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Isosorbide 5 mononitrate (ISMN) is an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN). It is a vasodilator, meaning it widens blood vessels, with effects on both arteries and veins.[2] The substance is a chemically synthesised small molecule, classified under ATC code C01DA14 as isosorbide mononitrate. It is already authorised as a medicine in Finland, where it is sold under the trade name Ismox 20 mg tablet.[1] The authorisation holder is Esteve Pharmaceuticals GmbH.[1]
The principal pharmacological action of ISMN and all organic nitrates is relaxation of vascular smooth muscle, producing dilatation of peripheral blood vessels. This widening of blood vessels reduces the workload on the heart and improves blood flow.[2] In the glaucoma trial, the medicine is being studied because it may improve blood flow to the optic nerve head, which could help protect the nerve even when eye pressure is normal.[1]
Isosorbide 5 mononitrate is given as a tablet taken by mouth. The glaucoma trial uses Ismox 20 mg tablets.[1] Extended-release formulations containing 30 mg, 60 mg or 120 mg of isosorbide mononitrate are also available for oral administration.[2] In the earlier cirrhosis study, a dose of 20 mg three times daily was used.[3]
One trial in the registry is investigating isosorbide 5 mononitrate. The Phase 3 trial for normal tension glaucoma is authorised and plans to enrol 100 participants.[1] The trial compares the medicine against another tablet with the product code YA 80746. The primary outcome is the change in retinal nerve fibre layer thickness around the optic nerve head, measured with optical coherence tomography, from the start of treatment to 18 months. Measurements at 6 and 12 months are interim time points, not final endpoints.[1] The trial also examines visual field changes and whether the medicine improves blood flow to the optic nerve head when used alongside standard local eye treatments.[1]
The provided sources do not include a detailed patient-oriented side effect list for isosorbide 5 mononitrate. However, one long-term study in cirrhosis reported that patients assigned to isosorbide-5-mononitrate had a higher likelihood of death than those assigned to propranolol, but only in patients older than 50 years (72% vs 48% at 6 years).[3] The likelihood of death without bleeding was also higher in the isosorbide-5-mononitrate group.[3] This finding comes from a different condition and patient population than the glaucoma trial, so it may not apply to people with normal tension glaucoma.
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