A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis

In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses.
Participants will be divided into 2 groups based on their weight:
* Group A will include children who weigh 40 kilograms (kg) or less. They will receive DRF in both Part 1 and Part 2 of the study.
* Group B will include children who weigh more than 40 kg. They will be randomly assigned to receive DRF, DMF, or fingolimod. Fingolimod is a drug already used to treat MS in adults. In Part 2, they will receive DRF.
This is a 2-part study. Part 1 treatment will last 96 weeks. Participants who complete Part 1 may move to Part 2. Part 2 is an extension period. Treatment will last another 96 weeks and will help researchers learn about the long-term safety and effects of treatment.
The main goal of the study is to learn about the safety of DRF and DMF and compare their effect on relapses and brain lesions with fingolimod.
The main questions researchers want to answer are:
* How many participants have adverse events and serious adverse events?
* How often do participants relapse after treatment with DRF and DMF compared to fingolimod?
Researchers will take brain imaging scans to check for any new areas of brain inflammation and compare the brain lesions before and after treatment.
Researchers will also measure the amount of drug in the blood to understand how the body processes it. To check safety, they will monitor participants' growth and development, and compare changes in heart tests, vital signs, and lab tests. They will also use rating scales to monitor depression symptoms.
The study will be done as follows:
Part 1 (Treatment Period)
* After screening, participants will join Part 1 and be divided into 2 groups based on their weight.
* Participants in Group A will receive DRF.
* Participants in Group B will be randomly assigned to receive either DRF, DMF, or fingolimod.
* Neither the researchers nor the participants will know which drug or dose the participants will receive in Group B. Participants in Group B will also receive a placebo so they do not know which drug is being given. A placebo looks like a study drug but contains no real medicine.
* All study drugs will be taken by mouth, once or twice a day. Participants who take DRF or DMF will start with a lower dose during the 1st week, then move to a standard dose.
* Treatment in Part 1 will last for 96 weeks. Participants will have up to 11 study visits and 7 phone calls.
* Participants who do not move onto Part 2 will also have a safety follow-up period of 4 to 8 weeks. This will include 1 study visit and 1 phone call.
* The total length of Part 1, including the screening, treatment, and follow-up, will be up to 108 weeks.
Part 2 (Extension Period)
* Participants who complete Part 1 can move on to Part 2 of the study.
* All participants in Part 2 will receive DRF by mouth for 96 weeks.
* Participants will have up to 10 more study visits and 1 telephone call during treatment.
* They will also have a 4-week safety follow-up, including 1 study visit and 1 phone call.
* The total length of Part 2 will be up to 100 weeks.

Start Date16 Nov 2026

Sponsor / Collaborator

Biogen, Inc.

NCT07275515

/ RecruitingPhase 2IIT

DIROXIMEL FUMARATE TO REDUCE PERIHAEMATOMAL OEDEMA IN INTRACEREBRAL HAEMORRHAGE: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL (DARLENE)

Spontaneous intracerebral haemorrhage (ICH) is a life-threatening condition, still devoided of specific treatment. Peri-haematomal oedema (PHO) develops in the ensuing days after ICH onset and worsens functional outcome. Hence, PHO is a promising therapeutic target but until now there is no specific treatment for PHO. The occurrence and growth of PHO is mainly mediated by inflammation. We hypothesize that a modulation of inflammation is effective in reducing PHO growth, therefore improving the functional outcome of ICH patients. From animal studies to human post-mortem studies, our team has demonstrated a key role for erythroid-related nuclear factor 2 (Nrf2) in PHO. Indeed, this transcription factor promotes the protective effect of inflammation: Nrf2 activation enhances antioxidant defenses and increases rates of blood resorption. Therefore, Nrf2 emerges as a promising and innovative therapeutic target. Taking into account the prolonged time interval between de novo drug discovery and use in clinical practice, drug repurposing is an interesting option for the unmet clinical need of reducing PHO. We chose Diroximel Fumarate (DRF) which is a safe and effective Nrf2 activator widely used in multiple sclerosis (dimethyl fumarate is on the market since 2013, and DRF since 2019) to modulate inflammation and to establish the efficacy of Nrf2 activation in reducing PHO growth and, ultimately, in improving the functional prognosis after ICH.

