomized, double-blind, placebo-controlled study with an open-label long-term safety phase, enrolling 675 adults with schizophrenia. Two Phase 1 trials, NCT06253546 and NCT06315283, evaluated safety, tolerability, pharmacokinetics, and bioavailability in schizophrenia patients.
TV-44749 is not the same as olanzapine, but a Phase 1 trial (NCT06315283) assessed the comparative bioavailability of TV-44749 to oral olanzapine in participants with schizophrenia. This open-label study enrolled 153 participants across the United States, Croatia, Spain, and the United Kingdom.