A Single Dose, Randomized, Open-label, Two-treatment, Three-period, Three-sequence, Partial Replicate Crossover Bioequivalence Study of Generic Edoxaban 60 mg Film-coated Tablets and Reference Product (Lixiana) in Healthy Thai Volunteers under Fasting Conditions

Start Date17 Aug 2026

Sponsor / Collaborator-

NCT07746882

/ Not yet recruitingPhase 3IIT

Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy

To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.

Start Date15 Aug 2026

Sponsor / Collaborator-

100 Clinical Results associated with Edoxaban Tosylate

100 Translational Medicine associated with Edoxaban Tosylate

100 Patents (Medical) associated with Edoxaban Tosylate

2,656

Literatures (Medical) associated with Edoxaban Tosylate

01 Aug 2026·DRUGS & AGING

Impact of Age on Bleeding, Stroke, and Mortality in Edoxaban-Treated Patients with Atrial Fibrillation: Results from the ETAF-TR Registry

Article

Author: Turan, Turhan ; Turk, Ugur Onsel ; Kul, Selim ; Basaran, Ozcan ; Çelik, Oğuzhan

BACKGROUND:

Data on age-specific outcomes in patients with atrial fibrillation (AF) treated with edoxaban in real-world settings are limited; this prespecified analysis of the ETAF-TR study aimed to investigate the influence of age on prespecified clinical outcomes, including overt bleeding, major bleeding, ischemic stroke, all-cause mortality, major adverse cardiovascular events (MACE), and net clinical benefit.

METHODS:

The ETAF-TR study is a prospective, multicenter, observational registry conducted at 50 cardiology clinics across Türkiye. Patients with AF receiving edoxaban (60 mg standard dose or 30 mg reduced dose) were categorized into three age groups: < 65 years (n = 265), 65-74 years (n = 397), and ≥ 75 years (n = 391). Time-to-event outcomes were analyzed using the Kaplan-Meier method and unadjusted Cox proportional hazards models, with the < 65-year age group as the reference.

RESULTS:

Of 1053 enrolled patients, 25.1% were aged < 65 years, 37.7% were aged 65-74 years, and 37.1% were aged ≥ 75 years. Older patients had higher Congestive heart failure, Hypertension, Age ≥75, Diabetes, Stroke, Vascular disease, Age 65-74, Sex category (female) (CHA₂DS₂-VASc) and Hypertension, Abnormal renal/liver function, Stroke, Bleeding history, Labile INR, Elderly, Drugs or Alcohol (HAS-BLED) scores, lower creatinine clearance, and more frequent use of reduced-dose edoxaban. Appropriate edoxaban dosing was documented in 82.2% of patients; 8.0% received an inappropriately low dose and 9.8% an inappropriately high dose. Nonsteroidal antiinflammatory drug (NSAID) use was observed in 8.7%, 5.3%, and 10.2% of patients in the < 65, 65-74, and ≥ 75 groups, respectively, and approximately 12% received concomitant antiplatelet therapy without a documented indication. Major bleeding rates were 0.94, 1.20, and 1.13 per 100 patient-years in the < 65, 65-74, and ≥ 75 groups, respectively. Thromboembolic event rates were 0.38, 0.26, and 1.88 per 100 patient-years, respectively. All-cause mortality increased with age: 2.54, 4.34, and 10.84 per 100 patient-years, respectively; the unadjusted hazard ratio for ≥ 75 versus < 65 years was 4.04 (95% CI 1.69-9.65). Of 56 deaths, 10 (17.9%) were attributed to coronavirus disease 2019 (COVID-19) pneumonia, whereas one death was attributed to ischemic stroke and none to major bleeding. Prespecified descriptive secondary composites, including major adverse cardiovascular events and net clinical benefit, were also higher in the ≥ 75 group.

CONCLUSIONS:

In this real-world cohort of patients with AF treated with edoxaban, major bleeding rates remained consistent across age groups despite an increased comorbidity burden in older patients. Thromboembolic or hemorrhagic events could not account for the excess mortality observed in the ≥ 75 age group; instead, higher comorbidity burdens and the ongoing COVID-19 pandemic may have played contributory roles. Furthermore, beyond issues related to inappropriate dosing and concomitant NSAID or antiplatelet use, significant prescribing concerns persist in clinical practice.

