Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

Phase 1 Completed 30 enrolled Santhera Pharmaceuticals

RandomizedParallel-groupOpen-labelOther

Summary

To evaluate if the trial drug vamorolone is able to block a specific receptor in the body called mineralocorticoid receptor. This receptor helps to regulate salt and water balance.

Timeline

Start: 2024-06-05
Primary completion: 2024-06-29
Completion: 2024-07-06

Publications

de Vera A, Clemens PR, Dang UJ, Dutreix C, Gresko E, Guglieri M, Hagerty L, Hasham S, Damsker J, Hathout Y, Linden A, Berglund A, Tobin R, Wahbi K, Hoffman EP. Mineralocorticoid receptor antagonism of vamorolone: Evidence from LIONHEART and VISION-DMD clinical trials. Steroids. 2025 Nov;223:109689. doi: 10.1016/j.steroids.2025.109689. Epub 2025 Sep 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Eplerenone	Unknown	200 mg	—
Subject	Vamorolone	Small molecule	20 mg/kg	—
Background	Fludrocortisone	Other / unclassified	0.1 mg	—

Indications

No indication recorded.