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 · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
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 ↗ |