The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta interferons, or glatiramer acetate]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.

Start Date01 Sep 2024

Sponsor / Collaborator

Biogen, Inc.

NCT06432764 / Not yet recruitingPhase 1

A Phase Ib Open Label Positron Emission Tomography Study to Assess Changes in Intestinal [11C]AZ14132516 Uptake Following Administration of Multiple Doses of AZD7798 to Patients With Crohn's Disease.

The purpose of this study is to measure the changes in intestinal uptake of radioligand [11C]AZ14132516 following multiple doses of AZD7798 in participants with Crohn's disease.

Start Date30 Aug 2024

Sponsor / Collaborator

AstraZeneca PLC

NCT06319339 / Not yet recruitingEarly Phase 1IIT

Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease

Purpose: Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. Eligibility: Individuals with PAD will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have a positive history of exercise-limiting claudication (Fontaine II or III), 3) do not have renal impairments, 4) do not have Fontaine stage IV PAD, and 5) are not currently pregnant or nursing. Age-matched controls will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have an ABI greater than 0.9 (no PAD), 3) do not have exercise-limiting diseases or injuries, 4) do not have renal impairments, and 5) are not currently pregnant or nursing. Intervention and Evaluation: During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. Follow-up: There will be a follow-up visit to assess blood work after diroximel fumarate.

Start Date01 Aug 2024

Sponsor / Collaborator

University of Nebraska

100 Clinical Results associated with Diroximel fumarate

100 Translational Medicine associated with Diroximel fumarate

100 Patents (Medical) associated with Diroximel fumarate

Literatures (Medical) associated with Diroximel fumarate

01 Feb 2024·Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

Epidemiology of distal radius fractures in Germany - incidence rates and trends based on inpatient and outpatient data

Article

Author: Haastert, Burkhard ; Arend, Werner ; Reiland, Kevin ; Icks, Andrea ; Thelen, Simon ; Andrich, Silke ; Klüppelholz, Birgit ; Windolf, Joachim

PURPOSE:

Although a distal radius fracture (DRF) is one of the most common fractures in the elderly population, epidemiological data are limited. Many studies examine only hospitalized patients, do not analyze time trends, or include only small populations. In this retrospective population-based observational study, routine data on inpatient and outpatient care of persons aged ≥ 60 years insured by a large statutory health insurance in Germany were analyzed from 2014 to 2018.

METHODS:

DRF were identified by ICD-10 codes. All DRF events of an individual were considered with a corresponding individual washout period. Incidence rates (IR) and time trends were estimated assuming a Poisson distribution per 100,000 person-years, with 95% confidence intervals [95% CI] and age-sex standardization to the German population in 2018. Associations of calendar year, age, sex, and comorbidity with IR were examined using Poisson regression estimating incidence rate ratios (IRR) with CI.

RESULTS:

The study population consists of 974,332 insured individuals, with 16,557 experiencing one or more DRF events during the observation period. A total of 17,705 DRF events occurred, of which 9961 (56.3%) were hospitalized. Standardized IR were 439 [424-453] (inpatient: 240 [230-251], outpatient: 199 [189-209]) in 2014 and 438 [423-452] (inpatient: 238 [227-249], outpatient: 200 [190-210]) in 2018. Female sex, older age, and comorbidity were associated with higher IR and adjusted Poisson regression showed no significant time trend (IRR overall 0.994 [0.983-1.006]).

CONCLUSION:

A relevant proportion of DRF were treated in outpatient settings, so both inpatient and outpatient data are necessary for a valid estimate.

