[Translation] A randomized, open-label, two-sequence, four-period, fully repeated crossover bioequivalence study of edoxaban tosylate tablets in healthy volunteers after single oral administration on an empty stomach or after a meal

主要目的：通过空腹/餐后试验研究，考察中国健康受试者在空腹/餐后状态下单剂量口服江西迪赛诺医药集团有限公司持有的甲苯磺酸艾多沙班片（规格：60mg/片）与Daiichi Sankyo Europe GmbH生产的甲苯磺酸艾多沙班片（规格：60mg/片；商品名：里先安®）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：研究单剂量口服甲苯磺酸艾多沙班片（规格：60mg/片）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of a single oral dose of edoxaban tosylate tablets (60 mg/tablet) produced by Jiangxi Desano Pharmaceutical Group Co., Ltd. and edoxaban tosylate tablets (60 mg/tablet; trade name: Lixianan®) produced by Daiichi Sankyo Europe GmbH in healthy Chinese subjects in the fasting/postprandial state through a fasting/postprandial trial study, and to evaluate the bioequivalence of the two preparations. Secondary objective: To investigate the safety of a single oral dose of edoxaban tosylate tablets (60 mg/tablet) in healthy Chinese subjects.

Start Date19 Apr 2024

Sponsor / Collaborator

Jiangxi Desaino Pharmaceutical Group Co., Ltd.

CTR20240760 / RecruitingNot Applicable

甲苯磺酸艾多沙班片在健康受试者中单中心、随机、开放、两制剂、单次给药、四周期、完全重复交叉空腹/餐后生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, single-dose, four-period, completely repeated crossover fasting/fed bioequivalence study of edoxaban tosylate tablets in healthy subjects

以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂甲苯磺酸艾多沙班片（规格：60mg，持证商：武汉熙瑞医药科技有限公司）与参比制剂甲苯磺酸艾多沙班片（规格：60mg，持证商：Daiichi Sankyo Europe GmbH，商品名：Lixiana®）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。观察受试制剂甲苯磺酸艾多沙班片和参比制剂甲苯磺酸艾多沙班片在健康受试者中的安全性。

[Translation]

The pharmacokinetic parameters were used as the primary endpoints to compare the pharmacokinetic behaviors of the test preparation Edoxaban Tosylate Tablets (Specification: 60 mg, licensee: Wuhan Xirui Pharmaceutical Technology Co., Ltd.) and the reference preparation Edoxaban Tosylate Tablets (Specification: 60 mg, licensee: Daiichi Sankyo Europe GmbH, trade name: Lixiana®) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. The safety of the test preparation Edoxaban Tosylate Tablets and the reference preparation Edoxaban Tosylate Tablets in healthy subjects was observed.

Start Date08 Apr 2024

Sponsor / Collaborator

Wuhan Xirui Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Edoxaban Tosylate

100 Translational Medicine associated with Edoxaban Tosylate

100 Patents (Medical) associated with Edoxaban Tosylate

1,961

Literatures (Medical) associated with Edoxaban Tosylate

01 Apr 2024·Talanta

Calibration-free electrochemical sensor to monitor factor-Xa inhibitors at the point-of-care anticoagulation therapy

Article

Author: Mruthunjaya, Ashwin K V ; Torriero, Angel A J ; Chatelier, Ronald C

This article presents a novel proof of concept for the blood plasma quantification of clinically relevant concentrations of direct oral anticoagulants, DOACs, including rivaroxaban and edoxaban, as well as low-molecular-weight heparins, LMWHs, such as enoxaparin and dalteparin, utilising a calibration-free disposable electrochemical sensor with co-facing electrodes. A dose-response curve was generated for rivaroxaban and edoxaban to demonstrate the sensor's ability to detect ≥9.00 ng mL^-1 rivaroxaban and quantify it in the 11.0-140 ng mL^-1 range. Similarly, the lower detection limit for edoxaban was 12.9 ng mL^-1, with a quantification range of 16.8-140 ng mL^-1. The significance of this sensor lies in its ability to quantify rivaroxaban and edoxaban below 30 ng mL^-1, which is crucial in emergency care centres when patients undergoing DOAC therapy require emergency surgery or reversal of DOACs due to bleeding or ischemic stroke. Furthermore, the sensor can detect ≥0.016 IU mL^-1 enoxaparin and ≥0.013 IU mL^-1 dalteparin and quantify them in the 0.025-0.75 and 0.019-0.75 IU mL^-1 range, respectively. Additionally, a dose-response curve was presented to demonstrate the potential ability of this sensor to quantify factor-Xa inhibitors independently of which DOACs or LMWHs are used. With the assay completed in less than 30 s using a minimal volume of 7 μL sample, the possibility to work at physiological pH and under calibration-free format makes this assay an excellent candidate for point-of-care testing.

