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

Structure/Sequence

Molecular FormulaC6H8O4

InChIKeyLDCRTTXIJACKKU-ONEGZZNKSA-N

CAS Registry624-49-7

163

Clinical Trials associated with Dimethyl fumarate

ChiCTR2500096164

/ SuspendedNot ApplicableIIT

Study on the Mechanism of Dimethyl Fumarate in Alleviating Dry Eye Syndrome by Inhibiting Th17 Cells

Start Date22 Jan 2025

Sponsor / Collaborator-

NCT06850597

/ RecruitingPhase 2IIT

Randomized, Double-blind, Placebo- Controlled Trial Evaluating Efficacy and Safety of Dimethyl Fumarate in Brain Atrophy Reduction, Synaptic Functional Connectivity, Cognitive Functions, Quality of Life, and Activity of Daily Living Improvement Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease

The goal of this clinical trial is to assess the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in diagnosed patients MCI and AD taking dimethyl fumarate 480 mg daily compared to patients taking placebo. Participant will be 55 to 90 years old, both genders. The main question it aims to answer is: Changing the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.

Start Date28 Oct 2024

Sponsor / Collaborator

Medical University of Lodz

CTRI/2023/10/058259

/ Not yet recruitingPhase 2IIT

Randomized controlled investigator blinded comparative study of the efficacy and tolerability of Test Product versus Cysteamine 5% cream in the treatment of facial epidermal melasma over 4 months - NIL

Start Date03 Sep 2024

Sponsor / Collaborator-

100 Clinical Results associated with Dimethyl fumarate

100 Translational Medicine associated with Dimethyl fumarate

100 Patents (Medical) associated with Dimethyl fumarate

7,179

Literatures (Medical) associated with Dimethyl fumarate

15 Apr 2025·CHINESE JOURNAL OF CHEMISTRY

1‐Methylpyridine‐2(1H)‐thione Photocatalyzed Giese Reaction with N‐Hydroxyphthalimide Esters via Single Electron Transfer

Author: Yuan, Li ; Li, Lanting ; Tang, Xinjun ; Wang, Yuzhuo

Comprehensive Summary:

We have developed a series of 1‐methylpyridine‐2(1H)‐thione (MPT) analogues to be used as organocatalysts. The MPT catalysts are easily prepared and bench‐stable. In our previous work, we found that the ground‐state MPT catalyst could act as a nucleophile to generate primary radicals via an SN2 pathway. However, this reaction was limited to benzyl radicals. Herein, we reported a new catalytic property of the MPT catalyst. The photoexcited MPT catalyst (E(MPT·+/MPT*) = –1.60 V vs. Ag/AgCl in MeCN) could reduce NHPI esters through a single electron transfer process. Various carbon radicals, including benzyl radical, as well as primary, secondary and tertiary alkyl radicals, could be generated easily. Notably, amino acids, peptide, pharmaceuticals, and other biologically active molecules could be modified by using this methodology showing the potential synthetic utility of this method.

01 Apr 2025·Translational Research

Caspase-12 exhibits non-redundant functions in response to endoplasmic reticulum stress to promote GSDMD-mediated NETosis, leading to thoracic aortic dissection

Article

Author: Ma, Xiang ; Ge, Junbo ; Li, Yulin ; Lyu, Yang ; Wei, Wei ; Yesitayi, Gulinazi ; Chen, Hanchuan ; Gao, Pingjin ; Yang, Kun ; Ling, Yunzhi ; Gao, Rifeng ; Sun, Aijun ; Shi, Jiaran ; Zhang, Shumin

BACKGROUND:

Thoracic aortic dissection (TAD) is a highly lethal condition that is characterized by inflammatory cell infiltration. Recent evidence has indicated that Gasdermin D (GSDMD) plays an important role in vascular inflammation and degeneration. However, its effects on neutrophil extracellular trap formation and release (NETosis) during TAD remain unknown.

METHODS:

A TAD mouse model was generated using four-week-old male neutrophil-specific GSDMD-knockout mice (GSDMD^F/F; Elane^Cre) and dimethyl fumarate (DMF)-treated C57BL/6J mice by administering β-aminopropionitrile monofumarate (BAPN; 1 g/kg/day) in their drinking water for 4 weeks. Immunoprecipitation and immunofluorescence assays were performed to examine the role of the endoplasmic reticulum (ER) and its associated protein, caspase-12, in GSDMD-induced NETosis.

