Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Olanzapine, Olanzapine for Extended-Release Injectable Suspension
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 ...
Top 15 of 16 competitors
TV-44749 is an investigational small molecule being developed by Teva Pharmaceutical Industries Limited for the treatment of schizophrenia. It is a Phase 3 candidate that has been studied in randomized, double-blind, placebo-controlled clinical trials in adults with schizophrenia. It is not described as an approved product.
TV-44749 is being developed as a treatment for schizophrenia in adults. Its clinical program includes a Phase 3 randomized, double-blind, placebo-controlled trial with an open-label long-term safety phase, plus two Phase 1 studies, all conducted in participants with schizophrenia rather than healthy volunteers.
TV-44749 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program for the asset, which includes three completed trials in schizophrenia across the United States, China, and several European and other countries.
TV-44749 is in Phase 3 development. Its Phase 3 trial, NCT05693935, was a randomized, double-blind, placebo-controlled study with an open-label long-term safety phase in adults with schizophrenia, and it has completed. Two completed Phase 1 studies, NCT06315283 and NCT06253546, support the program.
Three completed trials have studied TV-44749: the Phase 3 trial NCT05693935 in adults with schizophrenia, the Phase 1 comparative bioavailability trial NCT06315283 versus oral olanzapine, and the Phase 1 safety, tolerability, and pharmacokinetic study NCT06253546 in Chinese patients with schizophrenia. Total enrollment across the program was 852 participants.
Across the three completed TV-44749 trials, total enrollment was 852 participants. The Phase 3 study NCT05693935 enrolled 675 adults with schizophrenia, the Phase 1 bioavailability study NCT06315283 enrolled 153 participants, and the Phase 1 Chinese pharmacokinetic study NCT06253546 enrolled 24 patients.