Overview
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)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/20 | Early Phase 1 | Recruiting | |||
2023/03/14 | N/A | Not yet recruiting | |||
2023/01/18 | N/A | Recruiting | |||
2022/12/20 | N/A | Recruiting | |||
2021/11/19 | Phase 1 | Completed | |||
2021/10/19 | Phase 3 | Recruiting | |||
2021/07/02 | N/A | Terminated | |||
2021/02/10 | N/A | Terminated | |||
2020/12/19 | N/A | ENROLLING_BY_INVITATION | |||
2017/03/28 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Biogen Inc. | 64406-020 | ORAL | 231 mg in 1 1 | 5/19/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VUMERITY diroximel fumarate 231 mg enteric capsules bottle | 354530 | Medicine | A | 3/21/2022 |
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