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R&D Pipeline

Long-acting injectables based on BEPO®

Advancing Therapeutic Care with Precision Delivery

Our robust R&D pipeline aims to provide either the first or the best therapeutic options in key therapeutic areas. Our investigational candidates, crafted internally or alongside partners, aim to redefine patient care standards. Leveraging our proprietary BEPO® technology, we enhance the performance of well-established or novel active pharmaceutical ingredients (APIs).

Formulation

Preclinical

Clinical phase 1 & 2

Clinical phase 3

NDA

Schizophrenia

mdc-TJK

mdc-TJK

In partnership with Teva Pharmaceuticals

Indication

Schizophrenia

Molecule

Olanzapine

Status

Clinical Phase 3

Technology

BEPO®

mdc-TJK is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine for the treatment of schizophrenia. It has the potential to be the first long-acting olanzapine with a favorable safety profile as other LAIs of olanzapine have an FDA black box warning for PDSS (Postinjection Delirium/Sedation Syndrome) that limits their use.

News related to the project

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

Post-op pain

mdc-CWM

mdc-CWM

In partnership with AIC

Indication

Post-op pain

Molecule

Celecoxib

Status

Clinical Phase 3

Technology

BEPO®

Injected into the intra-articular space during Total Knee Replacement surgery and potentially active for as long as three months post-surgery, mdc-CWM is a sustained-release formulation of celecoxib for the reduction of postoperative pain and inflammation. The mdc-CWM project is a collaboration with Arthritis Innovation Corporation (AIC), based in Toronto, Canada, who fiance and conduct the clinical development activities.

News related to the project

Medincell and AIC Unveil New Positive Phase 3 Results for mdc-CWM
December 9, 2024

Medincell and AIC Unveil New Positive Phase 3 Results for mdc-CWM

Medincell Provides Update on Phase 3 mdc-CWM Clinical Trial
May 14, 2024

Medincell Provides Update on Phase 3 mdc-CWM Clinical Trial

MedinCell announces successful completion of patient enrollment in the Phase 3 study of F14 (mdc-CWM), a first-in-class therapy for localized pain relief after Total knee replacement
August 31, 2023

MedinCell announces successful completion of patient enrollment in the Phase 3 study of F14 (mdc-CWM), a first-in-class therapy for localized pain relief after Total knee replacement

MedinCell announces the initiation of Phase 3 study of F14 (mdc-CWM), a therapeutic first-in-class that aims to provide weeks of localized pain relief after Total Knee Replacement
November 7, 2022

MedinCell announces the initiation of Phase 3 study of F14 (mdc-CWM), a therapeutic first-in-class that aims to provide weeks of localized pain relief after Total Knee Replacement

MedinCell: mdc-CWM clinical phase 3 will start in 2021
March 25, 2021

MedinCell: mdc-CWM clinical phase 3 will start in 2021

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

MedinCell announces that mdc-CWM progresses as planned
September 25, 2019

MedinCell announces that mdc-CWM progresses as planned

Formulation

Preclinical

Clinical phase 1 & 2

Clinical phase 3

NDA

Contraception

mdc-WWM

mdc-WWM

Supported by the Bill & Melinda Gates Foundation

Indication

Contraception

Molecule

Progestin (non-MPA)

Status

Preclinical

Technology

BEPO®

mdc-WWM could be the first contraceptive to combine the following essential features to make it a best-in-class product worldwide: progestin molecule (non-MPA), 6-month duration, subcutaneous injection, full bio-resorption and affordability. Preclinical activities and phase 1 clinical studies are funded by a grant of up to $19 million from the Bill & Melinda Gates Foundation.

The Global Access strategy, jointly pursued by Medincell and the Bill & Melinda Gates Foundation, aims to make a significant impact on women’s lives by ensuring widespread availability of the product. Affordable pricing in emerging economies will eliminate cost barriers, thereby enhancing availability and voluntary access. Furthermore, the Gates Foundation holds a non-exclusive license for the non-commercial market in low- and middle-income countries.

