olanzapine LAI (TEV-'749) / Teva, MedinCell, Royalty - LARVOL DELTA

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 (GlobeNewswire) - "The NDA for TEV-'749 is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia."

FDA filing • Schizophrenia

Innovative late-stage pipeline continued to drive transformation (Teva Press Release) - "4 innovative product submissions targeted over the next 5 years. Up to $500 million in funding secured via Teva’s agreement with Royalty Pharma to fund the development of anti-IL-15 (TEV-’408) for vitiligo indication. duvakitug (anti-TL1A) Phase 3 initiated for ulcerative colitis and Crohn's disease. Preparing for olanzapine LAI U.S. launch, subject to regulatory approval; New Drug Application (NDA) submitted to FDA in December 2025."

Financing • Launch US • Trial status • Crohn's disease • Schizophrenia • Ulcerative Colitis • Vitiligo

Safety, Tolerability, and Pharmacokinetics of Subcutaneous Extended-Release Injectable Olanzapine in Patients with Schizophrenia and Schizoaffective Disorder. (PubMed, Clin Drug Investig) - P3 | "TV-44749 administration resulted in a sustained release profile and comparable exposure to daily therapeutic doses of oral olanzapine over a monthly dosing interval. The TV-44749 systemic safety profile was consistent with approved oral olanzapine. The local tolerability was acceptable, and there were no PDSS events. These results contributed to the dose selection of TV-44749 in a phase III study evaluating its efficacy and safety in adults with schizophrenia (SOLARIS; NCT05693935)."

Journal • PK/PD data • Anesthesia • CNS Disorders • Pain • Psychiatry • Schizophrenia

Population Pharmacokinetic Model-Based Dose Selection of Extended-Release Injectable Olanzapine (TV-44749) for Subcutaneous Use in Phase 3 Clinical Trial in Adults with Schizophrenia. (PubMed, J Clin Pharmacol) - P3 | "The predicted steady-state pharmacokinetic parameters (Cmax, Cavg, and Ctrough) of once-monthly TV-44749 doses of 318, 425, and 531 mg were comparable to daily oral doses of 10, 15, and 20 mg, respectively. The exposure values resulted in simulated D2RO levels within the recommended range (60%-80%) and were therefore selected for the Phase 3 trial of TV-44749 (SOLARIS; NCT05693935)."

Clinical • Journal • P3 data • PK/PD data • Anesthesia • CNS Disorders • Psychiatry • Schizophrenia • DRD2

Teva Pharmaceuticals Submits New Drug Application to FDA for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults (Teva Press Release) - "The NDA for olanzapine LAI is based on results from the Phase 3 SOLARIS trial, including Week 56 results studying its efficacy, safety and tolerability in participants aged 18 to 64 living with schizophrenia."

FDA filing • Schizophrenia

German claims data study analyzing clinical characteristics, treatment patterns, discontinuation rates and adherence of oral olanzapine among patients with schizophrenia (ECNP 2025) - "Patients with a 1-year pre-index olanzapine (oral or injectable) and clozapine treatment-free period (i.e., incident oral olanzapine population) were included...The proportion of patients who switched to another antipsychotic before, during or after oral olanzapine discontinuation was 18.7%, with most patients switching to oral antipsychotics, namely risperidone and quetiapine (5.1% and 4.5%, respectively)... This study examined the demographics, clinical characteristics, treatment patterns and discontinuation rates of incident oral olanzapine patients with schizophrenia in Germany. Although non-adherence and treatment discontinuation were observed in a substantial proportion of patients, it is important to note that this complex population had a high comorbidity burden (as indicated by high CCI scores). Notably, only a minority of patients transitioned to another antipsychotic."