Start Date19 May 2026

Sponsor / Collaborator

La Santé

IRCT20200105046010N142

/ SuspendedNot Applicable

In vivo bioequivalence study of Diroximel fumarate 231 mg EC .Capsules of zist daru danesh as Test Drug in compared with the reference Drug in Iranian Healthy Volunteers

Start Date23 Jul 2025

Sponsor / Collaborator-

100 Clinical Results associated with Diroximel fumarate

100 Translational Medicine associated with Diroximel fumarate

100 Patents (Medical) associated with Diroximel fumarate

108

Literatures (Medical) associated with Diroximel fumarate

01 Jul 2026·ADVANCES IN THERAPY

Comparative Effectiveness of Diroximel Fumarate vs. Dimethyl Fumarate in Persons with Multiple Sclerosis: A US Claims Analysis of Relapse Outcomes

Article

Author: Ulin, Sam ; Li, Minxing ; Conway, Devon ; Bandari, Daniel ; Roy, Mike ; Mendoza, Jason P ; Littlewood, Anne ; Belviso, Nicholas ; Amerian-Williams, Babak ; Lewin, James B ; Hong, Nicholas ; Zou, Chencan ; Avila, Mirla ; Dong, Liang

INTRODUCTION:

Diroximel fumarate (DRF) and dimethyl fumarate (DMF) are established disease-modifying therapies for relapsing multiple sclerosis (RMS). While DRF has demonstrated improved gastrointestinal tolerability compared to DMF, there is limited research evaluating whether this difference in tolerability translates into a difference in clinical effectiveness. This study evaluated the real-world effectiveness of DRF versus DMF on relapse outcomes in persons with MS (pwMS) in a large US population.

METHODS:

This retrospective cohort study utilized the Forian administrative claims database (January 1, 2018-June 30, 2025). Adult pwMS initiating DRF or DMF were identified and propensity score-matched (1:3 ratio) based on baseline demographic and clinical characteristics. Endpoints were assessed over 1- and 2-year follow-up periods. The primary endpoint was annualized relapse rate (ARR).

RESULTS:

The 1-year analysis included 1780 DRF-treated and 5340 DMF-treated pwMS; the 2-year analysis included 739 DRF-treated and 2217 DMF-treated pwMS. At 1 year of treatment, DRF was associated with a significantly lower ARR compared to DMF (0.12 vs. 0.16; p = 0.03), representing a 21% reduction in relapse rate (rate ratio 0.79; 95% CI 0.64-0.97). At 2 years of treatment, DRF maintained a lower ARR compared to DMF (0.11 vs. 0.16; p = 0.02), reflecting a 31% reduction in relapse rate (rate ratio 0.69; 95% CI 0.54-0.87).

CONCLUSION:

The results of this real-world analysis indicate DRF may be more effective than DMF in reducing relapses over 1 and 2 years of treatment in pwMS.

01 Apr 2026·ADVANCES IN THERAPY

Comparative Effectiveness and Risk of Severe Infection in Adult Patients With MS Treated With Diroximel Fumarate Versus Anti-CD20 Monoclonal Antibodies: A Real-World Claims Analysis

Article

Author: Gomes, Daniel ; Hua, Le H ; Belviso, Nicholas ; Bian, Boyang ; Farber, Rebecca Straus ; Bozin, Ivan ; Gudesblatt, Mark ; Obeidat, Ahmed Z ; Mendoza, Jason P ; Goff, Erica ; Shankar, Sai L ; Lewin, James B ; Santoro, Jonathan D ; Mao-Draayer, Yang ; Robertson, Derrick ; Wang, Tony ; Betz, Michelle

INTRODUCTION:

Multiple sclerosis (MS) is a chronic, immune-mediated neurological disease, leading to significant morbidity. Over 25 disease-modifying therapies (DMTs) are approved for MS; however, older patients may benefit less from high-efficacy DMTs. We compared the risk of severe infections (SIs) and annualized relapse rate (ARR) by age (< 45 and ≥ 45 years) between diroximel fumarate (DRF) and anti-CD20 monoclonal antibodies (mAbs) in patients with MS.