31 Jul 2026·International Heart Journal

Efficacy of 15 mg Edoxaban on Long-Term Outcome after Percutaneous Coronary Intervention in Patients with Atrial Fibrillation and High Bleeding Risk

Article

Author: Nakayama, Takashi ; Sugimura, Koichiro ; Tanimoto, Yoko ; Sugimoto, Kazumasa ; Tanimoto, Kojiro ; Kawamura, Akio ; Fukuoka, Ryoma ; Miyamoto, Toshihiro ; Kiyooka, Takahiko ; Aizawa, Yoshifusa ; Sato, Takao ; Fujimoto, Yoshihide

In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) plus oral anticoagulants increase bleeding risk. Low-dose edoxaban (15 mg) is safe for high-risk older patients with AF; however, its role after PCI compared with the standard 30 mg dose remains unclear. We aimed to compare outcomes of 15 mg and 30 mg edoxaban after PCI.We retrospectively analyzed data from patients with AF undergoing PCI for acute coronary syndrome who received edoxaban 30 mg (n = 99) or 15 mg (n = 49). During admission, DAPT was transitioned to P2Y12 inhibitor monotherapy. Bleeding and thrombotic events were assessed over 2 years, alongside CHADS2, HAS-BLED, and CREDO-Kyoto scores.Compared with 30 mg edoxaban, patients on 15 mg edoxaban were older (86 ± 2 versus 80 ± 6 years, P< 0.01) and had lower hemoglobin levels and body mass index (19.4 ± 3.1 versus 22.7 ± 2.7, P < 0.01) but higher CHADS2 (3.3 ± 0.9 versus 2.8 ± 0.9, P < 0.01), HAS-BLED (3.2 ± 0.9 versus 2.6 ± 0.6, P < 0.01), and CREDO-Kyoto thrombotic and bleeding (5.0 ± 1.1 versus 4.0 ± 1.8, P < 0.01; and 4.1 ± 1.7 versus 2.7 ± 1.2, P < 0.01, respectively) scores. Major bleeding, including clinically relevant non-major bleeding, was more frequent in the 30 mg group (19.7% versus 6.8%, P = 0.08); thrombotic events were comparable (7.4% versus 3.0%, P = 0.35).In weighted Cox analysis, 15 mg edoxaban showed numerically lower hazard ratios for thrombotic (HR: 0.12, 95% CI: 0.01-1.17; P = 0.09) and bleeding (HR: 0.24, 95% CI: 0.06-1.29; P = 0.07) events compared with 30 mg, although these differences did not reach statistical significance.Among older high bleeding-risk patients with AF undergoing PCI, 15 mg edoxaban did not demonstrate superiority over 30 mg with respect to thrombotic or bleeding outcomes.

15 Jul 2026·INTERNAL MEDICINE

Characteristics of Intracranial Hemorrhage in Patients on Factor-Xa Inhibitors: Japan Stroke Data Bank

Article

Author: Yoshimura, Sohei ; Arakaki, Yoshito ; Miyamoto, Yoshihiro ; Torii-Yoshimura, Takako ; Inoue, Masato ; Toyoda, Kazunori ; Morita, Kenichi ; Wada, Shinichi ; Yoshida, Yasuhisa ; Yagita, Yoshiki ; Koga, Masatoshi ; Miyazaki, Junji ; Katayama, Masateru

Objective Since andexanet alfa was approved in May 2022 in Japan, improvement in clinical outcomes of patients with intracranial hemorrhage while on factor Xa inhibitors (FXaIs) is expected. To assess real-world outcomes before approval, this study investigated the clinical outcomes in Japan prior to 2022. Methods Patients who developed intracerebral hemorrhage (ICH) or non-traumatic subarachnoid hemorrhage (SAH) and were admitted within 24 h of their last known well time or onset of symptoms between January 2016 and December 2021 were included. Data were obtained from the Japan Stroke Data Bank, a nationwide multicenter prospective registry. The outcomes were in-hospital mortality and favorable outcomes (modified Rankin Scale score of 0-2 at discharge). Results A total of 859 patients (rivaroxaban, n=227; apixaban, n=355; edoxaban, n=277) with ICH (ICH: n=822, age 79±9 years, 38.6% female; SAH: n=37, age 79±10, 75.7% female) were investigated. On admission, the median National Institutes of Health Stroke Scale (NIHSS) score in ICH patients was 13 [interquartile range (IQR): 6-24], and the median Glasgow Coma Scale score in patients with SAH was 11 (IQR: 6-14). During the in-hospital period [20 (IQR: 11-37) days], 167 patients with ICH (20.3%) and 14 patients with SAH (37.8%) died in hospital; 135 patients with ICH (16.4%) and 5 patients with SAH (13.5%) achieved a favorable outcome. Conclusion This study presents the clinical outcomes prior to the approval of andexanet alfa. Further studies are needed to evaluate post-approval outcome changes.

