Advancing the Limits

We are taking on the challenges of complex and debilitating conditions and are committed to meeting the needs of people suffering from serious and often life-threatening illnesses. Today, MTPC group companies are focused on driving scientific discovery in many areas, including amyotrophic lateral sclerosis (ALS) and Parkinson’s disease.

1Targeting ALS

More than a decade of research in ALS

Research in ALS has always been extraordinarily difficult, due in part to the significant heterogeneity of the disease. Prior to 2017, 86 clinical trials exploring more than 50 compounds were conducted, yet no Phase 3 studies in ALS demonstrated a meaningful positive effect on slowing or eliminating functional disease progression.

Clinical research of our ALS treatment diverged from typical clinical development design strategies previously used for ALS studies. It required demonstration of clinically meaningful efficacy within a limited time period of only six months after first dose, instead of endpoints measured in years. It prioritized the importance of day-to-day capabilities — the ability to climb stairs, swallow food and others, using the ALSFRS-R functional rating scale.

Innovative efforts implemented by the development program helped to advance the conversation about current and future paradigms for ALS clinical trial studies.

We know people with ALS and their families never give up and neither did we. Our determined researchers went to work on a disease that was not well understood. Each clinical trial became an opportunity to learn more about ALS and how edaravone could benefit patients.

Ongoing search for answers

Our focus remains on bringing treatment to people living with ALS as we strive to make a meaningful difference in their lives. We continue to expand our work to deepen our understanding of ALS, explore potential biomarkers to aid in further research and seek new answers.

MTPC group companies have invested in a private biotech company focused on discovering and developing new precision therapies to target distinct subtypes of ALS, including a device to remove toxic proteins and a drug that restores a dysfunctional waste clearance system in cells. MTPC group companies also have in place several research partnerships to investigate potential effects on ALS.

2Taking on
Parkinson’s disease

Always looking to the future, we have begun to explore new potential treatment options that we hope will help control the difficult symptoms and motor fluctuations associated with Parkinson’s disease. We hope the new data from our expanding CNS portfolio will help further understanding and treatment of this disease.

Our Pipeline

Mitsubishi Tanabe Pharma America is driving discovery every day through smart science with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases.

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Scientific Publications

Sharing findings from the scientific community helps further our understanding of complex diseases.

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Intravenous edaravone treatment in ALS and survival: an exploratory, retrospective, administrative claims analysis
Brooks BR, Berry JD, Ciepielewska M, et al. eClinicalMedicine. 2022;52:101590.
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Edaravone administered orally and via nasogastric tube in healthy adults: a comparative bioavailability phase 1 study
Shimizu H, Nishimura Y, Shiide Y. Clin Pharmacol Drug Dev. Published online Oct 12, 2022. doi:10.1002/cpdd.1175
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Long-term edaravone efficacy in amyotrophic lateral sclerosis: post-hoc analyses of Study 19 (MCI186-19)
Shefner J, Heiman-Patterson T, Pioro EP, et al. Muscle Nerve. 2020;61(2):218-221.
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Analysis of the US safety data for edaravone (Radicava®) from the third year after launch
Genge A, Brooks BR, Oskarsson B, et al. Drugs R D. 2022;22(3):205-211. doi:10.1007/s40268-022-00391-6
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Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: post-hoc analysis of Study 19 (MCI186-19)
[clinical trial NCT01492686]
Brooks BR, Heiman-Patterson T, Wiedau-Pazos M, et al. PloS One. 2022;17(6):e0258614.
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Engaging ALS patients and caregivers (the ALS research ambassadors) to help design the REFINE-ALS biomarker study
Berry JD, Bedlack R, Mathews D, et al. Amyotroph Lateral Scler Frontotemporal Degener. 2021;22(1-2):147-150. doi:10.1080/21678421.2020.1804939
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Evidence for generalizability of edaravone efficacy using a novel machine learning risk-based subgroup analysis tool
Brooks BR, Pioro EP, Beaulieu D, et al. Amyotroph Lateral Scler Frontotemporal Degener. 2022;23(1-2):49-57. doi:10.1080/21678421.2021.1927102
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Clinical staging in amyotrophic lateral sclerosis: analysis of edaravone Study 19
Al-Chalabi A, Chiò A, Merrill C, et al. J Neurol Neurosurg Psychiatry. 2021;92(2):165-171.
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Treatment persistence among amyotrophic lateral sclerosis patients receiving intravenous edaravone: results from a national infusion center
Hagan M, Ciepielewska M, Harrison A, et al. Poster presented at virtual 31st International Symposium on ALS/MND; December 9-11, 2020.
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Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial
The Writing Group on behalf of the Edaravone (MCI-186) ALS 19 Study Group. Lancet Neurol. 2017;16(7):505-512. doi:10.1016/S1474-4422(17)30115-1
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Post-hoc analyses of the edaravone clinical trials Study 16 and Study 19: a step toward more efficient clinical trial designs in amyotrophic lateral sclerosis
Palumbo JM, Hubble J, Apple S, et al. Amyotroph Lateral Scler Frontotemporal Degener. 2019;20(5-6):421-431. doi:10.1080/21678421.2019.1599955
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A post-hoc subgroup analysis of outcomes in the first phase III clinical study of edaravone (MCI-186) in amyotrophic lateral sclerosis
The Edaravone (MCI-186) ALS 16 Study Group. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(Sup1):11-19. doi:10.1080/21678421.2017.1363780
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Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
Shimizu H, Nishimura Y, Shiide Y, et al. Clin. Pharmacol. Drug Dev. 2021; 10: 1188-1197. doi: 10.1002/cpdd.952
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Evaluation of Pharmacokinetics, Safety, and Drug-Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults
Shimizu H, Nishimura Y, Shiide Y, et al. Clin. Pharmacol. Drug Dev. 2021; 10: 1174-1187. doi: 10.1002/cpdd.925
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Food Effect Study to Assess the Impact on Edaravone Pharmacokinetic Profiles in Healthy Participants
Hidetoshi H, Nishimura Y, Shiide Y, et al. Clin. Ther., Volume 44, Issue 12, 2022, Pages 1552-1565, ISSN 0149-2918. doi: 10.1016/j.clinthera.2022.10.001.
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Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients
Abe K, Itoyama Y, Sobue G, et al. 2014. Amyotroph Lateral Scler Frontotemporal Degener, 15(7-8):610-617. doi: 10.3109/21678421.2014.959024
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Edaravone Administered Orally and Via Nasogastric Tube in Healthy Adults: A Comparative Bioavailability Phase 1 Study
Shimizu H, Nishimura Y, Shiide Y, et al. Clin. Pharmacol. Drug Dev. 2023. 12: 77-84. Doi: 10.1002/cpdd.1175
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Explore our Treatments

For decades, we’ve been dedicated to research that drives scientific discovery for some of the most difficult-to-treat diseases.

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