01 Jan 2024·Experimental neurology

Assessing neuroprotective effects of diroximel fumarate and siponimod via modulation of pacemaker channels in an experimental model of remyelination

Article

Author: Budde, Thomas ; White, John A ; Oniani, Tengiz ; Kovac, Stjepana ; Meuth, Sven G ; Vinnenberg, Laura ; Williams, Brandon ; Rychlik, Nicole ; Hundehege, Petra

Cuprizone (CPZ)-induced alterations in axonal myelination are associated with a period of neuronal hyperexcitability and increased activity of hyperpolarization-activated and cyclic nucleotide-gated (HCN) channels in the thalamocortical (TC) system. Substances used for the treatment of multiple sclerosis (MS) have been shown to normalize neuronal excitability in CPZ-treated mice. Therefore, we aimed to examine the effects of diroximel fumarate (DRF) and the sphingosine 1-phospate receptor (S1PR) modulator siponimod on action potential firing and the inward current (I_h) carried by HCN ion channels in naive conditions and during different stages of de- and remyelination. Here, DRF application reduced I_h current density in ex vivo patch clamp recordings from TC neurons of the ventrobasal thalamic complex (VB), thereby counteracting the increase of I_h during early remyelination. Siponimod reduced I_h in VB neurons under control conditions but had no effect in neurons of the auditory cortex (AU). Furthermore, siponimod increased and decreased AP firing properties of neurons in VB and AU, respectively. Computational modeling revealed that both DRF and siponimod influenced thalamic bursting during early remyelination by delaying the onset and decreasing the interburst frequency. Thus, substances used in MS treatment normalize excitability in the TC system by influencing AP firing and I_h.

01 Dec 2023·Neurology and therapy

Response to Letter to the Editor Regarding “Real-World Analysis Affirms the High Persistence and Adherence Observed with Diroximel Fumarate in Patients with Multiple Sclerosis”

Letter

Author: England, Sarah M ; Božin, Ivan ; Liseno, Jacob ; Lewin, James B ; Shankar, Sai L ; Mendoza, Jason P ; Lager, Brittney

News (Medical) associated with Diroximel fumarate

01 May 2024

·www.prnewswire.com

Alkermes plc Reports First Quarter 2024 Financial Results

— First Quarter Revenues of $350.4 Million — — GAAP Net Income from Continuing Operations of $38.9 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.23 — — Company Reiterates 2024 Financial Expectations — DUBLIN, May 1, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2024. "The first quarter of 2024 marks our first full quarter as a profitable, pure-play neuroscience company. During the quarter, we continued to advance our strategic priorities across the business, highlighted by solid underlying prescription growth for LYBALVI® and advancement of ALKS 2680, our novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy," said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS 2680, we recently initiated our Vibrance-1 phase 2 study in narcolepsy type 1 and announced positive topline phase 1b results in narcolepsy type 2. With these new data now in hand, we plan to initiate a phase 2 study in narcolepsy type 2 in the second half of 2024. In an area where there remains significant unmet patient need, orexin 2 biology represents an important new potential approach to treating disorders characterized by excessive daytime sleepiness. ALKS 2680 is the first candidate from our orexin portfolio to advance in the clinic and we plan to share details regarding our other orexin development programs later this year." Key Financial Highlights Revenue Highlights LYBALVI Revenues for the quarter were $57.0 million. Revenues and total prescriptions for the quarter grew 50% and 56%, respectively, compared to the first quarter of 2023. Inventory in the channel decreased by approximately $2.3 million during the quarter. ARISTADAi Revenues for the quarter were $78.9 million. Inventory in the channel decreased by approximately $3.6 million during the quarter. VIVITROL Revenues for the quarter were $97.7 million. Inventory in the channel decreased by approximately $4.3 million during the quarter. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $62.7 million. VUMERITY® manufacturing and royalty revenues for the quarter were $31.3 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Year-over-year increase in R&D expense related to continuing operations was driven primarily by investment in the ALKS 2680 development program and approximately $3.2 million of non-recurring share-based compensation expenses. Year-over-year increase in SG&A expense related to continuing operations was driven primarily by investment in the LYBALVI direct-to-consumer advertising campaign and approximately $6.2 million of non-recurring share-based compensation expenses. Balance Sheet At March 31, 2024, the company recorded cash, cash equivalents and total investments of $807.8 million, compared to $813.4 million at Dec. 31, 2023. The company's total debt outstanding as of March 31, 2024 was $290.1 million. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In March 2024, the company announced the appointment of new independent director Nancy S. Lurker to the company's board of directors. In April 2024, the company presented data from its long-term safety study of LYBALVI (olanzapine and samidorphan) at the 2024 Congress of the Schizophrenia International Research Society (SIRS). In April 2024, the company announced positive topline results from the narcolepsy type 2 and idiopathic hypersomnia cohorts in its phase 1b study of ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy. In April 2024, the company announced initiation of the Vibrance-1 phase 2 study of ALKS 2680 in patients with narcolepsy type 1. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three months ended March 31, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, May 1, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects; the company's expectations regarding advancement of its development pipeline, including plans and expected timelines for the ALKS 2680 clinical development program; and the therapeutic and commercial potential of ALKS 2680 and the company's other development programs. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to sustain profitability; the unfavorable outcome of arbitration or litigation, including so-called "Paragraph IV" litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company's products or products using the company's proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company's regulatory approval strategies; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to government payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 SOURCE Alkermes plc