Adherence • Clinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Schizophrenia • Substance Abuse

Real-world evidence analysis of oral and long-acting injectable antipsychotic treatment patterns among patients with schizophrenia in Germany (ECNP 2025) - "Olanzapine, risperidone, quetiapine and aripiprazole were the most commonly prescribed OAs (17.7%, 16.8%, 15.2% and 11.6%, respectively), while paliperidone, aripiprazole, flupentixol and risperidone were the most commonly prescribed LAIs (5.7%, 2.3%, 2.1% and 1.8%, respectively)...Among OAs, olanzapine (n=1457) and ziprasidone (n=100) had the lowest proportion of discontinuations (36% and 26%, respectively), with patients treated with olanzapine, ziprasidone and aripiprazole remaining on treatment the longest (163, 162 and 155 days, respectively)... In this dataset from Germany, LAIs are less commonly prescribed than OAs, despite demonstrating better adherence and discontinuation outcomes. These findings are consistent with previous literature [1]. However, within OAs, some molecules exhibit more favourable outcomes than others."

Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

Clinician perspectives on the efficacy and safety/tolerability of olanzapine from the SONAR (Survey on Olanzapine Needs and Attitudes Research) study (ECNP 2025) - "The perception of olanzapine efficacy compared to other antipsychotics, except for aripiprazole, was consistent between NPs/PAs and the other respondents...However, olanzapine was viewed as safer or comparable to several other therapies (haloperidol, risperidone and paliperidone) regarding prolactin elevation and drug-induced movement disorders such as parkinsonism and akathisia.Clinicians were more likely to choose olanzapine than other antipsychotics for key clinical scenarios such as acute exacerbation, first-episode schizophrenia and suboptimal response to initial treatment. Overall, these results reflect the enduring clinician perception of olanzapine as a highly efficacious molecule for treating schizophrenia. Although clinicians associate olanzapine with higher risk of cardiometabolic adverse events, these results show that clinicians still prefer olanzapine over other antipsychotics owing to its efficacy in a wide variety of clinical scenarios."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Olanzapine LAI (TEV-'749) Data (Teva Press Release) - "Through Week 56, an integrated long-term safety analysis from the double-blind and open-label periods demonstrated a systemic safety profile for olanzapine LAI (TEV-'749) that was consistent with second-generation antipsychotic class effects and other olanzapine formulations. Consistent with previous results, no PDSS events (suspected or confirmed) were reported (3,470 total injections)...Additionally, long-term effectiveness data from SOLARIS demonstrated long-term symptom improvement and maintained clinical effectiveness in adult participants taking olanzapine LAI (TEV-'749)."

P3 data • Schizophrenia

A weight and metabolic analysis of the SOLARIS trial found that long-term metabolic safety data for olanzapine LAI (TEV-'749) were consistent with currently available olanzapine formulations. (Teva Press Release) - "The overall mean weight increase from baseline in participants who received olanzapine LAI (TEV-'749) for ≥48 weeks (n=137) was 5.6kg, which was comparable to those reported for oral and intramuscular olanzapine formulations. By week 32, all olanzapine LAI (TEV-'749) and placebo groups reached a similar mean weight increase versus baseline, which thereafter remained stable through week 48."

P3 data • Schizophrenia

Long-term effectiveness data from SOLARIS demonstrated long-term symptom improvement and maintained clinical effectiveness in adult participants taking olanzapine LAI (TEV-’749). (Teva Press Release) - "Across all olanzapine LAI (TEV-'749) doses, stable change from P2 baseline in Positive and Negative Syndrome Scale (PANSS) total and Clinical Global Impression-Severity (CGI-S) scale scores (mean change from baseline: -7.2 and -0.5, respectively) were observed. Olanzapine LAI (TEV-'749) also improved patient functioning scores, with a 4.6-point mean increase in Personal and Social Performance Scale (PSP) score from P2 baseline."