RESULTS:

GSDMD was elevated and co-localized primarily in neutrophils in the aortic tissues of patients with TAD and mice with BAPN-induced TAD. This was accompanied by increased NETosis. Neutrophil-specific GSDMD knockout and the NETosis inhibitor, GSK484, mitigated TAD development in mice. However, GSK484 did not provide additional therapeutic effects against TAD in the neutrophil-specific, GSDMD knockout mice. Mechanistically, ER stress promoted GSDMD cleavage by caspase-4/11, thereby inducing NETosis. Furthermore, caspase-12 exhibited non-redundant functions in the cleavage of GSDMD by caspase-4/11. The GSDMD inhibitor, DMF, partially prevented TAD development.

CONCLUSIONS:

The ER stress/GSDMD/NETosis signaling pathway provides a potential therapeutic target for the prevention and treatment of TAD.

06 Mar 2025·BRAIN

Broader anti-EBV TCR repertoire in multiple sclerosis: disease specificity and treatment modulation

Article

Author: Falk, Simon ; Muraro, Paolo A ; Klotz, Luisa ; Schwake, Carolin ; Gross, Catharina C ; Schlecht, Ulrich ; Kraemer, Markus ; Schmitter, Thomas ; Schneider-Hohendorf, Tilman ; Havla, Joachim ; Asgharian, Hosseinali ; Schwab, Nicholas ; Ayzenberg, Ilya ; Raposo, Catarina ; Dawin, Eva ; Kümpfel, Tania ; Rubelt, Florian ; Jarius, Sven ; Mirebrahim, Hamid ; Wünsch, Christian ; Hümmert, Martin W ; Zhou, Wenyu ; Wildemann, Brigitte ; Pawlitzki, Marc ; Schrot, Miriam-Carolina ; Kretschmer, Julian R ; Ringelstein, Marius ; Kleffner, Ilka ; Chen-Harris, Haiyin ; Trebst, Corinna ; Meuth, Sven G ; Fischer, Katinka ; Massey, Jennifer ; Lauks, Sarah ; Mattox, Daniel ; Aktas, Orhan ; Wiendl, Heinz

Abstract:

Epstein-Barr virus (EBV) infection has long been associated with the development of multiple sclerosis (MS). Patients with MS have elevated titres of EBV-specific antibodies in serum and show signs of CNS damage only after EBV infection. Regarding CD8+ T cells, an elevated but ineffective response to EBV was suggested in MS patients, who present with a broader MHC-I-restricted EBV-specific T-cell receptor beta chain (TRB) repertoire compared to controls. It is not known whether this altered EBV response could be subject to dynamic changes, e.g. by approved MS therapies, and whether it is specific for MS.Peripheral blood TRB repertoire samples (n = 1317) of healthy donors (n = 409), patients with MS (n = 710) before and after treatment, patients with neuromyelitis optica spectrum disorder (n = 87), MOG antibody-associated disease (MOGAD) (n = 64) and Susac’s syndrome (n = 47) were analysed.Apart from MS, none of the evaluated diseases presented with a broader anti-EBV TRB repertoire. In MS patients undergoing autologous haematopoietic stem-cell transplantation, EBV reactivation coincided with elevated MHC-I-restricted EBV-specific TRB sequence matches. Therapy with ocrelizumab, teriflunomide or dimethyl fumarate reduced EBV-specific, but not CMV-specific MHC-I-restricted TRB sequence matches.Together, these data suggest that the aberrant MHC-I-restricted T-cell response directed against EBV is specific to MS with regard to neuromyelitis optica, MOGAD and Susac’s syndrome and that it is specifically modified by MS treatments interfering with EBV host cells or activated lymphocytes.

