indobufen / Pfizer - LARVOL DELTA

Indobufen-based dual antiplatelet therapy in patients with multivessel coronary disease undergoing drug-eluting stent implantation: insight from the OPTION trial (ESC-WCC 2025) - No abstract available

Clinical • Cardiovascular

Indobufen dual antiplatelet therapy (DAPT) vs aspirin dual antiplatelet therapy (DAPT) after Percutaneous Coronary Intervention (PCI) a systematic review and meta-analysis (ESC-WCC 2025) - No abstract available

Retrospective data • Review • Cardiovascular

Efficacy and Safety of Indobufen Combined with Clopidogrel in the Treatment of Intracranial Artery Stenting (ChiCTR) - P4 | N=198 | Not yet recruiting | Sponsor: Beijing Hospital; Beijing Hospital

New P4 trial • Atherosclerosis • Cardiovascular • Vascular Neurology

Indobufen and Aspirin Hypersensitivity: A Promising Alternative or a Limited Option? (PubMed, J Cardiovasc Pharmacol) - No abstract available

Journal • Immunology

Role of Indobufen in coronary artery disease: the story of a neglected drug. A systematic review. (PubMed, J Cardiovasc Pharmacol) - "After years of empirical use, recent clinical studies have shed some light on the efficacy/safety profile of indobufen when compared to aspirin in low-risk CAD patients. However, also encouraged by promising pharmacodynamic data on platelet inhibition, further clinical investigations are strongly advocated."

Journal • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease

Indobufen versus aspirin in patients with indication for antiplatelet therapy: A systematic review and meta-analysis. (PubMed, Vascul Pharmacol) - "The efficacy and safety of antiplatelet therapy with indobufen were comparable to those of aspirin alone. Therefore, indobufen can be considered as a suitable alternative for patients who are intolerant or hypersensitive to aspirin. Nevertheless, additional trials involving larger populations are required to establish their clinical applicability."

Journal • Retrospective data • Review • Cardiovascular • Ischemic stroke • Myocardial Infarction

The efficacy and safety of indobufen in patients with ischemic cardiovascular or cerebrovascular diseases: systematic review and meta-analysis. (PubMed, Front Cardiovasc Med) - "However, compared to anticoagulants such as aspirin and clopidogrel, indobufen has a shorter history of use, and its evidence base is relatively limited, highlighting the need for further research. However, due to the potential risks in MACE, stroke, and other events, further clinical trials are needed to assess the clinical applicability of indobufen. https://www.crd.york.ac.uk/, identifier (CRD42024587938)."

Journal • Retrospective data • Review • Cardiovascular • CNS Disorders • Gastrointestinal Disorder • Hematological Disorders • Myocardial Infarction • Thrombosis • Vascular Neurology

Indobufen-based Dual Antiplatelet Therapy in Patients with Multivessel Coronary Disease Undergoing Drug-eluting Stent Implantation Insight From the OPTION Trial. (PubMed, Am Heart J) - P4 | "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."

Journal • Cardiovascular

Comparison of the Effects of Indobufen and Aspirin in Older Patients with Coronary Artery Disease After Coronary Drug-Eluting Stent Implantation: A Prospective Randomized Single-Center Study. (PubMed, Clin Appl Thromb Hemost) - "These findings highlight that, for older patients who underwent coronary DES implantation, indobufen-based DAPT may be a better choice, which can effectively improve patients' symptoms and prognosis. However, application to older patients with potential renal insufficiency requires caution."

Clinical • Journal • Cardiovascular • Coronary Artery Disease • Nephrology • Renal Disease

Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Henan Institute of Cardiovascular Epidemiology | N=594 ➔ 0 | Trial completion date: Dec 2022 ➔ Dec 2026 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2022 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Cardiovascular • Coronary Artery Disease • Heart Failure

Indobufen: A Viable Alternative to Aspirin for Antiplatelet Therapy in patients with Aspirin Intolerance (AHA 2024) - "Indobufen can be considered an alternative to aspirin in patients with intolerance or hypersensitivity. However, more trials with a larger population are needed to confirm the clinical applicability."

