The subjects will be admitted to the Phase I Clinical Research Center on day -1. Subjects received once-daily doses of Tecarfarin for up to 14 days.Subjects can leave the Phase I Clinical Research Center on the day 21.And returned to the research center for follow-up on the day 28 and 35.

Start Date19 Apr 2020

Sponsor / Collaborator

Lee's Pharmaceutical Holdings Ltd.

NCT03652779 / CompletedPhase 1

An Open-label, Phase 1, Sequential Cohort, Single-Dose Escalation Study to Assess the Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers

The purpose of the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated.

Start Date22 Jun 2018

Sponsor / Collaborator

Lee's Pharmaceutical Holdings Ltd.

NCT02522221 / Unknown statusPhase 3

A "Real-World", Randomized, Open-Label, Study on the Efficacy, Safety, and Tolerability of Tecarfarin (ATI-5923) a Novel Vitamin K Antagonist, Versus Warfarin in Subjects Requiring Chronic Anticoagulation

TACT is a "real world" randomized controlled trial of tecarfarin, a novel vitamin K antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two groups of subjects who require chronic oral anticoagulation for a broad panel of indications.

Start Date01 Jun 2018

Sponsor / Collaborator

Espero Pharmaceuticals, Inc.

100 Clinical Results associated with Tecarfarin

100 Translational Medicine associated with Tecarfarin

100 Patents (Medical) associated with Tecarfarin

Literatures (Medical) associated with Tecarfarin

01 Jan 2023·American Journal of Cardiovascular Drugs

Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial

Article

Author: Chen, Zhidong ; Wang, Zhiqiang ; Hu, Wei ; Zhang, Yong ; Zhou, Qiang ; Dai, Xiangrong ; Yu, Xiaohui ; Zhou, Renpeng ; Wang, Heming ; Li, Xiaoyi

BACKGROUNDTecarfarin (ATI-5923), a structural analog of warfarin, was designed to provide more uniform and stable anticoagulation.OBJECTIVEWe aimed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of tecarfarin when administered in multiple ascending doses (MADs) to healthy Chinese volunteers.METHODSForty healthy Chinese volunteers were enrolled into four sequential cohorts (10, 20, 30, and 40 mg), with 10 subjects in each cohort. Participants in the MAD study for each sequential cohort were dose-titrated to achieve the target international normalized ratio (INR 1.7-2.0) for 14 days. Safety and tolerability were assessed throughout the study.RESULTSThe pharmacokinetic and pharmacodynamic profile of tecarfarin was investigated in a healthy Chinese population. Dose titration of tecarfarin was necessary to keep the INR in the target range in all subjects in the 20, 30 and 40 mg cohorts and a few subjects (n = 3) in the 10 mg cohort. Tecarfarin was well tolerated without serious adverse events. Only one treatment-related adverse event (hematochezia) resulted in early withdrawal from the MAD 40 mg cohort.CONCLUSIONTecarfarin was well-tolerated by Chinese volunteers. Dose titration was needed for tecarfarin doses larger than 20 mg to keep the INR in the target range.REGISTRATIONClinicalTrials.gov identifier: NCT04627116.

01 Jan 2017·Thrombosis and HaemostasisQ2 · MEDICINE

Pharmacokinetics and pharmacodynamics of tecarfarin, a novel vitamin K antagonist oral anticoagulant

Q2 · MEDICINE

Article

Author: Druzgala, Pascal ; Combs, Daniel ; Ellis, David ; Milner, Peter G ; Midei, Mark G ; Albrecht, Detlef ; Canafax, Daniel M

SummaryTecarfarin is a vitamin K antagonist (VKA) with reduced propensity for drug interactions. To evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety of tecarfarin, we performed single ascending dose (SAD) (n=66), multiple ascending dose (MAD) (n=43), and tecarfarin versus warfarin (n=28) studies in human volunteers. In the SAD, tecarfarin was administered to 5 of 6 subjects (1 received placebo) in each of 11 cohorts. AUC0-∞ exhibited linearity and dose proportionality. Elimination T1/2 ranged from 87–136 hours (h) across all doses. In the MAD, tecarfarin was administered to 5 of 6 volunteers in each of 7 cohorts. The starting dose was continued until the subject’s INR reached the target range (TR) of 1.7 to 2.0. Dosing was down-titrated if the TR was achieved. Elimination T1/2 ranged from 107–140 h. Doses <10 mg had insignificant effect on INR. Higher doses raised INRs and required down-titration to maintain the TR. Steady state INR dosing was 10–20 mg. INR declined promptly after discontinuation. In the comparative study, subjects received tecarfarin or warfarin and dose titrated to a TR of 1.5–2.0. Mean dose after TR was achieved was 13.9 mg (range 10.0–25.5 mg) for tecarfarin and 5.3 mg (range 2.5–9.0 mg) for warfarin. At similar INR levels, the concentration of coagulation factors II, VII, IX, and X were similar for tecarfarin and warfarin. Tecarfarin was tolerated well without serious adverse events in all three studies.Supplementary Material to this article is available online at www.thrombosis-online.com.

