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# FDA ‘Fast Track’ for UroGen’s MitoGel
- URL: https://www.fdaweb.com/fda-fast-track-for-urogens-mitogel/
- Published: 2017-08-29T12:00:00.000Z
- Updated: 2026-09-14T22:44:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139501

FDA has granted UroGen Pharma a fast track designation for MitoGel and its use in treating patients with low-grade upper tract urothelial carcinoma. The product is currently being evaluated in the ongoing, single-arm, open-label, pivotal Phase 3 OLYMPUS clinical trial. There are currently no drugs approved by FDA for treating the condition.

MitoGel uses UroGen’s RTGel proprietary sustained release, hydrogel-based formulation to enable longer exposure of mitomycin C to the urinary tract tissue, the company says. It is designed to be administered to patients using standard intravesical catheters.