Clinical • Cardiovascular • Immunology • Ischemic stroke • Myocardial Infarction

Metabolomics revealed pharmacodynamic effects of aspirin and indobufen in patients after percutaneous transluminal angioplasty surgery. (PubMed, Front Cardiovasc Med) - "We identified several characteristic amino acids, including pro-leu, L-citrulline, his-glu, and L-glutamate, as important biomarkers for VR assessment in patients without medication after PTA. Taken together, our identification of metabolites involved in metabolic changes affected by aspirin and indobufen medication enhances the understanding of VR pathology after PTA. This may help identify early diagnostic biomarkers and therapeutic targets."

Journal • PK/PD data • Surgery

Multicenter retrospective cohort study demonstrates superior safety profile of indobufen over aspirin for Post-CABG antiplatelet therapy. (PubMed, Front Pharmacol) - "It can be considered a preferable alternative for patients who cannot tolerate or have contraindications to aspirin. Further large-scale clinical trials are needed to confirm its potential as the first-choice antiplatelet therapy post-CABG."

Journal • Retrospective data • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease • Gastrointestinal Disorder • Ischemic stroke • Myocardial Infarction

Safety and efficacy of aspirin and indobufen in the treatment of coronary heart disease: a systematic review and meta-analysis. (PubMed, Front Cardiovasc Med) - "Further clinical trials are necessary to determine whether indobufen can replace aspirin. https://www.crd.york.ac.uk/, identifier [CRD42024523477]."

Journal • Retrospective data • Review • Cardiovascular • CNS Disorders • Coronary Artery Disease • Gastrointestinal Disorder • Heart Failure • Myocardial Infarction • Peptic Ulcer • Vascular Neurology

Prior fecal immunochemical test positivity is associated with adverse prognosis in patients with acute ST-segment elevation myocardial infarction (ESC 2024) - "The prior positive FIT group had a higher proportion of prior clopidogrel and indobufen usage, while aspirin use during follow-up was lower. This study reveals a significant association between prior positive FIT and higher rates of NACE, MACCE, all-cause death, and gastrointestinal bleeding in STEMI patients within 1 year. A history of positive FIT results could serve as a prognostic indicator in this specific patient population."

Clinical • Atrial Fibrillation • Cardiovascular • Dyslipidemia • Hypertension • Ischemic stroke • Myocardial Infarction

The safety and efficacy of indobufen or aspirin combined with clopidogrel in patients with acute myocardial infarction after percutaneous coronary intervention (ESC 2024) - "The results of our study reveal no noteworthy distinctions in primary and secondary endpoints between the two groups. This finding indicates that the efficacy and safety of indobufen may be comparable to aspirin in Chinese patients with AMI after PCI, supporting its consideration as a potential substitute for aspirin in patients with AMI after PCI."

Clinical • Cardiovascular • Ischemic stroke • Myocardial Infarction • Thrombosis

Levosimendan improves the early prognosis of patients with Non ST-segment elevation myocardial infarction and Killip class > II (ESC 2024) - "Covariates adjusted in PSM included age, sex, Killip class, early PCI, previous PCI, previous medical conditions (diabetes, hypertension, ischemic stroke, and chronic kidney disease), and medications during hospitalization (aspirin, clopidogrel, indobufen, ticagrelor, statins, cedilanid, recombinant human brain natriuretic peptide [rhBNP], milrinone, dopamine, dobutamine, and angiotensin converting enzyme inhibitor/angiotensin receptor blockers [ACEI/ARB]). Conclusions Levosimendan was associated with a lower incidence of MACCE within 3 months in patients with NSTEMI and Killip> II, mainly driven by lower incidence of cardiac death. However, these findings are based on observational data and require confirmation through adequately powered, randomized, controlled trials."