METHODS:

This retrospective study utilized the Komodo Health Claims database to identify patients treated with DRF or anti-CD20 agents. Patients were propensity score matched 1:1 on baseline characteristics and stratified by age (younger: < 45 years; older: ≥ 45 years). Infection-related encounters were identified by diagnosis codes; SIs required hospitalization or intravenous antibiotics. MS relapses were based on inpatient or outpatient claims and associated treatments.

RESULTS:

Between 2016 and 2025, 2894 propensity score-matched patients with MS who initiated DRF (n = 1447) or anti-CD20s (n = 1447) were included. DRF-treated patients had a lower proportion of SIs at 12 and 24 months compared with anti-CD20-treated patients (p ≤ 0.002 at 24 months). Younger DRF-treated patients had significantly fewer SIs (p = 0.005), while older DRF-treated patients had lower non-SI rates. COVID-19-related SIs were also significantly lower in DRF-treated patients (p < 0.001). ARRs were similar between the two groups.

CONCLUSION:

DRF-treated patients with MS had a significantly lower risk of SI compared with anti-CD20-treated patients, with no difference in ARR. More real-world studies are needed to understand the efficacy and safety of DMTs in the setting of de-escalation in aging patients with MS.

01 Mar 2026·Multiple Sclerosis and Related Disorders

Retrospective review of lymphocyte changes when switching between fumarates in patients with multiple sclerosis

Article

Author: Schneider, Megan ; Choi, Leena ; Zuckerman, Autumn ; Banks, Aimee ; DeClercq, Josh ; Cruchelow, Katie R

BACKGROUND:

When treating multiple sclerosis, lymphopenia is an established side effect of fumaric acids. Research demonstrating the impact of switching fumarates on lymphocyte counts is scarce. The objective of this study is to characterize the incidence and severity of lymphopenia in patients transitioning from dimethyl fumarate (DMF) to monomethyl fumarate (MMF) or diroximel fumarate (DRF).

METHODS:

A single center, retrospective review of adult medical records at the Vanderbilt Multiple Sclerosis Clinic who filled prescriptions for DMF then either DRF or MMF between January 1st, 2019 and February 28th, 2023.

RESULTS:

Patients who switched to DRF experienced a greater median percent change in absolute lymphocyte count (ALC) [45% decrease (IQR -95 to -14)] compared to those who switched to MMF [6% increase (IQR -4 to 17)]. Patients who switched to MMF, on average, had an ALC at follow-up 1.8 times higher than those switched to DRF (95% CI 1.4 to 2.3; p < 0.001). Additionally, patients switched to DRF were more likely to experience grade 2 or 3 lymphopenia compared to patients switched to MMF.

CONCLUSION:

Our study demonstrated that patients switched to DRF had a significantly lower ALC at follow-up and were more likely to have lymphopenia compared to patients switched to MMF.

News (Medical) associated with Diroximel fumarate

23 Feb 2026

·www.biospace.com

QurAlis Demonstrates Effects on Disease Progression and Target Engagement in ANQUR Clinical Trial of QRL-201, a First-in-Class Precision Medicine in Development for Sporadic ALS