News (Medical) associated with Edoxaban Tosylate

31 Jul 2026

·www.biospace.com

Daiichi Sankyo Reports First Quarter Fiscal Year 2026 Financial Results

Revenue increased 21.1% to 574.7 billion yen year-over-year driven by Enhertu ® and Datroway ® Fiscal year 2026 guidance for revenue and operating profit revised upward Conference call to take place on Friday, July 31 at 5:30 pm Japan Standard Time TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) reported financial results for the first quarter of fiscal year 2026, ending June 30, 2026. “Daiichi Sankyo delivered strong revenue growth in the first quarter of fiscal year 2026 as we began execution of our new Five-Year Business Plan,” said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. “Three new U.S. approvals for Enhertu and Datroway were received in a single week in May, underscoring the continued strength of our portfolio where we anticipate delivering more than 20 new indications across five medicines by 2030. These results reinforce the durability of our growth trajectory and support our outlook for fiscal 2026 and beyond.” Q1 FY2026 Results Global revenue increased 21.1% year-over-year to 574.7 billion yen, driven by the company’s global oncology products. Operating profit decreased 12.0% year-over-year to 85.1 billion yen, primarily due to EU Specialty Business restructuring expenses. Global revenue from oncology products was driven by Enhertu ® and Datroway ® , the company's flagship antibody drug conjugates (ADCs). Enhertu revenue, including milestone payments, was 239.8 billion yen, a 48.9% increase. Datroway revenue, including milestone payments, was 23.9 billion yen, a 176.4% increase. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Revenue from the Japan Business was 120.0 billion yen, driven by Lixiana ® and Tarlige ® . ASCA (Asia, South and Central America) Business revenue was 68.7 billion yen, driven by Enhertu. EU Specialty Business revenue was 74.7 billion yen, driven by Lixiana and Nilemdo ® /Nustendi ® . Full fiscal year 2026 guidance has been revised upward from the forecast issued in May 2026. Global revenue is anticipated to increase from 2.28 to 2.34 trillion yen, driven by stronger sales anticipated in the U.S. and favorable foreign exchange rates. Operating profit is anticipated to increase from 315.0 to 320.0 billion yen. Further details on financial performance can be found in the Financial Results Presentation Material . Daiichi Sankyo will host an investor and media conference call and webcast to discuss Q1 FY2026 results on Friday, July 31 at 5:30 pm Japan Standard Time. Q4 FY2025 Results Revision Operating profit has increased from 229.1 billion yen to 258.0 billion yen. Following the announcement of the Q4 FY2025 financial results on May 11, 2026, the Company identified an error in the aggregation process for selling, general and administrative (SG&A) expenses. As a result of the decrease in SG&A expenses, operating profit has been revised upward. Portfolio and Pipeline Highlights Daiichi Sankyo continued to advance its portfolio and pipeline with several milestones across its oncology portfolio, demonstrating momentum towards its goal of launching 20 new indications across five medicines by 2030. Three new breast cancer indications were approved within one week in the U.S. for Enhertu and Datroway in May 2026, including simultaneous approval of two new indications for Enhertu in the neoadjuvant and adjuvant HER2 positive early breast cancer setting based on the DESTINY-Breast11 and DESTINY-Breast05 phase 3 trials, followed by one new indication for Datroway in the first-line metastatic triple negative breast cancer (TNBC) setting for patients not candidates for immunotherapy based on the TROPION-Breast02 phase 3 trial. Datroway received approval in the EU for the same TNBC indication and Enhertu received a positive CHMP opinion for the first-line treatment of HER2 positive metastatic breast cancer based on the DESTINY-Breast09 phase 3 trial in July 2026. A Biologics License Application (BLA) was accepted and granted priority