Drugs / Diroximel fumarate
Diroximel fumarate
also known as
DRF · ALKS 8700 · BIIB-098 · Diroximel fumarate (biib098) · Fumarate de diroximel · Fumarato de diroximel · RDC-5108 · Vumerity · +1 more
Small molecule targets KEAP1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed multiple sclerosis 2 milestones | |||||
| Filed | US (FDA) | — | multiple sclerosis | 2019-02-25 | “the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate” alkermes.com ↗ |
| Filed | US (FDA) | VUMERITY | multiple sclerosis | 2018-12-17 | “today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098),” alkermes.com ↗ “The FDA approval of VUMERITY was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.” alkermes.com ↗ “The FDA approval of VUMERITY was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway.” biogen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | VUMERITY | — | 2023-02-10 | fda.gov ↗ |
| Approved | EU (EMA) | Vumerity | — | 2021-11-15 | europa.eu ↗ |
| Approved | US (FDA) | VUMERITY | — | 2019-10-29 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06319339 | Nov 2024 → Dec 2026 expected | peripheral arterial disease, peripheral arterial occlusive disease 1 | University of Nebraska | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05127564 | Dec 2021 → Jun 2022 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02201849 | Jul → Dec 2014 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07275515 | May 2026 → May 2029 expected | stroke disorder | University Hospital, Lille | Recruiting | No outcome recorded |
| Phase 2 | NCT05798520 | Jul 2023 → Feb 2026 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT07483632 | Nov 2026 → Jul 2034 expected | multiple sclerosis | Biogen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07189325 | Jun 2026 → Jun 2031 expected | relapsing-remitting multiple sclerosis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT05083923 | Nov 2021 → Sep 2024 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT03093324 | Mar 2017 → Jun 2019 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT02634307 | Dec 2015 → Jun 2021 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06957808 | Jan 2025 → Jan 2027 expected | schizophrenia | King's College London | Recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT06663189 Comparator | Jan 2025 → Jan 2027 expected | relapsing-remitting multiple sclerosis | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04788615 Comparator | Jul 2021 → Nov 2025 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2025-11-13 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg (USRLD: Vumerity Delayed-Release Capsules, 231 mg). |
| 2024-07-10 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Diroximel Fumarate Delayed-Release Capsules, 231 mg zyduslife.com ↗ |
| 2022-10-26 | Biogen | Results New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS biogen.com ↗
Final safety and efficacy results from the Phase 3 EVOLVE-MS-1 trial demonstrate decreases in disease activity and favorable tolerability for VUMERITY ® (diroximel fumarate) consistent with previous assessments |
| 2022-04-04 | Biogen | Results New Data at AAN 2022 Highlight Real-World Evidence from Biogen’s MS Portfolio and Emerging Research on Disease Progression biogen.com ↗
Persistence as measured by the overall estimated proportion of patients remaining on VUMERITY at 16 months was 82.3%; 4.5% discontinued VUMERITY due to GI side effects. |
| 2021-11-16 | Biogen | Regulatory The European Commission Grants Marketing Authorization for VUMERITY® (diroximel fumarate) as Oral Treatment for Relapsing-Remitting Multiple Sclerosis biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has granted marketing authorization for VUMERITY ® (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS). |
| 2021-10-13 | Biogen | Results New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis biogen.com ↗
MS PATHS data indicate that 100 percent of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination |
| 2021-10-13 | Biogen | Results New Data at ECTRIMS 2021 Highlight Biogen’s Focus on Patient-Centered Outcomes and Improving the MS Patient Experience biogen.com ↗
