WELTRUZA™

Once-monthly long-acting olanzapine for adults with Schizophrenia.

WELTRUZA™ is the only once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of adults with schizophrenia.

Approved by the U.S. FDA in October 2026, WELTRUZA™ is the second product powered by Medincell’s BEPO® technology to receive FDA approval.

WELTRUZA™ does not require loading doses or oral supplementation at treatment initiation and eliminates the need for post-injection monitoring, addressing a major, long-standing gap in schizophrenia care.

WELTRUZA™ is a trademark of Teva Pharmaceuticals. Medincell’s BEPO® technology is licensed to Teva as SteadyTeq™, a trademark of Teva Pharmaceuticals.

Strong differentiation thanks to BEPO®

Once-monthly treatment

Available in three doses corresponding to oral olanzapine doses for treatment of schizophrenia

Immediate onset of action

No loading doses and no oral supplementation at initiation

Favorable safety profile

No mandatory post-injection monitoring period required

Small needle size

One of the smallest LAI needles used to treat schizophrenia

Injected just below the skin

Most other schizophrenia LAIs are injected into muscle

News related to WELTRUZA™

Medincell Brings Total Non-Dilutive Financing Secured Since July 2026 to €41.8 Million with an Additional €13.8 Million Loan
October 13, 2026

Medincell Brings Total Non-Dilutive Financing Secured Since July 2026 to €41.8 Million with an Additional €13.8 Million Loan

Medincell Achieves Major Milestone with U.S. FDA Approval of WELTRUZA™ (olanzapine)
October 9, 2026

Medincell Achieves Major Milestone with U.S. FDA Approval of WELTRUZA™ (olanzapine)

The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable for the Treatment of Schizophrenia in Adults
May 21, 2026

The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable for the Treatment of Schizophrenia in Adults

U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults
February 20, 2026

U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-‘749) for the Once-Monthly Treatment of Schizophrenia in Adults

UZEDY®: Net Sales Increased from $117M in 2024 to $191M in 2025 (+63%) ; OLANZAPINE LAI: EU Submission Expected in Q2 2026
January 28, 2026

UZEDY®: Net Sales Increased from $117M in 2024 to $191M in 2025 (+63%) ; OLANZAPINE LAI: EU Submission Expected in Q2 2026

Medincell’s Partner Teva Pharmaceuticals Announces the New Drug Application Submission to U.S. FDA for Olanzapine Extended-Release Injectable Suspension (TEV-‘749 / mdc-TJK) for the Once-Monthly Treatment of Schizophrenia in Adults
December 9, 2025

Medincell’s Partner Teva Pharmaceuticals Announces the New Drug Application Submission to U.S. FDA for Olanzapine Extended-Release Injectable Suspension (TEV-‘749 / mdc-TJK) for the Once-Monthly Treatment of Schizophrenia in Adults

UZEDY® continues strong growth; Teva setting the stage for US NDA Submission for Olanzapine LAI in Q4 2025
November 5, 2025

UZEDY® continues strong growth; Teva setting the stage for US NDA Submission for Olanzapine LAI in Q4 2025

New Pivotal Phase 3 Long-Term Data Supports Olanzapine Long-Acting Injectable (LAI) with Favorable Safety Profile – No PDSS Observed
September 22, 2025

New Pivotal Phase 3 Long-Term Data Supports Olanzapine Long-Acting Injectable (LAI) with Favorable Safety Profile – No PDSS Observed

Teva to Host Investor Call on Completed Phase 3 Olanzapine LAI Data Following Psych Congress 2025 Presentation
September 17, 2025

Teva to Host Investor Call on Completed Phase 3 Olanzapine LAI Data Following Psych Congress 2025 Presentation

UZEDY® Accelerates: 2025 Revenue Outlook Raised to $190–$200M (from ~$160M); Olanzapine LAI on Track for Submission in 2025
July 30, 2025

UZEDY® Accelerates: 2025 Revenue Outlook Raised to $190–$200M (from ~$160M); Olanzapine LAI on Track for Submission in 2025

UZEDY® Continues Strong Momentum in 2025; Olanzapine LAI on Track for FDA Filing in H2 2025
May 7, 2025

UZEDY® Continues Strong Momentum in 2025; Olanzapine LAI on Track for FDA Filing in H2 2025

