Clinical Development
A de-risked regulatory strategy
A smarter path to approval
The 505(b)(2) pathway allows SPORASTAT® to build upon decades of established clinical data, potentially reducing development costs by 70–90% compared with a traditional New Drug Application.
Pre-IND
Formulation finalized and supporting nonclinical data prepared for regulatory submission.
505(b)(2) NDA
Utilizes decades of published safety and efficacy data from established active ingredients.
FDA Review
FDA assesses safety, effectiveness, manufacturing quality, and overall submission integrity.
approval
Designed to support a more efficient and lower-risk route toward commercialization.
Four proven actives, decades of clinical confidence
Each active ingredient in SPORASTAT has been used in clinical practice for more than 30 years, contributing to a strong foundation of safety, efficacy, and physician familiarity.
Mupirocin
Inhibits bacterial protein synthesis; antibacterial against Staph/Strep including MRSA/MSSA.
Clotrimazole
Inhibits lanosterol 14α-demethylase (4–6+ weeks).
Terbinafine
Inhibits squalene epoxidase (4+ weeks).
Hydrocortisone
Anti-inflammatory, reduces erythema, edema, itching; used for eczema, contact dermatitis, insect bites, poison ivy, inflammation.
