indobufen / Pfizer - LARVOL DELTA

Suspected NIUAA after indobufen in a patient with ibuprofen allergy: a case report suggesting possible cross-reactivity. (PubMed, Front Pharmacol) - "Subsequent continued use of other concomitant medications, along with antiplatelet therapy with clopidogrel and cilostazol, did not elicit any allergic reactions; this case suggests indobufen as a possible culprit allergen, and its shared COX-1 inhibitory mechanism with ibuprofen-despite their different chemical groups-raises the possibility of cross-reactive hypersensitivity between the two agents, although this inference remains to be confirmed. Although allergic reactions to indobufen are rare in clinical practice, clinicians should remain vigilant about the potential risk of cross-reactivity when prescribing indobufen to patients with a history of NSAID hypersensitivity."

Journal • Allergy • CNS Disorders • Dermatology • Immunology • Pruritus

Indobufen-based dual antiplatelet therapy after percutaneous coronary intervention: A systematic review and network meta-analysis. (PubMed, J Int Med Res) - "The significant between-strategy differences concerned others: aspirin plus ticagrelor showed higher major bleeding (2.07, 1.46-2.94) and clopidogrel monotherapy lower (0.38, 0.22-0.64). Its relative position against other contemporary bleeding-reduction strategies remains unproven. These results reinforce the need for individualised antiplatelet therapy guided by patient-specific ischaemic and bleeding risk.INPLASY registration number: INPLASY202680037."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

One-year clinical outcomes of aspirin versus indobufen in patients with NSTEMI: a multicenter retrospective cohort study (ESC 2026) - "In this real-world NSTEMI population, aspirin was associated with superior 1-year survival and a more favorable bleeding safety profile compared with indobufen. The survival advantage of aspirin appears particularly evident when used in combination with clopidogrel."

Clinical data • Retrospective data • Cardiovascular • Hypertension • Myocardial Infarction

Indobufen Versus Aspirin After CABG for Unstable Angina in Patients Aged 70 Years and Older. (PubMed, J Cardiovasc Dev Dis) - "In this real-world cohort of older patients undergoing CABG for unstable angina, an initial indobufen-based discharge pathway was not statistically significantly associated with 24-month MACCE, BARC grade ≥2 bleeding, or NACE compared with an aspirin-based pathway after stabilized IPTW. These findings add exploratory CABG-specific data on indobufen in older patients and should be confirmed in larger prospective studies."

Journal • Cardiovascular • Myocardial Infarction

Differential myocardial responses to indobufen and aspirin across clinical and experimental models of myocardial infarction. (PubMed, Eur J Pharm Sci) - "These findings suggest that indobufen may exert myocardial protective effects beyond platelet inhibition, potentially through AKT/AMPK-associated regulation of autophagy, apoptosis, and fibroblast activation. These findings provide a rationale for further investigation of indobufen as a potential alternative antiplatelet strategy in myocardial infarction."

Journal • Cardiovascular • Fibrosis • Immunology • Metabolic Disorders • Myocardial Infarction • IL10 • IL12A • IL1B • TNNI3

Indobufen-based dual antiplatelet therapy in patients undergoing PCI: a systematic review and meta-analysis. (PubMed, Front Pharmacol) - "Subgroup analyses across ACS status and specific P2Y12 inhibitors (clopidogrel or ticagrelor) consistently supported these findings. For patients undergoing PCI, an indobufen-based DAPT regimen appears to reduce bleeding risk while offering comparable MACE prevention relative to conventional aspirin-based DAPT. However, these findings should be interpreted cautiously due to existing limitations."

Journal • Retrospective data • Acute Coronary Syndrome • Cardiovascular • Gastroenterology

A Simple and Accurate LC-MS/MS Method for the Determination of Indobufen in Human Plasma and Its Clinical Application. (PubMed, J Anal Methods Chem) - "For patients with severe renal insufficiency, the dosage should be reduced to 1/3-1/4 of the standard dose. For patients undergoing continuous renal replacement therapy (CRRT), indobufen can be gradually eliminated, and most patients do not require dose adjustment."

Journal • Nephrology • Renal Disease

Effect of indobufen combined with clopidogrel on efficacy and blood TGF-β and IL-6 expression after percutaneous transluminal angioplasty of arteriovenous fistula. (PubMed, Medicine (Baltimore)) - "Indobufen combined with clopidogrel can more effectively improve early postoperative efficacy and AVF function after AVF-PTA, significantly suppress the expression of inflammatory factors, and reduce the risk of short- to medium-term restenosis. Its mechanism may be related to synergistic antiplatelet and anti-inflammatory effects."