147

News (Medical) associated with Dimethyl fumarate

18 Mar 2025

·www.globenewswire.com

CAMP4 Appoints Multiple Industry Veterans to its Board of Directors

With decades of experience in pharmaceutical development and extensive genetic medicine expertise, Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, will provide strategic guidance for CAMP4’s multiple drug development efforts CAMBRIDGE, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing a pipeline of regRNA-targeting antisense oligonucleotide (ASO) therapies to upregulate gene expression to restore healthy protein levels, today announced the appointments of Doug E. Williams, Ph.D., and Murray Stewart, DM FRCP, to the Company’s Board of Directors. “We are delighted to welcome Drs. Williams and Stewart to our Board of Directors,” said Josh Mandel-Brehm, Chief Executive Officer of CAMP4. “With their combined expertise spanning critical aspects of R&D and clinical development, we will benefit greatly from their strategic insights as we advance our lead clinical program for urea cycle disorders and our preclinical program for SYNGAP1-related disorders, while continuing to develop additional RNA-targeting medicines designed to upregulate gene expression and meaningfully address diseases where we believe modest increases in protein levels can have a tremendous impact on the lives of patients.” Dr. Williams commented, “CAMP4’s approach is opening exciting possibilities to upregulate gene expression, a long-sought-after and challenging feat in the field of genetic medicine. I look forward to working with the team to unlock the full potential of this approach and ultimately advance novel therapeutics to the clinic.” Dr. Stewart added, “I’m thrilled to join the CAMP4 team and support its mission of advancing programmable RNA therapeutics for genetic diseases where decreased protein expression drives disease pathophysiology. By pioneering new ways to restore gene expression, CAMP4 has the potential to bring life-changing therapies to patients who currently have limited or no disease-modifying treatment options.” With over 30 years in the biopharma industry, Dr. Williams has contributed to the development of several transformative drugs, including LEUKINE®, ENBREL®, ADCETRIS®, TECFIDERA®, APROLIX®, ELOCTATE®, and SPINRAZA®. He was previously President of R&D at Sana Biotechnology and the Founding President & CEO of Codiak BioSciences. Prior to Sana, Dr. Williams served as EVP of R&D at Biogen, and earlier in his career was CEO of ZymoGenetics (acquired by BMS), and held leadership roles at Seattle Genetics, Amgen, and Immunex. Over the course of his career, he has served on the Board of Directors and Advisory Boards of more than two dozen biotech companies. Dr. Stewart currently serves as a Senior Medical Advisor to several biopharma companies, and was most recently the Chief Medical Officer at Rhythm Pharmaceuticals. Prior to this position, he served as Head of R&D at Novelion Therapeutics. Before joining Novelion, he served as corporate Chief Medical Officer at GlaxoSmithKline. With extensive clinical development experience, he has led studies across all stages, from first-in-human trials to large Phase 4 cardiovascular outcome studies. Dr. Stewart has played a key role in the successful registration and launch of multiple therapies, including AVANDIA®, ARIXTRA®, TANZEUM®, and XOLREMDI®. Before transitioning to industry, he served as a Consultant Physician and Head of Clinical Services at the Diabetes Centre in Newcastle upon Tyne, UK, where his research was focused on lipid metabolism and type 2 diabetes. About CAMP4 Therapeutics CAMP4 is developing disease-modifying treatments for a broad range of rare and prevalent genetic diseases where increasing healthy protein levels may offer meaningful therapeutic benefits. Our approach allows for targeted gene upregulation by harnessing a fundamental mechanism of how genes are controlled. To increase gene expression, our therapeutic ASO drug candidates target regRNAs, which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAP Platform™ enables the mapping of regRNAs and generation of therapeutic candidates designed to target the regRNAs associated with genes underlying haploinsufficient and recessive partial loss-of-function disorders, of which there are more than 1,200, in which a modest increase in protein expression may have the potential to be clinically meaningful. Learn more about us at www.CAMP4tx.com and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning CAMP4’s plans, objectives, expectations and intentions. The forward-looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward-looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third-party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward-looking statements in this press release are inherently uncertain and are not guarantees of future events. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, you should not unduly rely on these forward-looking statements. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward-looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contacts Investor Relations:Sandya von der WeidLifeSci Advisorssvonderweid@lifesciadvisors.com Media:Jason Braco, Ph.D.LifeSci Communicationsjbraco@lifescicomms.com

