TV-44749 for Schizophrenia

(SOLARIS Trial)

No longer recruiting at 106 trial locations

Overseen By Teva U.S. Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Must be taking: Antipsychotics

Must not be taking: Clozapine, LAI antipsychotics

Disqualifiers: Bipolar, Dementia, Substance use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 22

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the new medication, TV-44749 (Olanzapine extended-release injectable suspension), for individuals with schizophrenia. Researchers aim to determine its impact on symptoms and assess its safety. Participants will receive a low, medium, or high dose of the medication, or a placebo (a substance with no active drug). This trial may suit those diagnosed with schizophrenia for over a year and requiring hospitalization for recent symptom flare-ups. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently using a long-acting injectable antipsychotic, taking clozapine, or receiving daily oral olanzapine at a dose greater than 20 mg/day.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that TV-44749, a long-acting injectable form of olanzapine, is safe and effective for treating schizophrenia. Studies have found that olanzapine, the main ingredient in TV-44749, is usually well-tolerated by patients.

In these studies, patients using TV-44749 did not experience post-injection delirium/sedation syndrome (PDSS), a rare side effect sometimes linked to long-acting injections. This suggests that TV-44749 could be a safe choice for people with schizophrenia.

Overall, evidence indicates that TV-44749 may effectively manage schizophrenia symptoms, given its long-term use and proven safety in other situations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Researchers are excited about TV-44749 for schizophrenia because it may offer a new approach to treatment with its unique dosing regimens. Unlike standard antipsychotics like risperidone or olanzapine, which primarily work by blocking dopamine receptors, TV-44749 might operate through a different mechanism potentially targeting other pathways in the brain. This could mean fewer side effects or improved effectiveness for patients who don't respond well to current medications. Additionally, the study is exploring multiple dose levels, which could help tailor the treatment to individual needs, potentially enhancing outcomes for a broader range of patients.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research shows that TV-44749, a long-acting form of olanzapine, may help treat schizophrenia. Studies have found that it can lower the chances of relapse and help people adhere to their treatment plan. Specifically, patients using this treatment experienced fewer relapses and maintained their medication for longer periods. This trial will evaluate different dose levels of TV-44749, as well as a placebo, to determine its effectiveness and safety. This treatment might be a good option for those currently taking oral olanzapine or similar medications. Overall, early evidence suggests that TV-44749 could be an effective long-term option for managing schizophrenia symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Teva Medical Expert, MD

Principal Investigator

Teva Branded Pharmaceutical Products R&D, Inc.

Are You a Good Fit for This Trial?

Adults with recent schizophrenia flare-ups, a BMI of 18-40, and diagnosed over a year ago can join. Women must not plan pregnancy and use contraception. Excluded are those hospitalized for over 14 days recently, at risk of violence or suicide, on certain antipsychotics or treatments like clozapine in the past year, have significant other mental health diagnoses or substance abuse issues.

Inclusion Criteria

My schizophrenia symptoms worsened in the last 8 weeks, needing hospital care.

Body mass index between 18.0 and 40.0 kg/m2, inclusive, at the time of screening

My overall health, including heart and blood tests, is good.

Exclusion Criteria

I am currently on long-acting injectable antipsychotics.

The participant has a non-fasting glucose level of ≥200 mg/dL at screening

NOTE- Additional criteria apply, please contact the investigator for more information

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Double-blind, placebo-controlled, efficacy and safety period with weekly visits

8 weeks

8 visits (in-person)

Treatment Period 2

Open-label long-term safety period with monthly in-clinic visits and weekly calls

48 weeks

12 visits (in-person), weekly calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TV-44749

Trial Overview The trial tests TV-44749's effectiveness in adults with schizophrenia across three different doses compared to a placebo. It assesses improvement from baseline to week 56 with weekly then monthly check-ins.

How Is the Trial Designed?

Group I: TV-44749 - Dose level 3 Experimental Treatment 1 Intervention

High dose regimen

Group II: TV-44749 - Dose level 2 Experimental Treatment 1 Intervention

Medium dose regimen

Group III: TV-44749 - Dose level 1 Experimental Treatment 1 Intervention

Low dose regimen

Group IV: Placebo Placebo Group 1 Intervention

Matching Placebo

Who Is Running the Clinical Trial?

Teva Branded Pharmaceutical Products R&D, Inc.

Lead Sponsor

Trials

258

Recruited

3,487,000+

Dr. Eric Hughes

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Medical Officer since 2022

MD and PhD from Yale School of Medicine

Richard Francis

Teva Branded Pharmaceutical Products R&D, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Biochemistry from the University of Manchester

Published Research Related to This Trial

In a clinical safety review involving 2500 patients treated with olanzapine for acute schizophrenia, the overall discontinuation rate was low, indicating good tolerability of the medication.

While olanzapine was associated with some significant adverse effects such as somnolence, weight gain, and elevated liver enzymes, it showed minimal risk for parkinsonism, akathisia, and no cases of hematotoxicity, making it a relatively safe option compared to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of olanzapine. Beasley, CM., Tollefson, GD., Tran, PV.[2018]

In a 6-year study involving 669 patients with schizophrenia, olanzapine long-acting injection (LAI) demonstrated effectiveness in long-term maintenance treatment, with significant improvements in Clinical Global Impression-Severity scores.