review in the U.S. in April 2026 for ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy, with a Prescription Drug User Fee Act (PDUFA) date of October 10, 2026. Additional regulatory approvals were received in June 2026 for medicines in other major countries/regions. Enhertu received approval in the EU for a HER2 positive metastatic tumor agnostic indication and Vanflyta ® was approved in China in the newly diagnosed setting of FLT3 -ITD positive acute myeloid leukemia (AML). Data from more than 25 abstracts across multiple cancers were presented at the 2026 American Society of Clinical Oncology (#ASCO26) in June 2026. Medicine Indication Q1 FY2026 Update Enhertu Breast Enhertu Approved in the U.S. for Two New Indications for Patients with HER2 Positive Early Breast Cancer ( May 2026 ) Enhertu Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer ( July 2026 ) Tumor Agnostic Enhertu Approved in the EU as First Tumor Agnostic HER2 Directed Therapy and Antibody Drug Conjugate for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors ( June 2026 ) Datroway Breast Datroway Approved in the U.S. as First TROP2 Directed Antibody Drug Conjugate for First-Line Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not PD-1/PD-L1 Inhibitor Candidates ( May 2026 ) Datroway Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy ( July 2026 ) I-DXd Lung Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy ( April 2026 ) Vanflyta AML Vanflyta Approved in China as First and Only FLT3 Inhibitor for Patients with Newly Diagnosed FLT3 -ITD Positive AML ( June 2026 ) Pipeline Various Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO ( May 2026 ) Corporate Highlights Daiichi Sankyo announced its next Five-Year Business Plan (FY2026 - FY2030) in May 2026 outlining how the company plans to deliver more than 2.3 trillion yen in oncology revenue by 2030 and be a global top five oncology company by 2035 as part of its larger 2035 Vision to be recognized as a “trusted healthcare innovator transforming the lives of people through our science and technology.” As part of the company’s continued transformation into a global oncology company, Daiichi Sankyo announced in April 2026 that it will transfer in stages all of its shares of Daiichi Sankyo Healthcare Co., Ltd, its over-the-counter drug business in Japan, to Suntory Holdings Limited. The deal is estimated to be completed by June 2029. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements, including words such as “anticipate,” “estimated,” “favorable,” “goal,” “momentum,” “outlook,” “trajectory,” were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from the outlook of Daiichi Sankyo or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward. Some of the compounds under discussion are investigational agents and are not approved by the FDA or any other regulatory agency worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There are no guarantees that these compounds will become commercially available in indications under investigation. Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material but shall not be obliged to guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, any information regarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this material has been compiled or cited using publicly available information or other information, and Daiichi Sankyo has not performed in-house inspection of the accuracy, appropriateness, completeness and feasibility, etc. of such information, and does not guarantee the accuracy thereof. The information described in this material may be changed hereafter without notice. Accordingly, this material or the information described herein should be used at your own judgment, together with any other information you may otherwise obtain. This material does not constitute a solicitation of application to acquire or an offer to sell any security in the United States, Japan or elsewhere. This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretion. Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com Japan: DS-PR_jp@daiichisankyo.com

