SDD - 098
Minocycline is one of the largest selling oral antibiotics in USA for Acne. However, oral minocycline has various side effects. SPARC has formulated a novel topical Minocycline, which is expected to provide better bioavailability at the site of action with reduced systemic exposure. This may potentially lead to a better safety profile.
In the pre-clinical proof-of-concept study in the Acne model, the topical formulation demonstrated similar activity to marketed Clindamycin topical gel.
SPARC has completed toxicity study in rabbits while toxicity study in mini-pigs is ongoing.
Pre-IND meeting has been completed with USFDA and IND filing is expected by Q4 FY19
SPARC aims to file NDA by Q1 FY24