01 Apr 2024·DEN open

Dabigatran-induced esophagitis with full circumferential blue pigmentation.

Author: Koide, Yuji ; Nakao, Kazuhiko ; Imamura, Yoshifumi ; Araki, Tomonori ; Hayashi, Kohei ; Hamada, Hisayuki ; Honda, Takuya ; Sonoda, Yuki

Dabigatran is a useful and widely used drug for stroke prevention in patients with atrial fibrillation. However, it has been reported to cause esophagitis. Herein, we report the case of a 77-year-old man with dabigatran-induced esophagitis with blue pigmentation, which is known to be a rare adverse effect. The patient presented to our hospital with a tightness of the chest and anorexia. Computed tomography revealed a thickening of the entire esophageal wall, with an upper esophageal predominance. Esophagogastroduodenoscopy was performed, which showed that the cervical and upper thoracic esophagus had blue pigmentation with edematous changes, partial narrowing, and longitudinal sloping. We replaced dabigatran with edoxaban, a similar anticoagulation medication. The patient was closely monitored for 1 month after switching to edoxaban. The follow-up esophagogastroduodenoscopy showed marked improvements, revealing resolution of the bluish discoloration and edematous changes, and the patient's complaints regarding the tightness of the chest and anorexia were also resolved. It is important to recognize that such side effects can occur with dabigatran, a drug that is frequently used in daily practice. Considering the fact that strong edematous changes can cause indigo carmine pigmentation associated with dabigatran stagnation, we recommend switching to another anticoagulant if esophagitis occurs during dabigatran administration.

01 Mar 2024·American heart journal

Low- or standard-dose edoxaban versus antiplatelet therapy for leaflet thrombus and cerebral thromboembolism after TAVR: A prespecified analysis of randomized ADAPT-TAVR trial

Article

Author: Lin, Mao-Shin ; Kim, Won-Jang ; Koo, Hyun Jung ; Lee, Jinho ; Kang, Joon-Won ; Kang, Do-Yoon ; Ko, Euihong ; Lee, Jae-Hong ; Lam, Cheung Chi Simon ; Kim, Byungjun ; Kim, Hoyun ; Lee, Yung-Tsai ; Kim, Dae-Hee ; Kao, Hsien-Li ; Kim, Min-Ju ; Yang, Dong Hyun ; Wong, Yiu Tung Anthony ; Lee, Seung-Ah ; Choi, Yeonwoo ; Yu Ko, Tsung ; Park, Jinsun ; Jung, Seung Chai ; Kim, Kyung Won ; Park, Duk-Woo ; Wei, Jeng ; Yin, Wei-Hsian ; Ahn, Jung-Min ; Kang, Se Hun ; Kim, Mijin ; Park, Seung-Jung

BACKGROUND:

The risks of leaflet thrombosis and the associated cerebral thromboembolism are unknown according to different anticoagulation dosing after transcatheter aortic valve replacement (TAVR). The aim was to evaluate the incidence of leaflet thrombosis and cerebral thromboembolism between low-dose (30 mg) or standard-dose (60 mg) edoxaban and dual antiplatelet therapy (DAPT) after TAVR.

METHODS:

In this prespecified subgroup analysis of the ADAPT-TAVR trial, the primary endpoint was the incidence of leaflet thrombosis on 4-dimensional computed tomography at 6-months. Key secondary endpoints were new cerebral lesions on brain magnetic resonance imaging and neurological and neurocognitive dysfunction.

RESULTS:

Of 229 patients enrolled in this study, 118 patients were DAPT group and 111 were edoxaban group (43 [39.1%] 60 mg vs 68 [61.3%] 30 mg). There was a significantly lower incidence of leaflet thrombosis in the standard-dose edoxaban group than in the DAPT group (2.4% vs 18.3%; odds ratio [OR] 0.11; 95% confidence interval [CI], 0.01-0.55; P = .03). However, no significant difference was observed between low-dose edoxaban and DAPT (15.0% vs 18.3%; OR 0.79; 95% CI, 0.32-1.81; P = .58). Irrespective of different antithrombotic regiments, the percentages of patients with new cerebral lesions on brain MRI and worsening neurological or neurocognitive function were not significantly different.