First clinical development program in sporadic ALS patients to show potential to restore STATHMIN-2 expression, a statistically significant effect on a neurofilament biomarker, and an overall trend of slowing disease progression as measured by the ALSFRS-R Subgroup analysis showed statistically significant effect on ALSFRS-R Interim data support including an open-label extended dosing period to ANQUR protocol; approval received in Canada and under regulatory review in other regions; preparations underway to advance QRL-201 into pivotal Phase 3 clinical trial in 2027 CAMBRIDGE, Mass.--(BUSINESS WIRE)-- QurAlis Corporation (“QurAlis”), a clinical-stage biotechnology company driving scientific breakthroughs into powerful precision medicines that have the potential to alter the trajectory of neurodegenerative and neurological diseases, today announced interim data from its Proof-of-Concept Phase 1/2 ANQUR clinical trial of QRL-201 in people living with amyotrophic lateral sclerosis (ALS). Results from this study demonstrated QRL-201 had an effect on disease progression in ALS patients; this effect was confirmed by markers of clinical efficacy and changes in a clinically relevant biomarker, along with target engagement. QRL-201 is a first-in-class, potent antisense oligonucleotide (ASO) precision therapeutic in development to restore STATHMIN-2 (STMN2) expression in ALS patients with the aim to modify disease progression and improve outcomes. STMN2 is a protein important for muscle innervation that is regulated by TDP-43 and downregulated in the majority of ALS patients. ANQUR (QRL-201-01; NCT05633459) is the first-ever clinical trial to evaluate a potential therapy to rescue STMN2 expression in people with ALS. The ANQUR study is a double-blind, placebo-controlled study which dosed a total of 69 patients across the dose escalation (n=17) and dose-range finding (DRF) (n=52) phases of the study. “I am encouraged by these data from the ANQUR clinical trial of QRL-201. The combination of effects on target engagement biomarkers, disease biomarkers such as neurofilament, and clinical measures is very promising and remarkable to see from an early stage clinical trial,” said Merit E. Cudkowicz, M.D., M.Sc., director, Sean M. Healey & AMG Center for ALS and executive director of the Mass General Brigham Neuroscience Institute, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. “ALS is a devastating, fatal neurodegenerative disease with a significant unmet medical need. Our mission is to make a meaningful difference for people living with ALS. We believe QRL-201 has the potential to modify disease progression and improve outcomes for sporadic ALS patients,” said Kasper Roet, Ph.D., CEO and co-founder of QurAlis. “These results from the ANQUR clinical trial are well aligned with our understanding of STMN2 biology and the potential of STMN2 restoration to have a positive impact on ALS disease progression. We are grateful to the ANQUR clinical trial team, participants and their families, and look forward to advancing the QRL-201 clinical program to deliver a much-needed precision medicine option for people living with ALS.” Results from the interim analysis of the ANQUR clinical trial show: Target engagement, confirmed through tissue analysis, with broad distribution across the spinal cord and motor cortex, statistically significant increased levels of STMN2, above the estimated therapeutic target, and correction of STMN2 mis-splicing, as compared to a cohort of natural history samples. A statistically significant and clinically meaningful reduction in phosphorylated neurofilament heavy (pNfH) in the low dose group. An encouraging trend of slowing decline in ALSFRS-R in sporadic patients, including a strong trend on the gross motor sub-score, which is critical for patient independence. In a post-hoc analysis excluding patients with the highest levels of baseline neurofilament light, which is associated with faster disease progression, there was a statistically significant and clinically meaningful slowing of decline in ALSFRS-R at the six-month (24 week) timepoint in treated sporadic ALS patients compared to placebo. QRL-201 was generally safe and well tolerated with most adverse events (AEs) reported as mild or moderate. During all phases of the study, and most recently in December 2025, the unblinded Data Safety Monitoring Board has recommended the study continue without modification. These data support an open-label extended dosing period to the ANQUR clinical trial protocol under which all eligible trial participants will be given the opportunity to receive QRL-201 at the low dose of the DRF portion of the study. The open-label extended dosing period to the ANQUR clinical trial has been approved in Canada and is currently under regulatory review in the European Union and the United Kingdom. In parallel, QurAlis is preparing to advance QRL-201 into a pivotal Phase 3 clinical trial in 2027. About STATHMIN-2 STATHMIN-2 (STMN2) is a well-validated protein important for neural repair, axonal stability, and muscle innervation and is the most significantly regulated gene by TDP-43 exclusively in humans. STMN2 has the most consistently decreased expression across multiple ALS RNA expression studies. Loss of nuclear TDP-43 leads to mis-splicing of the pre-mRNA of STMN2, resulting in loss of full-length transcript and protein. QRL-201 rescues STMN2 loss of function and neurodegenerative phenotypes in QurAlis’ ALS patient-derived motor neuron disease models in the presence of TDP-43 pathology. TDP-43 pathology is associated with nearly all ALS patients, approximately 50 percent of patients with frontotemporal dementia (FTD), the second most common form of dementia, and with about a third of Alzheimer’s Disease (AD) patients. There are currently no cures for ALS or FTD, and there are limited therapeutic options available for ALS and FTD patients who are in desperate need of effective therapies. About ANQUR Clinical Trial QRL-201 is being evaluated in the Phase 1/2 ANQUR clinical trial (QRL-201-01; NCT05633459), the first-ever clinical study designed to assess a potential therapy aimed at rescuing STATHMIN-2 (STMN2) expression in people with amyotrophic lateral sclerosis (ALS). The ANQUR trial completed the dose-escalation phase, based on pharmacokinetic analyses from Cohorts 1 and 2 that demonstrated cerebrospinal fluid exposure levels of QRL-201 met or exceeded the targeted therapeutic range. The study then advanced to the dose range-finding phase, which is evaluating two dose levels of QRL-201 and incorporates additional biomarker assessments. The study is currently active in Canada, the United Kingdom, and the European Union, and includes participants with both sporadic ALS and C9orf72-related ALS. More information about the ANQUR clinical trial can be found at . About QurAlis Corporation At QurAlis, we are neuro pioneers on a quest to cure, boldly seeking to translate scientific breakthroughs into powerful precision medicines. We work collaboratively with a relentless pursuit of knowledge, precise attention to craft, and compassion to discover and develop medicines that have the potential to transform the lives of people living with neurodegenerative and neurological diseases. QurAlis is the leader in development of precision therapies for amyotrophic lateral sclerosis (ALS). In addition to ALS, QurAlis is advancing a robust precision medicine pipeline to bring effective disease-modifying therapeutics to patients suffering from severe diseases defined by genetics and clinical biomarkers. For more information, please visit or follow us on X @QurAlisCo or LinkedIn . Contacts Kathy Vincent kathy.vincent@quralis.com

