UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology
UroGen Pharma (Nasdaq: URGN) has published results from a Phase 3b study in Reviews in Urology, evaluating home administration of ZUSDURI™ (mitomycin) for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The study demonstrated that trained home health professionals can safely administer the treatment outside clinical settings.
Key findings include a 75% complete response rate at three months, with 6 out of 8 patients completing all scheduled treatments. The treatment involved weekly administration for six weeks, with the first dose given in clinic followed by five at-home instillations. 75% of completing patients would recommend the home-based approach to others.
UroGen Pharma (Nasdaq: URGN) ha pubblicato i risultati di uno studio di Fase 3b su ZUSDURI™ (mitomicina) per il trattamento del carcinoma della vescica non muscolo-invasivo a basso grado e rischio intermedio, valutando la somministrazione domiciliare. Lo studio, pubblicato su Reviews in Urology, ha dimostrato che professionisti sanitari domiciliari adeguatamente formati possono somministrare il trattamento in sicurezza al di fuori degli ambienti clinici.
I risultati principali evidenziano un tasso di risposta completa del 75% a tre mesi, con 6 pazienti su 8 che hanno completato tutti i trattamenti previsti. Il trattamento prevedeva una somministrazione settimanale per sei settimane, con la prima dose somministrata in clinica e le successive cinque a domicilio. Inoltre, il 75% dei pazienti che hanno completato il ciclo consiglierebbe questo approccio domiciliare ad altri.
UroGen Pharma (Nasdaq: URGN) ha publicado resultados de un estudio de Fase 3b en Reviews in Urology, evaluando la administración domiciliaria de ZUSDURI™ (mitomicina) para el tratamiento del cáncer de vejiga no músculo-invasivo de bajo grado y riesgo intermedio recurrente. El estudio demostró que profesionales de la salud capacitados pueden administrar el tratamiento de forma segura fuera de entornos clínicos.
Los hallazgos clave incluyen una tasa de respuesta completa del 75% a los tres meses, con 6 de 8 pacientes que completaron todos los tratamientos programados. El tratamiento consistió en una administración semanal durante seis semanas, con la primera dosis en clínica seguida de cinco instilaciones en casa. El 75% de los pacientes que completaron el tratamiento recomendarían el enfoque domiciliario a otros.
UroGen Pharma (나스닥: URGN)는 재발성 저등급 중간 위험 비근육침윤성 방광암 치료를 위한 ZUSDURI™ (미토마이신)의 가정 내 투여를 평가한 3상 b상 연구 결과를 Reviews in Urology에 발표했습니다. 이 연구는 교육받은 가정 건강 전문가들이 임상 환경 외부에서 안전하게 치료를 투여할 수 있음을 입증했습니다.
주요 결과로는 3개월 시점에 75% 완전 반응률을 보였으며, 8명 중 6명이 예정된 모든 치료를 완료했습니다. 치료는 6주 동안 주 1회 투여로 진행되었으며, 첫 번째 용량은 클리닉에서, 이후 5회는 가정에서 투여되었습니다. 치료를 완료한 환자의 75%는 가정 기반 치료 방식을 다른 사람들에게 추천할 것이라고 답했습니다.
UroGen Pharma (Nasdaq : URGN) a publié les résultats d’une étude de phase 3b dans Reviews in Urology, évaluant l’administration à domicile de ZUSDURI™ (mitomycine) pour le traitement du cancer de la vessie non invasif de bas grade à risque intermédiaire récurrent. L’étude a démontré que des professionnels de santé formés peuvent administrer ce traitement en toute sécurité en dehors des établissements cliniques.
Les résultats clés montrent un taux de réponse complète de 75% à trois mois, avec 6 patients sur 8 ayant terminé tous les traitements prévus. Le traitement consistait en une administration hebdomadaire pendant six semaines, la première dose étant administrée en clinique, suivie de cinq instillations à domicile. 75% des patients ayant terminé le traitement recommanderaient cette approche à domicile à d’autres.
UroGen Pharma (Nasdaq: URGN) hat Ergebnisse einer Phase-3b-Studie in Reviews in Urology veröffentlicht, in der die häusliche Verabreichung von ZUSDURI™ (Mitomycin) zur Behandlung von rezidivierendem niedriggradigem intermediärem Risiko nicht-muskelinvasivem Blasenkrebs untersucht wurde. Die Studie zeigte, dass geschulte Fachkräfte im häuslichen Gesundheitswesen die Behandlung sicher außerhalb klinischer Einrichtungen durchführen können.
Wichtige Ergebnisse umfassen eine 75%ige Komplettansprechrate nach drei Monaten, wobei 6 von 8 Patienten alle geplanten Behandlungen abgeschlossen haben. Die Behandlung bestand aus einer wöchentlichen Verabreichung über sechs Wochen, wobei die erste Dosis in der Klinik und die folgenden fünf als Heiminstillation verabreicht wurden. 75% der Patienten, die die Behandlung abgeschlossen haben, würden den häuslichen Ansatz anderen empfehlen.
