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Dextran sulfate LOW molecular weight is an investigational substance that appears in the product records under the name ILB.[1] It is a specified substance group 1 product, meaning it belongs to a defined chemical group rather than being a single chemically synthesised small molecule or a protein-based substance.[1] The substance is classified in the therapeutic area of nervous system diseases.[1] It has no marketing authorisation in the product records, so it remains an investigational medicine at this stage.[1] The authorisation holder listed in the records is Oslo University Hospital.[1] Dextran sulfate LOW molecular weight has been developed by a Swedish company called TikoMed.[3]
The supplementary sources do not describe a specific molecular target or mechanism of action for ILB in ALS. The broader class of low molecular weight dextran sulfate products is described in a dosage guide as having uses in conditions related to blood flow and clotting, such as shock and venous thromboembolism, where it is given intravenously.[2] However, that guide describes a different formulation and set of indications from the subcutaneous ILB product being studied in ALS, and no mechanism of action for the ALS trial is stated in the provided sources.
In the registered trial, ILB is prepared as a solution for injection and is given by subcutaneous injection at a dose of 1 mg per kilogram of body weight.[1] This is a different route from the intravenous low molecular weight dextran products described in a separate dosage guide, which are used for other indications.[2]
There is one registered clinical trial for dextran sulfate LOW molecular weight in ALS. It is a Phase 2, randomised, double-blind, double-dummy study that compares ILB with riluzole, an authorised medicine for ALS.[1] The trial is currently authorised, and it plans to enrol 116 participants.[1]
The trial has two active arms: ILB given by subcutaneous injection at 1 mg/kg, and riluzole given as 100 mg oral film-coated tablets. Each arm also has a matching placebo, making the study double-dummy in design.[1]
The main thing the trial measures is the change in the Amyotrophic Lateral Sclerosis Functional Rating Scale (revised), known as the ALSFRS-R, from the start of the study to week 24. The ALSFRS-R is a scale that rates how well a person with ALS can carry out everyday functions such as speech, swallowing and movement.[1]
The trial is sponsored by Oslo University Hospital, and the substance appears as the test product in one trial record.[1] Dextran sulfate LOW molecular weight also has an orphan designation in one product record, which means it is being developed for a rare disease.[1]
The provided supplementary sources do not describe side effects for the ILB product being studied in ALS. A dosage guide for a different intravenous low molecular weight dextran product lists precautions but does not provide a side effect profile relevant to the subcutaneous ILB formulation in this trial.[2] No side effect data from the ALS trial are reported in the registry record.
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