Journal • Retrospective data • Cardiovascular • IL6 • TGFB1

Efficacy and safety of indobufen- versus aspirin-based dual antiplatelet therapy following percutaneous coronary intervention: a systematic review and meta-analysis. (PubMed, Ann Med Surg (Lond)) - "Indobufen demonstrates comparable antiplatelet efficacy to aspirin while improving safety. Further large-scale, high-quality RCTs are warranted to solidify evidence and inform future guidelines, particularly to assess the role of indobufen in patients at high bleeding risk."

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

Efficacy and safety of treatment strategies for early neurological deterioration after acute ischemic stroke: a network meta-analysis of randomized controlled trials. (PubMed, BMC Neurol) - "Indobufen was associated with lower mean 90-day mRS and NIHSS scores, whereas tirofiban added to standard antiplatelet therapy increased the proportion of patients achieving a favorable functional outcome defined as mRS 0-2. Neither tirofiban nor argatroban significantly increased the proportion achieving an excellent functional outcome defined as mRS 0-1. These findings should be interpreted cautiously because of the limited number and size of the included trials."

Journal • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Efficacy and Safety of Indobufen, Aspirin, Cilostazol and Clopidogrel in the Treatment of Ischemic Stroke (clinicaltrials.gov) - P=N/A | N=2000 | Not yet recruiting | Sponsor: Nanfang Hospital, Southern Medical University

New trial • Cardiovascular • Ischemic stroke

Tirofiban-Associated Profound Thrombocytopenia in a Patient With Glucose-6-Phosphate Dehydrogenase Deficiency Undergoing Primary Percutaneous Coronary Intervention: A Case Report. (PubMed, Case Rep Cardiol) - "He received aspirin, ticagrelor, and unfractionated heparin...Clopidogrel was restarted at 48 h, followed by indobufen at 72 h...This case supports tirofiban-associated acute profound thrombocytopenia as the most likely diagnosis and underscores the importance of prompt drug withdrawal, structured differential diagnosis against heparin-induced thrombocytopenia, and individualized antithrombotic reinitiation. The contribution of G6PD deficiency remains hypothetical and requires further study."

Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Metabolic Disorders • Myocardial Infarction • Septic Shock • Thrombocytopenia • Thrombosis

Design, synthesis and bioactivity of indobufen derivatives. (PubMed, RSC Adv) - "In a RANKL-induced RAW264.7 osteoclastogenesis model, A1 inhibited osteoclast maturation at non-cytotoxic concentrations, markedly reducing the expression of osteoclast functional proteins (MMP9 and cathepsin K) and disrupting F-actin ring formation and multinucleation. Collectively, these findings demonstrate that indobufen scaffold modification can yield small molecules with dual anti-inflammatory and anti-osteoclastogenic activities and highlight A1 as a promising lead compound for the development of therapeutics targeting osteoporosis and inflammation-associated bone loss."

Journal • Inflammation • Osteoporosis • Rheumatology • CTSK • MMP9

Indobufen Versus Aspirin as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement(INDO-TAVR): A Randomized, Open-Label Clinical Trial (ChiCTR) - P=N/A | N=510 | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New trial • Cardiovascular

Indobufen versus Aspirin After CABG in Septuagenarians: A Propensity Score-Matched Cohort Study. (PubMed, Clin Interv Aging) - "Patients aged 70-79 years who underwent CABG between 2020 and 2022 received either indobufen- or aspirin-based dual antiplatelet therapy (DAPT) (with clopidogrel) for 12 months, followed by monotherapy with their respective baseline agent (indobufen or aspirin) for an additional year. For individuals with a high bleeding risk or aspirin intolerance, indobufen may represent a practical alternative. Larger prospective studies focusing on geriatric outcomes are warranted."

Clinical • Journal

Indobufen versus aspirin in dual antiplatelet therapy: a retrospective study of effects on serum uric acid levels and gout attacks in patients post-coronary stenting. (PubMed, PeerJ) - "This retrospective study compared the effects of indobufen versus aspirin, each combined with clopidogrel, on serum uric acid (SUA) levels and gout attacks in patients undergoing coronary stenting. Cardiovascular safety profiles were comparable between groups. Indobufen plus clopidogrel significantly reduced SUA levels and showed a favorable trend in reducing gout recurrences without compromising cardiovascular safety."

Clinical • Journal • Retrospective data • Cardiovascular • Gout • Inflammatory Arthritis • Rheumatology

Indobufen versus aspirin for platelet inhibition: efficacy and safety insights from the INSURE and OPTION trials. (PubMed, J Thromb Thrombolysis) - No abstract available

Journal

The impact of preoperative anticoagulant administration on postoperative coagulation function and blood loss following posterior lumbar interbody fusion: a case-control study. (PubMed, Front Med (Lausanne)) - "Patients who used anticoagulants [low-molecular-weight heparin (LMWH) or indobufen] preoperatively were recorded as the observation group (n = 29), and those who did not were recorded as the control group (n = 32)...There were no significant differences in HB, RBC, and HCT between the two groups on the postoperative 1st, 4th, 7th, and last-tested days (p > 0.05). The use of anticoagulants before PLIF has no significant effect on postoperative TT, FIB, APTT, and PLT (except for PT), and does not significantly affect blood loss."