Phase 2Financial StatementPhase 1Clinical ResultExecutive Change

14 Feb 2024

·www.biospace.com

DOJ, SEC Subpoenas Add to Biogen’s Compounding Problems

Pictured: Biogen's office and lab buildings in Cambridge, Massachusetts/iStock, hapabapa Biogen has disclosed in a Wednesday Securities and Exchange Commission filing that it has been served a subpoena by the U.S. Department of Justice, which is seeking more information regarding the company’s overseas operations. The Securities and Exchange Commission (SEC) has also issued subpoenas to Biogen, asking for additional information regarding the launch of its abandoned Alzheimer’s disease therapy Aduhelm (aducanumab), the company reported. In connection with the Department of Justice subpoena, Biogen is “providing information relating to our business operations in several foreign countries to the SEC,” it noted in Wednesday’ filing. Outside the U.S., Biogen has established a presence in more than 40 territories, according to its website. These include Australia, Canada, China, Japan and several European countries. Biogen’s international headquarters is in Switzerland. BioSpace reached out to Biogen for comment on the U.S. government investigations but the company was not immediately available. The news of the subpoenas come one day after Biogen reported its fourth-quarter and full-year financial results, posting disappointing sales figures and plotting a bleak forecast for 2024. In the fourth quarter of 2023, the pharma made over $2.3 billion in revenue, a 5% decline from the same period the prior year. Its multiple sclerosis business, anchored by Fampyra (fampridine), Tecfidera (dimethyl fumarate) and Vumerity (diroximel fumarate), suffered an 8% sales hit, bringing in only $1.1 billion in the most recent quarter. Tecfidera contributed heavily to Biogen’s poor financial performance, with its revenues tanking 17.8% in the fourth quarter. Though relatively small, Biogen also absorbed $60 million in close-out costs associated with Aduhelm. Late last month, the pharma announced that it would discontinue the development and commercialization of the controversial Alzheimer’s therapy and instead channel its resources and energy into Leqembi (lecanemab). CEO Chris Viehbacher called this decision “difficult” on Tuesday, but one that represents the most efficient use of the company’s capital. “By the time Aduhelm would get its confirmatory data we just felt that Leqembi would be so far ahead and there are going to be other agents.” Leqembi’s launch, however, has been slow. Eisai—Biogen’s development and commercialization partner for the Alzheimer’s therapy—reported last week that it will likely miss its March 2024 goal of treating 10,000 patients. Since winning the FDA’s full approval in July 2023, Leqembi has only reached around 2,000 patients so far, with about 8,000 more on waitlists. In the face of these compounding problems, Biogen CFO Mike McDonald said during the investor call on Tuesday that the company is expecting a low-to-mid-single-digit percentage drop in revenue in 2024, while its core revenue from products would be relatively flat. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Drug ApprovalFinancial StatementAccelerated Approval