01 Jan 2017·Thrombosis and HaemostasisQ2 · MEDICINE

Pharmacokinetics of Tecarfarin and Warfarin in Patients with Severe Chronic Kidney Disease

Q2 · MEDICINE

Article

Author: Marbury, Thomas ; Midei, Mark G ; Albrecht, Detlef ; Smith, William ; Turakhia, Mintu P ; Dillon, Debbie ; Ries, Daniel ; Milner, Peter G

AbstractChronic kidney disease (CKD) complicates warfarin anticoagulation partially through its effect on CYP2C9 activity. Tecarfarin, a novel vitamin K antagonist, is not metabolized by CYP2C9. To evaluate the effect of CKD on their metabolism, we measured PK parameters of warfarin and tecarfarin in subjects with and without CKD. CKD subjects with estimated glomerular filtration rate < 30 mL/min not on dialysis (n = 13) were matched to healthy volunteers (HVs) (n = 10). Each subject was randomized to either warfarin 10 mg or tecarfarin 30 mg and was later crossed over to the other drug. PK parameters were measured following each drug. Mean plasma concentrations of (S)-warfarin and (R,S)-warfarin were higher (44 and 27%, respectively) in the subjects with CKD than in the healthy subjects. Both of these values fell outside of the 90% confidence interval of equivalence. For tecarfarin, the difference was less than 15% higher. Elimination half-life (t 1/2) increased by 20% for (S)-warfarin and by 8% for (R,S)-warfarin and decreased by 8% for tecarfarin. The mean plasma concentration for tecarfarin's inactive metabolite ATI-5900 increased by approximately eightfold. CKD increased the effect of CYP2C9 genetic variation on (S)-warfarin and (R,S)-warfarin metabolism. Tecarfarin exposure was similar between the HVs and the CKD subjects regardless of CYP2C9 genotype. There were neither serious adverse events (SAEs) nor treatment-emergent adverse events (TEAEs) for any subject in the study. CKD inhibits metabolism of (S)-warfarin and (R,S)-warfarin, but not tecarfarin. The safety of repeated dosing of tecarfarin in CKD patients remains unknown. However, if the PK findings of this single-dose study are present with repeated dosing, tecarfarin may lead to dosing that is more predictable than warfarin in CKD patients who require anticoagulation therapy.

News (Medical) associated with Tecarfarin

24 Oct 2024

·www.prnewswire.com

Cadrenal Therapeutics Raises $5.1 Million via At-The-Market Facility

PONTE VEDRA, Fla., Oct. 24, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD) (the "Company" or "Cadrenal"), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions, today announced that is has raised gross proceeds of approximately $5.1 million through its at-the-market (ATM) facility, selling an aggregate of 391,243 shares of common stock at a weighted average price of $13.15 per share. Following the completion of the sales under the ATM facility, as of October 23, 2024, Cadrenal has 1,496,771 shares of common stock outstanding and a cash balance of approximately $7.4 million. "We are pleased to strengthen our balance sheet by efficiently using the ATM facility. The net proceeds provide us with added working capital as we continue developing tecarfarin, prepare for our pivotal Phase 3 trial, and progress our partnering activities," commented Quang X. Pham, Chief Executive Officer of Cadrenal. The shares in the ATM facility were sold pursuant to a shelf registration statement declared effective by the U.S. Securities and Exchange Commission (SEC) on March 20, 2024. H.C. Wainwright & Co. acted as the exclusive sales agent for the ATM facility. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. ABOUT CADRENAL THERAPEUTICS, INC. Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin, the most commonly used anticoagulant for these patients despite its prevalent side effects, drug-to-drug interactions and frequent dosing changes. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is planning pivotal clinical trials and pursuing clinical and commercial partnerships. The Company's plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. 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 continuing developing tecarfarin, preparing for the Company's pivotal trial and progress partnering activities, the Company's pursuit of clinical and commercial partnerships and the Company's study of tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. 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, including the Company's ability to continue developing tecarfarin, preparing for the Company's pivotal trial, the Company's pursuit of clinical and commercial partnerships and the Company's study of tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties, 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugFast Track

23 Oct 2024

·www.prnewswire.com

CADRENAL THERAPEUTICS JOINS CORPORATE COUNCIL OF ANTICOAGULATION FORUM

Participation Reinforces Cadrenal's Commitment to Innovation, Education and Improved Patient Outcomes with Anticoagulation Therapy PONTE VEDRA, Fla., Oct. 23, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to improve anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions, today announced its membership in the Corporate Council of the Anticoagulation Forum (AC Forum). The AC Forum is the largest professional organization of anticoagulation specialists, committed to advancing the quality and safety of chronic anticoagulation care globally. Through participation in the Corporate Council, Cadrenal Therapeutics will collaborate with the AC Forum as it works to identify and address unmet clinical needs, share cutting-edge research, and promote advocacy and educational initiatives for the organization's 15,000 healthcare professional members aimed at improving outcomes for patients on anticoagulants. "Our membership in the AC Forum's Corporate Council reflects our shared commitment to transforming anticoagulation care," said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. "We look forward to partnering with the AC Forum and contributing to programs that advance safer, more effective care and inform about ongoing research and anticoagulation best practice guidelines." Darren Triller, PharmD, Director of Strategic Initiatives at the Anticoagulation Forum, welcomed Cadrenal Therapeutics to the Corporate Council, saying: "We are excited to have Cadrenal Therapeutics join us in our mission to improve the quality of care for patients receiving antithrombotic therapies. We look forward to a productive partnership that will help us address the challenges in the anticoagulation landscape together." About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin, the most commonly used anticoagulant for these patients despite its prevalent side effects, drug-to-drug interactions and frequent dosing changes. Tecarfarin received an orphan drug designation for advanced heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is planning pivotal clinical trials and pursuing clinical and commercial partnerships. The company's plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit to learn more. About the Anticoagulation Forum The Anticoagulation Forum has led advancements in thrombosis-related care for over three decades. With more than 15,000 members across 3,000 healthcare institutions, the AC Forum is dedicated to enhancing the safety and quality of care for over 1 million patients annually. Through education, thought leadership, and partnerships with industry leaders, the AC Forum shapes the future of anticoagulation management to ensure the best outcomes for patients. 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugFast Track

23 Sep 2024

·www.prnewswire.com

Cadrenal Therapeutics to Participate in Lytham Partners Fall 2024 Investor Conference

PONTE VEDRA, Fla., Sept. 23, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc., (Nasdaq: CVKD), a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to be a superior and safer chronic anticoagulant for warfarin-dependent patients with implanted cardiac devices or rare cardiovascular conditions, announced today it will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Fall 2024 Investor Conference, taking place virtually on Tuesday, October 1, 2024. Company Webcast Cadrenal's webcast presentation will begin at 2:00 pm ET on Tuesday, October 1. Access will be available via the conference home page at or directly at . The webcast will also be available for replay following the event. One-on-one Meetings Cadrenal management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting, please contact Lytham Partners at [email protected] or register for the event at . ABOUT CADRENAL THERAPEUTICS, INC. Cadrenal Therapeutics is a late-stage biopharmaceutical company boldly challenging the status quo by innovating a new anticoagulant to elevate care for underserved patients. The company is developing the vitamin K antagonist (VKA) tecarfarin, designed to be a superior and safer anticoagulant for individuals with implanted cardiac devices or rare cardiovascular conditions. Cadrenal strives to improve outcomes and reduce major events for these patients, who lack chronic anticoagulation options besides warfarin, well-known for its prevalent side effects and cumbersome dosing. With its innovation, the company aims to unburden these patients and their healthcare providers from warfarin's many challenges. Cadrenal's late-stage drug candidate tecarfarin is a new VKA anticoagulant that is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin. Tecarfarin received an orphan drug designation for heart failure patients with implanted left ventricular assist devices (LVADs) as well as both orphan drug and fast-track status for end-stage kidney disease patients with atrial fibrillation. Cadrenal is opportunistically pursuing pivotal trials along with clinical and commercial partnership opportunities. The company's plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties. Visit . 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan Drug

100 Deals associated with Tecarfarin

External Link

KEGG	Wiki	ATC	Drug Bank
D09676	Tecarfarin	-	DB12823

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Antiphospholipid Syndrome	Phase 1	US	Cadrenal Therapeutics, Inc.	-
Thromboembolism	Discovery	-	Espero Pharmaceuticals, Inc.	01 Jun 2018
Thrombosis	Discovery	-	Espero Pharmaceuticals, Inc.	01 Jun 2018
Atrial Fibrillation	Discovery	US	ARYx Therapeutics, Inc.	01 May 2008
Atrial Flutter	Discovery	US	ARYx Therapeutics, Inc.	01 May 2008
Cardiomyopathies	Discovery	US	ARYx Therapeutics, Inc.	01 May 2008
Myocardial Infarction	Discovery	US	ARYx Therapeutics, Inc.	01 May 2008
Venous Thromboembolism	Discovery	US	ARYx Therapeutics, Inc.	01 May 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESC2016	Not Applicable	-	-	Tecarfarin	bqenaozkud(cjdjrvgwyt) = tvtbonbjnp hspgapknbl (ahauctbhgm )	-	29 Aug 2016
NCT00691470 (EmbraceAC, Pubmed \| Thromb Haemost) Manual	Phase 2/3	Thrombosis	607	tecarfarin	(dysjkhclxn) = tkzpwzijzb aptjtqhltm (volelyrvvw ) View more	Positive	01 Aug 2016
NCT00691470 (EmbraceAC, Pubmed \| Thromb Haemost) Manual	Phase 2/3	Thrombosis	607	warfarin	(dysjkhclxn) = wvvsdumujm aptjtqhltm (volelyrvvw ) View more	Positive	01 Aug 2016
NCT00431782 (Pubmed \| J Am Coll Cardiol)	Phase 2	Atrial Fibrillation	66	Tecarfarin	vscawpgngn(xzuwgvqcmi) = icjgaibacq dgudewgksp (wltydubojb ) View more	-	22 Sep 2009

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis