CLINICAL TRIALS PROFILE FOR DIROXIMEL FUMARATE

All Clinical Trials for diroximel fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03498131 ↗	Melatonin in Patients With Multiple Sclerosis (MS).	Active, not recruiting	Providence Health & Services	Early Phase 1	2018-05-09	To date, there are no published data on the role of melatonin supplementation or the appropriate dose for patients with multiple sclerosis. Because of the potential benefits of melatonin, this pilot study will be an exploratory investigation to evaluate the effect of supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this study will support the rationale and be a prelude to a larger trial which can focus on clinical efficacy of melatonin therapy outcomes.
NCT05083923 ↗	A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)	Not yet recruiting	Biogen	Phase 3	2021-11-19	The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate [MMF] and 2-hydroxyethyl succinimide [HES]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).
NCT05127564 ↗	A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants	Not yet recruiting	Biogen	Phase 1	2022-01-31	The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.
NCT05181215 ↗	Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects	Completed	Banner Life Sciences LLC	Phase 1	2021-05-14	A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.
NCT05798520 ↗	A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis	Not yet recruiting	Biogen	Phase 2	2023-06-02	The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.

Clinical Trial Conditions for diroximel fumarate

Condition Name

Condition Name for diroximel fumarate
Intervention	Trials
Relapsing Forms of Multiple Sclerosis	2
Relapsing Remitting Multiple Sclerosis	2
Peripheral Artery Disease	1
Peripheral Vascular Diseases	1

Condition MeSH

Condition MeSH for diroximel fumarate
Intervention	Trials
Multiple Sclerosis	4
Sclerosis	3
Multiple Sclerosis, Relapsing-Remitting	2
Psychotic Disorders	1

Clinical Trial Locations for diroximel fumarate

Trials by Country

Trials by Country for diroximel fumarate
Location	Trials
United States	3
United Kingdom	2

Trials by US State

Trials by US State for diroximel fumarate
Location	Trials
Nebraska	1
Missouri	1
Oregon	1

Clinical Trial Progress for diroximel fumarate

Clinical Trial Phase

Clinical Trial Phase for diroximel fumarate
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for diroximel fumarate
Clinical Trial Phase	Trials
Not yet recruiting	3
RECRUITING	2
Completed	1

Clinical Trial Sponsors for diroximel fumarate

Sponsor Name

Sponsor Name for diroximel fumarate
Sponsor	Trials
Biogen	3
Providence Health & Services	1
Banner Life Sciences LLC	1

Sponsor Type

Sponsor Type for diroximel fumarate
Sponsor	Trials
Other	4
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Diroximel Fumarate

Last updated: November 4, 2025

Introduction

Diroximel fumarate (DRF) is an oral disease-modifying therapy (DMT) primarily indicated for multiple sclerosis (MS). Introduced as a successor to dimethyl fumarate (DMF), DRF aims to offer similar efficacy with improved gastrointestinal tolerability. It is marketed under the brand name Vumerity® (by Alkermes and Biogen). As MS therapies evolve, comprehensive insights into clinical trial updates, market dynamics, and future projections are pivotal for stakeholders, including investors, healthcare providers, and policymakers.

Clinical Trial Landscape for Diroximel Fumarate

Regulatory Approval and Clinical Evidence

Diroximel fumarate received FDA approval in October 2019 based on pivotal phase III trials demonstrating non-inferiority to DMF with a reduced gastrointestinal (GI) adverse event profile ([1]). The pivotal studies include:

• EVOLVE-MS-1: An ongoing open-label phase III safety study assessing long-term safety and tolerability.
• EVOLVE-MS-2 (2019): A randomized, controlled trial comparing DRF to DMF, primarily focusing on GI tolerability. Results confirmed that DRF significantly reduces GI side effects compared to DMF, improving patient adherence ([2]).

Ongoing and Future Clinical Trials

While the primary approvals are based on existing data, ongoing clinical investigations aim to expand DRF’s therapeutic profile. Notably:

• EVOLVE-MS-3: Evaluates the efficacy of DRF in patients transitioning from other DMTs.
• Combination Therapy Trials: Limited studies are examining DRF in conjunction with other MS therapies to understand combined efficacy.

Additionally, real-world evidence (RWE) from post-marketing surveillance is increasing, capturing data on safety, adherence, and effectiveness outside controlled trial settings ([3]).

Emerging Indications and Research

Although currently approved for relapsing-remitting MS (RRMS), research is exploring DRF's potential in:

• Secondary progressive MS (SPMS)
• Progressive forms of MS

However, these indications are nascent, pending comprehensive clinical data.

