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isosorbide mononitrate (Mono Mack 50D / Mono Mack)

✓ Approved

Novartis AG · Small Molecule · Small Molecule

What is isosorbide mononitrate?

isosorbide mononitrate is a small molecule developed by Novartis AG. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesMono Mack 50D, Mono Mack
CompanyNovartis AG
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Novartis AG

Therapeutic Indications

isosorbide mononitrate is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Cardiac disordersAngina pectoris✓ Approved

Related Research Articles

PubMedKyobu geka. The Japanese journal of thoracic surgery2026-11-05

[Coronary Artery Bypass Grafting for Right Coronary Artery Spasm During Mitral Valve Repair With Cryoablation:Report of a Case].

Goto Hiroshi H, Takagi Hisato H

A 64-year-old man with medical histories of diabetes, hypertension, and Basedow's disease complained of dyspnea on effort and lower-extremity edema. The patient underwent mitral valve repair and tricuspid annuloplasty for severe regurgitation, cryoablation (Cox-maze IV) and left atrial-appendage closure for atrial fibrillation, and coronary artery bypass grafting to the left anterior-descending branch using the left internal-thoracic artery. Cardiopulmonary bypass was unable to be weaned, and transesophageal echocardiography revealed inferolateral wall-motion impairment. After aortic re-clamping, additional bypass grafting to the posterior descending branch using the great saphenous vein was performed. The wall motion was slightly improved, and cardiopulmonary bypass could be weaned using intraaortic balloon pumping. Coronary angiography was performed immediately after the surgery and detected diffuse right coronary artery spasm. Isosorbide dinitrate was directly injected into the right coronary artery, and the spasm was improved. Bypass grafting for coronary artery spasm might be beneficial to increase coronary blood flow.

PMID 42987961
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PubMedEuropean heart journal2026-11-04

Hydralazine-isosorbide dinitrate in chronic heart failure with reduced ejection fraction: the H-HeFT trial.

Køber Lars L, Skak-Hansen Kim Wadt KW, Larsen Anders Hostrup AH, Vraa Søren S et al.

Hydralazine-isosorbide dinitrate (H-ISDN) has shown benefit in earlier randomized trials of patients with reduced left ventricular ejection fraction (LVEF) and chronic heart failure. This trial tested if H-ISDN could reduce worsening heart failure or mortality in patients with chronic heart failure with reduced ejection fraction (HFrEF) receiving contemporary treatment. The Hydralazine-Isosorbide Dinitrate in Patients With Chronic Heart Failure Trial (H-HeFT) was a multicentre, randomized (1:1), double-blind, placebo-controlled trial in patients with HFrEF at 23 Danish hospitals (New York Heart Association class II-IV, elevated N-terminal pro-B-type natriuretic peptide and LVEF ≤40%). Target treatment was hydralazine 75 mg/isosorbide dinitrate 40 mg three times a day (t.i.d). The primary endpoint was a composite of hospitalization with worsening heart failure, an urgent outpatient visit resulting in intravenous/metolazone therapy for heart failure, heart transplantation, left ventricular assist device implantation, or death. Secondary endpoints included components of the primary outcome. Overall, 592 predominantly White patients (median age 72 years, 18% women) were randomized with a mean follow-up of 3.7 years. The primary outcome occurred in 90 of 294 patients (30.6%) in the H-ISDN group and in 91 of 298 patients (30.5%) in the placebo group [hazard ratio (HR) 0.90; 95% confidence interval (CI) 0.67-1.21; P = .48]. There were 57 deaths in the H-ISDN group vs 72 in the placebo group (HR 0.72; 95% CI 0.51-1.02); worsening heart failure events occurred in 52 vs 47 patients (HR 1.01; 95% CI 0.68-1.50). Hydralazine-isosorbide dinitrate did not change the incidence of the composite endpoint of heart failure events or death in patients with heart failure and LVEF ≤40%.

PMID 42978512
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PubMedPharmaceutics2026-10-27

3D-Printed Gastroretentive Floating Modified-Release Device for Dual Cardiovascular Drug Delivery: Isosorbide Dinitrate and Hydralazine.

Jaiseri Dareena D, Pengnam Supusson S, Opanasopit Praneet P, Suriyaamporn Phuvamin P et al.

Background: Isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HDZ) are dual cardiovascular drugs used to treat heart failure. However, the drugs have limitations such as short plasma half-life, low bioavailability, and potential for tolerance of the nitrate component. To address the need for prolonged drug release, a floating dual-compartment drug delivery system was developed to provide controlled drug release under simulated gastric dissolution conditions. Objectives: This study aimed to develop floating dual-compartment devices (FDCDs) to contain ISDN and HDZ gel and modify drug release under simulated gastric conditions. Methods: The FDCD was designed in a cylindrical shape consisting of an air chamber on the upper part for floating ability, and two compartments for loaded drug gel and controlling the drug release rate. Fused deposition modeling (FDM) was selected to fabricate FDCDs using polylactic acid (PLA) filament. The ISDN formulation varied the ratio of polyvinylpyrrolidone (PVP) to achieve drug release for 12 h. The HDZ formulation was optimized by varying the ratio of PVP and hydroxypropyl methylcellulose (HPMC) to extend drug release at 24 h. Results: The shape dimension and weight variation in the FDCDs showed low standard deviation (SD). FDCDs exhibited immediate floating, resisted overturning, and demonstrated in vitro floating ability for more than 24 h. The formulation ISDN3 at a PVP: drug: water ratio of 5:2:3 exhibited complete release at 12 h, while the formulation of HDZ1 at an HPMC: PVP: drug: water ratio of 0.3:2.5:2:5.2 showed complete release within 24 h. The ISDN3- and HDZ1-loaded FDCDs demonstrated prolonged release behavior, with ISDN and HDZ release profiles showing the best fit to the zero-order and Higuchi models, respectively, based primarily on the coefficient of determination (R2), while root mean square error (RMSE) was used as a complementary measure of fitting error. Conclusions: These findings suggest that the developed dual-drug-loaded FDCD has potential as a dual-drug oral delivery platform for simultaneous delivery of ISDN and HDZ with prolonged drug release characteristics and further development of oral combination drug delivery systems.

