Pipeline

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.

 

MitoGel™

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™ 

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™ 

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™,

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.