While the safety profile of olanzapine LAI was generally consistent with oral olanzapine, there were notable concerns regarding weight gain (average +2.19 kg, with 40.8% of patients gaining ≥7%) and occurrences of post-injection delirium/sedation syndrome (PDSS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 6-year open-label study of the efficacy and safety of olanzapine long-acting injection in patients with schizophrenia: a post hoc analysis based on the European label recommendation. Anand, E., Berggren, L., Deix, C., et al.[2020]

In a study involving 8,288 patients, it was found that older patients (50 years or older) experience increased dose-adjusted concentrations of olanzapine when taken orally, indicating that age affects how the body processes this form of the medication.

However, for the long-acting injectable (LAI) formulation of olanzapine, age did not impact systemic exposure, suggesting that LAI can be safely used in older patients without the need for dosage adjustments based on age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Age Impacts Olanzapine Exposure Differently During Use of Oral Versus Long-Acting Injectable Formulations: An Observational Study Including 8,288 Patients. Tveito, M., Smith, RL., Molden, E., et al.[2019]

Olanzapine pamoate, a long-acting injectable form of the antipsychotic olanzapine, has shown significant efficacy in treating schizophrenia, with a study of 404 patients demonstrating its effectiveness compared to placebo over 8 weeks.

In a larger study of 1,065 stabilized patients, the depot formulation was effective in delaying the exacerbation of symptoms or hospitalization, with safety profiles similar to oral olanzapine, aside from some local injection reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olanzapine: a review of rapid and long-acting parenteral formulations. Owen, RT.[2018]

Olanzapine pamoate (OLAI) has a safety profile similar to oral olanzapine, but it carries a specific risk of post-injection delirium/sedation syndrome (PDSS), which requires monitoring in patients.

OLAI can be a suitable treatment option for schizophrenia patients who have previously responded well to oral olanzapine, provided they have access to emergency care for potential PDSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olanzapine pamoate for the treatment of schizophrenia--a safety evaluation. Samalin, L., Garay, R., Ameg, A., et al.[2018]

In a study of 404 patients with acute schizophrenia, olanzapine long-acting injection (LAI) demonstrated a significant reduction in psychiatric symptoms, with a mean decrease in Brief Psychiatric Rating Scale (BPRS) scores of 14 to 15 points over 6 weeks, comparable to oral olanzapine and haloperidol.

Olanzapine LAI showed a rapid onset of action, with significant symptom improvement observed as early as 3 days, and had a similar efficacy and tolerability profile to oral olanzapine, with fewer extrapyramidal symptoms and no cases of post-injection delirium/sedation syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data. Detke, HC., Zhao, F., Witte, MM.[2021]

Paliperidone extended-release tablets (3-12 mg/day) were effective in maintaining symptom improvements in schizophrenia patients over a 52-week open-label extension phase, following initial 6-week placebo-controlled trials involving 1083 participants.

The treatment was generally well tolerated, with common side effects including insomnia, headache, and akathisia, while serious adverse events occurred in 16% of patients, including two suicides, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies. Emsley, R., Berwaerts, J., Eerdekens, M., et al.[2015]

Olanzapine pamoate (OLAI) has been shown to be more effective than placebo in treating symptoms of schizophrenia in two pivotal trials lasting 8 or 24 weeks, and it is comparable to oral olanzapine in preventing psychotic exacerbations for patients stabilized on the oral form.

OLAI is generally well tolerated, with a low incidence of post-injection syndrome (<0.1%), but requires a risk management plan for monitoring after administration, making it a suitable option for patients who struggle with adherence to oral medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Olanzapine long-acting injection: a review of its use in the treatment of schizophrenia. Frampton, JE.[2021]

Citations

1. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/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/default.aspx

New Long-term Safety Data from the Completed Phase 3 ... “These encouraging results from the SOLARIS trial show that olanzapine LAI (TEV-'749) has the potential to be the first long-acting olanzapine ...

2. tevausa.com tevausa.com/news-and-media/press-releases/teva-presents-latest-schizophrenia-portfolio-data-including-real-world-outcomes-with-uzedy-risperidone/

Teva Presents Latest Schizophrenia Portfolio Data ... Patients receiving UZEDY had lower rates of and longer time to relapse as well as better treatment adherence and persistence rates.

3. ir.tevapharm.com ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-New-Phase-3-Efficacy-Safety-and-Tolerability-Data-from-SOLARIS-Trial-Evaluating-TEV-749-olanzapine-as-a-Once-Monthly-Subcutaneous-Long-Acting-Injectable-for-Adult-Patients-Diagnosed-with-Schizophrenia/default.aspx

Teva Presents New Phase 3 Efficacy, Safety and Tolerability ... These data demonstrate the potential role of TEV-'749 as an LAI treatment option for schizophrenia patients taking daily oral olanzapine or other antipsychotic ...

4. medincell.com medincell.com/wp-content/uploads/2025/09/MDC_Psych2025_Olanzapine_EN_22092025.pdf

New Pivotal Phase 3 Long-Term Data Supports Olanzapine ... “These encouraging results from the SOLARIS trial show that olanzapine LAI (TEV-'749) has the potential to be the first long- acting olanzapine ...

5. globenewswire.com globenewswire.com/news-release/2025/09/21/3153528/0/en/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-Schizoph.html

New Long-term Safety Data from the Completed Phase 3 “These encouraging results from the SOLARIS trial show that olanzapine LAI (TEV-'749) has the potential to be the first long-acting olanzapine ...