Clinical ResultPhase 3

20 Feb 2026

·firstwordpharma.com

Biopharma bites: Blockbuster hopes for Brinsupri, Biogen stops MS study, plus mRNA patent fight heats up

Insmed guides for $1B in Brinsupri salesBiogen bins mid-stage MS studyModerna's mNEXSPIKE faces patent suitInsmed guides for $1B in Brinsupri salesHaving been approved in the US last August, and subsequently authorised in the EU, as the first treatment for non-cystic fibrosis bronchiectasis (NCFB), Insmed now expects Brinsupri (brensocatib) to generate revenue of at least $1 billion in 2026. "Our US commercial launch…continues to exceed our expectations," said CEO Will Lewis.The oral, once-daily DPP1 inhibitor — designed to block the activation of neutrophil serine proteases in neutrophils that are responsible for the underlying inflammation in NCFB — generated sales of $144.6 million in the fourth quarter of 2025 and $172.7 million for the full year.Insmed expects regulatory decisions for Brinsupri for the treatment of NCFB in the UK and Japan in 2026. However, the company cautioned that it "continues to evaluate the potential effect of evolving US policies," which could impact the timing of potential international commercial launches.-Matthew DennisBiogen bins mid-stage MS study Biogen this week terminated the Phase II FUSION study evaluating BIIB091 in patients with relapsing multiple sclerosis (MS), according to an update on ClinicalTrials.gov. The candidate, a reversible, non-covalent BTK inhibitor, was being studied alone or in combination with diroximel fumarate; the trial had enrolled 127 patients. The study discontinuation comes as at least one BTK inhibitor seems to have found its footing in MS. While the drug class has shown tantalising promise in treating the disease, none have yet reached the finish line — though Roche's fenebrutinib may be nearing approval (see – Physician Views Results: Neurologists share cautious optimism for Roche's fenebrutinib in PPMS).However, Sanofi was recently hit with a controversial FDA rejection for its BTK inhibitor, tolebrutinib, to treat non-relapsing secondary progressive MS. For more on how BTK inhibitors may shake up the MS treatment landscape, see KOL Views Q&A: What Sanofi’s PERSEUS, Roche’s FENtrepid divergence says about BTK inhibitors in MS.-Elizabeth EatonModerna's mNEXSPIKE faces patent suit BioNTech has filed a patent infringement lawsuit alleging that Moderna's next-generation COVID-19 vaccine unlawfully infringes on a patent related to the German company's own mRNA shot, Comirnaty. The complaint, filed Thursday in US District Court for the District of Delaware, claims Moderna's mNEXSPIKE infringes US Patent No. 12,133,899, which covers a streamlined mRNA vaccine design that allows for lower dosing. The case intensifies a long-running legal battle between the companies behind two of the world's most successful COVID-19 vaccines. BioNTech developed Comirnaty with Pfizer, while Moderna brought its own shot, Spikevax, to market in late 2020. In 2022, Moderna sued BioNTech and Pfizer, claiming they "unlawfully copied" its mRNA inventions to make Comirnaty; that case remains ongoing. Moderna recently highlighted mNEXSPIKE, which was approved by the FDA in 2025, as a significant growth driver with expected approvals this year in Europe and Japan. According to BioNTech's complaint, mNEXSPIKE accounted for 55% of COVID-19 vaccines sold by Moderna in the 2025-2026 respiratory virus season. A spokesperson for Moderna said Thursday it would defend itself against the new allegations.-Anna Bratulic

