FDA approves WELTRUZA, first once-monthly subcutaneous olanzapine for schizophrenia

Overview

Updated Oct 29

Teva's WELTRUZA is the first once-monthly subcutaneous olanzapine injection for schizophrenia. Patients skip the loading doses, oral supplementation and post-injection observation that shaped use of the older injectable form.

The FDA approved it on October 9, 2026, based on the Phase 3 SOLARIS trial, which tested 318 mg, 425 mg and 531 mg doses. Teva says it will be on the U.S. market in the coming weeks, and Medincell has said it plans a Q4 2026 launch. As of October 29, no launch has been confirmed. A European application was accepted in May 2026, and the drug has not been approved in Europe.

Why it matters

WELTRUZA is the first olanzapine injection that doesn't require post-dose clinic observation, removing a burden that pushed patients and clinicians toward other antipsychotics.

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Key Indicators

Dose strengths: 318, 425, 531 mg

Strengths correspond to 10, 15, and 20 mg daily oral olanzapine.

Mid- to high-single digit

Medincell royalty on worldwide net sales

Medincell's stated royalty range on WELTRUZA net sales, per its Oct 9 release.

WELTRUZA discontinuation rate from adverse events

Placebo discontinuation rate in the SOLARIS trial was 4%.

Confirmed PDSS cases in SOLARIS

Across about 3,487 active injections as of March 2025, no PDSS cases were reported. The label still warns the risk is unknown with subcutaneous delivery.

Voices

Curated perspectives — historical figures and your fellow readers.

People Involved

Christophe Douat

Chief executive, Medincell

Leading Medincell after WELTRUZA approval

Organizations Involved

Teva Pharmaceuticals

Pharmaceutical company

Developer and U.S. commercializer of WELTRUZA

Drove development of WELTRUZA and will commercialize it across the U.S.

Medincell

Biotechnology company

Technology partner — developed SteadyTeq delivery platform

Developed the copolymer technology that releases olanzapine steadily over a month.

U.S. Food and Drug Administration

Federal regulator

Approved WELTRUZA on October 9, 2026

The federal agency that reviews and approves new drugs for the U.S. market.

Timeline

April 2023 October 2026

3 events Latest: October 9th, 2026 · 1 month ago

October 2026
FDA approves WELTRUZA
Latest Regulatory

FDA approves WELTRUZA, first once-monthly subcutaneous olanzapine injection for schizophrenia.
October 9th, 2026
May 2026
EMA accepts olanzapine LAI application
Regulatory

European Medicines Agency accepts Teva's marketing application for TEV-'749, the olanzapine long-acting injectable.
May 2026
April 2023
FDA approves Uzedy
Regulatory

FDA clears Uzedy (risperidone), first drug on Medincell's SteadyTeq long-acting platform.
April 2023

Scenarios

WELTRUZA reaches U.S. patients within weeks

Likely Resolves by End of 2026

Discussed by: Teva Pharmaceuticals, Medincell

Teva says the drug will be available in the coming weeks across three strengths. For this to resolve YES, Teva must confirm commercial availability or the product must appear in pharmacy channels. Launch timing is the clearest near-term checkpoint.

EMA grants European approval for TEV-'749

Likely Resolves by Q2 2027

Discussed by: European Medicines Agency review process

EMA accepted the marketing application for TEV-'749 in May 2026, supported by the same SOLARIS study. A standard review typically concludes within about a year of acceptance. The U.S. approval strengthens the case but doesn't guarantee the European decision.

Post-marketing data answers the PDSS question

Uncertain Resolves by End of 2027

Discussed by: PharmTech, pharmacovigilance community

WELTRUZA's label still carries the post-injection delirium/sedation syndrome language from the intramuscular product, noting it's unknown whether PDSS can occur with subcutaneous delivery. The key question: does the copolymer's controlled release prevent the rapid drug spikes behind PDSS? The first year of real-world use will show.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

Pre-2026

The intramuscular olanzapine era

The prior long-acting olanzapine was given intramuscularly and linked to post-injection delirium/sedation syndrome, where too much drug enters the bloodstream too quickly. Patients needed extended observation after each dose.

Then

Clinics built observation time into every injection visit, making injectable olanzapine logistically heavy.

Now

The monitoring burden shaped how readily clinicians prescribed injectable olanzapine, steering many toward alternative antipsychotics.

Why this matters now

WELTRUZA removes the monitoring requirement. Its label still describes the PDSS risk from the intramuscular product, and says it's unknown whether the syndrome can occur with the subcutaneous formulation.

April 2023

Uzedy validates the SteadyTeq platform (2023)

FDA approved Uzedy, a risperidone long-acting injectable using Medincell's copolymer technology. It was the first product cleared on the SteadyTeq platform.

Then

The approval showed the polymer delivery system could safely release an antipsychotic over a month.

Now

WELTRUZA is the second approval on the same platform, suggesting polymer depot technology can extend to other molecules with established efficacy.

Why this matters now

Two approvals on one delivery system may shorten development timelines for future drugs, since polymer supply, analytical methods, and sterile manufacturing experience already exist.

Sources

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