TEV-'749 · program
Olanzapine extended-release injectable suspension (TEV-'749) for Schizophrenia
TEV-'749 (olanzapine extended-release injectable suspension) is under FDA review for the once-monthly treatment of schizophrenia in adults. The FDA accepted the New Drug Application (NDA) on February 20, 2026. The NDA is supported by the Phase 3 SOLARIS trial (NCT05693935), in which once-monthly subcutaneous TEV-'749 met its primary PANSS endpoint across all three dose groups and, notably, recorded no post-injection delirium/sedation syndrome (PDSS) events through Week 56 of the open-label safety phase.
Development timeline
- metFDA accepted Teva's NDA for olanzapine extended-release injectable suspension (TEV-'749) for once-monthly treatment of schizophrenia in adults.↗
- metCompleted Phase 3 SOLARIS long-term safety data: no PDSS observed through Week 56, supporting TEV-'749 as the first long-acting olanzapine without a post-injection monitoring requirement.↗
- metPhase 3 SOLARIS trial: TEV-'749 met primary PANSS endpoint across all three dose groups at Week 8 (all P<0.0001), with key secondary endpoints (CGI-S, PSP) also met.↗
- Phase 3 SOLARIS trial (NCT05693935) reached primary completion; TEV-'749 met its primary PANSS endpoint across all three dose groups at Week 8 versus placebo.
Readouts
- 2026-02-20ReportedRegulatorymet
FDA accepted Teva's NDA for olanzapine extended-release injectable suspension (TEV-'749) for once-monthly treatment of schizophrenia in adults. ↗
- 2025-05-19ReportedFull resultsmetNCT05693935
Completed Phase 3 SOLARIS long-term safety data: no PDSS observed through Week 56, supporting TEV-'749 as the first long-acting olanzapine without a post-injection monitoring requirement. ↗
- 2024-05-29ReportedTopline datametNCT05693935
Phase 3 SOLARIS trial: TEV-'749 met primary PANSS endpoint across all three dose groups at Week 8 (all P<0.0001), with key secondary endpoints (CGI-S, PSP) also met. ↗
Clinical trials in Schizophrenia
NCT06253546Phase 1Completedn=24
Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
NCT06315283Phase 1Completedn=153
An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia
NCT05693935TV-44749Phase 3Completedn=675
SOLARIS: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study With an Open-Label, Long-Term Safety Phase to Evaluate the Efficacy, Safety, and Tolerability of Olanzapine for Extended-Release Injectable Suspension (TV-44749) for Subcutaneous Use as Treatment of Adult Patients With Schizophrenia
metsecondaryClinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) scale at Week 8
TEV-'749 met key secondary endpoints with improvements in both CGI-S and PSP scale scores compared with placebo at Week 8.
metprimaryChange in PANSS total score from baseline to Week 8 (low dose, 318 mg / 10 mg/day oral equivalent) — -9.69 points vs placebo (<0.0001)
TEV-'749 low-dose group showed a statistically significant placebo-adjusted reduction in PANSS total score of -9.69 points at Week 8.
metprimaryChange in PANSS total score from baseline to Week 8 (medium dose, 425 mg / 15 mg/day oral equivalent) — -11.25 points vs placebo (<0.0001)
TEV-'749 medium-dose group showed a statistically significant placebo-adjusted reduction in PANSS total score of -11.25 points at Week 8.
metprimaryChange in PANSS total score from baseline to Week 8 (high dose, 531 mg / 20 mg/day oral equivalent) — -9.71 points vs placebo (<0.0001)
TEV-'749 high-dose group showed a statistically significant placebo-adjusted reduction in PANSS total score of -9.71 points at Week 8.
metsecondaryPost-injection delirium/sedation syndrome (PDSS) events through Week 56 (open-label long-term safety phase) — 0 PDSS events
No suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events were observed with TEV-'749 through Week 56; the long-term systemic safety profile was consistent with other olanzapine formulations.
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| Olanzapine extended-release injectable suspension (TEV-'749) once-monthly SCSteadyTeq copolymer in-situ depot (Medincell) Once-monthly subcutaneous long-acting injectable; no post-injection monitoring / no REMS required in Phase 3 SOLARIS | Subcutaneous depot (LAI) | Once monthly | — |
Mechanism of action
Olanzapine is a multi-receptor atypical antipsychotic. Its antipsychotic activity is attributed primarily to antagonism of dopamine D2 and serotonin 5-HT2A receptors, with additional antagonist/inverse-agonist activity at other serotonin (5-HT2C, 5-HT6), histamine H1, muscarinic (M1-M5), and alpha-1 adrenergic receptors. The TEV-'749 long-acting injectable does not alter the molecular mechanism; it provides sustained subcutaneous delivery of olanzapine.
| Target | Action | Affinity |
|---|---|---|
| D2primaryDRD2 | Antagonist | —ⓘ |
| 5-HT2AHTR2A | Antagonist | —ⓘ |
| 5-HT2CHTR2C | Antagonist | —ⓘ |
| alpha-1A adrenoceptorADRA1A | Antagonist | —ⓘ |
| H1 receptorHRH1 | Antagonist | —ⓘ |
| M1CHRM1 | Antagonist | —ⓘ |
← Full TEV-'749 compound page (identity, identifiers, all indications)
Sources
- clinicaltrials.gov — clinicaltrials.gov
- clinicaltrials.gov — clinicaltrials.gov
- New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed — Teva Pharmaceutical Industries Ltd.
- Olanzapine ligand summary (GtoPdb Ligand ID 47) — IUPHAR/BPS Guide to Pharmacology
- SOLARIS: Study to Evaluate the Efficacy and Safety of TV-44749 in Adults With Schizophrenia — ClinicalTrials.gov (U.S. National Library of Medicine)
- TEV-'749 Demonstrates No Incidence Of Postinjection Delirium/Sedation Syndrome in New Data — Psychiatric Times
- Teva Submits NDA to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for Once-Monthly Treatment of Schizophrenia — Teva Pharmaceuticals (GlobeNewswire)
- U.S. Food and Drug Administration (FDA) Accepts Teva's New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults — Teva Pharmaceutical Industries Ltd.