Executive ChangeOligonucleotide

13 Mar 2025

·www.prnewswire.com

GeminiBio Submits Drug Master File (DMF) to FDA

Simplifying IND and BLA filings for cell therapy developers WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ -- Gemini Bioproducts, LLC ("GeminiBio"), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Fort Lauderdale-based healthcare private equity firm, announced today the submission of a Drug Master File (DMF) to the US FDA in support of the company's cGMP grade human serum products. Continue Reading GeminiBio provides serum, customized media, buffers, and process liquids to biopharma and advanced therapy companies focused on the research and production of mRNA, AAV, monoclonal antibody, and cell therapy technologies. Human serum is a critical raw material supplement for cell therapy manufacturing and is used to support the expansion of human immune cells (e.g., T cells, NK cells, etc.) that form the backbone of the cell therapy industry. GeminiBio Submits Drug Master File (DMF) to FDA - Simplifying IND and BLA filings for cell therapy developers Post this With the filing of a DMF for GeminiBio's Human Serum with the FDA, GeminiBio has made it easier for cell therapy companies to progress towards commercialization. Because the FDA requires detailed information about human serum as part of their Investigational New Drug (IND) applications and Biologics License Applications (BLA), the DMF from GeminiBio reduces the burden for cell therapy companies in their regulatory submissions - enabling customers to incorporate manufacturing, quality, and compliance data with ease into their filings. "As an ancillary product used in cell therapy manufacturing processes, human serum has very specific quality and safety requirements as communicated by various global regulatory agencies," said Robert Perry, Chief Scientific Officer at GeminiBio, "and, over the last several years we have seen a significant increase in the regulatory support required by our customers as the cell therapy industry has gained traction. This was the catalyst to compile and submit our DMF to the FDA." Brian Parker, GeminiBio's CEO, added, "We are very excited to support cell therapy developers across the globe, and the company has hundreds of cell therapy customers spanning the clinical development process, including pre-clinical, phase I, phase II, and phase III." Mr. Parker continued, "We are particularly excited to see one of customers receive US FDA approval of their BLA and are currently supporting the commercialization of this product. The submission of our DMF will further simplify our customer's regulatory process and enable them to focus on progressing their advanced therapies." For more information on GeminiBio, please visit: About GeminiBio GeminiBio is a portfolio company of BelHealth Investment Partners. GeminiBio was founded in 1985 and serves the global biopharma, cell and gene therapy industries. Its focus is on helping customers (from basic research to commercial production) accelerate the development of life-enhancing biotherapeutics by streamlining and improving their cell culture and process liquid manufacturing workflows. The company provides critical raw materials used in cell therapy, gene therapy and biotherapeutics manufacturing – including serum, customized media and buffers solutions, and process liquids. Located in West Sacramento, California, GeminiBio has 57,000 square feet of cGMP manufacturing space, segregated between animal origin-free and animal component manufacturing. GeminiBio is an ISO 13485:2016 certified, FDA-registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820. Contact Brian Parker (CEO) Email: [email protected] Phone: +1(832) 541-9668 About BelHealth Investment Partners BelHealth Investment Partners, based in Fort Lauderdale, Florida, is a healthcare private equity firm focused on lower middle market companies. BelHealth acquires majority positions in entrepreneur-owned companies that it believes will benefit from its extensive investing, executive management and entrepreneurial experience. Contact Inder Tallur (Partner) Email: [email protected] Phone: +1(917) 975-6604 SOURCE Gemini Bioproducts, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell TherapyGene Therapy

12 Feb 2025

·www.fiercepharma.com

Biogen CEO hails quartet of new launches as multiple sclerosis competition weighs on 2025 guidance

