Teva Pharmaceutical Industries Limited filed a New Drug Application with the U.S. Food and Drug Administration for its once‑monthly olanzapine extended‑release injectable suspension, TEV‑749, on December 09 2025. The submission is based on the Phase 3 SOLARIS trial, which demonstrated that the subcutaneous formulation meets both efficacy and safety endpoints in adults with schizophrenia.
The SOLARIS study enrolled more than 1,200 patients and reported a 52% reduction in relapse rates compared with placebo over 12 months. Importantly, the trial recorded no cases of post‑injection delirium/sedation syndrome (PDSS), a serious adverse event that has limited the use of Eli Lilly’s Zyprexa Relprevv. The absence of PDSS events suggests that TEV‑749 could be administered without the 30‑minute observation period required for current olanzapine long‑acting injectables, potentially improving patient convenience and adherence.
The U.S. schizophrenia treatment market is the largest segment of the global antipsychotic market, valued at roughly US$10 billion in 2024 and projected to reach US$15.6 billion by 2032. Long‑acting injectables (LAIs) account for a growing share of this market, with a projected global value of US$8.9 billion by 2033. Teva’s existing LAI, Uzedy, captured more than 60% of the risperidone LAI market and generated US$117 million in revenue in 2024. TEV‑749 would add a second olanzapine LAI to the portfolio, positioning Teva to capture 5–10% of the LAI market by 2030 and to compete directly with Zyprexa Relprevv without the PDSS risk.
The filing aligns with Teva’s “Pivot to Growth” strategy, which aims to build a $5 billion innovative medicines franchise by 2030. The company has set a target of $1.5 billion to $2 billion in annual sales for its LAI schizophrenia franchise. By expanding its LAI platform, Teva seeks to leverage its SteadyTeq™ copolymer technology—already used in Uzedy—to deliver sustained drug release and to strengthen its competitive position in a high‑margin therapeutic area.
Regulatory guidance from the FDA indicates that the review of a new LAI typically takes 12–18 months. Teva has indicated that it expects a potential launch in 2026 if the NDA is approved. The company’s recent Q3 2025 earnings beat—driven by strong performance of its innovative portfolio—has reinforced investor confidence in its growth trajectory and supports the strategic importance of the TEV‑749 filing.
Executive Vice President, Global R&D and Chief Medical Officer Eric Hughes said, “The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once‑monthly subcutaneous formulation. This filing is a critical step in our mission to address unmet needs in schizophrenia and to expand our high‑margin specialty portfolio.”
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.