P3 data • Schizophrenia

Teva to Host Conference Call to Discuss Data from the Completed Phase 3 SOLARIS Trial For Olanzapine LAI (TEV-‘749) on September 22, 2025 After Presentations at the Psych Congress Annual meeting (Teva Press Release)

P3 data • Schizophrenia

An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia (clinicaltrials.gov) - P1 | N=153 | Completed | Sponsor: Teva Branded Pharmaceutical Products R&D LLC | Active, not recruiting ➔ Completed | N=116 ➔ 153

Enrollment change • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D LLC | Trial completion date: Jun 2025 ➔ Sep 2025

Trial completion date • CNS Disorders • Psychiatry • Schizophrenia

Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Active, not recruiting ➔ Completed | N=36 ➔ 24

Enrollment change • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved (Teva Press Release) - "We anticipate upcoming milestones for olanzapine LAI (NDA filing in 2025) and for DARI (Dual-action Asthma Rescue Inhaler; Phase 3 full enrollment in 2025 and potential Phase 3 event-driven read-out in 2026), as well the announcement of the start of the Phase 3 IBD programs for duvakitug in H2 2025."

FDA filing • New P3 trial • P3 data • Trial status • Asthma • CNS Disorders • Inflammatory Bowel Disease • Schizophrenia

New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable (GlobeNewswire) - P3 | N=70 | "Teva Pharmaceuticals...announced the presentation of a patient and healthcare professional (HCP) attitudes and experiences survey study, complementing the successful Phase 3 Subcutaneous Olanzapine Extended-Release Injection Study (SOLARIS) evaluating TEV-'749. More than 92% of patients, 87% of nurses and 72% of physicians were either satisfied or very satisfied when asked about TEV-'749, overall, including initiation regimen, monthly dosing schedule and dosing options...Post-injection monitoring requirements: Despite reporting low levels of social, emotional, financial or time impact, nearly all patients noted it would be helpful to have an LAI without a post-injection monitoring period (90.0%) or caregiver accompaniment requirement (92.9%)....Dosing schedule: A majority of participants valued a monthly dosing schedule “a lot” (patients: 61.4%; physicians: 72.7%; nurses: 66.7%)."

P3 data • Schizophrenia

New Data Strengthens Teva’s Schizophrenia Portfolio... (GlobeNewswire) - "Below is the full set of schizophrenia data presented by Teva at SIRS 2025: TEV-'749 (olanzapine): (De novo) Patient and healthcare professional attitudes and trial experiences with a subcutaneous long-acting injectable olanzapine (TV-44749) for the treatment of schizophrenia; UZEDY (risperidone): (De novo) Predictors of response and non-response to treatment for schizophrenia: machine learning analysis of patients treated with TV-46000 or placebo in the RISE study; Schizophrenia Treatment Landscape: (De novo) Healthcare professionals’ attitudes toward use of long-acting injectable antipsychotics for schizophrenia treatment differ among settings of care: ADVANCE survey results; (De novo) The evolving schizophrenia treatment landscape in the United States: A real-world claims analysis of treatment patterns and use of long-acting injectable antipsychotics; (De novo) Real-world antipsychotic prescription patterns among patients with schizophrenia in Australia:..."

Clinical data • Schizophrenia

Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Trial completion date: Jan 2025 ➔ Jun 2025 | Trial primary completion date: Jan 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder (clinicaltrials.gov) - P1 | N=91 | Completed | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

SOLARIS: 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 (clinicaltrials.gov) - P3 | N=675 | Completed | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder (clinicaltrials.gov) - P1 | N=95 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Psychiatry • Schizophrenia

Long-acting subcutaneous injectable olanzapine (TV-44749) demonstrates efficacy in patients with schizophrenia: Results from a randomised, double-blind, placebo-controlled trial (SOLARIS) (ECNP 2024) - P3 | "The Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS; NCT05693935) is an ongoing phase 3 study designed to assess the efficacy, safety and tolerability of TV-44749 in patients with schizophrenia. In patients with schizophrenia, once-monthly subcutaneous TV-44749 demonstrated significantly greater efficacy versus placebo with no reported PDSS. TV-44749 may provide an effective LAI olanzapine formulation while avoiding the risk of PDSS and will be further studied in the open-label, long-term safety period of SOLARIS."

Clinical • CNS Disorders • Psychiatry • Schizophrenia