Delving into the Latest Updates on Dimethyl fumarate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(E)-But-2-enedioic acid dimethyl ester, 1,2-bis(methoxycarbonyl)-trans-ethylene, BG-12 oral fumarate

+ [27]

Target

Nrf2

Action

stimulants

Mechanism

Nrf2 stimulants(Nuclear factor erythroid 2-related factor 2 stimulants)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesSkin and Musculoskeletal Diseases+ [3]

Active Indication

Plaque psoriasisMultiple SclerosisMultiple Sclerosis, Relapsing-Remitting+ [3]

Inactive Indication

Chronic large plaque psoriasisFlushingMultiple Sclerosis, Primary Progressive+ [5]

Originator Organization

Biogen, Inc.

Active Organization

BIOGEN NETHERLANDS BV

Almirall SA

Nanjing Agricultural University

+ [8]

Inactive Organization

Accord Healthcare SLU

Polpharma SA

Teva GmbH

+ [1]

License Organization

Biogen, Inc.

Eisai Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (27 Mar 2013),

Multiple sclerosis relapse

RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)

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Structure/Sequence

Molecular FormulaC6H8O4

InChIKeyLDCRTTXIJACKKU-ONEGZZNKSA-N

CAS Registry624-49-7

Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.

Start Date01 Sep 2025

Sponsor / Collaborator

University Hospital of Montpellier

NCT07138833

/ Not yet recruitingPhase 4

A Multicenter, Open-label, Single Group, Phase 4 Study to Evaluate Dimethyl Fumarate Enteric-coated Capsules in Relapsing Multiple Sclerosis (RMS)

The goal of this clinical trial is to evaluate the efficacy and safety] in [subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS).
The main questions it aims to answer are:
[Question 1] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS.
[Question 2] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS.
Participants will:
Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks.
The annualized relapse rate (ARR) at Week 48 will be observed.

Start Date01 Sep 2025

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

100 Clinical Results associated with Dimethyl fumarate

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100 Translational Medicine associated with Dimethyl fumarate

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100 Patents (Medical) associated with Dimethyl fumarate

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6,274

Literatures (Medical) associated with Dimethyl fumarate

01 Feb 2026·Central nervous system agents in medicinal chemistry

Dimethyl Fumarate Attenuates Behavioral and Structural Impairments Associated with Brain Ischemia in Rats

Article

Author: Namavar, Mohammad Reza ; Bakhtiari, Mohammad ; Emamghoreishi, Masoumeh ; Ardakani, Maryam Khastkhodaei

Introduction::

Ischemic stroke remains one of the leading causes of death and physical and mental disability. Oxidative stress, free radicals, and inflammation play critical roles in ischemic brain damage. Free radical scavengers such as edaravone and dimethyl fumarate (DMF), known for their antioxidant and anti-inflammatory properties, are considered promising targets for ischemic stroke treatment. This study aimed to assess the impact of these drugs on brain ischemia

Methods::

Forty-nine rats were randomly divided into seven groups: sham, edaravone, and DMF controls, as well as edaravone, DMF 5, 15, and 30 groups. Middle cerebral artery occlusion (MCAO) was induced in all groups except the sham group. The MCAO groups were administered with either the vehicle, edaravone (3 mg/kg), or DMF at doses of 5, 15, and 30 mg/kg twice daily for 14 days. Neurobehavioral assessments were conducted throughout the experiment, and anatomical changes in the brain were evaluated using stereological methods.

Results::

Edaravone and three doses of DMF improved neurobehavioral functions. All treated rats showed a reduction in the ischemic volume and cell loss in the brain regions when compared with the control animals. MCAO reduced the total number of neurons and just DMF doses had a significant effect on this factor. Interestingly, MCAO increased the number of non-neurons and only the DMF 30 group significantly decreased this parameter. DMF 30 was more effective in ischemic stroke.

Conclusions::

Although edaravone improved neurological functions and reduced the size of brain ischemia and cell loss, DMF, especially at higher doses, exerted a more beneficial effect on these parameters. Therefore, DMF could be proposed as a reinforcement to currently conventional therapies.

