Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.
Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).
Study design: Open-label, single-centre, randomized controlled trial pilot.
Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.
Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.
Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.

Start Date01 Sep 2025

Sponsor / Collaborator-

NCT06821191

/ Not yet recruitingPhase 4IIT

Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study - The Switching Antiplatelet-8 (SWAP-8) Study

Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.

Start Date17 Feb 2025

Sponsor / Collaborator

University of Florida

NCT06691191

/ RecruitingPhase 4IIT

Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors: Pharmadodynamic Comparison Between Prasugrel and Ticagrelor Monotherapy. The Switching Antiplatelet -7 (SWAP-7) Study

Ticagrelor currently represents the most tested and commonly used P2Y12 inhibitor monotherapy following percutaneous coronary intervention. The purpose of this study is to conduct a head-to-head comparison on the pharmacodynamic efficacy of ticagrelor-based and prasugrel-based single antiplatelet therapy. To determine if the PD profiles of ticagrelor- and prasugrel-based SAPT are comparable, we aim to conduct a non-inferiority study between the two strategies.

Start Date08 Jan 2025

Sponsor / Collaborator

University of Florida

100 Clinical Results associated with Prasugrel Hydrochloride

100 Translational Medicine associated with Prasugrel Hydrochloride

100 Patents (Medical) associated with Prasugrel Hydrochloride

3,569

Literatures (Medical) associated with Prasugrel Hydrochloride

01 Jul 2025·AMERICAN HEART JOURNAL

Genotype-guided de-escalation and abbreviation of dual antiplatelet therapy in patients with myocardial infarction and high bleeding risk: Design and rationale of the investigator-initiated, multicenter, randomized, controlled trial, DAN-DAPT

Article

Author: Mæng, Michael ; Sørensen, Rikke ; Veien, Karsten ; Grove, Erik Lerkevang ; Freeman, Philip ; Charlot, Mette Gitz ; Hougaard, Mikkel ; Jacobsen, Mia Ravn ; Jabbari, Reza ; Kelbæk, Henning ; Engstrøm, Thomas

RATIONALE:

Approximately one-third of patients with myocardial infarction (MI) treated with percutaneous coronary intervention (PCI) are at high risk of bleeding side-effects when on dual antiplatelet therapy (DAPT). High bleeding risk is often accompanied by high ischemic risk, thus challenging the choice of P2Y₁₂ inhibitor and duration of DAPT. The optimal DAPT strategy for these patients remains debated, and it is unknown whether genotype-guided DAPT de-escalation to clopidogrel and aspirin, with or without abbreviation of DAPT to 3 months, is noninferior in terms of net adverse clinical events (NACE) and superior in reducing bleeding side-effects compared with standard DAPT for 6 months.

DESIGN:

The DAN-DAPT trial is an investigator-initiated, open-label, multicenter, multiarm, randomized controlled trial conducted at all Danish hospitals performing PCI. From 2022 to 2029, we planned to randomize 2,700 patients with MI and high bleeding risk in a 1:1:1 ratio to 1 of 3 groups: CYP2C19-genotyping and 6 months DAPT (experimental group 1), CYP2C19-genotyping and 3 months DAPT (experimental group 2), and 6 months DAPT with prasugrel (or ticagrelor) and aspirin (control group). The coprimary outcomes are NACE defined as the composite of all-cause mortality, recurrent MI, definite stent thrombosis, stroke, and BARC type 3-5 bleeding (Bleeding Academic Research Consortium), and major and minor bleedings defined as the composite of BARC type 2-5 bleedings at 1 year.

CONCLUSION:

DAN-DAPT trial is an open-label, multicenter, randomized controlled trial comparing genotype-guided DAPT de-escalation to clopidogrel - with or without DAPT abbreviation to 3 months - and standard DAPT for 6 months after PCI in high bleeding risk patients with MI. As of March 2025, 36% of the planned 2,700 patients have been enrolled in the study.

TRIAL REGISTRATION:

ClincialTrials.gov (NCT05262803) and EU number (2022-500125-32-00).

01 Apr 2025·Cardiovascular Intervention and Therapeutics

Safety of crushed/chewed P2Y12 inhibitors in acute coronary syndromes — a meta-analysis of randomized controlled trials

Review

Author: Kirov, Hristo ; Di Franco, Antonino ; Doenst, Torsten ; Moustafa, Amr Osama ; Pascalis, Luca ; Cardoso, Rhanderson ; Treml, Ricardo E ; Fazzini, Luca ; Caldonazo, Tulio ; Schulze, Christian

The administration of crushed or chewed P2Y12 inhibitors (P2Y12i) allows faster platelet inhibition in patients presenting acute coronary syndrome (ACS). Whether this administration approach is safe needs further analysis. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing chewed/crushed to integral P2Y12i administration in patients with ACS. Major bleeding, minor bleeding, and major adverse cardiovascular events (MACE) were analyzed as binary outcomes. Platelet reactivity unit (PRU) was assessed as a continuous outcome to estimate the impact on platelet physiology. A subgroup analysis of P2Y12i administered was performed. Nine studies comprising 1091 patients with ACS were included, 77% were males. Overall, 87% presented with ST-segment elevation acute myocardial infarction. Six studies administered Ticagrelor, while 3 studies used Prasugrel. The absolute risk of bleeding, assessed by TIMI, was low in both intervention and control arms (0.36% vs. 0.95% for major bleedings and 3.3% vs. 4.4% for minor bleedings), and crushed/chewed administration did not increase the relative risk of bleeding events for TIMI major or minor bleedings (RR 0.51, 95% CI 0.09-2.77, p = 0.293; RR 0.76, 95% CI 0.24-2.43, p = 0.542) or MACE (RR 0.94, 95% CI 0.28-3.19, p = 0.902). PRU was significantly reduced within 1 h after administration in the crushed/chewed P2Y12i group (MD: -70.0%, 95% CI, -89.0 to -51.1%, p<0.01) while we did not observe a significant difference after 4 h (MD: -15.1%, 95% CI -34.2 to 4.0%, p = 0.12). The type of drug did not influence the relative risk of crushed/chewed P2Y12i on major or minor bleeding (p_interaction = 0.62 and p_interaction = 0.23_, respectively). The crushed/chewed administration of P2Y12i in the setting of ACS was not associated with an increased risk of bleeding, suggesting the safety of this strategy.

13 Mar 2025·European Heart Journal-Cardiovascular Pharmacotherapy

Aspirin vs. clopidogrel monotherapy beyond 1 month after complex percutaneous coronary intervention: a pre-specified subgroup analysis of the STOPDAPT-3 trial

Article

Author: Kimura, Takeshi ; Natsuaki, Masahiro ; Kawahatsu, Kando ; Tamura, Toshihiro ; Domei, Takenori ; Takenaka, Hiroyuki ; Isawa, Tsuyoshi ; Ando, Kenji ; Kawamura, Takayuki ; Hagikura, Arata ; Yamamoto, Ko ; Serikawa, Takeshi ; Nishikawa, Ryusuke ; Shibata, Naoki ; Ono, Koh ; Mori, Hiroyoshi ; Abe, Mitsuru ; Morimoto, Takeshi ; Obayashi, Yuki ; Hayashi, Fujio ; Ishikawa, Tetsuya ; Kimura, Tomoya ; Suwa, Satoru ; Watanabe, Hirotoshi

Abstract:

Aims:

There were no previous studies comparing aspirin vs. P2Y12 inhibitor monotherapy following short dual antiplatelet therapy (DAPT) after complex percutaneous coronary intervention (PCI).

Methods and results:

We conducted a pre-specified subgroup analysis based on complex PCI in the 1-year results of the STOPDAPT-3 (ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3) trial, which randomly compared 1-month DAPT followed by aspirin monotherapy (aspirin group) with 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). The main analysis in the present study was the 30-day landmark analysis. The co-primary endpoints were cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and major bleeding (Bleeding Academic Research Consortium 3 or 5). In the 30-day landmark analysis (N = 5833), there were 1415 patients (24.3%) who underwent complex PCI. There was a significant interaction between complex PCI and the effect of the aspirin group relative to the clopidogrel group for cardiovascular events (complex PCI: 3.3% vs. 5.2%, non-complex PCI: 4.3% vs. 3.6%, interaction P = 0.04) and net adverse clinical events (complex PCI: 4.8% vs. 7.2%, non-complex PCI: 5.3% vs. 4.4%, interaction P = 0.02), but not for bleeding events (complex PCI: 2.1% vs. 2.7%, non-complex PCI: 1.7% vs. 1.4%, interaction P = 0.35).

Conclusions:

There was a significant interaction between complex PCI and the effect of aspirin monotherapy relative to clopidogrel monotherapy beyond 1 month and up to 1 year for cardiovascular events due to numerically lower risk of aspirin monotherapy in patients with complex PCI, while the effect of aspirin monotherapy relative to clopidogrel monotherapy was not different for bleeding regardless of complex PCI.

Clinical trial registration:

ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111.

News (Medical) associated with Prasugrel Hydrochloride

17 Dec 2024

·www.accesswire.com

Esteemed Harvard Medical School Professor Dr. Michael Gibson Appointed Chief Medical Advisor at Lexaria Bioscience

Dr. Gibson joining Lexaria's new scientific advisor board KELOWNA, BC / ACCESSWIRE / December 17, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces the appointment of Dr. Michael Gibson as its new Chief Medical Advisor. Dr. Gibson will collaborate directly with President John Docherty as Lexaria's patented DehydraTECH drug delivery platform continues to expand its applications in GLP-1 and hypertension.C. Michael Gibson M.S., M.D., is an interventional cardiologist, cardiovascular researcher & educator. He is the CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School. Gibson founded PERFUSE in 1987 which served as the TIMI Data coordinating center that coordinated data for the first 50 TIMI trials. The Baim institute was formerly known as Harvard Clinical Research Institute and was founded in 2000.The combined institutes have led over 1,250 studies, published 5,500 manuscripts in peer review literature (including 144 in the New England Journal of Medicine) and have led 70 FDA submissions from their network of 7,000 sites in 57 countries worldwide. Since 2014, Gibson has consistently been ranked as one of the world's most highly cited authors in all of science by Thomson Reuters. In 2021, he was named one of the Fifty of the Most Influential Voices in Healthcare by Medika Life. His work has been cited over 170,000 times."Lexaria's drug delivery technology offers exciting new pathways towards improving pharmacokinetic drug performance that could unlock a new era of reduced drug waste and adverse side effects combined with enhanced efficacy," said Dr. Gibson. "I'm excited to pursue new and improved applications for this exciting technology.""Dr. Gibson has a wealth of knowledge and experience that will benefit Lexaria, particularly in the area of hypertension which remains an area of intense interest for Lexaria," said John Docherty, President. "On behalf of everyone at Lexaria, I welcome Dr. Gibson's contributions as our new Chief Medial Advisor and member of our scientific advisory board."As Chief Medical Advisor, Dr. Gibson will participate with other scientific and medical experts within Lexaria's newly-formed scientific advisory board in pursuing Lexaria's prioritized objectives in the fields of drug delivery optimization.Dr. Gibson has led phase 1-4 clinical trials, and cardiology megatrials of over 34,000 patients which eventuate in international approval of drugs like prasugrel, rivaroxaban, betrixaban and andexanet as well as devices such as one that alarms to alert a patient to heart attack. He founded WikiDoc.org and WikiPatient.org and is Editor-In-Chief of over 2,200 active contributors who have edited the content of over 100,000 chapters millions of times over the past 15 years. Gibson also founded www.clinicaltrialresults.org. Gibson serves as Chief Medical Correspondent for the American College of Cardiology. Gibson has over 435,000 followers on social media where he is a leading influencer, second only to Sanjay Gupta in some pollsAbout Lexaria Bioscience Corp. & DehydraTECHDehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.CAUTION REGARDING FORWARD-LOOKING STATEMENTSThis press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.INVESTOR CONTACT:George Jurcic - Head of Investor Relations[email protected]Phone: 250-765-6424, ext 202SOURCE: Lexaria Bioscience Corp.

Executive Change

24 Nov 2023

·synapse.patsnap.com

What are COX inhibitors and how do you quickly get the latest development progress?

COX, or cyclooxygenase, is an enzyme that plays a crucial role in the human body's inflammatory response. It is responsible for the production of prostaglandins, which are hormone-like substances involved in various physiological processes. COX exists in two isoforms, COX-1 and COX-2. COX-1 is constitutively expressed and involved in maintaining normal bodily functions, such as protecting the stomach lining and regulating blood clotting. On the other hand, COX-2 is induced during inflammation and is primarily responsible for the production of prostaglandins that cause pain, fever, and swelling. Understanding the role of COX has led to the development of drugs called COX inhibitors, which are used to manage pain, inflammation, and other related conditions. COX inhibitors, can be categorized into two main types. The first are non-selective COX inhibitors, which can simultaneously inhibit both COX-1 and COX-2 enzymes, with Aspirin being a primary example. The second type involves selective COX-2 inhibitors, such as celecoxib, which was the first COX-2-specific inhibitor approved by the FDA for use in the treatment of familial adenomatous polyposis (FAP). There are two isozymes of cyclooxygenase, namely COX-1 and COX-2. COX-1 is an always-present enzyme in different tissues, including the stomach lining, platelets, and kidneys. On the other hand, COX-2 is an enzyme generally induced in the context of inflammation or tissue healing. Extensive research indicates that most tumors overexpress COX-2, while the expression of COX-1 shows no significant discrepancies between tumorous and normal tissues. Therefore, studies focusing on the role of cyclooxygenase in tumor progression primarily concern COX-2. The analysis of the target COX reveals a competitive landscape with several companies making progress in the development of COX inhibitors. GSK Plc, Viatris Inc., and Pfizer Inc. are among the companies growing fastest in this area. Pain, rheumatoid arthritis, and osteoarthritis are the most common indications for approved drugs. Small molecule drugs are progressing rapidly, indicating intense competition in the development of innovative drugs. China, the United States, and Japan are the leading countries/locations in COX inhibitors development. Overall, the target COX presents opportunities for further research and development, particularly in addressing pain management and rheumatic conditions. The mechanism of action of COX inhibitorsCOX inhibitors are a type of medication that inhibit the activity of cyclooxygenase (COX) enzymes. These enzymes play a crucial role in the production of prostaglandins, which are chemical messengers involved in inflammation, pain, and fever. COX inhibitors work by blocking the action of COX enzymes, thereby reducing the production of prostaglandins. From a biomedical perspective, COX inhibitors are commonly used in the treatment of pain, inflammation, and fever. They are widely prescribed for conditions such as arthritis, menstrual cramps, headaches, and post-operative pain. By reducing the production of prostaglandins, COX inhibitors help alleviate symptoms associated with these conditions. There are two main types of COX inhibitors: COX-1 inhibitors and COX-2 inhibitors. COX-1 inhibitors, such as aspirin, naproxen, and ibuprofen, inhibit both COX-1 and COX-2 enzymes. They are effective in relieving pain and inflammation but can also cause side effects such as stomach ulcers and bleeding. On the other hand, COX-2 inhibitors, such as celecoxib, selectively inhibit the COX-2 enzyme while sparing COX-1. This selective inhibition reduces the risk of stomach ulcers and bleeding associated with COX-1 inhibitors. COX-2 inhibitors are commonly used for long-term management of chronic conditions like osteoarthritis and rheumatoid arthritis. In summary, COX inhibitors are a class of medications that inhibit the activity of COX enzymes, reducing the production of prostaglandins. They are commonly used to treat pain, inflammation, and fever, with different types of COX inhibitors offering varying degrees of selectivity and side effects. List of COX InhibitorsThe currently marketed COX inhibitors include: Celecoxib/Tramadol HydrochlorideDiclofenac etalhyaluronateBupivacaine/MeloxicamAspirin/Vonoprazan FumarateBirch bark extractPrasugrel Hydrochloride/AspirinDiclofenac/LidocaineEsflurbiprofenAspirin ZincPolmacoxibFor more information, please click on the image below. What is the purpose of using COX inhibitors?COX inhibitors are commonly used for conditions such as angina, atrial fibrillation, arrhythmia, and myocardial infarction.For more information, please click on the image below to log in and search. How to obtain the latest development progress of COX inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of COX inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

15 Nov 2021

·endpts.com

Eyeing an accelerated BLA, PhaseBio says its monoclonal antibody reversed the dangerous effects of AstraZeneca's blood thinner

A class of blood thinners called P2Y12 inhibitors has been used for the last couple decades to treat and prevent a range of cardiovascular conditions, including stroke and heart attack. But the antiplatelet drugs come with a risk of increased bleeding, which can prove fatal — especially for those who need urgent surgery and don’t have time to wean off their medication. PhaseBio is working on a solution for that. And on Monday, the company presented positive Phase III data that could pave the way for a mid-2022 BLA submission. The company’s lead drug bentracimab was shown to reverse the effects of AstraZeneca’s blood thinner Brilinta in an interim analysis of more than 100 patients who needed urgent surgery or an invasive procedure, PhaseBio announced at this year’s American Heart Association conference. Patients who took bentracimab in the pivotal REVERSE-IT trial saw a 135% reduction in platelet inhibition within 5 to 10 minutes of infusion (p<0.001) and saw those effects last over 24 hours, according to PhaseBio. The drug also met its co-primary endpoint, defined as good or excellent hemostasis within 24 hours of administration. Regulators previously told PhaseBio that an interim analysis from the first 100 patients in REVERSE-IT would be sufficient for an accelerated BLA submission, CEO Jonathan Mow told Endpoints News. “When we then looked at the Phase III data and saw that not only did we hit the VerifyNow, platelet biomarker endpoint, we also hit the clinical endpoint — albeit with a slightly larger number of patients, you know, 150 in total — but still, that’s a fantastic achievement for us. One that was not expected at this point in time,” he said. Bentracimab appeared safe, according to PhaseBio. And though 91% of patients reported a treatment-emergent side effect, the most common was pain associated with the surgical procedure. Eight experienced thrombotic events, though none of the cases were tied to bentracimab. “With no approved reversal agents for oral P2Y12 inhibitors, patients who are prescribed these medications to reduce the risk of cardiac events are at increased risk for spontaneous major bleeding events, and physicians are faced with a complex dilemma of balancing bleeding risk and thrombotic risk, should these patients require urgent surgery,” said Deepak Bhatt, executive director of interventional cardiovascular programs at Boston’s Brigham and Women’s Hospital, who presented the study at AHA. Doctors typically recommend patients stop taking P2Y12 inhibitors five to seven days before any type of surgical procedure. But while other P2Y12 inhibitors like Sanofi’s Plavix and Eli Lilly’s Effient aren’t reversible, Brilinta is. That’s because Plavix and Effient bind to the P2Y12 receptor permanently, so to regain functionality, you need to wait for platelet turnover. Brilinta, on the other hand, binds transiently and only has about a 15-minute residence time on the receptor. Bentracimab is a monoclonal antibody fragment that binds to Brilinta when it’s in that off state, and removes it from the platelet environment. “Essentially it just sequesters ticagrelor [Brilinta] from the platelet,” CMO John Lee told Endpoints. The Phase III readout comes just a couple weeks after PhaseBio reported positive topline results for a Phase IIb study evaluating bentracimab in healthy, older volunteers on Brilinta. Earlier results have also shown promise in treating younger volunteers. The news also bodes well for the Italian biotech Alfasigma, which back in June put down up to $245 million for the European rights to bentracimab. PhaseBio originally licensed the drug from MedImmune, the biologics arm of AstraZeneca, in 2017 for an upfront fee of $100,000, with $68 million in potential milestones. A little over a year later, the biotech rode that deal to an IPO with MedImmune owning 5% of the stock. And in 2019, bentracimab received breakthrough therapy designation from the FDA. While bentracimab would be the first antiplatelet reversal therapy for a P2Y12 inhibitor, it would not be the first to address the risk of bleeding in patients on blood thinners. Back in 2018, the FDA approved Portola Pharmaceuticals’ Andexxa as the first reversal agent for Factor Xa inhibitors, such as Janssen’s Xarelto and Bristol Myers Squibb and Pfizer’s Eliquis. PhaseBio is still recruiting patients with uncontrolled major or life-threatening bleeding for the REVERSE-IT trial, and aims to be fully-enrolled as soon as possible.

AntibodyBreakthrough TherapyAHAIPO

100 Deals associated with Prasugrel Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D05597	Prasugrel Hydrochloride	B01AC22	DB06209

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Brain Ischemia	Japan	Daiichi Sankyo Co., Ltd.	24 Dec 2021
Angina, Stable	Japan	Daiichi Sankyo Co., Ltd.	24 Mar 2014
Myocardial Infarction	Japan	Daiichi Sankyo Co., Ltd.	24 Mar 2014
Acute Coronary Syndrome	European Union	Vygoris Ltd.	24 Feb 2009
Acute Coronary Syndrome	Iceland	Vygoris Ltd.	24 Feb 2009
Acute Coronary Syndrome	Liechtenstein	Vygoris Ltd.	24 Feb 2009
Acute Coronary Syndrome	Norway	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	European Union	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	Iceland	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	Liechtenstein	Vygoris Ltd.	24 Feb 2009
Angina, Unstable	Norway	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	European Union	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	Iceland	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	Liechtenstein	Vygoris Ltd.	24 Feb 2009
Non-St Elevated Myocardial Infarction	Norway	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	European Union	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	Iceland	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	Liechtenstein	Vygoris Ltd.	24 Feb 2009
ST Elevation Myocardial Infarction	Norway	Vygoris Ltd.	24 Feb 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Anemia, Sickle Cell	Phase 3	United States	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	United States	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Belgium	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Belgium	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Brazil	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Brazil	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Canada	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Canada	Daiichi Sankyo, Inc.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Egypt	Eli Lilly & Co.	01 Apr 2013
Anemia, Sickle Cell	Phase 3	Egypt	Daiichi Sankyo, Inc.	01 Apr 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISAR-REACT5 (ESC2024)	Not Applicable	Acute Coronary Syndrome	-	Prasugrel	iihyyvosgc(jwiostenxo) = vuqtrbdndr hnnucxxvch (etlslaqepe )	Positive	02 Sep 2024
				Ticagrelor	iihyyvosgc(jwiostenxo) = ocwrgwvtsg hnnucxxvch (etlslaqepe )
ESC2024	Not Applicable	Acute Coronary Syndrome	-	Clopidogrel	-	-	02 Sep 2024
				Prasugrel
ESC2024	Not Applicable	Acute Coronary Syndrome	-	Standard dose ticagrelor	nvufpoppbb(almdwphczq) = wtwbgsadbe ubtfuozqdf (zojmrlmkdv ) View more	Positive	01 Sep 2024
				Reduced dose prasugrel	nvufpoppbb(almdwphczq) = mpceyixmia ubtfuozqdf (zojmrlmkdv ) View more
ESC2024	Not Applicable	Coronary Disease	-	Prasugrel monotherapy	wzqyjxtpfz(rkueaorkzc) = wrleuyijan tttgvsenqd (stvhnjnpal )	-	01 Sep 2024
ESC2024	Not Applicable	Non-St Elevated Myocardial Infarction	-	Prasugrel monotherapy (3.75mg/day)	nscspnfyho(zfksjvscuv) = tqyjtzeony yzkiicinzm (eekshwdvss ) View more	-	01 Sep 2024
ESC2024	Not Applicable	Myocardial Infarction	-	Prasugrel	lkgplpjqqq(rfqtnpzera): HR = 0.67 (95% CI, 0.47 - 0.95) View more	-	30 Aug 2024
				Ticagrelor
ESC2024	Not Applicable	Coronary Disease	-	Clopidogrel	repiirqcgb(vupnuemckp) = skqkpygfqj tfalhiskkh (dbmxjnefkm )	-	30 Aug 2024
				Prasugrel or Ticagrelor	repiirqcgb(vupnuemckp) = yvrzemrmzs tfalhiskkh (dbmxjnefkm )
NCT04668144 (SWAP-6, CTgov)	Phase 4	Acute Coronary Syndrome \| Coronary Artery Disease	359	Prasugrel (Prasugrel)	ranwbykqqt(wrqcmmtqyb) = gkybbghetm klvetvfbvn (xlkpklibtw, 31) View more	-	20 Mar 2024
				Cangrelor+Prasugrel (Prasugrel + Cangrelor)	ranwbykqqt(wrqcmmtqyb) = msibeucnid klvetvfbvn (xlkpklibtw, 104) View more
NCT05223335 (CTgov)	Phase 4	Hemorrhage	98	Tricagrelor+Prasugrel (Genotype-Guided Therapy)	bnxjjqgusd = ouybnbsikl fgzvmvfquy (impojpqltp, vwlxzuzyfy - ozembxjaqv) View more	-	21 Feb 2024
				Clopidogrel (Conventional Therapy)	bnxjjqgusd = wgorzuviit fgzvmvfquy (impojpqltp, ahdjlcqkxp - lvaafgdldt) View more
NCT01944800 (ISAR-REACT 5, ESC2023)	Phase 4	Acute Coronary Syndrome	-	Ticagrelor	uyxdjybrgc(kqfkfcjqvb): HR = 1.62 (95% CI, 1.09 - 2.41)	Negative	27 Aug 2023
				Prasugrel

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