amiselimod phosphate (investigational drug)

Action and Spectrum

Actions and Spectrum 

Actions and spectrum: 

Actions: Amiselimod phosphate specifically modulates the sphingosine 1-phosphate receptor. 

Spectrum: This might treat autoimmune, inflammatory, multiple sclerosis, and colitis. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Decreased count of lymphocytes 

Headache 

Cold 

Hemorrhoids 

Nausea 

Stomatitis 

Diarrhea 

Reduced weight 

Discomfort in chest 

Pain in the upper abdomen 

Frequency defined 

Nasopharyngitis (23.5%) 

Infections of the upper respiratory tract 

Black Box Warning

Black Box Warning 

No special black box warnings are available for this drug 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

Hypersensitivity 

Caution: 

Diabetes Miletus 

Pregnancy 

Basal cell carcinoma 

Pregnancy / Lactation

Pregnancy/Lactation 

Pregnancy consideration: 

USFDA pregnancy category: Not assigned 

Lactation: 

Safety and efficacy study is not established 

Pregnancy category: 

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There was a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

Amiselimod phosphate is an immunomodulatory drug currently in phase 3 of clinical trials 

Pharmacodynamics: 

It is a novel modulator of S1P1 (sphingosine 1-phosphate receptor-1), which is designed to possess less bradycardic effects due to various S1P receptor modulators and fingolimod 

Pharmacokinetics: 

Data on how it’s absorbed and distribution with amiselimod phosphate are not available. 

Metabolism 

Amiselimod phosphate passes hepatic metabolism. 

Elimination and excretion 

This drug is being studied due to its non-renal elimination mechanism. About 0.05% of the recommended medication is eliminated in urine. 

Half-life: 

404 hours 

Adminstartion

Administration: 

Amiselimod phosphate should be taken oral before or after eating. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: amiselimod phosphate 

Why do we use amiselimod phosphate? 

Amiselimod phosphate as a new immunomodulatory drug now in phase 2 clinical studies. The medicine is being researched for its effectiveness in treating ulcerative colitis, multiple sclerosis, bowel inflammation, systemic lupus erythematosus.