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 are investigational new drug formulations of the chemotherapy agent mitomycin, also known as mitomycin C, or MMC. The Company is developing our novel formulations as chemoablation agents, which means they are designed to ablate 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 investigational pipeline includes:

Cancer Chemoablation Therapy

UGN-101 is (formerly known as MITOGEL™) (mitomycin) urothelial gel, 0.4% , a novel formulation of mitomycin which provides slow release of the drug over time by using a proprietary hydrogel known as RTGel. It is administered locally via instillation into the Upper Tract and is under investigation as a first line chemoablation agent in the treatment of low-grade UTUC. UroGen is investigating the safety and efficacy of UGN-101 in an ongoing pivotal Phase 3 program. If the clinical trial demonstrates that the UGN-101 is safe and effective, then it could potentially spare patients from repeated tumor surgical procedures and reduce the need for kidney and upper urothelial tract removal.  FDA has granted Fast Track Status to the development of UGN-101 as an Orphan Drug for the treatment of LG-UTUC.

UGN-102 (VESIGEL™), (mitomycin) urothelial gel, 0.18%  is a novel  formulation of mitomycin which provides slow release of the drug over time by using a proprietary hydrogel known as RTGel. It is administered locally via instillation into the bladder and is under investigation as a first line chemoablation agent in the treatment of low-grade bladder cancer. UroGen will be conducting a Phase 2b program to further investigate the safety and efficacy of UGN-102 in the treatment of this condition.

Cancer Immunotherapy

UGN-201 is proprietary a toll-like receptor 7 (TLR7 agonist) designed to elicit a focused immune response to cancer. UroGen is developing a novel formulation of UGN-201 using RTGel Technology as an alternative strategy for the treatment of High Grade UTUC using local administration into the Upper Tract. UroGen will be conducting clinical research on UGN-201 in late 2018.

Overactive Bladder

BOTUGEL™ is a proprietary RTGel-based formulation of BOTOX®* (onabotulinumtoxin A) an investigational new drug being studied for the treatment of Overactive Bladder (OB) and Interstitial Cystitis (IC). UroGen has licensed the worldwide rights to BotuGel to Allergan Pharmaceuticals International Limited, or Allergan, a wholly owned subsidiary of Allergan plc.

* BOTOX is a registered trademark of Allergan Pharmaceuticals

RTGel Technology

RTGel is a proprietary hydrogel technology which has reverse thermal gelation properties with temperature dependent viscosity that allows gel instillation at lower temperatures in liquid form and solidification at body temperature. The hydrogel is formulated using FDA approved inactive ingredients and can be used to create a sustained release formulation for both new and existing drugs.