Drug intelligence / Profile preview

fluorouracil (Spear Pharmaceuticals)

Development stage
Approved
Lead developer
Assertio
Modality
Small Molecules
Administration
Topical
01

Overview

Fluorouracil 0.5% cream is a topical antimetabolite developed by Spear Pharmaceuticals as a generic equivalent to Carac. It is indicated for the treatment of actinic keratosis (AK) on the face and anterior scalp. The formulation utilizes a patented Microsponge delivery system, which consists of porous microscopic spheres that entrap the active ingredient, allowing for controlled release. This technology is designed to reduce skin irritation and limit systemic absorption while maintaining efficacy with once-daily application. As a pyrimidine analog, fluorouracil inhibits thymidylate synthase, disrupting DNA synthesis and leading to the death of rapidly proliferating precancerous cells. Spear Pharmaceuticals also produces a 5% fluorouracil cream, which is a generic version of Efudex.

Other names
5-fluorouracil5-FU
02

Targets

TS (Thymidylate synthase)

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