Small Molecule · TEV-'749
Olanzapine extended-release injectable suspension (TEV-'749)
A once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine, co-developed by Teva Pharmaceuticals and Medincell using Medincell's SteadyTeq (BEPO) copolymer sustained-release technology. The active drug is olanzapine, a second-generation (atypical) antipsychotic. TEV-'749 is engineered to deliver a controlled steady release of olanzapine that avoids the post-injection delirium/sedation syndrome (PDSS) associated with the older olanzapine pamoate LAI, with the goal of providing the first long-acting olanzapine without a post-injection monitoring requirement.
Also known as: TEV-'749, TEV-749, TV-44749, Olanzapine extended-release injectable suspension, Olanzapine LAI, Olanzapine, 132539-06-1
- Modality
- Small molecule
- Chemical class
- thienobenzodiazepine
- DEA schedule
- Unscheduled
- Chemistry
- Achiral
- Mechanism
- D2 antagonist
- Highest phase
- Filed (NDA)
- Lead indication
- Schizophrenia
- Developer
- Teva Pharmaceutical Industries Ltd. (TEVA)
- Trials
- 1 tracked · 82 sites
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 | —ⓘ |
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 | — |
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.
Olanzapine extended-release injectable suspension (TEV-'749) for Schizophrenia
Filed (NDA)ActiveSchizophrenia indication →
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.
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
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.
Conference coverage
TEV-'749 appears in 9 CNS Pulse conference abstracts:
- Antipsychotic switching among patients with bipolar I depression after initiating cariprazine vs lumateperone: A real-world claims-based study
- Real-world persistence on olanzapine/samidorphan versus other oral second-generation antipsychotics in patients with schizophrenia
- Olanzapine and samidorphan in adults with schizophrenia or bipolar I disorder: Updated review of clinical data
- Real-world impact of olanzapine and samidorphan on rates of relapse among young adults with schizophrenia or bipolar I disorder
- Efficacy and safety of xanomeline/trospium chloride during transition from atypical antipsychotics in participants with stable schizophrenia symptoms in EMERGENT-5
- Effects of glucagon-like peptide 1 receptor agonists (GLP-1RAs/GLP-1s) integration in patients utilizing antipsychotics
- Real-world comparison of olanzapine/samidorphan vs olanzapine: An assessment of treatment patterns and acute care events among patients with schizophrenia or bipolar I disorder
- Open-label, randomized study to assess safety and efficacy of slow and accelerated switching to xanomeline/trospium from standard of care atypical antipsychotics in participants with schizophrenia
+ 1 more.
Identifiers
Sources
- 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.