"We have been faced with increased competition for our multiple sclerosis franchise, and really all of our priorities are thinking about ‘how do we build a new Biogen, how do we build a new phase of growth,’” Biogen's CEO, Chris Viehbacher, said Wednesday. While the continued erosion of Biogen’s multiple sclerosis franchise and weaker-than-expected 2025 guidance doesn’t seem to be sitting well with investors, company leadership remains confident that a crop of new drugs can pick up the slack in the months and years to come.“As you all know, we have been faced with increased competition for our multiple sclerosis franchise, and really all of our priorities are thinking about ‘how do we build a new Biogen, how do we build a new phase of growth,’” the company’s CEO, Chris Viehbacher, said on a call with analysts Wednesday.To chart that change, Biogen is focusing on building up four recent drug launches, reprioritizing its pipeline and cutting operating expenses, Viehbacher said. On the last point, Biogen has been undergoing a restructuring initiative under Viehbacher to help save around $1 billion by the end of this year.Still, investor sentiment around Biogen’s earnings release was lukewarm, with the company’s share price trading down more than 5% on Wednesday. In the fourth quarter, sales for Biogen’s multiple sclerosis (MS) franchise—which includes drugs like Tysabri and Tecfidera—declined 9% at constant currencies to a little more than $1 billion. For all of 2024, Biogen’s multiple sclerosis sales came in at $4.4 billion, a 7% drop over the sum the business brought home in 2023.Much of that decline was driven by generic competition to Tecfidera around the world, as well as Tysabri’s limited exposure to biosimilars in Europe, Michael McDonnel, Biogen’s outgoing finance chief, said on the company’s call.“Although a biosimilar has not yet launched in the U.S., we continue to see competition increasing in the high efficacy class,” McDonnell said of Tysabri’s performance at home.Summarizing the current situation Biogen finds itself in, Viehbacher postulated that there’s about $4.5 billion left to gain in MS revenue, and about $3 billion in remaining profit for the business.“So that’s going to be the headwind over the next five to 10 years,” he said.The silver lining for Biogen, however, is that sales from four recent launches—Skyclarys, Leqembi, Zurzuvae and Qalsody— “more than offset the decline in our multiple sclerosis product revenue,” according to Viehbacher.Skylcarys, approved in the rare neuromuscular disorder Friedreich’s ataxia in early 2023, ginned up sales of $102 million in the fourth quarter, with Biogen noting in its earnings release that it has nearly doubled the number of patients on the therapy globally compared to the end of 2023.Overall, Biogen estimates there are about 4,800 Friedreich’s ataxia patients in the U.S., according to Viehbacher. Locating those potential Skyclarys users is tricky, though, given that the company is dealing with “quite a large prescriber base for a very narrow patient population," the CEO acknowledged.Elsewhere, Biogen’s launch of Zurzuvae in postpartum depression last year “certainly exceeded our expectations,” said Viehbacher, who pointed out that roughly 80% of prescriptions for the drug are being written by obstetrician-gynecologists (OB-GYNs), rather than the high-prescribing psychiatrists Biogen had initially tried to target.The company is hopeful it can expand Zurzuvae’s reach in 2025 thanks to regulatory filings currently under review in Europe, the United Kingdom and Canada, the CEO added.As for Qalsody, which was approved by the FDA to treat amyotrophic lateral sclerosis (ALS) in April 2023, the oligonucleotide drug is “not necessarily a big revenue generator,” though it still has merit as a “breakthrough treatment in ALS,” Viehbacher said on Biogen’s earnings call.“This is the first time we’ve been able to demonstrate that neurofilament can really help predict drugs early in development as to whether or not they are likely to work, and that allows just the whole research and development in ALS to be accelerated,” Viehbacher explained. As for Biogen’s Eisai-partnered Alzheimer’s disease drug Leqembi—which has been expanding more sluggishly in the U.S. than many initially expected—Viehbacher described the antibody’s growth trajectory in 2024 as “good, steady, quarter-on-quarter progress.”For the last three months of 2024, Leqembi generated global sales of $87 million, growing about 30% quarter over quarter.Viehbacher was quick to acknowledge that Leqembi’s performance overseas has been significant in the drug’s overall rollout thus far.“Clearly, the ex-U.S. launch is contributing more than we have seen in prior launches in other areas,” the CEO said, chalking up the trend to a number of factors, including Eisai’s strength in its home territory of Asia, as well as the prevalence of single-payer systems outside the U.S., which remove many of the obstacles that can impede treatment uptake stateside.Echoing statements made by Eisai management last week, Viehbacher highlighted several potential growth catalysts for Leqembi moving forward, such as the FDA’s recent approval of a less burdensome, four-week maintenance dosing schedule for the drug, as well as an expected increase in quality blood-based diagnostics that could make identification of eligible patients easier. Biogen and Eisai also expect the FDA to make a decision on the approval of a subcutaneous autoinjector version of Leqembi late this summer, which could present patients and caregivers with the option to administer the antibody at home. Overall, Biogen’s fourth-quarter revenues clocked in at $2.46 billion, coming in above Wall Street’s estimate of $2.41 million. Full-year revenues declined 2% over 2023 to $9.7 billion, which fell in line with Biogen’s established 2024 guidance.Looking at the year ahead, Biogen expects 2025 revenue to fall by a mid-single-digit percentage point versus 2024. That’s a greater fall than consensus expectations of a 2.8% decline this year, analysts at William Blair wrote in a note to clients Wednesday.