Drug ApprovalPhase 2VaccinemRNAPatent Infringement

19 Feb 2026

·www.fiercebiotech.com

Novartis winds down ph. 1 solid tumor program after lacking efficacy

Novartis had previously shared data from the phase 1 study of QEQ278 showing that none of the patients achieved an objective response.\n Novartis has jettisoned an anti-cancer protein from its pipeline after the molecule failed to shrink tumors in 30 patients with advanced disease.The pharma giant halted the phase 1 trial of QEQ278 and has dropped the candidate entirely, a spokesperson confirmed with Fierce Biotech. Novartis had previously shared early data from the trial showing that none of the patients treated with the protein achieved an objective response, with 26 of them halting treatment partway through the trial because their cancer got worse. Patients included in the trial had advanced malignancies and exhausted standard of care treatments.“Following review in 2024, Novartis made the decision to discontinue development of QEQ278 in the phase 1 study,” the spokesperson told Fierce. “This decision was not based on any safety concern and the asset was removed from the Novartis pipeline.”Despite the discontinuation occurring years ago, the trial’s status was only just updated “per protocol” after “the remaining participant recently discontinued study treatment,” the spokesperson added.News of the terminated trial was first reported by ApexOnco. QEQ278 was designed to target a group of proteins that bind to the natural killer group 2D receptor (NKG2D) on the surface of natural killer (NK) cells. Many tumor cells are littered with ligands that bind to NKG2D, which normally, the natural killer cells, could use to identify the cancer and destroy it. As a decoy, these cancers tend to shed some of the ligands into the bloodstream, which distracts the immune cells and allows the tumor to evade detection.With QEQ278, Novartis hoped to both nullify the decoy ligands floating in the body and also attach to the surface of tumor cells and flag them for destruction.Other companies have also tried to target NKG2D ligands, with limited success. For example, Nkarta engineered NK cells to express a boosted NKG2D receptor and saw some early wins in blood cancer, but ultimately dropped the candidate in March 2024 after the response rate plummeted when more patients were treated.Astellas similarly canned an early CAR-T lymphoma candidate using NKG2D in January 2025, which a company spokesperson told Fierce at the time was a “difficult decision” driven by “prioritization efforts.”Novartis’ decision coincides with Biogen discontinuing a combination arm of a phase 2 trial for multiple sclerosis candidate BIIB091. While Biogen is no longer testing the asset in combination with Vumerity (diroximel fumarate) as a “strategic decision,” monotherapy data for BIIB091 is still expected in the second quarter of 2026, a spokesperson told Fierce.

Phase 1PROTACsPhase 2Clinical Trial Termination

100 Deals associated with Diroximel fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
D11154	Diroximel fumarate	L03	DB14783

