Drug intelligence / Profile preview

DMI-4983 (danazol)

Development stage
Phase 2
Lead developer
Ampio Pharmaceuticals
Modality
Small Molecules
Administration
Oral
01

Overview

Danazol (DMI-4983) is an ultra-low dose oral formulation of the synthetic steroid danazol, a derivative of ethisterone. Originally developed by DMI BioSciences and later by Ampio Pharmaceuticals, DMI-4983 was designed to repurpose danazol—traditionally used at high doses for endometriosis—at significantly lower doses (typically 15-45 mg) for the treatment of inflammatory vascular conditions. Its primary development focus was **diabetic macular edema (DME)** and **diabetic retinopathy**, where it is thought to stabilize the blood-retinal barrier and reduce vascular permeability by inhibiting the release of pro-inflammatory cytokines and modulating endothelial cell function. The same low-dose formulation was also investigated under the name **Zertane** for the treatment of premature ejaculation and other conditions such as muscle spasms and pain.

Brand names
OptinaZertane
Other names
low-dose danazolultra-low dose danazol
02

Targets

AR (Adrenergic receptors)GR (Glucocorticoid receptor)PR (Progesterone receptor)

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