Journal • Cardiovascular • Hematological Disorders • Thrombosis

INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT) (clinicaltrials.gov) - P=N/A | N=2500 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Vascular Neurology

OPTION2: IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome (clinicaltrials.gov) - P4 | N=2846 | Recruiting | Sponsor: Shanghai Zhongshan Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ Dec 2028 | Trial primary completion date: May 2026 ➔ Dec 2028

Enrollment open • Trial completion date • Trial primary completion date • Acute Coronary Syndrome • Cardiovascular • Coronary Artery Disease

Clopidogrel-induced drug-induced hypersensitivity syndrome following percutaneous coronary intervention: a case report of therapeutic dilemma and management strategy. (PubMed, Front Pharmacol) - "The patient was successfully managed with indobufen and low dose corticosteroids, resulting in complete symptom resolution. This case highlights the diagnostic complexity of clopidogrel-induced DIHS and presents the detailed account of successful management of it. Early recognition using standardized diagnostic criteria and multidisciplinary management are crucial for patient outcomes."

Journal • Allergy • Cardiovascular • Dermatology • Eosinophilia • Gastroenterology • Hematological Disorders • Hypotension • Immunology • Thrombosis

The Efficacy and Safety of Indobufen-Based DAPT in ACS Patients with a History of Gastrointestinal Damage Undergoing PCI: A Single-Center, Observational Study. (PubMed, Clin Appl Thromb Hemost) - "Concurrently, the composite of clinically significant adverse gastrointestinal events has been designated as a composite endpoint comprising peptic ulcer disease and gastrointestinal hemorrhage.ResultsIndobufen significantly reduced the incidence of the composite of major adverse gastrointestinal events (25.6% vs 39.4%, HR = 0.58, 95% CI:0.36-0.94, P = 0.026) and the composite of clinically significant adverse gastrointestinal events (18.9% vs 33.3%, HR = 0.53, 95% CI:0.30-0.90, P = 0.020) compared to aspirin. There was no significant difference in major adverse cardiovascular events (MACE) incidence between the two groups (4.4% vs 6.7%, P = 0.400).ConclusionIn conclusion, compared with aspirin, the use of indobufen-based DAPT was associated with a lower incidence of the composite of major adverse gastrointestinal events, which was mainly driven by a reduction in the clinical symptoms and an improvement in quality of life."

Journal • Observational data • Retrospective data • Acute Coronary Syndrome • Cardiovascular • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Peptic Ulcer

Indobufen ameliorates ischemic stroke by suppressing the signal transducer and activator of transcription 1/NIMA-related kinase 7/NOD-like receptor family pyrin domain-containing 3 signaling axis. (PubMed, Neuroreport) - "IND downregulated STAT1 to inhibit STAT1-mediated transcriptional activation of NEK7, thereby reducing NLRP3 inflammasome activation and ultimately mitigating neuronal pyroptosis in ischemic stroke."

Journal • Cardiovascular • Ischemic stroke • IL18 • NLRP3 • STAT1

Indobufen Dual Antiplatelet Therapy (DAPT) Versus Aspirin Dual Antiplatelet Therapy (DAPT) After Percutaneous Coronary Intervention (PCI): A Systematic Review and Meta-Analysis. (PubMed, Catheter Cardiovasc Interv) - "Indobufen-based (DAPT) had a lower incidence of bleeding than aspirin-based (DAPT), with no difference between the two groups for MACCE, myocardial infarction, ischemic stroke, cardiovascular death, repeat vascularization, or stent thrombosis."

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

The efficacy and safety of indobufen versus aspirin in patients with acute myocardial infarction: a retrospective observational study. (PubMed, Expert Rev Clin Pharmacol) - "Boruta and SHAP analyses identified antiplatelet therapy, particularly aspirin, as a predictor of GUSTO mild bleeding. Indobufen may be considered an alternative antiplatelet therapy for AMI patients with a high bleeding risk and/or aspirin intolerance/hypersensitivity, however, prospective studies are needed to confirm these findings."

Journal • Observational data • Retrospective data • Cardiovascular • Congestive Heart Failure • Diabetes • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Immunology • Metabolic Disorders • Myocardial Infarction • Peptic Ulcer • Type 2 Diabetes Mellitus