Dosing regimen for a selective S1P1 receptor agonist (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-o-tolyl-thiazolidin-4-one
Disclosed herein is the use of (R)-5-[3-Chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylimino)-3-o-tolyl-thiazolidin-4-one (Compound 1), or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for oral administration for use in the treatment and/or prevention of diseases or disorders associated with an activated immune system wherein the diseases or disorders are selected from the group consisting of rejection of transplanted organs, graft-versus-host diseases brought about by stem cell transplantation, autoimmune syndromes, atopic diseases, asthma, type I diabetes, post-infectious autoimmune diseases, solid cancers, tumor metastasis, multiple sclerosis and psoriasis, whereby said medicament is to be administered to a subject in such a way that during the initial treatment phase Compound 1 is administered at an initial dose that is between 2- to 5-fold lower than the target dose, until no further acute heart rate reduction occurs, wherein acute heart rate reduction refers to a heart rate decrease from pre-dose values of 10 or more beats per minute (bpm) that is maximal within 1-3 hours after drug administration, followed by dose up-titration to the target dose, wherein the target dose is 20-40 mg of Compound 1 to be administered p.o. once daily, whereby the dose below the target dose is to be administered at a dosing frequency of once or twice daily and whereby dose up-titration to the target dose is to be done in one or several dose increments.