31 Dec 2025·REDOX REPORT

Therapeutic combination of L-ascorbic acid, N-acetylcysteine, and dimethyl fumarate in Friedreich’s ataxia: insights from in vitro models

Article

Author: Ge, Haobo ; Ramchunder, Zenouska ; Valle Gómez, Adamo ; Marobbio, Carlo Marya Thomas ; Virmouni, Sara Anjomani ; Pourzand, Charareh ; Edzeamey, Fred Jonathan

Friedreich's Ataxia (FRDA) is a rare neurological disorder caused by an abnormal expansion of Guanine-Adenine-Adenine (GAA) repeat in intron 1 of the FXN gene, which encodes frataxin, leading to reduced expression of frataxin, a mitochondrial protein essential for cellular homeostasis. Frataxin deficiency results in oxidative stress and mitochondrial dysfunction and impaired redox balance. Currently, there is no cure for FRDA. This study aimed to evaluate the therapeutic potential of antioxidants dimethyl fumarate (DMF), N-acetylcysteine (NAC), and L-ascorbic acid (LAA) in restoring mitochondrial redox homeostasis and frataxin levels in FRDA patient-derived fibroblasts and 2D sensory neurons. We assessed cell viability, mitochondrial and cellular reactive oxygen species (ROS) levels, mitochondrial DNA copy number, mitochondrial membrane potential, and frataxin and NRF2 expression at both mRNA and protein levels following antioxidant treatment, either individually or in combination. Treatment with LAA, NAC, and DMF resulted in significant reductions in mitochondrial and cellular ROS, along with increased FXN and NRF2 expression, and enhanced NRF2 nuclear translocation. Furthermore, these compounds improved aconitase/citrate synthase activity, GSH/GSSG ratios, and mitochondrial membrane potential. Notably, the combination of LAA and NAC consistently alleviated multiple disease-associated defects in FRDA cells, suggesting its potential as a promising therapeutic approach.

01 Dec 2025·CELLULAR SIGNALLING

Dimethyl fumarate is an inhibitor of pathological angiogenesis

Article

Author: Shu, Daisy Y ; Hu, Zhengping ; McLellan, Fergus C ; Vuong, Mong Linh ; Chaudhary, Suman ; Huang, Kelvin ; Yang, Menglu ; Lennikov, Anton ; Ng, Pei Qin ; Appiah, Alena C

Vascular endothelial growth factor (VEGF), a pro-angiogenic molecule, supports blood vessel growth during wound healing but also drives pathological neovascularization in blinding eye diseases such as neovascular age-related macular degeneration (nAMD). Dimethyl fumarate (DMFu), an FDA-approved drug for multiple sclerosis, has shown promising anti-inflammatory properties in the retinal pigment epithelium, a crucial structure disrupted in nAMD. Here, we extend the therapeutic potential of DMFu by discerning the anti-angiogenic capabilities of DMFu in choroidal and retinal endothelial cells. Choroidal endothelial cell proliferation was significantly attenuated by DMFu in the mouse choroidal sprouting assay. Even in the presence of VEGF, DMFu disrupted cell migration and tube formation in human microvascular retinal endothelial cells (HRECs). Bulk RNA sequencing highlighted that DMFu successfully ameliorated the expression of VEGF-controlled gene expression. Weighted gene co-expression network and gene set enrichment analyses confirmed downregulation of pathways involved in branching blood vessel morphogenesis but also revealed novel transcriptional mechanisms of action, including control of microtubule transport and ATP synthesis coupled electron transport. DMFu induced a decrease in maximal mitochondrial respiration, an increase in glycolysis and glycolytic capacity and reduced Complex II protein expression of the SDHB subunit on western blot. Such metabolic rewiring may limit the bioenergetic demands required to support angiogenic growth. With therapies available for nAMD being both limited and invasive, DMFu is a contender to be rapidly repurposed as an oral, patient-friendly therapeutic alternative.