Clinical • Cardiovascular • Hypertension • Ischemic stroke • Myocardial Infarction • NPPB

The safety and efficacy of indobufen or aspirin combined with clopidogrel in patients with acute myocardial infarction after percutaneous coronary intervention. (PubMed, Platelets) - "Additionally, the incidence of gastrointestinal symptoms were significantly lower in indobufen DAPT group compared to the aspirin DAPT group (7.1% vs. 14.3%, p = .022).Our research reveals that the efficacy and safety of indobufen are comparable to aspirin in Chinese patients with AMI following PCI. Given the potential advantages of indobufen in alleviating gastrointestinal symptoms, we propose it as a viable alternative for individuals intolerant to aspirin."

Journal • Retrospective data • Cardiovascular • Gastrointestinal Disorder • Hematological Disorders • Ischemic stroke • Myocardial Infarction • Thrombosis

Catalytic Regio- and Enantioselective Remote Hydrocarboxylation of Unactivated Alkenes with CO2. (PubMed, J Am Chem Soc) - "This process directly furnishes a range of different alkyl-chain-substituted or benzo-fused α-chiral carboxylic acids bearing various functional groups in high yields and regio- and enantioselectivities. Furthermore, the synthetic utility of this methodology was demonstrated by the concise synthesis of the antiplatelet aggregation drug (R)-indobufen from commercial starting materials."

Journal

OPTION2: IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome (clinicaltrials.gov) - P4 | N=2846 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

New P4 trial • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease

Indobufen nicht besser als ASS nach Apoplex. (PubMed, MMW Fortschr Med) - No abstract available

Journal • Review

Indobufen alleviates ischemic stroke injury by regulating transcription factor NRF2 and inhibiting ATG5 expression. (PubMed, J Pharm Pharmacol) - "IND could inhibit autophagy, oxidative stress, and apoptosis in SH-SY5Y cells with OGD/R exposure, further alleviating IS injury by regulating transcription factor NRF2 and inhibiting ATG5 expression."

Journal • Cardiovascular • CNS Disorders • Ischemic stroke • BECN1 • NFE2L2

Real-world performance of indobufen versus aspirin after percutaneous coronary intervention: insights from the ASPIRATION registry. (PubMed, BMC Med) - "Indobufen shared the same risk of MACCE but a lower risk of bleeding after PCI versus aspirin from a real-world perspective. Due to the observational nature of the current analysis, future studies are still warranted to further evaluate the efficacy of indobufen based DAPT, especially in patients with ACS."

Journal • Real-world • Real-world evidence • Acute Coronary Syndrome • Cardiovascular

Bifunctional Chiral Agent Enables One-pot Spontaneous Deracemization of Racemic Compounds. (PubMed, Angew Chem Int Ed Engl) - "Specifically, chiral α, (α-diphenyl-2-pyrrolidinemethanol) formed enantiospecific cocrystals with racemic dihydromyricetin, and used its own alkaline catalysis to catalyze the racemization between the (2R,3R)-enantiomer and (2S,3S)-enantiomer in solution, achieving a one-pot spontaneous deracemization.  This strategy was also successfully extended to the deracemization of three other racemic compound drugs: (R,S)-carprofen, (R,S)-indoprofen, and (R,S)-indobufen.The one-pot deracemization method based on the BCA strategy provides a feasible approach to address the incompatibility between cocrystallization and racemization reactions that are commonly encountered in the cocrystallization-induced deracemization process and opens a new window to develop essential enantiomerically pure pharmaceutical products with atom economy."

Journal

Clopidogrel with indobufen or aspirin in minor ischemic stroke or high-risk transient ischemic attack: a randomized controlled clinical study. (PubMed, BMC Neurol) - "The combination of indobufen and clopidogrel has shown non-inferior and potentially superior effectiveness and safety compared to aspirin combined with clopidogrel in patients with minor ischemic stroke and high-risk TIA in the CARMIA study (registered under chictr.org.cn with registration number ChiCTR2100043087 in 01/02/2021)."

Clinical • Journal • Cardiovascular • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Ischemic stroke • Myocardial Infarction • Vascular Neurology