Drug intelligence / Profile preview

simvastatin + vitamin D3

Development stage
Unknown
Lead developer
Rami Burstein
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules
Administration
Oral
01

Overview

This combination therapy consists of simvastatin, a small molecule HMG-CoA reductase inhibitor (statin), and vitamin D3 (cholecalciferol). Investigated by Dr. Rami Burstein at Beth Israel Deaconess Medical Center and Harvard Medical School, the regimen involves 20 mg of simvastatin and 1000 IU of vitamin D3 taken twice daily. The therapy is intended for the prophylactic treatment of episodic migraine in adults, leveraging the potential synergistic anti-inflammatory and immunomodulatory effects of both components. A Phase 2 clinical trial demonstrated that participants using this combination experienced significantly fewer migraine days compared to placebo, with a responder rate of 29% at 24 weeks. This approach represents an investigational use of existing generic medications rather than a novel branded drug product.

Other names
simvastatin and vitamin D3 for migrainesimvastatin and vitamin D for migraine prophylaxissimvastatin and vitamin D3
02

Targets

CYP3A4 (Cytochrome P450 3A4)HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase)

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