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Clinical Context of RADIANCE

Unmet Need in Schizophrenia

Though prevalence varies by country, schizophrenia affects an estimated 0.16 to 0.44% of the global population.1

Schizophrenia is a severely debilitating mental disorder associated with a slow decline in mental function and social relationships, which may lead to2,3:  

  • personality change 
  • social isolation 
  • employment disability 
  • poor health 
  • reduced quality of life 

Although antipsychotic therapies help reduce relapse risk, real-world outcomes are often affected by challenges such as incomplete adherence, treatment discontinuation, and inconsistent long-term persistence, emphasizing the need for sustained treatment approaches and continuity of care.4,5

About TV-44749

TV-44749 is a long-acting injectable that combines an olanzapine base and copolymer-based drug delivery technology to prevent an uncontrolled release of olanzapine. It is intended for once-monthly subcutaneous administration.6,7

The mechanism of action of olanzapine, for the treatment of schizophrenia in adults, is unproven. However, the efficacy of olanzapine in schizophrenia could be mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism.8 

Please refer to the Prescribing Information for more details.

Clinical Relevance of Phase 4 Trials

Phase 4 clinical trials are observational studies conducted after a product receives regulatory approval. They are vital for evaluating the healthcare resource utilization, treatment experience, and effectiveness of an approved product in real-world patient populations that may differ from controlled, clinical trial settings. Phase 4 trials may also identify less common adverse reactions.9 

Because TV-44749 is a treatment that was approved in October 2026, real-world evidence is needed to better understand its effectiveness, safety, treatment experience, functional outcomes, and associated healthcare resource utilization.

References

  1. Charlson FJ, Ferrari AJ, Santomauro DF, et al. Global epidemiology and burden of schizophrenia: findings from the Global Burden of Disease Study 2016. Schizophr Bull. 2018;44(6):1195-1203. doi:10.1093/schbul/sby058 
  2. Millier A, Schmidt U, Angermeyer MC, et al. Humanistic burden in schizophrenia: a literature review. J Psychiatr Res. 2014;54:85-93. doi:10.1016/j.jpsychires.2014.03.021 
  3. Patel KR, Cherian J, Gohil K, Atkinson D. Schizophrenia: overview and treatment options. P T. 2014;39(9):638-645. 
  4. Buchanan RW, Kreyenbuhl J, Kelly DL, et al. The 2009 schizophrenia PORT psychopharmacological treatment recommendations and summary statements. Schizophr Bull. 2010;36(1):71-93. doi:10.1093/schbul/sbp116 
  5. Weiden PJ, Kozma C, Grogg A, Locklear J. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv. 2004;55(8):886-891. doi:10.1176/appi.ps.55.8.886
  6. Correll CU, Shulman K, Bar-Nur T, et al. Safety and tolerability of TV-44749: results from a randomized, placebo-controlled phase 3 trial in adults with schizophrenia (SOLARIS). Poster presented at: Neuroscience Education Institute; November 7-10, 2024; Colorado Springs, CO. 
  7. Correll CU, Shulman K, Bar-Nur T, et al. Monthly olanzapine extended-release injectable suspension (TV-44749) for subcutaneous use leads to early, consistent symptom improvements through week 8 in adults with acute exacerbation of schizophrenia: phase 3 SOLARIS trial. Poster presented at: Psych Congress; October 29 - November 2, 2024; Boston, MA. 
  8. Li P, Snyder GL, Vanover KE. Dopamine targeting drugs for the treatment of schizophrenia: past, present and future. Curr Top Med Chem. 2016;16(29):3385-3403. doi:10.2174/1568026616666160608084834
  9. Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials: a narrative review. Postgrad Med. 2011;123(5):194-204. doi:10.3810/pgm.2011.09.2475