News related to the project

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

Additional US$ 4 million received for next development steps of MedinCell’s 6-month active injectable bioresorbable subcutaneous contraceptive
November 30, 2022

Additional US$ 4 million received for next development steps of MedinCell’s 6-month active injectable bioresorbable subcutaneous contraceptive

MedinCell launches Regulatory Development of mdc-WWM Program
April 22, 2020

MedinCell launches Regulatory Development of mdc-WWM Program

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

MedinCell receives $19 million grant for its mdc-WWM program
November 28, 2019

MedinCell receives $19 million grant for its mdc-WWM program

MedinCell receives funding for the second formulation phase of its 6-month injectable contraceptive
January 24, 2019

MedinCell receives funding for the second formulation phase of its 6-month injectable contraceptive

MedinCell receives grant to develop long-acting injectable contraceptive
December 7, 2017

MedinCell receives grant to develop long-acting injectable contraceptive

Malaria

mdc-STM

mdc-STM

Supported by Unitaid

Indication

Malaria

Molecule

Ivermectin

Status

Preclinical

Technology

BEPO®

Malaria remains pandemic in 91 countries representing 50% of the world’s population. According to WHO estimates, 228 million people were infected worldwide in 2018, 93% of them in Africa, leading to 405,000 deaths. Children under 5 years are the most vulnerable, accounting for 67% of deaths from malaria.

Administered at the beginning of the transmission season, the 3-month ivermectin formulation could have a significant epidemiological impact. This is supported by the results of preliminary in vivo studies conducted in Burkina Faso by IRD, IRSS, CIRDES and MedinCell. MedinCell has been collaborating for more than 10 years with these three French and Burkinabe research institutes, engaged together for more than 40 years in the fight against malaria. They provide theoretical and practical expertise and the essential infrastructure to support the development of a 3-month active injectable ivermectin.

To ensure equitable access to health products in low- and middle-income countries (LMICs), and to have a significant impact on the most vulnerable populations, MedinCell will grant a non-exclusive license to the Medicines Patent Pool to ensure distribution of the final product via the public sector in LMICs.

News related to the project

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

Unitaid Awards Medincell up to $6 million Extension Grant to Fight Malaria
April 8, 2024

Unitaid Awards Medincell up to $6 million Extension Grant to Fight Malaria

MedinCell signs a licence agreement with the Medicines Patent Pool to fight malaria transmission, as part of its global health mission
September 13, 2022

MedinCell signs a licence agreement with the Medicines Patent Pool to fight malaria transmission, as part of its global health mission

MedinCell’s Long-Acting Injectable to fight Malaria ready to enter Regulatory Development
June 14, 2021

MedinCell’s Long-Acting Injectable to fight Malaria ready to enter Regulatory Development

MedinCell receives $ 6.4 million grant from Unitaid to fight Malaria
March 25, 2020

MedinCell receives $ 6.4 million grant from Unitaid to fight Malaria

Confidential

mdc-AbbVie-1

mdc-AbbVie-1

In partnership with AbbVie

Indication

Confidential

Molecule

Confidential

Status

Formulation

Technology

BEPO®

News related to the project

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

Videoconference • Collaboration with AbbVie (French)
April 17, 2024

Videoconference • Collaboration with AbbVie (French)

Medincell enters into strategic co-development and licensing agreement with AbbVie to develop next-generation long-acting injectable therapies
April 16, 2024

Medincell enters into strategic co-development and licensing agreement with AbbVie to develop next-generation long-acting injectable therapies

Formulation

Preclinical

Clinical phase 1 & 2

Clinical phase 3

NDA

In-house programs (confidential)

Partnered programs (confidential)

Portfolio extension

We have designed a structured approach to identify new opportunities and enlarge our portfolio of proprietary and partnered products. This assessment process aims to identify unmet needs in a large panel of indications that could be met with long acting injectable treatments, and identify the most compatible APIs with our technology and its evolutions. This preliminary step is essential to significantly increase the likelihood of success for each product entering formulation stage.