13 Feb 2024

·www.biospace.com

Biogen Misses Q4 Revenue Estimates on Aduhelm Costs, Lower MS Drug Sales

Pictured: Biogen signage at its headquarters in Massachusetts/iStock, JHVEPhoto Biogen’s fourth-quarter financial results were weighed down by declining multiple sclerosis sales and one-time costs related to dropping its Alzheimer’s drug Aduhelm, the biotech reported on Tuesday. The Massachusetts-based biotech posted over $2.3 billion in total revenue for the fourth quarter, a 5% drop from the same period in 2022. Biogen’s revenue from multiple sclerosis products was $1.1 billion in the most recent quarter, down 8% from last year. Hit with generic competition, Tecfidera’s revenue dropped 17.8% to $244.3 million in the fourth quarter. Another multiple sclerosis medication, Vumerity, generated $156.4 million in sales in the quarter—below analysts’ estimates of $174.4 million. Biogen paid $60 million in one-time, close out costs in the fourth quarter related to its controversial and now-defunct Alzheimer’s treatment Aduhelm. Late last month, the company announced it was discontinuing sales and development of Aduhelm, as it focused on Leqembi instead. On a Tuesday press call, Biogen CEO Chris Viehbacher described the decision to axe Aduhelm as “difficult” but in the best interests of the company over the short term. “The reality is that as we look out into the market over the next few years, by the time Aduhelm would get its confirmatory data we just felt that Leqembi would be so far ahead and there are going to be other agents,” Viehbacher said. “That wasn’t the best place for us to put our capital. That was an expensive study that was going to cost at least half a billion dollars, and we just felt that it would be better to reinvest a lot of that money and redeploy that money within the company.” Fourth-quarter revenue for the Alzheimer’s treatment Leqembi came in at around $7 million, while the revenue for full-year 2023 generated $10 million. The revenue in the quarter for Friedreich’s ataxia medication Skyclarys was $56 million. Looking at 2024 guidance, Biogen CFO Mike McDonald said on Tuesday morning that revenue would decline by the low to mid-single-digit percentage in 2024. Biogen’s press release noted that its core revenue from its products would be relatively flat this year as it expects a further decline in multiple sclerosis to be offset by revenue from its new product launches. New product launches, such as Skyclarys and Leqembi, are part of Biogen’s plan to bring revenue back up, according to Viehbacher. Skyclarys on Monday secured approval from the European Commission to treat the neurodegenerative disorder Friedreich’s ataxia (FA). In March 2023, Skyclarys got U.S. approval becoming the first-ever FDA-approved therapy for FA. “We’ve had several years of declining revenue and profit, which is not unusual when dealing with patent [expirations]. The question is, how do you return to growth? And so, we had identified five key primary objectives to do that,” Viehbacher said on the press call. “The first one was what we needed to reposition the company away from our legacy multiple sclerosis franchise towards new products. And, last year, we had four product approvals, the second highest in the industry.” Viehbacher said that as the “iceberg” from its multiple sclerosis line continues to “melt” the new products will take on a more significant share of the revenue and is confident that the company can see revenue growth over the next 10 years. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Drug ApprovalFinancial Statement

