Diroximel fumarate

Generic Name: Diroximel fumarate

Brand Names: Vumerity

Drug Type: Small Molecule

Chemical Formula: C_₁₁H_₁₃NO_₆

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 symptom...

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)

Associated Therapies: -

Clinical Trials

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: Diroximel Fumarate
Drug: Dimethyl Fumarate
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

Recruiting

Conditions: Multiple Sclerosis

Interventions: Biological: Alemtuzumab
Drug: Diroximel Fumarate
Drug: Fingolimod
Drug: Glatiramer acetate
Biological: Interferon beta
Biological: Natalizumab
Biological: Ocrelizumab
Biological: Ofatumumab
Drug: Ozanimod
Biological: Peginterferon beta-1a
Drug: Ponesimod
Drug: Siponimod

First Posted Date: 2023-01-18

Last Posted Date: 2023-10-13

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: Drug: Avonex
Drug: Diroximel Fumarate
Drug: Dimethyl Fumarate
Biological: Tysabri

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: Drug: Diroximel fumarate

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: Drug: Diroximel fumarate

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: Drug: Diroximel Fumarate

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: Drug: Diroximel Fumarate

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

Conditions: Multiple Sclerosis
Adherence, Medication

Interventions: Drug: Cladribine
Drug: Fingolimod
Drug: Ozanimod
Drug: Dimethyl fumarate
Drug: Teriflunomide
Drug: Diroximel fumarate

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

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