152

News (Medical) associated with Dimethyl fumarate

30 Oct 2025

·firstwordpharma.com

Biogen cuts profit guidance following Alcyone, Vanqua deals

Biogen cut its annual guidance as it said that the cost of two recent deals will weigh on profit in the final quarter of the year, dragging it down by $1.25 per share. The company indicated that earnings per share in 2025 are now predicted to be between $14.50 and $15.00, trimmed from an earlier range of $15.50 to $16.00. In September, Biogen agreed to acquire Alcyone Therapeutics, gaining full rights to the latter’s investigational intrathecal drug delivery system for an upfront cash payment of $85 million. More recently, Biogen licensed a preclinical oral C5aR1 antagonist from Vanqua Bio for $70 million upfront. The company said that it expects to incur charges of around $225 million in the fourth quarter related to the Alcyone and Vanqua transactions, as well as an additional one or two research-stage deals that will be announced by the end of the year. Resilience in MS Having previously guided for flat sales in 2025, Biogen said that revenue may now grow by up to 1% on a constant currency basis. The company explained that despite increased competition to Tecfidera in Europe in the fourth quarter, the uplift reflects the resilience of its multiple sclerosis (MS) business in the US. In the third quarter, sales of MS products increased 1% to $1.1 billion, while revenue from Friedreich's ataxia therapy Skyclarys climbed 30% to $133 million. Biogen's overall sales climbed 3% to $2.5 billion, with net income reaching $466.5 million, up from $388.5 in the prior-year period. "We delivered another quarter of strong financial performance driven by continued commercial momentum in our launch products, resilience in our MS franchise and our ongoing focus on disciplined cost management," remarked CEO Christopher Viehbacher. Biogen said that Eisai-partnered Alzheimer's disease drug Leqembi achieved global sales of $121 million in the third quarter, representing year-over-year growth of 82%. Revenue from the product in the US reached $69 million, showing "continued steady growth."

AcquisitionDrug ApprovalPhase 1

24 Jun 2025

·www.prnewswire.com

CivicaScript® Launches Low-Cost Multiple Sclerosis Treatment to Increase Patient Access, Create Significant Savings

Generic dimethyl fumarate delayed-release capsules are 2nd launch in 3 months Average savings of $4,300/month compared with other generic versions LEHI, Utah, June 24, 2025 /PRNewswire/ -- CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines to U.S. patients, today announced the availability of dimethyl fumarate delayed-release capsules. Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. CivicaScript will offer dimethyl fumarate 240 mg capsules for sale to pharmacies for $47 per bottle of 60 capsules – typically a month's supply. CivicaScript recommends that pharmacies charge patients no more than $68 per bottle (CivicaScript's maximum retail price, or MaxRP TM). CivicaScript's MaxRP policy provides a way for healthcare providers, caregivers, patients and others to compare prices; consumers can confirm they are being charged no more than the MaxRP by scanning the QR code featured on the CivicaScript product label. CivicaScript will offer the 120 mg and 240 mg strengths of dimethyl fumarate capsules for sale. CivicaScript's MaxRP for dimethyl fumarate is about $4,300 per month less than the average claim cost for prescriptions filled at traditional PBM-affiliated pharmacies. 1 It could significantly reduce patients' out-of-pocket costs during the deductible phase of their health insurance, in which they pay full price for their medicines. Savings also could be substantial for patients with co-insurance, which charges them a percentage of their medicines' price. "Today's launch is yet another step in our journey to make necessary medications more affordable for the patients who need them," said CivicaScript President Brent J. Eberle. "We're bringing transparency and affordability to the generic drug market in a sustainable way – saving money for patients and payers and making medicines more accessible." The launch comes on the heels of a report in The New England Journal of Medicine Catalyst that CivicaScript's abiraterone saved consumers 64% and payers 92% when they switched from other versions of the same drug. CivicaScript partners with manufacturers to produce low-cost generic medicines, then works with payers and pharmacies across the country to pass along the cost savings to patients. CivicaScript's business model focuses on transparency and collaboration throughout the value chain from manufacturing through dispensing — with every stakeholder along the way knowing the price of the medicine and driving savings through to the patient. Dimethyl fumarate was chosen by CivicaScript members as a priority generic medicine based on its high list price from other manufacturers and significant patient need for the product. While many generic medicines cost less than brand-name drugs, some high-cost generics are more expensive than they need to be. Numerous studies confirm that medication costs can dictate whether patients ration their prescriptions or even fill them in the first place. About CivicaScript CivicaScript is bringing unprecedented transparency to the drug supply chain to make quality generic medicines affordable and available for everyone. A nonprofit company, CivicaScript is committed to the principles of providing affordable, essential generic medicines to promote the social welfare and health of the community. For more information on the organization and our mission, visit our website. CivicaScript is the Civica, Inc. operating unit for outpatient medications to help drive affordability and price transparency. About dimethyl fumarate For full prescribing information and patient information, including important warnings and precautions, potential adverse reactions and drug interactions, please refer to the Package Insert, available here. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. MEDIA CONTACT: Liz Power [email protected] +1 860 501 3849 1 Compared with 2021 average reimbursement rate for all strengths of Dimethyl Fumarate. See Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers, Federal Trade Commission Second Interim Staff Report, January 2025, at Fig. A2, Table A (pg. 34), available at SOURCE CivicaScript WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

