BHR-100

BHR-100 is a proprietary intravenous lipid emulsion formulation of progesterone developed by BHR Pharma, LLC for the treatment of severe traumatic brain injury (TBI). Progesterone is a neurosteroid that acts as a neuroprotective agent through multiple mechanisms, including stabilization of the blood-brain barrier, reduction of cerebral edema, down-regulation of inflammatory cytokines, and inhibition of apoptosis and necrosis. Despite promising early-phase data, BHR-100 failed to demonstrate clinical benefit in the large-scale Phase 3 SyNAPSe trial, which compared a 120-hour continuous infusion of the drug to a placebo lipid emulsion in patients with severe TBI. The drug received orphan drug designation from both the U.S. FDA and the European Medicines Agency for the treatment of moderate and severe TBI before development was halted following the Phase 3 results.

Other names

intravenous progesteroneprogesterone lipid emulsion