CONCLUSIONS:

In patients without an indication for anticoagulation after TAVR, the incidence of leaflet thrombosis was significantly lower with standard-dose edoxaban but not with low-dose edoxaban, as compared with DAPT. However, this differential effect of edoxaban on leaflet thrombosis was not associated with a reduction of new cerebral thromboembolism and neurological dysfunction.

News (Medical) associated with Edoxaban Tosylate

11 Mar 2024

·www.prnewswire.com

Cadrenal Therapeutics Provides Fourth Quarter 2023 Corporate Update

PONTE VEDRA, Fla., March 11, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes and deaths due to blood clots in patients with rare cardiovascular conditions, today provided a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December 31, 2023. Recent Highlights Expanded focus for tecarfarin development beyond end-stage kidney disease (ESKD) with atrial fibrillation (AFib), to include patients with implanted medical devices such as left ventricular assist devices (LVADs) for heart failure as well as for the treatment of patients with antiphospholipid syndrome (APS) who require chronic anticoagulation. These two new potential rare medical conditions increase the total addressable market for tecarfarin in excess of $2 billion in the U.S. annually. Engaged The Sage Group to assist the company in exploring strategic partnerships, co-development, and licensing agreements for tecarfarin. Appointed Jeff Cole to the newly created position of Chief Operating Officer, responsible for the Company's manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin. Engaged pharmaceutical contract development and manufacturing organizations (CDMOs) to supply active pharmaceutical ingredients (API) and clinical trial materials. Highlighted recent peer-reviewed article in the Journal of the American College of Cardiology (JACC) titled, "When Direct Oral Anticoagulants Should Not Be Standard Treatment" by Antoine Bejjani, MD, et.al examined the numerous medical conditions where direct oral anticoagulants (DOACs), such as Eliquis, Xarelto, Pradaxa, and Savaysa, should not be prescribed. The article is consistent with the evolving evidence documenting the need for improved VKA-based anticoagulant therapy. Tecarfarin is the only new molecular entity (NME) that has been developed specifically to address this need. Q4 2023 operating expenses (excluding non-cash items) totaled $1,160,000. Cash used in operating activities totaled $694,000 during Q4 2023. As of December 31, 2023, cash balances were $8.5 million. Recent Reports and Presentations Noble Capital Markets initiated equity research coverage on the Company with an "Outperform" rating and a price target of US$4.00 per share. The full report by Noble Capital Markets Senior Life Sciences Analyst Robert LeBoyer can be obtained from . Douglas Losordo, M.D., Chief Medical Officer of Cadrenal, participated in a fireside chat moderated by Joe Pantginis, Ph.D., Managing Director of Research at H.C. Wainwright & Co., at the Lytham Partners 2024 Investor Select Conference. The webcast can be accessed HERE. Company presented at Biotech Showcase™ 2024, alongside the J.P. Morgan 42nd Annual Healthcare Conference. Participated in the Technology and Heart Failure Therapeutics Conference (THT 2024), which is produced by the Cardiovascular Research Foundation (CRF). Filed updated corporate slide presentation in January 2024 highlighting the opportunity for tecarfarin. Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics, commented, "We believe there is a significant unmet need and market opportunity for tecarfarin in patients with rare cardiovascular conditions requiring chronic anticoagulation. Specifically, there is a lack of approved anticoagulation therapies for patients with left ventricular assist devices (LVADs), patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib), and patients with thrombotic anti-phospholipid syndrome (APS)." "During the past year, an increasing number of industry articles and presentations have concurred with our positioning, which we believe enhances our opportunity from both a regulatory and commercial perspective. We have enhanced our intellectual property protection through the application and receipt of orphan drug designations, which provides for 7 years of market exclusivity, engaged industry leaders to explore strategic partnerships, co-development and licensing agreements for tecarfarin, and have expanded our manufacturing and supply chain capabilities in preparation of an expected pivotal trial. These activities pave the way for what we believe will be an exciting year for Cadrenal." ABOUT CADRENAL THERAPEUTICS, INC. Cadrenal Therapeutics is developing tecarfarin for unmet needs in anticoagulation therapy. Tecarfarin is a late-stage novel oral and reversible anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions. Tecarfarin has orphan drug and fast track designations from the FDA for the prevention of systemic thromboembolism (blood clots) of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib). Cadrenal is also pursuing additional regulatory strategies for unmet needs in anticoagulation therapy for patients with left ventricular assist devices (LVADs) and those with thrombotic antiphospholipid syndrome (APS). Tecarfarin is specifically designed to leverage a different metabolism pathway than the oldest and most commonly prescribed Vitamin K Antagonist (warfarin). Tecarfarin has been evaluated in eleven (11) human clinical trials and more than 1,000 individuals. In Phase 1, Phase 2, and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease. For more information, please visit: . Safe Harbor Statement Any statements contained in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include statements regarding the two new potential rare medical conditions increasing the total addressable market for tecarfarin to in excess of $2 billion in the U.S. annually, exploring strategic partnerships, co-development, and licensing agreements for tecarfarin, there being a significant unmet need and market opportunity for tecarfarin in patients with rare cardiovascular conditions requiring chronic anticoagulation, the increasing number of industry articles and presentations having concurred with the Company's positioning, enhancing the Company's opportunity from both a regulatory and commercial perspective, engaging industry leaders to explore strategic partnerships, co-development and licensing agreements for tecarfarin, 2024 being an exciting year . The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, the ability to enter into strategic partnerships, the ability to treat patients with rare cardiovascular conditions requiring chronic anticoagulation with tecarfarin, the ability to enhance the Company's opportunity from both a regulatory and commercial perspective and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, and the Company's subsequent filings with the SEC, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. For more information, please contact: Cadrenal Therapeutics: Matthew Szot, CFO 858-337-0766 [email protected] Investors: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected] SOURCE Cadrenal Therapeutics, Inc.

Fast TrackExecutive ChangeOrphan DrugAHA

20 Feb 2024

·www.fiercepharma.com

Daiichi Sankyo plots €1B expansion to beef up antibody-drug conjugate production in Germany

An expansion process has already kicked off in Germany, with work on the project expected to wrap up by 2030 “at the latest,” Daiichi Sankyo said last week. After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. Aiming to create an “international innovation center,” Daiichi is plugging roughly 1 billion euros ($1.08 billion) into an expansion of its production and development site in Pfaffenhofen an der Ilm, just north of the company’s European headquarters in Munich. The project—which is expected to create at least 350 new jobs by 2030—will equip the site to develop and manufacture future ADCs targeting malignancies like breast, lung and stomach cancers, Daiichi said in a recent press release. The expansion process has already kicked off, with work on the project expected to wrap up by 2030 “at the latest,” Daiichi said. The new ADC infrastructure being added at Pfaffenhofen is slated for completion by the end of 2026. Once the site’s ADC facilities are up and running, Daiichi figures it will “most likely rise to the top league of biotech companies” in the region. With a legacy spanning more than 60 years, the Pfaffenhofen site contributes “significantly” to Daiichi Sankyo’s global production capacity, the company says on its European website. Traditionally, the site has focused on manufacturing and developing medicines for cardiovascular diseases, including the stroke, thrombosis and pulmonary embolism drug edoxaban and the olmesartan product line for hypertension. Aside from adding ADC capabilities, the expansion has been tipped to boost capacity for the Pfaffenhofen site’s bread-and-butter work in cardiovascular disease. The investment will also strengthen the site’s quality assurance and logistics and help bring more renewable energy online, Daiichi added. The site manufactures both active pharmaceutical ingredients and solid dose forms like tablets and film-coated capsules, which Daiichi ships from Pfaffenhofen to more than 50 countries. “The fact that we will focus more on oncological therapies in Pfaffenhofen in the future is positive in two respects,” Matthias Kühn, Daiichi’s site manager at the facility, said in a statement. “On the one hand, we can make a significant contribution to the increased global demand for ADC cancer therapies. On the other hand, we are demonstrating our future viability and the top quality that we provide here.” The ADC field has been on the rise in recent years, yielding investments and acquisitions across the biopharma industry. While companies like Pfizer and Roche originally beat Daiichi to the regulatory finish line with their own ADCs, Daiichi and its AstraZeneca-partnered treatment Enhertu helped put the modality on the map. Daiichi is slated to keep that winning streak rolling through the rest of the decade, too, analysts at GlobalData predicted last summer. The analysts expect Daiichi’s ADC sales will top $10 billion by 2029, well ahead of the respective $5.8 billion and $3.6 billion GlobalData figures Seagen and Roche will generate with their ADCs in that same span. Looking beyond its pipeline and portfolio, Daiichi charted another ADC manufacturing move last fall when it unveiled an absorption-type merger of two of its subsidiaries—Daiichi Sankyo Propharma and Daiichi Sankyo Chemical Pharma—which is expected to go into effect on April 1, 2025. At the time, Daiichi said the merger was necessary to “stably supply” ADCs and accelerate the development of new modalities.