Drug ApprovalOligonucleotideBiosimilar

100 Deals associated with Dimethyl fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
D03846	Dimethyl fumarate	L04AX07	DB08908

R&D Status

Approved

10 top approved records.

to view more data

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, Chronic Progressive	Phase 3	United States	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Chronic Progressive	Phase 3	Belgium	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Chronic Progressive	Phase 3	Czechia	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Chronic Progressive	Phase 3	Netherlands	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Chronic Progressive	Phase 3	Poland	Biogen, Inc.	01 May 2015
Multiple Sclerosis, Chronic Progressive	Phase 3	Slovakia	Biogen, Inc.	01 May 2015
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02047097 \| NCT02525874 (ESTEEM Phase 4 and PROCLAIM Phase 3, Pubmed \| Adv Ther)	Phase 3	Multiple Sclerosis \| Multiple Sclerosis, Relapsing-Remitting \| Multiple sclerosis relapse Absolute lymphocyte counts (ALCs)	-	Dimethyl Fumarate (Patients < 50 years old)	arvamfwcge(spxjbczrgb) = extyclzreb dbdauijpww (kwgwrhdhir ) View more	Positive	21 Nov 2024
				Dimethyl Fumarate (Patients ≥ 50 years old)	arvamfwcge(spxjbczrgb) = zcsbxgeljy dbdauijpww (kwgwrhdhir ) View more
NCT04221191 (TEC-ADHERE, Pubmed \| Neurol Ther)	Phase 4	Multiple Sclerosis, Relapsing-Remitting	341	Dimethyl Fumarate (OroSEP)	ohgnoauome(piagizhtdi) = goxfqlqgui rgpinivxhb (llpybsjwtr )	Positive	11 Nov 2024
				Dimethyl Fumarate (Standard of Care (SoC))	ohgnoauome(piagizhtdi) = havfsnndxm rgpinivxhb (llpybsjwtr )
EHA2024	Not Applicable	Chronic graft-versus-host disease	-	Dimethyl Fumarate	olhrzthbfa(qceaaymqvc) = hfkmijwzyj sybuufyoxj (cqydfymfkl ) View more	-	14 May 2024
AAN2024	Not Applicable	Multiple Sclerosis	-	Fumarates (Black)	baqnkpufjt(cdtkojdzdq) = umexmmqswq bmiddkphki (ppdyrprrgd, 73.7–80.3)	-	09 Apr 2024
				Fumarates (Hispanic)	baqnkpufjt(cdtkojdzdq) = salbpctkkx bmiddkphki (ppdyrprrgd, 71.0–80.0)
ACTRIMS2024	Not Applicable	Multiple Sclerosis	-	Fumarates (Black)	jpikjfxeyz(owugfwejvo) = zpamzlvqfg lwnxyvhiqy (gazkejbqrj ) View more	-	01 Mar 2024
				Fumarates (Hispanic)	jpikjfxeyz(owugfwejvo) = juhvsiqjji lwnxyvhiqy (gazkejbqrj ) View more
ACTRIMS2024	Not Applicable	Hepatitis C	-	Dimethyl fumarate	pmbzflojfv(vicdkmyiho) = npupoylwlp tkaeuehrib (tfpwitmfaa ) View more	-	29 Feb 2024
ECTRIMS2023	Not Applicable	Multiple Sclerosis	29	Dimethyl Fumarate (DMF)	ztgrexcxbu(hbnjpncoot) = The incidence of lymphopenia (ALC <910) in this cohort of PwMS who transitioned from DMF to DRF increased from 24% at baseline to 52% 12 months after treatment change. lvljnroknr (uyfdrzkhzx ) View more	Positive	01 Oct 2023
IMSE 5 (ECTRIMS2023)	Not Applicable	Lymphopenia lymphopenia	111	Dimethyl fumarate (DMF)	yybatpyafw(biriqukjyx) = mxrlkozlpv vvnupjatzz (oipdtdrfnj, 0.48 - 0.61)	Positive	30 Sep 2023
ECTRIMS2023	Phase 3	Multiple Sclerosis	118	DMF treatment	nzrazgiuhu(fpaczdyodi) = ugebfuvxjf nhfnawdnqa (rfbyqkhcad )	Positive	30 Sep 2023
ECTRIMS2023	Not Applicable	Multiple Sclerosis First line	110	Teriflunomide	peyjeczkgm(lakaggmzvx) = mbkqikdsse bfnriwdkxg (amhwhvmgli, 0.09) View more	-	30 Sep 2023
				Dimethyl Fumarate	peyjeczkgm(lakaggmzvx) = lcbbdccsgu bfnriwdkxg (amhwhvmgli, 0.05) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Dimethyl fumarate

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation