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Last update 24 Mar 2025

Clopidogrel Bisulfate

Last update 24 Mar 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryClopidogrel Bisulfate, a medication trademarked as Plavix®, was approved by Bristol Myers Squibb in the US in 1997. Its mechanism of action is to inhibit P2Y12 receptors, which reduces platelet activation and aggregation. This subsequently decreases the risk of blood clots and their potentially fatal consequences. Clopidogrel is indicated for treating myocardial infarction, stroke, peripheral vascular disease, coronary artery disease, and cerebrovascular disease. With its role as an antiplatelet agent, Clopidogrel proves invaluable in preventing severe complications from blood clots such as heart attacks, strokes, and even death. The drug has shown efficacy in the management and prevention of cardiovascular events, making it an essential medication in modern medicine.

Drug Type

Small molecule drug

Synonyms

clopidogrel, Clopidogrel Bisufate, Clopidogrel bisulfate (USP)

+ [32]

Target

P2Y12 receptor

Action

antagonists

Mechanism

P2Y12 receptor antagonists(Purinergic receptor P2Y12 antagonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesOther Diseases

Active Indication

AtherosclerosisIschemiaAngina, Stable+ [15]

Inactive Indication

Chronic heart failureHeart ArrestHeart Defects, Congenital+ [3]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Zentiva ks

Sanofi Winthrop Industrie SATaw Pharma (Ireland) Ltd.

+ [12]

Inactive Organization

Acino Pharma AGAcino AGBristol-Myers Squibb Pharma EEIG

+ [8]

Drug Highest PhaseApproved

First Approval Date

United States (17 Nov 1997),

Myocardial InfarctionStroke

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC16H18ClNO6S2

InChIKeyFDEODCTUSIWGLK-RSAXXLAASA-N

CAS Registry120202-66-6

457

Clinical Trials associated with Clopidogrel Bisulfate

NCT05643651

/ Not yet recruitingPhase 4IIT

Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children With Giant Coronary Artery Aneurysms After Kawasaki Disease: a Multicenter, Open-label, Parallel, Exploratory, Randomized Controlled Trial

Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children with giant coronary artery aneurysms after Kawasaki disease

Start Date01 Jul 2025

Sponsor / Collaborator

Paediatrics Hospital Affiliated To Fudan University

NCT06757764

/ Not yet recruitingPhase 4IIT

The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial

Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial. However, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. Cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. The post-hoc analysis of CSPS.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. The effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.

Start Date15 Mar 2025

Sponsor / Collaborator

Asan Medical Center

[+1]

ChiCTR2500095929

/ SuspendedPhase 4

Clinical application research and evaluation of biomarkers predicting clopidogrel resistance in patients with ischemic stroke

Start Date01 Feb 2025

Sponsor / Collaborator-

100 Clinical Results associated with Clopidogrel Bisulfate

100 Translational Medicine associated with Clopidogrel Bisulfate

100 Patents (Medical) associated with Clopidogrel Bisulfate

20,829

Literatures (Medical) associated with Clopidogrel Bisulfate

01 May 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous quantification of eighteen therapeutic oral anticoagulants, rodenticides, and antiplatelet agents by LC-MS/MS and its application in post-mortem forensic cases

Article

Author: Bidat, Carolyne ; Feliu, Catherine ; Duband, Sébastien ; Escal, Jean ; Dellinger, Sandrine ; Hodin, Sophie ; Drague, Angélique ; Delavenne, Xavier

Anticoagulants and antiplatelet agents, which interfere with blood coagulation, can lead to fatal bleeding. Moreover, their widespread use as drugs or rodenticides poses a high risk of accidental or intentional poisoning. Therefore, quantifying these substances is essential in forensic investigations. This research aimed to develop and validate a liquid chromatography-tandem mass spectrometry method capable of quantifying eighteen anticoagulant or antiplatelet compounds (apixaban, rivaroxaban, dabigatran, warfarin, acenocoumarol, fluindione, brodifacoum, bromadiolone, difenacoum, difethialone, chlorophacinone, coumatetralyl, flocoumafen, acetylsalicylic acid, clopidogrel, dipyridamole, ticagrelor, and ticlopidine) in a single run with simple sample preparation. The method was validated according to the FDA recommendations for all compounds, with an eight-min run time in human whole blood, the gold standard in toxicological forensic investigation. The method was also validated for therapeutic compounds and most rodenticides in bile and vitreous humor. Following validation, the method was applied to seven forensic cases with a known history of anticoagulant or antiplatelet agent use to prove the validity of the method. This method provides a valuable tool for legal contexts where precise determination of anticoagulant compound presence and concentration is required.

01 Apr 2025·AMERICAN HEART JOURNAL

Indobufen-based dual antiplatelet therapy in patients with multivessel coronary disease undergoing drug-eluting stent implantation insight from the OPTION trial

Article

Author: Qian, Juying ; Ge, Junbo ; Wu, Shujing ; Cheng, Kang ; Zhang, Huanyi ; Wei, Guanghe ; Lan, Jun ; Xu, Huajie ; Zhao, Xin ; Qi, Zhiyong ; Wu, Hongyi ; Huang, Jiangnan ; Chen, Manhua ; Xu, Lili ; Li, Guangping ; Wang, Xiaoyan

BACKGROUND:

It remains unclear whether indobufen-based dual antiplatelet therapy (DAPT) preserves ischemic protection while limiting bleeding risk in patients with multivessel coronary disease (MVD). This study aimed to investigate the efficacy and safety of indobufen-based DAPT in patients with MVD.

METHODS:

Patients in the OPTION trial were stratified based on the presence of MVD. We compared the ischemic and bleeding risks of indobufen-based DAPT (indobufen 100mg twice a day plus clopidogrel 75 mg/d for 12 months) vs conventional DAPT (aspirin 100 mg/d plus clopidogrel 75 mg/d for 12 months) in patients with and without MVD, using landmarks at 6 months and 1-year post-percutaneous coronary intervention (PCI).

RESULTS:

Patients with MVD tended to be older and contained a higher prevalence of high-risk features. Compared with patients without MVD, those with MVD were at higher risk for net adverse clinical events and ischemic events. The risk of ischemic events between indobufen-based DAPT vs conventional DAPT was similar either in patients with MVD or without MVD during the first and second 6 months. During the first 6 months, indobufen-based DAPT decreased the risk of bleeding events consistently in patients with and without MVD. Of note, during the second 6 months, indobufen-based DAPT continually decreased the risk of bleeding events in patients with MVD but not in those without MVD.

CONCLUSIONS:

In patients with MVD, indobufen plus clopidogrel DAPT compared to aspirin plus clopidogrel DAPT could reduce the risk of bleeding events while preserving ischemic protection during both the first and second 6 months post-PCI. Indobufen presents an effective option for patients with MVD, especially those at high ischemic risk requiring DAPT beyond 6 months post-PCI.

TRIAL REGISTRATION:

The trial was registered at www.chictr.org. A Randomized Controlled Trial of Indobufen vs Aspirin after Coronary Drug-eluting Stent Implantation: the OPTION Trial (ChiCTR-IIR-17013505).

01 Apr 2025·DEN open

Influence of antiplatelet drugs on gastric ulcer healing after endoscopic submucosal dissection in patients with early gastric cancer

Article

Author: Akazawa, Yu ; Takahashi, Kazuto ; Matsuda, Hidetaka ; Nakamoto, Yasunari ; Suto, Hiroyuki ; Nosaka, Takuto ; Ohani, Masahiro ; Tanaka, Tomoko ; Sugata, Ryotaro ; Murata, Yosuke ; Naito, Tatsushi

Abstract:

Objectives:

The causes of drug‐induced gastroduodenal injuries primarily include antithrombotic drugs, including low‐dose aspirin, non‐steroidal anti‐inflammatory drugs, and corticosteroids. These drugs are suspected to affect gastric ulcer healing after endoscopic submucosal dissection (ESD). This study aimed to investigate the effects of these drugs on post‐ESD ulcer healing.

Methods:

This study included 170 lesions (149 patients) who had undergone ESD for early gastric cancer. Post‐ESD ulcers were endoscopically measured on the 1st, 28th, and 56th days after ESD and were analyzed to identify potential risk factors for delayed ulcer healing among patients taking antiplatelet drugs, anticoagulant drugs, non‐steroidal anti‐inflammatory drugs, corticosteroids, and no drugs.

Results:

Multivariate analysis for the frequency of scarring on the 56th day after ESD showed that antiplatelet drugs (odds ratio [OR], 3.905; p = 0.017), ulcer size of ≥40 mm on the first day (OR, 4.903; p = 0.006), hemoglobin A1c ≥6.5% (OR 7.659, p = 0.012), and age of ≥75 (OR, 5.227; p = 0.007) were independent risk factors of delayed ulcer healing. Anticoagulant drugs, non‐steroidal anti‐inflammatory drugs, and corticosteroids were not significant factors. Among antiplatelet drugs, the ulcer reduction ratio for clopidogrel on the 28th day after ESD was 84.8%, which was significantly lower than the ulcer reduction ratio of 92.8% for no drug (p < 0.05).

Conclusions:

As antiplatelet drugs, particularly clopidogrel, may delay gastric ulcer healing after ESD, careful endoscopic follow‐up and drug therapy are suggested for patients taking these drugs.

149

News (Medical) associated with Clopidogrel Bisulfate

26 Feb 2025

·ir.madrigalpharma.com

Madrigal Announces New Two-Year Data from the Compensated MASH Cirrhosis Arm of the MAESTRO-NAFLD-1 Trial Demonstrating Potential Benefit of Rezdiffra™ (resmetirom) in Patients with Compensated MASH Cirrhosis

Patients achieved a mean 6.7 kPa reduction in liver stiffness as measured by vibration-controlled transient elastography (VCTE); this represents the largest reduction in liver stiffness reported in a compensated MASH cirrhosis patient population 51% of patients achieved a ≥25% reduction in liver stiffness; a reduction of this magnitude has been associated with reduced progression to end-stage liver disease Company to review topline data during its fourth-quarter and full-year 2024 financial results conference call today, February 26, 2025, at 8 a.m. EST CONSHOHOCKEN, Pa., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today reported positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra (resmetirom). Patients treated with Rezdiffra achieved marked reductions in liver stiffness, a surrogate for fibrosis, measured by vibration-controlled transient elastography (VCTE). The Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra included an open-label active treatment arm of patients with compensated MASH cirrhosis. Madrigal previously reported one-year results from this cohort. Following two years of treatment, 101 patients had VCTE results for analysis. Mean liver stiffness at baseline was 25 kPa and patients achieved a mean 6.7 kPa reduction in liver stiffness at two years (6.1 kPa at one year), which was statistically significant compared to baseline. This represents the largest reduction in liver stiffness reported to date in an F4c MASH population. Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Director Houston Research Institute and C.S.O. Summit Clinical Research, stated, “These data demonstrating patients with compensated MASH cirrhosis achieved marked reductions in VCTE are highly encouraging. We use the ‘Baveno rule of 5 kPa’ to stratify risk of liver-related events in patients with MASH, so a mean 6.7 kPa reduction suggests that many patients are moving into a lower risk category. The results are particularly meaningful in light of recently published, multi-center, longitudinal studies1,2 demonstrating VCTE is a strong predictor of clinical outcomes and may be more predictive of clinical outcomes than fibrosis stage assessed by liver biopsy.” In a responder analysis examining ≥25% improvement or worsening of liver stiffness, 51% of patients achieved improvement. An improvement of this magnitude has been associated with reduced progression to end-stage liver disease.1 The safety and tolerability profile of Rezdiffra in the compensated MASH cohort of MAESTRO-NAFLD-1 was consistent with other Rezdiffra clinical trials, with a low rate of discontinuations due to adverse events. Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality, so there is an urgent need to improve care for this underserved population with no approved treatment options. The new two-year data from MAESTRO-NAFLD-1 reinforce our confidence in the ongoing, fully enrolled MAESTRO-NASH OUTCOMES trial of Rezdiffra in patients with compensated MASH cirrhosis. If our OUTCOMES trial is successful, Rezdiffra has the potential to become the first therapy for F2-F4c MASH. It is important to remember that Rezdiffra should not be used for the treatment of patients with compensated MASH cirrhosis until safety and efficacy are established in our Phase 3 trial and the medication receives approval for this indication from regulatory authorities.” Draft FDA guidance recommends that Phase 3 clinical trials in MASH cirrhosis use outcomes as an endpoint, as opposed to biopsy-based surrogate endpoints. This guidance, along with data from the open-label compensated MASH cirrhosis arm of MAESTRO-NAFLD-1, informed the design of the ongoing Phase 3 MAESTRO-NASH OUTCOMES trial. Madrigal plans to present additional results from the compensated MASH cirrhosis arm of the MAESTRO-NAFLD-1 trial at a future medical conference. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. Rezdiffra is not approved for the treatment of patients with MASH cirrhosis. About MASH Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, need for liver transplantation, and premature mortality. MASH is expected to become the leading cause of liver transplantation in the U.S. and is already the leading cause of liver transplantation among women. Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10-17 times higher risk of liver-related mortality as compared to patients without fibrosis. Those who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients. An estimated 1.5 million patients have been diagnosed with MASH in the U.S., and Madrigal is focused on reaching approximately 315,000 patients with moderate to advanced fibrosis who are under the care of liver specialists. As MASH disease awareness improves and disease prevalence increases, the number of diagnosed patients with MASH with moderate to advanced fibrosis is expected to grow. About Rezdiffra What is Rezdiffra? Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. It is not known if Rezdiffra is safe and effective in children (under 18 years old). This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra. Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you: have any liver problems other than NASH. have gallbladder problems or have been told you have gallbladder problems, including gallstones. are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works. Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines. Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Rezdiffra? Rezdiffra may cause serious side effects, including: liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen). gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting. The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation. These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324. Please see the full Prescribing Information, including Patient Information, for Rezdiffra. About the Rezdiffra Phase 3 Program Madrigal is currently conducting multiple Phase 3 clinical trials to evaluate the safety and efficacy of Rezdiffra for the treatment of moderate to advanced fibrosis (consistent with fibrosis stages F2-F3) and compensated MASH cirrhosis (consistent with F4c): Data from the 52-week portion of MAESTRO-NASH, together with data from MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE, Phase 2 and Phase 1 data, including safety parameters, formed the basis for accelerated approval of Rezdiffra for treatment of MASH with moderate to advanced liver fibrosis. About Madrigal Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c). For more information, visit www.madrigalpharma.com. Forward Looking Statements This press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including Rezdiffra’s potential ability to treat patients with compensated MASH cirrhosis, Madrigals intentions to present data from the MAESTRO-NAFLD-1 trial at a medical conference and expectations regarding the MAESTRO NASH OUTCOMES trial. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that does not have commercial experience; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of Madrigal’s clinical studies, including, but not limited to Madrigal’s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal’s studies; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action; enrollment and trial conclusion uncertainties; market demand for and acceptance of Rezdiffra; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms; the ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive studies; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the timing and outcomes of clinical studies of Rezdiffra (resmetirom); the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission, or SEC, for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 28, 2024, and Part II, Item 1A of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on October 31, 2024, and as updated from time to time by Madrigal’s other filings with the SEC. 1. Lin H, Lee HW, Yip TC, et al. Vibration-Controlled Transient Elastography Scores to Predict Liver-Related Events in Steatotic Liver Disease. JAMA. 2024;331(15):1287–1297. 2. Gawrieh, S, et al. Increases and Decreases in Liver Stiffness Measurement are independently associated with the risk of liver-related events in NAFLD. Journal of Hepatology. 2024;81(4):600–608. Investor Contact Tina Ventura, IR@madrigalpharma.com Media Contact Christopher Frates, media@madrigalpharma.com Source: Madrigal Pharmaceuticals, Inc.

Clinical ResultPhase 3Accelerated ApprovalPhase 2Drug Approval

13 Jan 2025

·www.globenewswire.com

Humacyte Provides Update on Commercial Launch and Pricing of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma

– Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair – – Highly experienced sales team onboard and trained in preparation for commercial launch – – Budget Impact Model supports pricing of Symvess – DURHAM, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced an update of plans for the commercial launch of Symvess (acellular tissue engineered vessel-tyod) for extremity arterial injury. Humacyte is responding to requests for quotations from hospitals and has initiated the Value Analysis Committee approval processes at multiple hospitals as part of the preparation for market launch. The U.S. Food and Drug Administration (FDA) granted a full approval for Symvess on December 19, 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. Shortly after approval, Humacyte provided the final packaging and product batch release information required for FDA review prior to shipment of product. Humacyte currently expects to have authorization to commence product shipment early this quarter and continues to build product supply to support market launch. Humacyte has recruited and trained a highly experienced sales team for the commercial launch of Symvess. All ten sales team members are multi-year President’s Club winners, representing the top 10% of achievers in their prior sales organizations. All sales team members have demonstrated consistent overachievement with average hospital medical device and biotech experience exceeding 15 years. Each sales team member has experience in vascular surgery and/or trauma surgery, and 80% have previous experience selling regenerative therapies. All team members have experience selling clinically differentiated disruptive technologies and premium priced portfolios. Humacyte announced that the price of Symvess will be $29,500 per unit. The Company has developed a Budget Impact Model based on the clinical results supporting the approval of Symvess, and the estimated reduction in clinical complications potentially achievable by treating specific patients with Symvess versus current standard of care. Based on the model, the per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating trauma patients with synthetic grafts, cryopreserved allografts, or xenografts. Major drivers of cost savings associated with Symvess were attributed to reductions in the rate of amputation and vascular conduit infection. Additionally, Humacyte submitted an NTAP (New Technology Add-On Payment) application for Symvess to CMS in October 2024. Humacyte presented the Symvess data at a public Town Hall with the Centers for Medicare and Medicaid Services (CMS) on December 11, 2024. If successful, NTAP reimbursement will start for discharges on October 1, 2025, offering hospitals additional payment to cover a portion of the costs associated with Symvess. “We are very excited to take the major steps in providing healthcare providers a novel alternative for treating patients suffering from extremity arterial injury,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “We are pleased to see interest from multiple hospitals and to have commenced the Value Analysis Committee approval processes. We look forward to the anticipated publication of our Budget Impact Model which highlights the major drivers of cost savings associated with Symvess and complement our strong clinical results.” Symvess, or the ATEV™ (acellular tissue engineered vessel), is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. While harvesting vein from a trauma patient takes valuable surgical time and is not always feasible due to damage to veins or to the limbs, Symvess is available off-the-shelf, and does not require further injuring the patient to obtain vascular repair material. Humacyte’s BLA included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. Symvess was used to repair many types of traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents. It was utilized by vascular and trauma surgeons in Level 1 Trauma centers throughout the U.S. and Israel to repair severe limb-threatening and life-threatening injuries, and in front-line hospitals in Ukraine to treat wartime injuries. Results from these studies were published in JAMA Surgery on November 20, 2024. In the civilian and military clinical studies, Symvess was observed to have high rates of patency, or blood flow, and low rates of amputation and infection. INDICATION SYMVESS is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Graft Rupture Vascular graft rupture has occurred in patients treated with SYMVESS. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic Failure Anastomotic failure has occurred in patients treated with SYMVESS. In clinical studies of SYMVESS, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis Thrombosis has occurred in patients treated with SYMVESS. In clinical trials of SYMVESS, patients received antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with SYMVESS. Transmission of Infectious Diseases SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of SYMVESS are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain. Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for SYMVESS. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize our ATEV in the United States under the brand name SYMVESS in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, our quarterly report on Form 10-Q for the quarter ended September 30, 2024, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Drug ApprovalFast Track

21 Dec 2024

·pipelinereview.com

Humacyte Announces FDA Approval of SYMVESS™ (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma

– SYMVESS is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair – – In clinical testing SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection – – Highly experienced sales team already recruited and trained in preparation for commercial launch – DURHAM, NC, USA I December 19, 2024 I Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) has granted a full approval for SYMVESS (acellular tissue engineered vessel-tyod) for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. “We are very excited and proud to provide patients suffering from arterial injury with a novel treatment option. SYMVESS has been made possible by our innovative bioengineering science along with the contributions of many patients, healthcare providers and Humacyte team members.” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “SYMVESS approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte. The FDA’s full approval of SYMVESS is a transformational event for the Company and our bioengineering technology platform. Even more importantly, we believe SYMVESS provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades. We look forward with great excitement to our upcoming commercial launch of SYMVESS, and we have recruited and trained a terrific team to execute on our sales and marketing missions.” “The approval of a vascular conduit that resists infection and remodels into native arteries is an extraordinary technological advancement that will have a huge impact on the quality of trauma care around the world,” said Charles J. Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 clinical trial. “SYMVESS is perfectly sized to treat most injuries, has excellent handling properties, and reduces time necessary to save both life and limbs. The Humacyte team has responsibly and scientifically solved a major clinical problem that I believe will reduce the amputation rate for traumatic vascular injury. They should be congratulated on an accomplishment that will undoubtedly advance our specialty to the next level.” “I believe that SYMVESS will revolutionize vascular trauma care and be profoundly beneficial to our patients,” said Rishi Kundi, MD, Surgical Critical Care, Vascular Surgery, University of Maryland Medical System. “From my experience so far, SYMVESS will allow reconstructions that are currently impracticable because of contamination and infection. It will make reconstructions that we now perform with prosthetic or even biologic grafts more successful. I am most excited about the promise that SYMVESS holds for the long-term experience of our patients. I hope that, with SYMVESS, the 19-year-old patient with vascular reconstruction after trauma will no longer spend the six decades after their surgery anticipating disaster, but that their chances for reintervention will be no different than if they had autologous conduit.” SYMVESS, or the ATEV™, is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. While harvesting vein from a trauma patient takes valuable surgical time, SYMVESS is available off-the-shelf, and does not require further injuring the patient to obtain vascular repair material. Humacyte’s BLA included positive results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. SYMVESS was used to repair many types of traumatic injuries including car accidents, gunshot wounds, blast wounds, and industrial accidents. It was utilized by vascular and trauma surgeons in Level 1 Trauma centers throughout the U.S. and Israel to repair severe limb-threatening and life-threatening injuries, and in front-line hospitals in Ukraine to treat wartime injuries. Results from these studies were published in JAMA Surgery on November 20, 2024. In the civilian and military clinical studies, SYMVESS was observed to have high rates of patency, or blood flow, and low rates of amputation and infection. “Finally, we have an innovative technology for battlefield vascular injuries using a tissue engineered human arterial replacement that can resist infections that are so prevalent in modern combat zones,” added Dr. Fox. “SYMVESS shows promise to reduce amputation rates since an alternative conduit for war injuries is often needed but up until now has not been a good option.” “The FDA approval of SYMVESS will make it the preferred conduit for complex vascular injuries, and particularly those at risk for infection.” said Ernest E. Moore, MD, FACS, Director of Research at the Ernest E. Moore Shock Trauma Center at Denver Health, a clinical investigator in the V005 trial. “I look forward to using SYMVESS in my practice.” Arterial injuries resulting from vascular trauma are common in civilian and military populations, frequently resulting in the loss of life or limb. In civilian populations, trauma injuries are primarily caused by motor vehicle, workplace and sporting accidents, gun violence, mass casualty terrorist attacks, stabbings, blunt trauma, and iatrogenic injuries (injuries caused by medical treatment or examination). Autologous vein, which is harvested from the patient’s body through a separate surgical incision, is the current preferred conduit for arterial repair. However, harvesting of autologous vein is not always feasible due to damage to veins or to the limbs. Harvesting autologous vein is also an invasive procedure that requires additional time and resources, delaying the time from injury to restoration of blood flow for the injured patient. In contrast, SYMVESS may be removed from its packaging and ready for implantation within minutes and does not involve creating additional incisions in already-injured patients. The SYMVESS trauma program was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in May 2023, a Biologic License Application (BLA) was submitted to the FDA in December 2023, and in February 2024 the FDA granted a Priority Review. On August 9, 2024, the FDA informed Humacyte that it needed additional time to complete its review of the BLA, although there were no outstanding pre-approval requirements for SYMVESS as of that date. The FDA completed its review today, granting full approval. INDICATION SYMVESS is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of SYMVESS integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use SYMVESS in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Vascular graft rupture has occurred in patients treated with SYMVESS. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic failure has occurred in patients treated with SYMVESS. In clinical studies of SYMVESS, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis has occurred in patients treated with SYMVESS. In clinical trials of SYMVESS, patients received antiplatelet therapy following implantation of SYMVESS to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with SYMVESS. SYMVESS is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of SYMVESS are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain. Please see full Prescribing Information, including Boxed Warning, for SYMVESS. Humacyte filed the BLA with trauma clinical data based upon the accepted statistical analysis plan. These data were also peer reviewed and published in JAMA Surgery on November 20, 2024. In the package insert, the FDA elected to exclude the synthetic graft comparator that was in the statistical analysis plan. The FDA also applied a different imputing methodology for SYMVESS patients who did not have a day 30 assessment. Nine patients without day 30 data were imputed as failures of patency in the package insert, despite the fact that they had favorable patency results at the last assessment. In addition, multiple patients who never underwent an amputation were imputed as failures of limb salvage. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of acellular tissue engineered vessels (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication was approved by the FDA in December 2024. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received an RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com . For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. SOURCE: Humacyte