AcquisitionADC

15 Feb 2024

·www.pmlive.com

MHRA launches second phase of genetic biobank for stroke prevention medicines

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its Yellow Card Biobank will begin investigating a new group of medicines to prevent strokes. First launched in partnership with Genomics England in June 2023, the Yellow Card Biobank will help to improve understandings of how genetic makeup can impact the safety of medicines and to improve personalised medicine approaches. Accumulated genetic data and patient samples will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse drug reactions (ADRs), which involve medicines and medical devices. In total, ADRs account for one in 16 hospital admissions in the UK and continue to be a significant burden on the NHS. In its second phase, the genetic biobank will begin investigating direct oral anticoagulants, such as apixaban, dabigatran, edoxaban and rivaroxaban. A stroke, responsible for more than 100,000 cases in the UK every year, occurs when the blood supply to parts of the brain is cut off. Scientists will use the biobank to investigate whether specific genetic traits can cause side effects from a particular medicine, which will enable healthcare professionals to target prescriptions using rapid screening tests, allowing patients to receive the safest medication for them. The MHRA has urged anyone who has experienced excessive bleeding following the use of direct oral anticoagulants to report it via its Yellow Card scheme. This information will be used to explore whether some people are at a higher risk of excessive bleeding due to their genetic makeup and to reduce the occurrence of serious ADRs. In spring 2024, sequencing of the patients’ genetic material will begin, with initial research findings from the pilot expected in 2025. Dr June Raine, chief executive officer at the MHRA, said: “Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing” and “the Yellow Card Biobank will help us move towards our goal of personalised medicine”. Professor Matt Brown, chief scientific officer at Genomics England, said: “We hope that through the Yellow Card Biobank pilot we will gain a deeper understanding of these genetic influences that, in turn, could help patients to receive the best and safest treatment possible."

100 Deals associated with Edoxaban Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Edoxaban Tosylate	B01AF03	DB09075

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Atrial Fibrillation	EU	Daiichi Sankyo Europe GmbH	19 Jun 2015
Atrial Fibrillation	IS	Daiichi Sankyo Europe GmbH	19 Jun 2015
Atrial Fibrillation	LI	Daiichi Sankyo Europe GmbH	19 Jun 2015
Atrial Fibrillation	NO	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	EU	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	IS	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	LI	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	NO	Daiichi Sankyo Europe GmbH	19 Jun 2015
Systemic embolism	CH	Daiichi Sankyo (Schweiz) AG	31 Mar 2015
Venous Thromboembolism	JP	Daiichi Sankyo Co., Ltd.	26 Sep 2014
Embolism	JP	Daiichi Sankyo Co., Ltd.	22 Apr 2011
Pulmonary Embolism	JP	Daiichi Sankyo Co., Ltd.	22 Apr 2011
Stroke	JP	Daiichi Sankyo Co., Ltd.	22 Apr 2011
Venous Thrombosis	JP	Daiichi Sankyo Co., Ltd.	22 Apr 2011