Phase 3 Survey Results Demonstrate Patient and Healthcare Professional Satisfaction with Olanzapine LAI
March 31, 2025

Phase 3 Survey Results Demonstrate Patient and Healthcare Professional Satisfaction with Olanzapine LAI

Completion of the Pivotal Phase 3 Trial for Olanzapine LAI in Schizophrenia
February 10, 2025

Completion of the Pivotal Phase 3 Trial for Olanzapine LAI in Schizophrenia

UZEDY® Surges to $117M in Sales in 2024, First Full Year of Commercialization
January 29, 2025

UZEDY® Surges to $117M in Sales in 2024, First Full Year of Commercialization

25% Raise in 2024 UZEDY® Revenue Outlook & Key Milestone Reached for Olanzapine LAI clinical Phase 3
November 6, 2024

25% Raise in 2024 UZEDY® Revenue Outlook & Key Milestone Reached for Olanzapine LAI clinical Phase 3

New Phase 3 Positive Results for Olanzapine LAI and Real-World Data on UZEDY®
November 4, 2024

New Phase 3 Positive Results for Olanzapine LAI and Real-World Data on UZEDY®

New Efficacy, Safety, and Tolerability Data from Pivotal Phase 3 of Olanzapine LAI
September 23, 2024

New Efficacy, Safety, and Tolerability Data from Pivotal Phase 3 of Olanzapine LAI

Olanzapine LAI: No PDSS Observed After Completion of c.99% of the Targeted Injections for Submission
September 5, 2024

Olanzapine LAI: No PDSS Observed After Completion of c.99% of the Targeted Injections for Submission

Progress in the Development of the Products Portfolio and the R&D Pipeline
September 3, 2024

Progress in the Development of the Products Portfolio and the R&D Pipeline

Teva provides update on pivotal clinical Phase 3 of investigational Olanzapine LAI and UZEDY® commercial progress
July 31, 2024

Teva provides update on pivotal clinical Phase 3 of investigational Olanzapine LAI and UZEDY® commercial progress

Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia
May 8, 2024

Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia

MedinCell’s partner Teva provides guidance for UZEDY in 2024 and an update on olanzapine LAI (mdc-TJK)
January 31, 2024

MedinCell’s partner Teva provides guidance for UZEDY in 2024 and an update on olanzapine LAI (mdc-TJK)

Teva announces recruitment completion of phase 3 clinical study of mdc-TJK
January 9, 2024

Teva announces recruitment completion of phase 3 clinical study of mdc-TJK

Phase 1 data of mdc-TJK investigational long-acting injectable of olanzapine for schizophrenia patients, exhibited favorable characteristics of an extended-release profile
May 22, 2023

Phase 1 data of mdc-TJK investigational long-acting injectable of olanzapine for schizophrenia patients, exhibited favorable characteristics of an extended-release profile

MedinCell: mdc-TJK’s (Teva’s codename: TEV-44749) Phase 1 study pharmacokinetics to be presented for the first time by Teva at SIRS 2023 (May 11-15, 2023, Toronto, Canada)
May 4, 2023

MedinCell: mdc-TJK’s (Teva’s codename: TEV-44749) Phase 1 study pharmacokinetics to be presented for the first time by Teva at SIRS 2023 (May 11-15, 2023, Toronto, Canada)

Initiation of the Phase 3 study for the second long-acting injectable antipsychotic using MedinCell’s technology (program mdc-TJK)
January 24, 2023

Initiation of the Phase 3 study for the second long-acting injectable antipsychotic using MedinCell’s technology (program mdc-TJK)

Phase 3 study to be initiated for second long-acting injectable antipsychotic using MedinCell’s technology
August 29, 2022

Phase 3 study to be initiated for second long-acting injectable antipsychotic using MedinCell’s technology

MedinCell provides a portfolio update for J.P. Morgan Healthcare Conference 2020
January 13, 2020

MedinCell provides a portfolio update for J.P. Morgan Healthcare Conference 2020

Long-acting injectable antipsychotic using MedinCell’s technology receives FDA IND clearance to initiate clinical activities
August 26, 2019

Long-acting injectable antipsychotic using MedinCell’s technology receives FDA IND clearance to initiate clinical activities

BEPO® technology