100 Deals associated with Diroximel fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
D11154	-	L03	DB14783

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	EU	Biogen Netherlands BV	15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting	IS	Biogen Netherlands BV	15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting	LI	Biogen Netherlands BV	15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting	NO	Biogen Netherlands BV	15 Nov 2021
Multiple Sclerosis	CH	Biogen, Inc.	20 Sep 2021
Multiple sclerosis relapse	US	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	US	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	BE	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	BG	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	CA	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	DE	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	PL	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	RU	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	RS	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	ES	Biogen, Inc.	10 Dec 2015
Gangliosidosis, GM1	Phase 3	UA	Biogen, Inc.	10 Dec 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECTRIMS2023	Not Applicable	Multiple Sclerosis	29	Dimethyl Fumarate (DMF)	umrmpkfpxq(qvffwmyjen) = 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. edmqiqkkdr (oquhevrwot ) View more	Positive	01 Oct 2023
ECTRIMS2023	Not Applicable	Lymphopenia	72	Dimethyl Fumarate (DMF)	kioqrwsarf(ulzogswzsc) = cxbkwbgdzu kpfdyhipdf (etbjdszjlx )	-	30 Sep 2023
				Diroximel Fumarate (DRF)	kioqrwsarf(ulzogswzsc) = mlbevxrros kpfdyhipdf (etbjdszjlx )
ECTRIMS2023	Not Applicable	Neuroinflammation	-	Diroximel fumarate (DRF)	jeqnxhijvk(qtwyzqnwog) = significantly reduced IFNγ secretion in splenocytes isolated from DRF treated mice kzjfxghekq (ckmtnremlf ) View more	Positive	30 Sep 2023
				Vehicle (methocel)
SUNBEAM (RPC01-301), RADIANCE phase 3 (RPC01-201B), EVOLVE-MS-1 (ACTRIMS2023)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	-	Ozanimod 1.0 mg	hrnetktsiu(rramibdlts): risk ratio = 0.924 (95% CI, 0.646 - 1.324) View more	Positive	30 May 2023
				Diroximel fumarate 462 mg
ACTRIMS2023	Not Applicable	Multiple Sclerosis	11	Diroximel Fumarate	ateohzsqqi(lkykwqosnt) = pcfxvuyexd xfucxyhrph (dzcsttjgze ) View more	Positive	30 May 2023
				Dimethyl Fumarate	ateohzsqqi(lkykwqosnt) = dsjzvccret xfucxyhrph (dzcsttjgze ) View more
EVOLVE-MS-1, OPTIMUM (Pubmed)	Phase 3	Multiple sclerosis relapse	-	Diroximel fumarate	aroyuikfmu(xhxegnyvgr) = pzypgkietn szctvqanav (cbnonoyaea )	-	08 May 2023
NCT02634307 (EVOLVE-MS-1, AAN2023)	Phase 3	Multiple Sclerosis	1,057	Diroximel fumarate	egkpcsaaeu(jsyhgcmwzb) = fgktnwpjqc wubuhiuaun (bfuwfgtjrp ) View more	Positive	25 Apr 2023
				Placebo	egkpcsaaeu(jsyhgcmwzb) = sermwhszah wubuhiuaun (bfuwfgtjrp ) View more
NCT02634307 (EVOLVE-MS-1, AAN2023)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	239	Diroximel Fumarate	ceudtyxvpp(zmnpgzrooi) = 23 (9.6%) patients discontinued DRF due to adverse events aoiyotrsjy (ijyokzxnaj ) View more	Positive	25 Apr 2023
NCT02634307 (CTgov)	Phase 3	Multiple Sclerosis, Relapsing-Remitting \| Gangliosidosis, GM1	1,057	ALKS 8700+DMF (De Novo)	usrbqaqbxd(yzjkhatijn) = xhquiazgsb sptzbsigyb (zvhzifkpxm, ljkeqqxiyu - chbhdaocif) View more	-	24 Jun 2022
				ALKS 8700 (Rollover: ALKS 8700)	usrbqaqbxd(yzjkhatijn) = nqybpxxjvf sptzbsigyb (zvhzifkpxm, xvvmjiirui - vovvztrykq) View more
P9-4.007 (AAN2022)	Not Applicable	Multiple Sclerosis	-	Diroximel Fumarate	uqdnmfyqqd(uhaaupyhef) = dktlpdwzow pidsweqtbk (ngsbdvtoqv, 89.2 - 92.5) View more	Positive	03 May 2022
				Prior DMF	uqdnmfyqqd(uhaaupyhef) = esmxzoxnxm pidsweqtbk (ngsbdvtoqv, 83.3 - 87.4)

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