FDA Approves UroGen’s Zusduri for Recurrent Low-Grade Intermediate-Risk Bladder Cancer

UroGen Pharma has received FDA approval for its intravesical therapy, Zusduri, marking the first authorized treatment specifically for adult patients in the U.S. diagnosed with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The drug combines the chemotherapy agent mitomycin with UroGen’s proprietary sustained-release RTGel hydrogel, designed to allow localized and prolonged drug exposure in the bladder.
The therapy is administered directly into the bladder through a urinary catheter during an outpatient procedure, avoiding the need for anesthesia or surgery. Before Zusduri’s approval, patients with this recurrent bladder cancer subtype were generally limited to repeated transurethral resections under anesthesia, due to high rates of tumor recurrence.
Zusduri is UroGen’s second commercial product following Jelmyto, which was approved in April 2020 for low-grade upper tract urothelial cancer and utilizes a similar delivery mechanism. Like Jelmyto, Zusduri is a liquid mixture intended to deliver mitomycin directly to the target area via UroGen’s gel-based system.

The FDA based its approval on interim data from the ongoing phase 3 ENVISION trial. In the study, a 79.6% complete response rate was observed at three months. Among those with complete responses, 79% remained free of disease events after 12 months. Additional data shared in April showed an 80.6% duration of response at 18 months. The company is required to continue the ENVISION study as a post-marketing commitment in order to “further characterize” the clinical benefit of the therapy.
Despite the eventual FDA approval, an earlier review by the Oncologic Drugs Advisory Committee (ODAC) in May resulted in a narrow 5–4 vote against Zusduri, citing concerns about the lack of a randomized control arm and limited follow-up in the trial. Some committee members expressed skepticism about whether the single-arm trial design could conclusively support the drug’s effectiveness. Others were persuaded by the treatment’s ability to deliver results without surgery.
“This historic achievement is a bold leap forward in our mission to redefine uro-oncology and bring innovation to patients who need it most,” said Liz Barrett, CEO of UroGen.

The company has announced its plans to make Zusduri commercially available in the United States “on or around July 1.”
In addition to its clinical obligations, UroGen faces legal scrutiny. The Gross Law Firm has reminded shareholders of their eligibility to participate in a class-action lawsuit if they purchased UroGen stock between July 27, 2023, and May 15, 2025. The lawsuit alleges that UroGen made “materially false and/or misleading statements” during that period regarding the design and limitations of the ENVISION trial. It claims that the company did not disclose that the study was “not designed to demonstrate substantial evidence of effectiveness” and failed to address the FDA’s concerns regarding the trial’s methodology, exposing shareholders to potential risk.
Following the announcement of Zusduri’s approval, UroGen’s stock rose nearly 52% by market close on Thursday. The company’s only other commercial product, Jelmyto, generated $20.3 million in first-quarter sales, representing an 8% year-over-year increase. Sales projections for Jelmyto in 2025 range from $94 million to $98 million.