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	BR	Daiichi Sankyo, Inc.	14 Sep 2021
Acute myocardial infarction	Phase 3	BR	University of Sao Paulo	14 Sep 2021
Coronary Artery Disease	Phase 3	BR	University of Sao Paulo	14 Sep 2021
Coronary Artery Disease	Phase 3	BR	Daiichi Sankyo, Inc.	14 Sep 2021
Short Chain Acyl CoA Dehydrogenase Deficiency	Phase 3	BR	University of Sao Paulo	14 Sep 2021
Short Chain Acyl CoA Dehydrogenase Deficiency	Phase 3	BR	Daiichi Sankyo, Inc.	14 Sep 2021
Heart Diseases	Phase 3	US	Daiichi Sankyo, Inc.	15 May 2018
Heart Diseases	Phase 3	AT	Daiichi Sankyo, Inc.	15 May 2018
Heart Diseases	Phase 3	CA	Daiichi Sankyo, Inc.	15 May 2018
Heart Diseases	Phase 3	HR	Daiichi Sankyo, Inc.	15 May 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02744092 (CANVAS, CTgov)	Not Applicable	Pulmonary Embolism \| Neoplasms \| Venous Thrombosis ... View more	811	Rivaroxaban+Edoxaban+Apixaban+Dabigatran (Randomized Arm 1 (DOACs))	mirgserdul(tecwxijdeo) = gjqptnvxgz zdscxiqyai (htaxmuuxtr, gjdewqyajr - josvynkiub) View more	-	03 Oct 2023
				Warfarin+Fondaparinux+Enoxaparin+Dalteparin (Randomized Arm 2 (LMWH))	mirgserdul(tecwxijdeo) = vfyfxaxgeh zdscxiqyai (htaxmuuxtr, dkzyeoutsw - fuzlxjqqtc) View more
NCT02944019 (ETNA-AF-Europe, ESC2023)	Not Applicable	Atrial Fibrillation	13,980	Edoxaban 60 mg	fozjxlyyzd(zzififgtoy) = rchbrpnzyk qdhfbnthtt (ovblmzteew ) View more	-	28 Aug 2023
COMMAND VTE Registry-2 (ESC2023)	Not Applicable	Venous Thromboembolism	2,004	Edoxaban 60 mg/day	yopmnpvrql(qacdgbbosr) = rtittoclqs bdhdkhopss (faegwxgjor ) View more	-	28 Aug 2023
				Edoxaban 30 mg/day	yopmnpvrql(qacdgbbosr) = gbdfjtoyhk bdhdkhopss (faegwxgjor ) View more
Global ETNA-AF (ESC2023)	Not Applicable	Atrial Fibrillation	-	edoxaban	gvopqcoyoc(rnapdhnelo) = gcurxfmgrb utxcddszju (mjusaprohg )	-	26 Aug 2023
NCT02618577 (NOAH-AFNET 6, Pubmed)	Phase 3	-	2,536	Edoxaban	iutypcnqpk(vtmfsyuqus) = otehapdcgw gdfiuhjlei (reducsubej ) View more	-	25 Aug 2023
				Placebo	iutypcnqpk(vtmfsyuqus) = gylzqioyjb gdfiuhjlei (reducsubej ) View more
ISTH2023	Not Applicable	-	-	Edoxaban	cpithulndn(bwzwucpvkp) = uybekerrvv snjxalhbuo (uuptislwzt ) View more	-	24 Jun 2023
				Edoxaban	cpithulndn(bwzwucpvkp) = gassgwqhxa snjxalhbuo (uuptislwzt ) View more
NCT02798471 (CTgov)	Phase 3	Pulmonary Embolism \| Venous Thrombosis \| Venous Thromboembolism	290	Edoxaban (Edoxaban)	pgekbokfec(iiqgwekjiy) = evzbxsjefz ltxplqroaf (emselynkfu, ubrotngwfk - xafnatffzt) View more	-	06 Mar 2023
				Standard of Care (Standard of Care)	pgekbokfec(iiqgwekjiy) = kwhyiuvjah ltxplqroaf (emselynkfu, okurikzeal - eqhzzbzgbu) View more
NCT02944019 (ETNA-AF-EU, ESC2022) Manual	Not Applicable	Atrial Fibrillation	13,024	Edoxaban Tosylate (Receiving lipid-lowering therapies)	lxyfckmyyc(yeboqlkuvn) = pqekvdhllb ernlcgygku (opelonijsg ) View more	Positive	03 Oct 2022
				Edoxaban Tosylate (Not receiving lipid-lowering therapies)	lxyfckmyyc(yeboqlkuvn) = dikvnlrntb ernlcgygku (opelonijsg ) View more
NCT02801669 (ELDERCARE-AF, Pubmed)	Phase 3	Atrial Fibrillation	984	Edoxaban 15 mg	rqwlfrkvia(rzbqqfvbjt): HR = 7.15 (95% CI, 1.92 - 26.71)	-	03 Sep 2022
				Placebo
ETNA-AF-Europe registry (ESC2022)	Not Applicable	Diabetes Mellitus \| Atrial Fibrillation diabetes mellitus	-	edoxaban	puxnjigvwp(dqhoumanif) = ttxehaltgl otyydopkxo (tftxglkolb ) View more	-	29 Aug 2022
				edoxaban	puxnjigvwp(dqhoumanif) = lraftfqzlp otyydopkxo (tftxglkolb ) View more

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