After daily oral administration of crisdesalazine at 200 mg/kg (40 times the recommended dose for dogs) for 13 weeks, no significant differences were found between the crisdesalazine-treated dogs and the normal control group in vital signs (blood pressure, heart rate, etc.), electrocardiogram, ophthalmic examination, complete blood cell count, serum chemistry, urinalysis, or histological examination of other organs.
Additionally, no significant abnormalities were observed in our phase III clinical trial for CCDS approval, where similar tests were conducted on dogs.
In a comparison of gastrointestinal side effects following high doses of crisdesalazine and several NSAIDs (representative anti-inflammatory drugs) in rats, those treated with aspirin, ibuprofen, or celecoxib showed significant gastrointestinal bleeding. In contrast, rats treated with crisdesalazine, even at a dose of 1000 mg/kg (200 times the recommended dose), showed no gastrointestinal side effects.