New data from EVOLVE-MS-2 demonstrate that a favorable gastrointestinal (GI) tolerability profile for VUMERITY ® (diroximel fumarate) is achieved and maintained with dose titration |
| 2021-09-17 | Biogen | Regulatory CHMP Recommends VUMERITY® (diroximel fumarate) for Approval in the European Union as a Treatment for Relapsing-Remitting Multiple Sclerosis biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), issued a positive opinion and has recommended granting marketing authorization for VUMERITY ® (diroximel fumarate) in the European Union (EU). |
| 2021-04-16 | Biogen | Results New Data at AAN 2021 from Across Biogen’s MS Portfolio Demonstrate Positive Impact of Treatment on People Living with Relapsing Multiple Sclerosis biogen.com ↗
New findings on the use of VUMERITY in a real-world setting reinforce the benefits of improved gastrointestinal (GI) tolerability and confirm that the experience in clinical trials is consistent with clinical practice. |
| 2020-09-11 | Biogen | Results New Data at ACTRIMS-ECTRIMS Meeting Showcase Safety and Efficacy of Biogen’s Industry-Leading MS Portfolio biogen.com ↗
Findings from the five-week EVOLVE-MS-2 study reinforce clinically meaningful improvements in patient-assessed gastrointestinal (GI) tolerability associated with VUMERITY treatment (n=253) compared to TECFIDERA ® (dimethyl fumarate) (n=251), and support its impact on quality of life for people with relapsing MS. |
| 2020-05-19 | Biogen | Results New Data at AAN Showcase Biogen’s Commitment to Advancing Innovation in MS biogen.com ↗
Patients treated with VUMERITY ® (diroximel fumarate) and TECFIDERA ® (dimethyl fumarate) showed a significant reduction of gadolinium-enhancing lesions compared to baseline |
| 2019-11-22 | Biogen | Results Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate) biogen.com ↗
Results for the primary endpoint show patients treated with VUMERITY self-reported 46 percent fewer days with intensity scores of ≥2 on the Individual Gastrointestinal Symptom and Impact Scale (IGISIS), compared to TECFIDERA (adjusted rate ratio [95% confidence interval]: 0.54 [0.39−0.75], p = 0.0003). |
| 2019-10-30 | Biogen | Regulatory Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis biogen.com ↗ |
| 2019-10-30 | Alkermes, Inc. | Regulatory Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis alkermes.com ↗ |
| 2019-09-11 | Biogen | Results New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years biogen.com ↗
Latest interim data from Phase 3 EVOLVE-MS-1 trial show Biogen and Alkermes’ investigational treatment, diroximel fumarate, was generally well tolerated with low rates of treatment discontinuation over 18 months |
| 2019-07-30 | Biogen | Results Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis biogen.com ↗
The overall proportion of patients with AEs leading to study discontinuation were 1.6% for diroximel fumarate and 6.0% for dimethyl fumarate. |
| 2019-07-30 | Alkermes, Inc. | Results Diroximel Fumarate Demonstrated Significantly Improved Gastrointestinal Tolerability Profile Compared to Dimethyl Fumarate in Patients with Multiple Sclerosis alkermes.com ↗
Diroximel fumarate was statistically superior to dimethyl fumarate on the study's pre-specified primary endpoint |
| 2019-05-30 | Biogen | Results New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) announced today new interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that the investigational treatment diroximel fumarate was generally well tolerated in people with relapsing multiple sclerosis (MS). |
| 2019-05-07 | Biogen | Results Data at AAN Demonstrate Biogen’s Leadership and Commitment to Innovation in MS biogen.com ↗
New interim data further support safety and efficacy of Biogen and Alkermes’ investigational treatment, diroximel fumarate, to be marketed as VUMERITY™ if approved by the FDA |
| 2019-02-25 | Biogen | Regulatory Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis biogen.com ↗ |
| 2019-02-25 | Alkermes, Inc. | Regulatory Alkermes and Biogen Announce U.S. Food and Drug Administration Acceptance of Diroximel Fumarate New Drug Application for Multiple Sclerosis alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis (MS). |
