FDA approves Teva’s once‑monthly subcutaneous olanzapine injection Weltruza
Teva Pharmaceuticals received U.S. FDA approval for Weltruza, a once‑monthly subcutaneous long‑acting injectable (LAI) formulation of olanzapine for adults with schizophrenia. The product is available in three strengths – 318 mg, 425 mg and 531 mg – and does not require loading doses, oral supplementation or post‑injection monitoring. Approval was based on the Phase 3 SOLARIS trial, which enrolled 675 patients and showed significant symptom improvement and a safety profile consistent with oral olanzapine. The drug uses Medincell’s SteadyTeq copolymer technology, for which Medincell may receive mid‑ to high‑single‑digit royalties and up to $112 million in milestone payments.
Why it matters
The company expects Weltruza to open a new revenue stream in the U.S. antipsychotic market and generate royalty income from Medincell. The lack of required monitoring could simplify administration and expand use in outpatient settings, potentially boosting sales.
Key facts
- 1The FDA granted approval on 9 October 2026. manufacturingchemist.com
- 2Weltruza will be launched in three strengths: 318 mg, 425 mg and 531 mg. manufacturingchemist.com
- 3The approval relied on the Phase 3 SOLARIS trial, which enrolled 675 adult participants. pharmacytimes.com
- 4All three doses met the primary endpoint of PANSS total score change versus placebo. pharmacytimes.com
- 5The formulation uses Medincell’s SteadyTeq copolymer technology and eliminates post‑injection monitoring. manufacturingchemist.com
- 6Medincell is eligible for mid‑ to high‑single‑digit royalties on worldwide net sales and up to $112 million in development and commercial milestone payments. manufacturingchemist.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.