01 May 2025

·pharma.economictimes.indiatimes.com

Biogen beats quarterly profit estimates on strong demand for rare disease drugs

Bengaluru: Biogen beat first-quarter profit and revenue expectations on Thursday, as strong demand for its rare disease drugs helped offset declining sales of its multiple sclerosis drugs . The drugmaker has been counting on newer launches such as genetic disorder drug Skyclarys as demand falls for its once top-selling multiple sclerosis medicines in the face of stiff competition in a crowded treatment market. CEO Christopher Viehbacher, who took the helm in 2022, has focused on deals, cost-cutting measures and newer drugs to address investor pressure for growth. The company has been doubling down on its Alzheimer's drug Leqembi , but it has failed to live up to lofty expectations due to concerns over cost, efficacy and side effects. It sells for $26,500 annually in the U.S. The company said it does not expect any material impact from President Trump's sweeping tariffs implemented to date. Biogen said about 75 per cent of its U.S. revenue last year came from products manufactured in the country, which includes Leqembi and spinal muscular atrophy treatment Spinraza. Biogen expects 2025 profit per share of $14.50 to $15.50, compared with its previous forecast of $15.25 to $16.25. It reported an adjusted profit of $3.02 per share for the quarter, compared with analysts' expectations of $2.52 per share, according to estimates compiled by LSEG. U.S. sales of Leqembi, which the company sells with Japan's Eisai, were $52 million for the first quarter ended March 31. The Wall Street consensus estimate was at $54 million, according to brokerage Jefferies. Sales of multiple sclerosis drugs such as Tecfidera fell 11 per cent to $953 million. Sales of rare disease drugs, including Skyclarys and Spinraza, rose 33 per cent to $563 million in the quarter. Revenue rose 6 per cent to $2.43 billion, and came above analysts' average estimate of $2.23 billion. (Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Devika Syamnath)