| 2018-12-17 | Biogen | Regulatory Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis biogen.com ↗
Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate |
| 2018-12-17 | Alkermes, Inc. | Regulatory Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis alkermes.com ↗ |
| 2017-10-27 | Alkermes, Inc. | Results Alkermes Presents Data Demonstrating Safety and Gastrointestinal Tolerability Profile of ALKS 8700 for the Treatment of Multiple Sclerosis alkermes.com ↗
Safety data from the first month of the EVOLVE-MS-1 study (N=580) showed that treatment with ALKS 8700 was associated with low rates of GI adverse events (AEs) leading to discontinuation (0.5%) and no occurrence of serious GI AEs. |
| 2015-10-29 | Alkermes, Inc. | Results Alkermes Announces Positive Clinical Trial Results and Streamlined Registration Pathway for ALKS 8700 for Treatment of Multiple Sclerosis alkermes.com ↗
Initial data from this study showed that ALKS 8700 met the pharmacokinetic criteria for bioequivalence to TECFIDERA. |
| 2015-05-29 | Alkermes, Inc. | Results Alkermes to Present Clinical Data on ALKS 8700 at Annual Meeting of the Consortium of Multiple Sclerosis Centers alkermes.com ↗
Data from the study showed that ALKS 8700 was generally well tolerated and provided MMF exposures comparable to TECFIDERA, with less variability and favorable gastrointestinal (GI) tolerability. |
| 2015-02-09 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Phase 1 Study of ALKS 8700 for Treatment of Multiple Sclerosis alkermes.com ↗
Data from the phase 1 study showed that ALKS 8700 was generally well tolerated and provided MMF exposures comparable to TECFIDERA, with less variability and improved gastrointestinal (GI) tolerability. |
All press releases naming this drug 34 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | diroximel fumarate | “Patients randomized in the experimental group will be treated with platform therapies (Dimethyl Fumarate, Diroximel Fumarate, Teriflunomide, Glatiramer Acetate,...” NCT07189325 ↗10“BACKGROUND: Diroximel fumarate (DRF) is a novel oral fumarate approved for relapsing forms of multiple sclerosis (MS).” PMID 33796143 ↗ Mar 2021 “We chose Diroximel Fumarate (DRF) which is a safe and effective Nrf2 activator widely used in multiple sclerosis” NCT07275515 ↗ “Interferon-β (IFN-β), glatiramer acetate, dimethyl fumarate, teriflunomide or diroximel fumarate” NCT06663189 ↗ “In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF).” NCT05798520 ↗ “Diroximel fumarate minimum dose of 231mg or maximum dose of 462mg twice a day” NCT04788615 ↗ “Vumerity (diroximel fumarate)” NCT03535298 ↗ |
| Known as | ALKS 8700 | “This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.” NCT02201849 ↗ |
| Known as | BIIB-098 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989944 ↗ |
| Known as | Diroximel fumarate (biib098) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989944 ↗ |
| Known as | DRF | “Diroximel fumarate (DRF) and dimethyl fumarate (DMF) are orally administered fumarate disease-modifying therapies (DMTs) for multiple sclerosis (MS).” PMID 38878121 ↗ Jun 20243“We chose Diroximel Fumarate (DRF) which is a safe and effective Nrf2 activator widely used in multiple sclerosis” NCT07275515 ↗ “Diroximel fumarate (DRF)” NCT06957808 ↗ |
| Known as | Fumarate de diroximel | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989944 ↗ |
| Known as | Fumarato de diroximel | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989944 ↗ |
| Known as | RDC-5108 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989944 ↗ |
| Known as | Vumerity | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06319339 ↗ |
| Known as | Vumerity (diroximel fumarate) | “Vumerity (diroximel fumarate)” NCT03535298 ↗ |
| Action | Inhibit | “Kelch-like ECH-associated protein 1 inhibitor” CHEMBL3989944 ↗ |
| Modality | Small molecule | — CHEMBL3989944 ↗ |
| Route | Oral | “Oral ALKS 8700” NCT02201849 ↗ |
| Target | KEAP1 | “Kelch-like ECH-associated protein 1 inhibitor” CHEMBL3989944 ↗ |