Drug ApprovalPriority ReviewFast Track

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KEGG	Wiki	ATC	Drug Bank
D00769	Clopidogrel Bisulfate	B01AC04	DB00758

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Atherosclerosis	Australia	Sanofi-Aventis Australia Pty Ltd.	06 Jul 2001
Ischemia	Australia	Sanofi-Aventis Australia Pty Ltd.	06 Jul 2001
Angina, Stable	China	Shenzhen Salubris Pharmaceuticals Co., Ltd.	01 Jan 2000
Cerebrovascular Disorders	China	Shenzhen Salubris Pharmaceuticals Co., Ltd.	01 Jan 2000
Myocardial Ischemia	China	Shenzhen Salubris Pharmaceuticals Co., Ltd.	01 Jan 2000
Non-St Elevated Myocardial Infarction	China	Shenzhen Salubris Pharmaceuticals Co., Ltd.	01 Jan 2000
Non ST segment elevation acute coronary syndrome	European Union	Sanofi Winthrop Industrie SA	15 Jul 1998
Non ST segment elevation acute coronary syndrome	Iceland	Sanofi Winthrop Industrie SA	15 Jul 1998
Non ST segment elevation acute coronary syndrome	Liechtenstein	Sanofi Winthrop Industrie SA	15 Jul 1998
Non ST segment elevation acute coronary syndrome	Norway	Sanofi Winthrop Industrie SA	15 Jul 1998
Non-Q wave myocardial infarction	European Union	Sanofi Winthrop Industrie SA	15 Jul 1998
Non-Q wave myocardial infarction	Iceland	Sanofi Winthrop Industrie SA	15 Jul 1998
Non-Q wave myocardial infarction	Liechtenstein	Sanofi Winthrop Industrie SA	15 Jul 1998
Non-Q wave myocardial infarction	Norway	Sanofi Winthrop Industrie SA	15 Jul 1998
ST Elevation Myocardial Infarction	European Union	Sanofi Winthrop Industrie SA	15 Jul 1998
ST Elevation Myocardial Infarction	Iceland	Sanofi Winthrop Industrie SA	15 Jul 1998
ST Elevation Myocardial Infarction	Liechtenstein	Sanofi Winthrop Industrie SA	15 Jul 1998
ST Elevation Myocardial Infarction	Norway	Sanofi Winthrop Industrie SA	15 Jul 1998
Acute Coronary Syndrome	European Union	Sanofi Winthrop Industrie SA	14 Jul 1998
Acute Coronary Syndrome	Iceland	Sanofi Winthrop Industrie SA	14 Jul 1998

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Defects, Congenital	Phase 3	United States	Sanofi SA	01 Jan 2009
Heart Defects, Congenital	Phase 3	United States	Bristol Myers Squibb Co.	01 Jan 2009
Heart Defects, Congenital	Phase 3	Brazil	Sanofi SA	01 Jan 2009
Heart Defects, Congenital	Phase 3	Brazil	Bristol Myers Squibb Co.	01 Jan 2009
Heart Defects, Congenital	Phase 3	France	Bristol Myers Squibb Co.	01 Jan 2009
Heart Defects, Congenital	Phase 3	France	Sanofi SA	01 Jan 2009
Heart Defects, Congenital	Phase 3	Germany	Bristol Myers Squibb Co.	01 Jan 2009
Heart Defects, Congenital	Phase 3	Germany	Sanofi SA	01 Jan 2009
Heart Defects, Congenital	Phase 3	Hungary	Sanofi SA	01 Jan 2009
Heart Defects, Congenital	Phase 3	Hungary	Bristol Myers Squibb Co.	01 Jan 2009