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	European Union	BIOGEN NETHERLANDS BV	15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting	Iceland	BIOGEN NETHERLANDS BV	15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	BIOGEN NETHERLANDS BV	15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting	Norway	BIOGEN NETHERLANDS BV	15 Nov 2021
Multiple Sclerosis	Switzerland	Biogen, Inc.	20 Sep 2021
Multiple sclerosis relapse	United States	Biogen, Inc.	29 Oct 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gangliosidosis, GM1	Phase 3	United States	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	United States	Alkermes, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Belgium	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Belgium	Alkermes, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Bulgaria	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Bulgaria	Alkermes, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Canada	Alkermes, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Canada	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Germany	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	Germany	Alkermes, Inc.	10 Dec 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05083923 (CTgov)	Phase 3	Multiple sclerosis relapse	136	DRF 462+DRF (Cohort 1: Japanese Participants)	jpjptsrsab = xutspikode jdpkgtzoby (ziguejadis, jznfccfhqe - hjlxelfsng) View more	-	24 Oct 2025
				DRF 462+DRF (Cohort 2: Chinese Participants)	jpjptsrsab = mtyetcjkch jdpkgtzoby (ziguejadis, rassscifrd - dqshmotygd) View more
NCT02634307 (EVOLVE-MS-1, AAN2025)	Phase 3	Gangliosidosis, GM1 \| Multiple Sclerosis, Relapsing-Remitting	1,057	Diroximel Fumarate (DRF)	gsshmphwmd(tkprylzume) = ufngllqdrf qsjberkvhg (jeoyssesfn, 3.8 - 8.7) View more	Positive	07 Apr 2025
				Ocrelizumab (OCR)	gsshmphwmd(tkprylzume) = rrhogzsoju qsjberkvhg (jeoyssesfn, 7.1 - 11.1) View more
NCT02634307 (EVOLVE-MS-1, Pubmed)	Phase 3	Multiple Sclerosis, Relapsing-Remitting lymphopenia \| ALC decline	-	Diroximel Fumarate	qhpjzmjcfm(qztjyezobt) = mxslrjaxdd uzzdnildtw (watweipekc )	Positive	27 Jun 2024
NCT02634307 (EVOLVE-MS-1, Pubmed)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	1,057	Diroximel fumarate	cnkznwmclm(dnrkvzmnfj) = ahxnblsebe usiklzjjwg (erkpmqdxbz )	Positive	15 Jun 2024
				Dimethyl fumarate	cnkznwmclm(dnrkvzmnfj) = nqernjzxpb usiklzjjwg (erkpmqdxbz )
AAN2024	Not Applicable	Multiple Sclerosis	-	Fumarates (Black)	jvylhxeoks(kgohfccdiq) = rbbjzaeqax oxvravxhkn (ejdqsupzoe, 73.7–80.3)	-	09 Apr 2024
				Fumarates (Hispanic)	jvylhxeoks(kgohfccdiq) = xlvvnaifva oxvravxhkn (ejdqsupzoe, 71.0–80.0)
ACTRIMS2024	Not Applicable	Multiple Sclerosis	-	Fumarates (Black)	mrmxeusjfq(gocftkkwmf) = xykbssxryw eniabpompq (menlawcies ) View more	-	01 Mar 2024
				Fumarates (Hispanic)	mrmxeusjfq(gocftkkwmf) = rybhoehdaa eniabpompq (menlawcies ) View more
SUNBEAM (RPC01-301), RADIANCE phase 3 (RPC01-201B), EVOLVE-MS-1 (ACTRIMS2023)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	-	Ozanimod 1.0 mg	sispavfaea(vbrquhqinv): risk ratio = 0.924 (95% CI, 0.646 - 1.324) View more	Positive	30 May 2023
				Diroximel fumarate 462 mg
NCT02425644 \| NCT02634307 (EVOLVE-MS-1 \| OPTIMUM, Pubmed)	Phase 3	Multiple sclerosis relapse	-	Diroximel fumarate	iznknyvvsk(hnpdulihao) = zlmicmcmpb nrmklkdcfk (zlyunxsriu )	-	08 May 2023
NCT02634307 (EVOLVE-MS-1, AAN2023)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	239	Diroximel Fumarate	pbwjiqhbyk(ebjffltmho) = 23 (9.6%) patients discontinued DRF due to adverse events nfgqwfawka (rslwdmrxmd ) View more	Positive	25 Apr 2023
NCT02634307 (EVOLVE-MS-1, AAN2023)	Phase 3	Multiple Sclerosis	1,057	Diroximel fumarate	wvqwveaces(sszpnmcudb) = bnflbyangz jvzkimsvpu (avqtowlbyh ) View more	Positive	25 Apr 2023
				Placebo	wvqwveaces(sszpnmcudb) = fmihddnewc jvzkimsvpu (avqtowlbyh ) View more

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Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis