Diroximel Fumarate
drugOn this page
Also known as Alks 8700ALKS-8700ALKS8700BIIB-098BIIB098Diroximel fumarate (biib098)Fumarate de diroximelFumarato de diroximelRDC-5108RDC5108Vumerity
Summary
Diroximel Fumarate (CHEMBL3989944) is an approved small molecule (ATC L04AX09); indicated across 4 conditions including relapsing-remitting multiple sclerosis and immune system disorder.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: L04AX09
- Indications: 4 conditions
- Clinical trials: 13
- Chemistry: 255.22 Da · C11H13NO6
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL3989944 |
| Name | Diroximel Fumarate |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 73330464 |
| ATC | L04AX09 |
| Molecular formula | C11H13NO6 |
| Molecular weight | 255.22 |
| InChIKey | YIMYDTCOUQIDMT-SNAWJCMRSA-N |
SMILES: COC(=O)/C=C/C(=O)OCCN1C(=O)CCC1=O
IUPAC name: 4-O-[2-(2,5-dioxopyrrolidin-1-yl)ethyl] 1-O-methyl (E)-but-2-enedioate
Also known as: Alks 8700, ALKS 8700, ALKS-8700, ALKS8700, BIIB-098, BIIB098, Diroximel fumarate, Diroximel fumarate (biib098), Fumarate de diroximel, Fumarato de diroximel, RDC-5108, RDC5108
Patent coverage: 210 distinct patent families (528 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
4 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| relapsing-remitting multiple sclerosis | 4 | MONDO:0005314 | EFO:0003929 |
| immune system disorder | 4 | MONDO:0005046 | EFO:0000540 |
| multiple sclerosis | 4 | MONDO:0005301 | MONDO:0005301 |
| peripheral arterial disease | 0 | MONDO:0005386 | EFO:0004265 |
Clinical trials
Total trials: 13.
Phase distribution
| Phase | Trials |
|---|---|
| Not specified | 6 |
| PHASE3 | 4 |
| PHASE1 | 2 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT07483632 | PHASE3 | NOT_YET_RECRUITING | A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) |
| NCT02634307 | PHASE3 | COMPLETED | A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1 |
| NCT03093324 | PHASE3 | COMPLETED | A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2 |
| NCT05083923 | PHASE3 | COMPLETED | A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS) |
| NCT05127564 | PHASE1 | COMPLETED | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants |
| NCT05181215 | PHASE1 | COMPLETED | Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects |
| NCT06319339 | EARLY_PHASE1 | RECRUITING | Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease |
| NCT04676204 | Not specified | ENROLLING_BY_INVITATION | Relationship Between Oral DMT Burden and Adherence in MS |
| NCT05658497 | Not specified | RECRUITING | Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate) |
| NCT05688436 | Not specified | RECRUITING | A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babies |
| NCT05767736 | Not specified | ACTIVE_NOT_RECRUITING | A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS) |
| NCT04746976 | Not specified | TERMINATED | Study of Diroximel Fumarate in the Real-World Setting |
| NCT04948606 | Not specified | TERMINATED | Exploring Diroximel Fumarate Real-world Experience in Canada and Israel |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).