Drug ApprovalImmunotherapyPhase 3ASCOFinancial Statement

08 Jul 2026

·www.fiercepharma.com

Foreign drugmaker caught faking doctors’ petition to evade China’s price cut scheme

Amid an ongoing expansion of China’s volume-based procurement (VBP) scheme to lower drug costs, the Chinese government has singled out a fraud case involving a foreign originator drug in a warning to the industry. In an attempt to influence whether a drug gets selected for price bidding, a foreign drug innovator faked doctors’ signatures in a petition, China’s National Healthcare Security Administration (NHSA) said in a post (Chinese) on Tuesday. Among the 78 signatures from 31 hospitals, over 80% were found to be doctored. Some signatures were forged by sales representatives, some used misappropriated images from other sources, and some pointed to individuals that do not exist, according to the agency. As for the few signatures that the experts themselves indeed wrote, the doctors were mostly tricked into signing the document under the guise of survey questionnaires or post-sales follow-up, the agency said. The drug has since been included in the latest VBP batch of 65 drug varieties, which together represent a total market value of nearly 60 billion Chinese yuan ($8.8 billion), according to the NHSA. The VBP, now in its 12th round, is a government-led drug-buying program targeting off-patent medicines. Under the program, generics and the originators offer price cuts to secure procurement contracts with hospitals. The government unveiled the latest list on June 23 and is now in the bidding process. In a statement to local news outlet The Paper , Novartis confirmed it was not the unnamed drugmaker flagged in the NHSA alert. The Swiss pharma’s blockbuster heart failure treatment Entresto (sacubitril/valsartan) is one of the biggest products in this VBP round. According to local reports, Entresto and its generics generated more than 6 billion yuan of end-market sales ($880 million) at public hospitals in China last year, with the Novartis originator accounting for more than 90%. The VBP program now threatens to split up that huge market by rewarding significant shares to companies that offer lower prices. In what’s slated to be an über-competitive bidding process, more than 30 Entresto generics competitors are vying for a place under VBP, according to local drug intelligence database DXY Insight. As part of the largest patent expiry in Novartis’ history, Entresto lost its U.S. market exclusivity last year and has seen major sales declines since. Some uncertainties remain for VBP’s potential impact on Entresto. The Novartis drug is among eight products that carry an asterisk, which indicates ongoing patent disputes. A few days before the revelation of the latest VBP list last month, China’s National Intellectual Property Administration doled out a five-year patent-term extension to Entresto to make up for time lost during its drug regulatory review process, effectively pushing back the expiration of its core patent to November 2031. In a new rule introduced into VBP this time, generic rivals to those asterisked drugs must submit a declaration of non-infringement or be removed from procurement platforms. Takeda’s angiotensin II receptor blocker Edarbi (azilsartan medoxomil) and acid blocker Takecab (vonoprazan fumarate), Eli Lilly’s JAK inhibitor Olumiant, Daiichi Sankyo’s factor Xa inhibitor edoxaban and AstraZeneca’s Xigduo XR (dapagliflozin and metformin extended release) are also included in VBP despite ongoing patent disagreements. Takeda, Bayer and Eisai have also denied they were the company in the NHSA’s announcement, according to The Paper. Bayer’s drospirenone/ethinyl estradiol oral contraceptive, known commercially as Yaz or Yasmin, and its imaging contrast agent Ultravist (iopromide) are included for VBP bidding against generics. Eisai has anti-vertigo medication Merislon (betahistine) and anti-seizure med Fycompa (perampanel) on the list. In addition to the companies above, the 65-item roster includes brand-name products from almost all major pharmas, including Astellas, Fresenius Kabi, GSK, Johnson & Johnson, Pfizer, Merck & Co., Merck KGaA, Otsuka, Sanofi and Servier. Among the smaller firms involved are Cheplapharm, Dr. Falk Pharma and Grünenthal from Germany; Japan’s Maruishi Pharmaceutical, Sumitomo Pharma, LTL Pharma and Minophagen Pharmaceutical; as well as the Wellcome Foundation and Tillotts Pharma in Switzerland.

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

100 Deals associated with Edoxaban Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D09710	Edoxaban Tosylate	B01AF03	DB09075