PMID 42942809
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PubMedPreparative biochemistry & biotechnology2026-10-23

Biomimetic mineralization in layered ZIF-8 enables lipase immobilization for the synthesis of isosorbide dihexanoate.

Kong Lingwen L, Long Huiyi H, Zhou Yuyang Y, Zhou Hua H

Immobilization of lipases in metal-organic frameworks offers a potential route for developing robust biocatalysts for ester synthesis, but achieving efficient enzyme incorporation within structurally favorable hosts remains challenging. Here, we report a biomimetic mineralization strategy based on layered ZIF-8 for immobilization of Candida antarctica lipase B (CALB) and evaluate the resulting biocatalyst for the synthesis of isosorbide dihexanoate (SDH). Under optimized immobilization conditions, namely a CALB dosage of 1 mL, a Zn2+/2-methylimidazole molar ratio of 1:3, and a mineralization time of 6 h, CALB@mZIF-8 exhibited a protein loading of 201.50 mg/g and an activity of 36.71 U/g. The protein loading was higher than that obtained by conventional adsorption-based immobilization using ZIF-8. Applied to SDH synthesis in a 10 mL reaction system containing n-hexane (10%, v/v) as co-solvent, 0.4 g CALB@mZIF-8, an isosorbide-to-hexanoic acid molar ratio of 1:6, agitation at 150 rpm and 40 °C, the SDH yield reached 65.03%. Compared with free CALB, the immobilized biocatalyst exhibited enhanced operational stability and improved tolerance toward different reaction environments. These results demonstrate that layered ZIF-8 generated through biomimetic mineralization provides a tunable platform for lipase immobilization and represents a promising strategy for the synthesis of sterically hindered bio-based esters.

PMID 42908347
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PubMedChemPlusChem2026-10-19

Tunable Acidity of Sulfated Zr-Sn Mixed Oxides for Solvent-Free Sorbitol Dehydration to Isosorbide.

Trivedi Jay B JB, Rana Paresh H PH

One of the most important processes in creating sustainable monomers for high-performance polymers is the catalytic dehydration of sorbitol obtained from biomass to isosorbide. This study investigated a series of sulfated ZrxSn1 - xO2 (x = 0.1-0.9) mixed oxides prepared by coprecipitation method for sorbitol dehydration under solvent-free conditions. Comprehensive evaluation of different characterization techniques, i.e., X-ray diffraction, Fourier transform infrared, transmission electron microscope, N2 physisorption, and NH3-TPD demonstrated that surface acidity, textural characteristics, and catalytic activity were greatly affected by catalyst composition. Catalyst with intermediate Zr content (0.4-0.6) had an ideal balance of weak, medium, and strong Brønsted acid sites, which resulted in complete conversion of sorbitol and higher isosorbide selectivity. 100% sorbitol conversion and 87% isosorbide selectivity were achieved with sulfated (S)-Zr0.5Sn0.5O2 at 220 °C within 3 h, exceeding many reported heterogeneous solid acids catalyst. A minor loss in catalyst activity was observed after four cycles, showing its potential for long-term isosorbide production.

PMID 42897100
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PubMedInternational journal of stroke : official journal of the International Stroke Society2026-10-19

Vascular dementia and vascular cognitive impairment-current treatments and future prospects.

Markus Hugh S HS

Vascular cognitive impairment (VCI) and vascular dementia (VaD) represent a substantial and growing global health burden, yet remain under-recognized and comparatively under-researched. Two broad categories are post-stroke cognitive impairment, and VCI secondary to chronic cerebrovascular disease of which the most common cause is cerebral small vessel disease (SVD). In addition, cerebrovascular pathology frequently coexists with Alzheimer's disease (AD), increasing the probability that AD pathology will manifest as clinical dementia. Current management focuses primarily on prevention through modification of cardiovascular risk factors and lifestyle interventions. Intensive blood-pressure control has shown the strongest evidence, reducing future all-cause dementia while slowing progression of white-matter abnormalities. Multidomain lifestyle interventions incorporating exercise, diet, cognitive training, and vascular risk monitoring may also preserve cognition, although results across trials remain variable. In established VCI and VaD, treatment options are limited; cholinesterase inhibitors and memantine lack convincing evidence of benefit, and no pharmacological therapy has definitively demonstrated symptomatic improvement or delayed disease progression. Advances in understanding SVD and VCI pathophysiology are, however, identifying promising therapeutic targets. Emerging evidence highlights endothelial dysfunction, impaired cerebral autoregulation, increased blood-brain barrier permeability, inflammation, and glymphatic dysfunction as possible mechanisms underlying SVD. Current trials are evaluating treatment approaches based on this framework including cerebral vasodilators such as cilostazol, isosorbide mononitrate and phosphodiesterase-5 inhibitors, anti-inflammatory therapies, glucagon-like peptide-1 receptor agonists, remote ischemic conditioning, and strategies targeting glymphatic function. Improved mechanistic understanding, appropriately targeted interventions, and adequately powered long-term clinical trials are required to translate these emerging approaches into effective treatments for VCI and VaD.

PMID 42894468
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