Man in lab with beaker

A pipeline for new possibilities in uro-oncology

We are on the cutting edge of urologic treatment advances with our investigational product candidates, which offer the potential to upend the status quo and open up new avenues in treating patients with urologic conditions.

Our Current Pipeline

URO-ONCOLOGY

Nonclinical

Phase 1

Phase 2

Phase 3

Registration

Unmet Need

Bladder cancers are described as muscle invasive or non-muscle invasive based on whether they have invaded into the wall of the bladder. Of the more than 80,000 new cases of bladder cancer diagnosed in the US each year, ~70%-75% are considered non-muscle invasive.1-3 Of those NMIBC cases, 9 in 10 initially present as low grade.2

The current standard of care for treating NMIBC patients is transurethral resection of bladder tumor (TURBT), followed by adjuvant chemotherapy or, in certain cases, immunotherapy at the discretion of the treating physician.3,4

For patients with low-grade intermediate risk NMIBC, recurrence is common after TURBT—24%-61% likelihood at 1 year and up to 78% at 5 years.4

Given the high disease recurrence rates, it is not unusual for patients to require multiple surgical procedures to control NMIBC over a lifetime, leading to a high cost of treatment over time.2

There are currently no drugs approved by the US FDA for first-line treatment of NMIBC—the 3 drugs approved to treat NMIBC are all indicated for use as adjuvant therapies.

About

UGN-102 (mitomycin gel) is an investigational formulation that utilizes our innovative technology, RTGel reverse-thermal hydrogel, for the treatment of low-grade NMIBC.

Administered locally via standard catheters, UGN-102 is designed to fill and conform to the anatomy of the bladder and dwell for a period of several hours before being excreted via normal urine flow.

Status

UroGen has fully enrolled and conducted a readout of a phase 2b study to further investigate UGN-102 for the treatment of intermediate-risk low-grade NMIBC. Phase 3 is now enrolling.

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IMMUNO-URO-ONCOLOGY

Unmet Need

Bladder cancers are described as muscle invasive or non-muscle invasive based on whether they have invaded into the wall of the bladder. The majority of bladder cancer is considered low-grade non-muscle invasive and is often associated with a favorable prognosis.2,5 Unfortunately, prognosis is not as favorable for patients diagnosed with high-grade NMIBC.5

Of the ~80,000 patients diagnosed with bladder cancer in the US each year, approximately 10% will present with high-grade NMIBC.1,2 High-grade NMIBC is associated with an increased risk of recurrence and progression.5,6

Transurethral resection of bladder tumor (TURBT) followed by intravesical bacillus Calmette-Guérin (BCG) is currently the standard of care for treatment of high-grade NMIBC.3,4 Recurrence rates are high for this approach, and the highest-risk patients are left with radical bladder removal surgery as the best remaining option.3,4,6

Challenges of the current standard of care can be severe, and underscore the need for new treatment options4-6

About

UGN-201 is an investigational local immunotherapy for the treatment of high-grade NMIBC. It is a proprietary formulation of imiquimod, a toll-like receptor 7/8 (TLR7/8) agonist, which is known to elicit an immune response to bladder cancer.

Status

  • A phase 1b study suggested a preliminary efficacy signal associated with UGN-201 in patients with high-grade NMIBC
  • The FDA has granted Orphan Drug Designation to UGN-201 for the treatment of carcinoma in situ (CIS)
  • UroGen continues to advance research on UGN-201 in combination with checkpoint inhibitors for the treatment of bladder cancer

Unmet Need

Bladder cancers are described as muscle invasive or non-muscle invasive based on whether they have invaded into the wall of the bladder. The majority of bladder cancer is considered low-grade non-muscle invasive and is often associated with a favorable prognosis.2,5 Unfortunately, prognosis is not as favorable for patients diagnosed with high-grade NMIBC.5

Of the ~80,000 patients diagnosed with bladder cancer in the US each year, approximately 10% will present with high-grade NMIBC.1,2 High-grade NMIBC is associated with an increased risk of recurrence and progression.5,6

Transurethral resection of bladder tumor (TURBT) followed by intravesical bacillus Calmette-Guérin (BCG) is currently the standard of care for treatment of high-grade NMIBC.3,4 Recurrence rates are high for this approach, and the highest-risk patients are left with radical bladder removal surgery as the best remaining option.3,4,6

Challenges of the current standard of care can be severe, and underscore the need for new treatment options4-6

About

UGN-302, an investigational intravesical immunotherapy, combines UGN-201 (a toll-like receptor 7/8 agonist) with a CTLA-4 antagonist for the treatment of high-grade NMIBC.

Status

Preclinical data from murine models suggest positive results with UGN-302 combination treatment. Research is ongoing.

Our Partners

We know transforming the treatment paradigm takes diverse perspectives. We're excited to pursue collaboration opportunities, including the development of novel applications of our technology platform, RTGel™ reverse-thermal hydrogel, within urology, uro-oncology, and other therapeutic areas.

URO-ONCOLOGY

Nonclinical

Phase 1

Phase 2

Phase 3

Registration