Market Analysis of Diroximel Fumarate

Market Position and Competitive Landscape

DRF entered a competitive MS therapeutic market dominated by established agents such as:

• Dimethyl fumarate (Tecfidera®)—market leader since 2013.
• Glatiramer acetate (Copaxone®)
• Fingolimod (Gilenya®)
• Natalizumab (Tysabri®)
• Ocrelizumab (Ocrevus®)

DRF’s primary advantage lies in its improved GI tolerability, which addresses a significant patient adherence barrier ([4]).

Sales Performance and Market Penetration

Since its approval, DRF has experienced moderate market penetration, primarily within developed markets like the US and Europe. Alkermes and Biogen report steady growth, bolstered by physician education on tolerability benefits ([5]).

• US sales: Estimated at approximately $200 million in 2022.
• European uptake: Slow but increasing, driven by formulary inclusions and clinical education.

Pricing and Reimbursement Environment

DRF’s pricing aligns with other branded MS therapies, typically ranging between $60,000 to $70,000 annually per patient. Reimbursement policies favor oral therapies, which aid market penetration, but high drug costs remain a barrier in some regions.

Regulatory and Commercial Challenges

• Generic Competition: As patents mature, generic versions of DMF may erode DRF’s market share.
• Clinical Preference Shifts: Emerging therapies with higher efficacy or novel mechanisms may challenge DRF’s positioning.
• Side-effect Profile: While GI tolerability is improved, other adverse events such as lymphopenia remain monitored.

Market Projection and Future Outlook

Growth Drivers

• Clinical Advantages: The superior GI tolerability enhances patient adherence and persistence.
• Expanding Market: The global MS population exceeds 2.8 million, with an annual growth rate of approximately 3%(^6).
• Pipeline Expansion: Trials exploring DRF in other MS subtypes or autoimmune diseases could broaden usage.

Forecasted Market Trends

• Compound Annual Growth Rate (CAGR): Projected to grow at approximately 7-9% annually over the next five years, driven by increasing MS diagnoses and patient preferences for oral DMTs ([7]).
• Market Share: DRF is expected to capture 15-20% of the oral MS therapy segment by 2030, contingent on clinical and regulatory developments.

Potential Challenges to Growth

• Emergence of biosimilars or generics.
• Competitive innovations offering superior efficacy.
• Regulatory hurdles in expanding indications.

Strategic Opportunities

• Expansion into Emerging Markets: Countries like China and India are witnessing MS prevalence increases.
• Combination Therapy Use: Clinical trials may confirm DRF's utility alongside other DMTs.
• Patient-Centric Marketing: Emphasizing tolerability benefits can sustain growth momentum.

Key Takeaways

• Diroximel fumarate is established as a well-tolerated oral DMT for RRMS, with clinical trials demonstrating its efficacy and superior GI tolerability versus DMF.
• Its market growth remains steady, supported by preferences for oral therapies and improved patient adherence, but faces future hurdles from generic competition and emerging therapies.
• The global MS landscape's expanding patient population and clinical pipeline promise evolving opportunities for DRF, especially if ongoing and future trials yield positive outcomes.
• Market projections indicate sustained growth, with strategic expansion and differentiation critical for maintaining competitive advantage.

FAQs

1. How does Diroximel fumarate differ from dimethyl fumarate in clinical practice?
DRF offers similar efficacy to DMF but significantly reduces gastrointestinal side effects, improving patient compliance and overall treatment satisfaction.

2. What are the main safety concerns associated with DRF?
Similar to other fumarates, lymphopenia is a concern requiring monitoring. Generally, DRF has a favorable safety profile, with lower rates of GI adverse events compared to DMF.

3. Are there ongoing clinical trials exploring DRF in other neurological conditions?
Current trials are mainly focused on MS, but research into broader autoimmune indications remains an area of interest pending supportive data.

4. What are the key barriers to DRF's market expansion?
Barriers include patent expiration of competitors, emergence of biosimilars, high cost, and the development of alternative therapeutic options offering higher efficacy.

5. Will DRF become the standard oral therapy for MS?
While promising, DRF’s future dominance depends on ongoing clinical results, comparative efficacy, safety data, and market dynamics. It currently holds a strong positioning within oral DMTs but is one of multiple effective options.

References

[1] FDA. (2019). FDA Approves Vumerity for Multiple Sclerosis.
[2] BioPharm International. (2019). EVOLVE-MS-2 Results: Diroximel Fumarate GI Tolerability.
[3] Real-World Evidence Insights. (2022). Post-Marketing Surveillance of Diroximel Fumarate.
[4] MarketWatch. (2021). MS Oral Therapies and Market Trends.
[5] Biogen and Alkermes Financial Reports. (2022). Sales Data and Market Penetration.
[6] World Health Organization (WHO). (2022). Global MS Prevalence and Epidemiology.
[7] Global Data. (2023). MS Market Forecast and Trends.