Our Drug Candidates

UroGen Pharma is a clinical-stage biopharmaceutical company focused on developing novel therapies designed to change the standard of care for urological pathologies with a focus on uro-oncology. The lead product candidates, MitoGel and VesiGel, are proprietary formulations of the chemotherapy drug Mitomycin C, or MMC, a generic drug which is currently used off-label for urothelial cancer treatment in a water-based formulation as an adjuvant, post-surgery, therapy. The Company is developing our product candidates as chemoablation agents, which means they are designed to remove tumors by non-surgical means, to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial carcinoma, or UTUC, and low-grade bladder cancer.  The Company’s clinical stage pipeline includes Vesimune, its proprietary immunotherapy product candidate for the treatment of high-grade non-muscle invasive bladder cancer. Vesimune is a novel, liquid formulation of Imiquimod, a generic toll-like receptor 7, or TLR7, agonist.   In addition, BotuGel is a proprietary novel RTGel-based formulation of BOTOX, a branded drug, that the Company believes can potentially serve as an effective treatment option for patients suffering from overactive bladder. UroGen has licensed the worldwide rights to BotuGel, a proprietary novel RTGel-based formulation of BOTOX, a branded drug, to Allergan Pharmaceuticals International Limited, or Allergan, a wholly owned subsidiary of Allergan plc.



MiroGel is a sustained release formulation of the chemotherapy agent Mitomycin C for the treatment of low-grade upper tract urothelial carcinoma (UTUC), an urothelial cancer in the upper tract. UroGen has received Orphan Drug Designations from the FDA for MitoGel for the treatment of UTUC.


VesiGel is a sustained release formulation of a high dose Mitomycin C for the treatment of low grade non-muscle invasive bladder cancer (LG-NMIBC).


Vesimune is a new formulation of the TLR7 agonist Imiquimod for local intravesical delivery for the treatment of Carcinoma In-Situ (CIS), a high-grade form of NMIBC. UroGen has received Orphan Drug Designation from the FDA for Vesimune for the treatment of CIS.


BotuGel is a novel intravesical sustained release formulation of botulinum toxin for Overactive Bladder (OAB) and Interstitial Cystitis (IC).  The Company recently licensed the BotuGel program to Allergan for further development.