Financial StatementBiosimilar

100 Deals associated with Dimethyl fumarate

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External Link

KEGG	Wiki	ATC	Drug Bank
D03846	Dimethyl fumarate	L04AX07	DB08908

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Plaque psoriasis	European Union	Almirall SA	23 Jun 2017
Plaque psoriasis	Iceland	Almirall SA	23 Jun 2017
Plaque psoriasis	Liechtenstein	Almirall SA	23 Jun 2017
Plaque psoriasis	Norway	Almirall SA	23 Jun 2017
Multiple Sclerosis	Japan	Biogen, Inc.	19 Dec 2016
Multiple Sclerosis, Relapsing-Remitting	European Union	BIOGEN NETHERLANDS BV	30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting	Iceland	BIOGEN NETHERLANDS BV	30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	BIOGEN NETHERLANDS BV	30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting	Norway	BIOGEN NETHERLANDS BV	30 Jan 2014
Multiple sclerosis relapse	United States	Biogen, Inc.	27 Mar 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Secondary Progressive	Phase 3	United States	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Secondary Progressive	Phase 3	Belgium	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Secondary Progressive	Phase 3	Czechia	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Secondary Progressive	Phase 3	Netherlands	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Secondary Progressive	Phase 3	Poland	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Secondary Progressive	Phase 3	Slovakia	Biogen, Inc.	01 May 2015
Chronic large plaque psoriasis	Phase 3	Austria	Almirall SA	01 Nov 2012
Chronic large plaque psoriasis	Phase 3	Germany	Almirall SA	01 Nov 2012
Chronic large plaque psoriasis	Phase 3	Netherlands	Almirall SA	01 Nov 2012
Chronic large plaque psoriasis	Phase 3	Poland	Almirall SA	01 Nov 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04756687 (LymphoTEC, Pubmed \| Adv Ther)	Not Applicable	Multiple Sclerosis	1,429	Dimethyl Fumarate (Patients with lymphopenia)	lgmjombzyx(etmltzfuwi) = ldfzqwfmnq mmqwlekfzt (urqfsgetbx )	Positive	01 Apr 2025
NCT02047097 \| NCT02525874 (ESTEEM Phase 4 and PROCLAIM Phase 3, Pubmed \| Adv Ther)	Phase 3	Multiple Sclerosis \| Multiple Sclerosis, Relapsing-Remitting Absolute lymphocyte counts (ALCs)	-	Dimethyl Fumarate (Patients < 50 years old)	gfqcylwhhy(hctaxyiedm) = ttxeczkpui zimqrnsxhv (tbfeexbqjy ) View more	Positive	21 Nov 2024
				Dimethyl Fumarate (Patients ≥ 50 years old)	gfqcylwhhy(hctaxyiedm) = syaetiikiu zimqrnsxhv (tbfeexbqjy ) View more
NCT04221191 (TEC-ADHERE, Pubmed \| Neurol Ther)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	341	Dimethyl Fumarate (OroSEP)	ypeuvlllql(gyrtbwzwnk) = ftjtnhmozu zarybthjlh (qfbgcqyxzn )	Positive	11 Nov 2024
				Dimethyl Fumarate (Standard of Care (SoC))	ypeuvlllql(gyrtbwzwnk) = gmwuvzykmm zarybthjlh (qfbgcqyxzn )
S31.010 (AAN2024)	Not Applicable	Multiple Sclerosis	930	Fingolimod	humgsrmlmf(lcwvvcuiyg) = zaibrkdwcs xdljgrxojr (bcnjjtvjek )	Negative	09 Apr 2024
				Natalizumab	humgsrmlmf(lcwvvcuiyg) = jwvdkhqujs xdljgrxojr (bcnjjtvjek )
AAN2024	Not Applicable	Multiple Sclerosis	-	Fumarates (Black)	ahqmsgqjri(kdmgrqiitx) = vmrzhxeush ckwkiyzdqt (fknrupxlce, 73.7–80.3)	-	09 Apr 2024
				Fumarates (Hispanic)	ahqmsgqjri(kdmgrqiitx) = wjoupswncf ckwkiyzdqt (fknrupxlce, 71.0–80.0)
ACTRIMS2024	Not Applicable	Multiple Sclerosis	-	Fumarates (Black)	bjtjfgrmbk(jvkfeeajtl) = cmoxljpbqw iaaafmjwtt (psgtfjhpdy ) View more	-	01 Mar 2024
				Fumarates (Hispanic)	bjtjfgrmbk(jvkfeeajtl) = owhacccnoe iaaafmjwtt (psgtfjhpdy ) View more
ECTRIMS2023	Phase 3	Multiple Sclerosis	118	DMF treatment	jgvtgvsnkj(zkobgtktaq) = msrmndbyiy bcaeuprvke (pvrwhnouzv )	Positive	30 Sep 2023
EAN2023	Not Applicable	Multiple Sclerosis	-	DMF interruption at early pregnancy	benpdeprys(uqvitkftuj) = iigwvdfvpa mvxvpdafiq (abwhxujuka, ±433.29) View more	Positive	28 Jun 2023
				Prompt DMF restart after delivery	-
EAN2023	Not Applicable	-	127	Dimethyl Fumarate (DMF)	ivjqorgkbq(jzumnyvzvi) = tyuzqbimic sblwvbsmdp (meczpsivej, 1.71 - 12.31) View more	Positive	28 Jun 2023
				Non-specific Immunosuppressants (NSIS)	fvdbfvagfo(xrlxwbmjow) = xstknmoxho ryvluttnna (jzycvucpip )
NCT03870763 (CTgov)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	11	Dimethyl Fumarate (Dimethyl Fumarate 240 mg)	gzbyzwakdw(kpyuepfvqy) = npvpgkoflh wqldgxukxk (jfhnxiappa, tnzfskbjxd - zdxkdbympw) View more	-	16 May 2023
				Peginterferon Beta-1a (Peginterferon Beta-1a 125 µg)	gzbyzwakdw(kpyuepfvqy) = gatfbkesdu wqldgxukxk (jfhnxiappa, tynisgatss - gqrwihiymx) View more