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Diroximel fumarate

Generic Name
Diroximel fumarate
Brand Names
Vumerity
Drug Type
Small Molecule
Chemical Formula
C11H13NO6
CAS Number
1577222-14-0
Unique Ingredient Identifier
K0N0Z40J3W
Background

Multiple Sclerosis (MS) is a chronic, debilitating neurological disease that can lead to profound cognitive and physical symptoms, severely affecting quality of life. It is the main cause of neurological disability not caused by trauma in the young adult population of both North America and Europe. Relapsing-remitting forms of MS lead to neurological symptoms that resolve and recur periodically. More than 80% of patients suffering from this disease have relapsing-remitting MS.

Diroximel fumarate is a new drug from the fumarate class formulated to treat various relapsing forms of MS. This drug is bioequivalent to Dimethyl fumarate(initially manufactured in 2013), but is less likely to cause gastrointestinal side effects, owing to its unique chemical structure. Diroximel fumarate was formulated by Alkermes in collaboration with Biogen, and was approved by the FDA in October 2019 and by the EMA in November 2021.

Indication

Diroximel fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults; specifically active secondary progressive disease and clinically isolated syndrome, as well as relapsing-remitting MS.

Associated Conditions
Clinically Isolated Syndrome (CIS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease

Early Phase 1
Recruiting
Conditions
Peripheral Arterial Disease
Peripheral Arterial Occlusive Disease
Peripheral Artery Disease
Peripheral Vascular Diseases
Interventions
Other: Placebo
First Posted Date
2024-03-20
Last Posted Date
2025-03-27
Lead Sponsor
University of Nebraska
Target Recruit Count
20
Registration Number
NCT06319339
Locations
🇺🇸

University of Nebraska - Omaha, Omaha, Nebraska, United States

A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

Not yet recruiting
Conditions
Multiple Sclerosis
Interventions
Drug: Disease-Modifying Therapies (DMTs)
First Posted Date
2023-03-14
Last Posted Date
2024-05-28
Lead Sponsor
Biogen
Target Recruit Count
10500
Registration Number
NCT05767736
Locations
🇺🇸

Research Site, Cambridge, Massachusetts, United States

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

First Posted Date
2023-01-18
Last Posted Date
2025-01-30
Lead Sponsor
Biogen
Target Recruit Count
1178
Registration Number
NCT05688436
Locations
🇺🇸

OptumInsight, Eden Prairie, Minnesota, United States

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Recruiting
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2022-12-20
Last Posted Date
2024-06-24
Lead Sponsor
Biogen
Target Recruit Count
908
Registration Number
NCT05658497
Locations
🇨🇭

Inselspital, Bern, Switzerland

🇺🇸

IQVIA US Office, Durham, North Carolina, United States

🇮🇪

St Vincent's University Hospital, Dublin, Ireland

and more 2 locations

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2021-11-19
Last Posted Date
2022-07-05
Lead Sponsor
Biogen
Target Recruit Count
32
Registration Number
NCT05127564
Locations
🇳🇿

Research Site, Christchurch, New Zealand

A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)

Phase 3
Recruiting
Conditions
Relapsing Forms of Multiple Sclerosis
Interventions
First Posted Date
2021-10-19
Last Posted Date
2024-08-26
Lead Sponsor
Biogen
Target Recruit Count
100
Registration Number
NCT05083923
Locations
🇨🇳

The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

🇨🇳

Beijing Hospital, Beijing, Beijing, China

🇨🇳

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China

and more 49 locations

Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

Terminated
Conditions
Relapsing Forms of MS
Interventions
First Posted Date
2021-07-02
Last Posted Date
2023-05-10
Lead Sponsor
Biogen
Target Recruit Count
64
Registration Number
NCT04948606
Locations
🇮🇱

Lady Davis Carmel Medical Center, Haifa, Israel

🇮🇱

Meir Medical Center, Kfar Saba, Israel

🇮🇱

Rabin Medical Center, Petah Tikva, Israel

and more 3 locations

Study of Diroximel Fumarate in the Real-World Setting

Terminated
Conditions
Relapsing Forms of MS
Interventions
First Posted Date
2021-02-10
Last Posted Date
2023-05-26
Lead Sponsor
Biogen
Target Recruit Count
75
Registration Number
NCT04746976
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

MS Center at St Barnabas, Livingston, New Jersey, United States

🇺🇸

Memorial Healthcare, Owosso, Michigan, United States

and more 15 locations

Relationship Between Oral DMT Burden and Adherence in MS

First Posted Date
2020-12-19
Last Posted Date
2022-08-31
Lead Sponsor
Monash University
Target Recruit Count
323
Registration Number
NCT04676204
Locations
🇦🇺

Monash University, Melbourne, Victoria, Australia

A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

Phase 3
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2017-03-28
Last Posted Date
2020-07-14
Lead Sponsor
Biogen
Target Recruit Count
506
Registration Number
NCT03093324
Locations
🇵🇱

Alkermes Investigational Site, Szczecin, Poland

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