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Thromboembolism	Canada	Daiichi Sankyo, Inc.	04 Nov 2016
Atrial Fibrillation	European Union	Daiichi Sankyo Europe GmbH	19 Jun 2015
Atrial Fibrillation	Iceland	Daiichi Sankyo Europe GmbH	19 Jun 2015
Atrial Fibrillation	Liechtenstein	Daiichi Sankyo Europe GmbH	19 Jun 2015
Atrial Fibrillation	Norway	Daiichi Sankyo Europe GmbH	19 Jun 2015
Atrial Fibrillation	United Kingdom	Daiichi Sankyo UK Ltd.	19 Jun 2015
Recurrent deep vein thrombosis	European Union	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	Iceland	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	Liechtenstein	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	Norway	Daiichi Sankyo Europe GmbH	19 Jun 2015
Recurrent deep vein thrombosis	United Kingdom	Daiichi Sankyo UK Ltd.	19 Jun 2015
Systemic embolism	Switzerland	Daiichi Sankyo (Schweiz) AG	31 Mar 2015
Embolism	United States	Daiichi Sankyo, Inc.	08 Jan 2015
Stroke	United States	Daiichi Sankyo, Inc.	08 Jan 2015
Venous Thromboembolism	Japan	Daiichi Sankyo Co., Ltd.	26 Sep 2014
Pulmonary Embolism	Japan	Daiichi Sankyo Co., Ltd.	22 Apr 2011
Venous Thrombosis	Japan	Daiichi Sankyo Co., Ltd.	22 Apr 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	Brazil	Daiichi Sankyo Co., Ltd.	14 Sep 2021
Coronary Artery Disease	Phase 3	Brazil	Daiichi Sankyo Co., Ltd.	14 Sep 2021
Short Chain Acyl CoA Dehydrogenase Deficiency	Phase 3	Brazil	Daiichi Sankyo Co., Ltd.	14 Sep 2021
Chronic thromboembolic pulmonary hypertension	Phase 3	Japan	Daiichi Sankyo Co., Ltd.	23 Mar 2021
COVID-19	Phase 3	Belgium	Daiichi Sankyo Europe GmbH	21 Jan 2021
COVID-19	Phase 3	Italy	Daiichi Sankyo Europe GmbH	21 Jan 2021
COVID-19	Phase 3	Switzerland	Daiichi Sankyo Europe GmbH	21 Jan 2021
Aortic Valve Stenosis	Phase 3	Netherlands	Daiichi Sankyo Co., Ltd.	01 Aug 2019
Heart Diseases	Phase 3	United States	Daiichi Sankyo Co., Ltd.	15 May 2018
Heart Diseases	Phase 3	Austria	Daiichi Sankyo Co., Ltd.	15 May 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05869591 (EASL2026)	Phase 2	Liver Cirrhosis	42	Edoxaban 60 mg OD	vtsirarteh(leszzpfiml) = the reduction in DD was −32% with edoxaban (p = 0.08) and −22% with apixaban (p < 0.05). Patients with thrombocytopenia exhibited less DD reduction compared to those with platelets ≥150 G/L (−6% versus −37%; p < 0.05). elwkgunsij (asreobyklj )	Positive	27 May 2026
				Apixaban 5 mg BID
NCT03718559 (EPIC-CAD, Pubmed \| JACC Asia)	Phase 4	Coronary Artery Disease \| Atrial Fibrillation	1,040	Edoxaban monotherapy	szxdsavswv(nyxfxctaqe): HR = 0.36 (95.0% CI, 0.23 - 0.57), P-Value = < 0.001	Negative	01 May 2026
				Edoxaban plus a single antiplatelet agent
NCT03718559 (EPIC-CAD, Pubmed \| EuroIntervention)	Phase 4	Coronary Artery Disease \| Atrial Fibrillation	1,040	Edoxaban monotherapy (Low creatinine clearance)	icglbekbch(fwzgfojgfm) = lnswviivhc hgsadpmmld (moomdvouky )	Positive	01 Apr 2026
				Edoxaban plus a single antiplatelet agent (Low creatinine clearance)	icglbekbch(fwzgfojgfm) = cucngkaaus hgsadpmmld (moomdvouky )
NCT05732506 (EDO-FRAG-001, Pubmed \| Thromb Res)	Not Applicable	Atrial Fibrillation	411	Edoxaban	ffrenvstzj(dnfgciwqzc) = krpncsrign thzwxraimg (oazwlzagfm, 0.5 - 3.5) View more	Positive	01 Mar 2026
NCT00986154 \| NCT00781391 (Hokusai-VTE, Pubmed \| Thromb Res)	Phase 3	Pulmonary Embolism \| Atrial Fibrillation \| Venous Thrombosis	23,618	Warfarin	hxcasnycmc(pzvklfyhlt): reduction = -2.3 (95.0% CI, -2.9 to -1.7) View more	Positive	01 Oct 2025
				Edoxaban
ISTH2025	Phase 3	Venous Thromboembolism	286	Edoxaban	zlqjdoacob(odhsvgzpyd) = qsjdvssanh ztcifaoxqr (ohkcmrxlcd ) View more	Non-inferior	21 Jun 2025
				Standard of care (SOC) anticoagulation	zlqjdoacob(odhsvgzpyd) = bupwsbzxoj ztcifaoxqr (ohkcmrxlcd ) View more
ISTH2025	Not Applicable	Thrombophilia \| Venous Thromboembolism	67	Rivaroxaban	xivkhrivck(faqzhtvafd) = dokjdbohvi sxjnupvyju (pznkephqri )	Positive	21 Jun 2025
ISTH2025	Not Applicable	Neoplasms \| Atrial Fibrillation \| Venous Thromboembolism	5,252	Edoxaban (Non-cancer patients)	hintakjjfz(gebwtbvznl) = gcwxxoevfx qshfamfprp (yiopqigdrr )	Positive	21 Jun 2025
ISTH2025	Not Applicable	Atrial Fibrillation	138	Apixaban 10 mg/day	lhulutlzgr(usniclttle) = kfqsoytwye ilwrouvxxy (vxsmdpzapv ) View more	Positive	21 Jun 2025
				Rivaroxaban 15 mg/day	lhulutlzgr(usniclttle) = voomqaiccv ilwrouvxxy (vxsmdpzapv ) View more
NCT02951039 \| NCT02944019 \| NCT03247582 \| NCT03247569 (Global ETNA-AF Program, Pubmed \| Clin Cardiol)	Not Applicable	Atrial Fibrillation	-	Edoxaban	mxithlsove(solxrhteeb) = lkuuykzglg ixzemifitg (sfpozgzxur ) View more	Positive	01 Mar 2025

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