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISC2025	Not Applicable	CYP2C19*2	114	Clopidogrel (CYP2C19*2)	bfzaqmoham(bwmbpzpmey) = igmlkotqcg bmmhvpyfvp (dnlqnflbgx )	-	30 Jan 2025
				Clopidogrel (CYP2C19*3)	dmynlcxqoa(ceapfewzhe) = sdqqbehlwp usjvkbrmkt (jybjzldxrq )
NCT02777580 (STREAM-2, CTgov)	Phase 4	Myocardial Infarction	609	Coronary angiography+clopidogrel+Tenecteplase (Pharmaco-invasive Strategy)	ikjizocpew = yzfszfcxjr umxnhfgdoc (tjtlfqoptp, alcdsnrsuu - wrqszllgvc) View more	-	04 Oct 2024
				Primary PCI (Standard Primary PCI)	ikjizocpew = iwukbtgitd umxnhfgdoc (tjtlfqoptp, xxxfqsovdm - qvcpjeyzpw) View more
ESC2024	Not Applicable	Acute Coronary Syndrome	-	Clopidogrel	-	-	02 Sep 2024
				Prasugrel
FAST-MI 2015 (ESC2024)	Not Applicable	Acute myocardial infarction	-	Ticagrelor	fziekwbcci(nrpeddxmoj): HR = 0.61 (95% CI, 0.43 - 0.86), P-Value = 0.004 View more	Positive	01 Sep 2024
				Clopidogrel
ESC2024	Not Applicable	Myocardial Ischemia	-	600 mg clopidogrel loading dose	drfnyqepra(wxdnhfakoe): OR = 0.82 (95% CI, 0.74 - 0.91), P-Value = 0.0002 View more	-	01 Sep 2024
				300 mg clopidogrel loading dose
ESC2024	Not Applicable	-	-	Clopidogrel monotherapy	hipngwedxq(ffipmuyoox) = fqhyymftri xbnksxrzhx (ykfkiwupnl ) View more	-	30 Aug 2024
				Aspirin monotherapy	hipngwedxq(ffipmuyoox) = lsekhlqthe xbnksxrzhx (ykfkiwupnl ) View more
NCT03161678 (CTgov)	Phase 4	Thrombosis \| Myocardial Infarction \| Blood Platelet Disorders	111	clopidogrel+Ticagrelor (Wild-Type Genotype)	tgomgzrizx(vlucbjvpsx) = hryshztlho kwfqtdwqim (ikujecoihk, 2.7) View more	-	06 May 2024
				clopidogrel+Ticagrelor (Carriers of the CES1 G143E Mutation)	tgomgzrizx(vlucbjvpsx) = hpgjdxlvkg kwfqtdwqim (ikujecoihk, 2.1) View more
AAN2024	Not Applicable	Intracranial Aneurysm	13	Clopidogrel	tkshjovzqx(shnhnnljtl): OR = 1.01 (95% CI, 0.59 - 1.73), P-Value = 0.97 View more	Positive	09 Apr 2024
				Ticagrelor
NCT04409834 (COVID-PACT, CTgov)	Phase 4	COVID-19 \| Arterial thrombosis \| Venous Thromboembolism	390	Unfractionated Heparin IV+Clopidogrel+Enoxaparin 1 mg/kg (Full-dose Anticoagulation (FDAC))	xapaszstoi(murtqtrulr) = vwdfnpngwm oeaykpztgx (sgrhzkkeaw, bhervvggco - nwswfkhdar) View more	-	19 Jan 2024
				Unfractionated heparin SC+clopidogrel+Enoxaparin 40 mg SC (Standard-dose Prophylactic Anticoagulation (SDPAC))	xapaszstoi(murtqtrulr) = tntgffdvsz oeaykpztgx (sgrhzkkeaw, zorpityymj - niinjqbkrp) View more
NCT03774394 (CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Coronary Artery Disease \| Chronic Kidney Diseases	61	Clopidogrel+Clopidogrel active metabolite (Diabetes Mellitus Patients With Chronic Kidney Disease)	gxynlpgtem(jjetpnrwuo) = fzszayprzc mkiaiqqyij (cdqadirjcu, 27.4) View more	-	21 Aug 2023
				Clopidogrel+Clopidogrel active metabolite (Diabetes Mellitus Patients Without Chronic Kidney Disease)	gxynlpgtem(jjetpnrwuo) = eqycyugryu mkiaiqqyij (cdqadirjcu, 30.2) View more

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