- Achieved 75% complete response rate at three months
- 75% of patients (6 of 8) successfully completed all scheduled treatments
- No new safety concerns identified in home administration setting
- Most adverse events were only mild-to-moderate urinary symptoms
- Small sample size of only 8 patients limits study significance
- Study limitations include open-label and single-arm design
Insights
UroGen's Phase 3b study shows ZUSDURI can be safely administered at home, potentially improving patient experience while maintaining 75% efficacy for bladder cancer.
The Phase 3b study results for ZUSDURI (mitomycin) represent a significant potential advancement in treatment delivery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The 75% complete response rate at three months with home administration is particularly noteworthy, as it suggests efficacy comparable to traditional clinical settings.
What makes this development clinically meaningful is the demonstration that trained home health professionals can safely administer intravesical therapy in a home environment. This addresses a major pain point in bladder cancer management, as traditional treatment requires frequent clinical visits that can be particularly burdensome for elderly patients or those with limited mobility.
The study shows 6 of 8 patients (75%) completed all scheduled treatments, with most indicating they would recommend the approach to others. This suggests good patient acceptability of the home-based administration model. The safety profile remained consistent with previous ZUSDURI studies, with primarily mild-to-moderate urinary symptoms reported.
However, several limitations warrant caution in interpreting these results. The extremely small sample size (n=8), single-arm design, and open-label nature of the study represent significant methodological constraints. These limitations mean the findings should be considered preliminary until validated in larger, more robust studies. Additionally, the study doesn't address long-term durability of response or comparative effectiveness versus traditional administration approaches.
If these results can be replicated in larger studies, this home administration model could represent a meaningful advance in patient-centered care for bladder cancer while potentially reducing healthcare resource utilization.
PRINCETON, N.J., July 28, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative treatments for urothelial and specialty cancers, today announced the publication in Reviews in Urology of results from a Phase 3b study evaluating the feasibility of administering ZUSDURI™ (mitomycin) for intravesical solution (formerly known as UGN-102) in the home setting. The study, titled "Home Instillation of UGN-102 for Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm, Open-Label, Phase 3b Trial," demonstrated that trained home health professionals (HHPs) can safely and effectively administer ZUSDURI outside of a traditional clinical setting.
“The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources,” said David Morris, MD, lead investigator and practicing urologist at Urology Associates, PC, Nashville, TN. “As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction.”
The study assessed the feasibility, safety, and early efficacy of at-home instillations of ZUSDURI in patients with recurrent LG-IR-NMIBC. Six of eight patients (
“This patient-centered approach to care reflects our commitment to redefining how urologic cancers are treated, offering patients access to effective and convenient treatment options,” said Mark Schoenberg, MD, Chief Medical Officer, UroGen. “The ability to potentially administer ZUSDURI safely in the home represents a meaningful advancement for patients and caregivers alike, especially those who may face challenges traveling to frequent clinic visits.”
In this study, ZUSDURI was administered via urinary catheter once weekly for six weeks, with the first dose administered in the clinic, followed by five at-home instillations by HHPs. Investigators found no meaningful differences between home and office instillation for most patients. The safety profile was consistent with previous studies, with most adverse events being mild-to-moderate urinary symptoms.
Study limitations include, among others, the small sample size of eight patients, and the open-label and single-arm design.
About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. Patients can visit ZUSDURI.com for more information.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Jelmyto®, our first product to treat low-grade upper tract urothelial cancer, and ZUSDURI (mitomycin) for intravesical solution, our first product to treat recurrent LG-IR-NMIBC, are both designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit www.UroGen.com to learn more or follow us on X, @UroGenPharma.
APPROVED USE FOR ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is a prescription medicine used to treat adults with a type of cancer of the lining of the bladder called low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) after previously receiving bladder surgery to remove tumor that did not work or is no longer working.
IMPORTANT SAFETY INFORMATION
You should not receive ZUSDURI if you have a hole or tear (perforation) of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in ZUSDURI.
Before receiving ZUSDURI, tell your healthcare provider about all of your medical conditions, including if you:
- have kidney problems
- are pregnant or plan to become pregnant. ZUSDURI can harm your unborn baby. You should not become pregnant during treatment with ZUSDURI. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZUSDURI.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with ZUSDURI and for 6 months after the last dose.
Males being treated with ZUSDURI: You should use effective birth control (contraception) during treatment with ZUSDURI and for 3 months after the last dose. - are breastfeeding or plan to breastfeed. It is not known if ZUSDURI passes into your breast milk. Do not breastfeed during treatment with ZUSDURI and for 1 week after the last dose.
How will I receive ZUSDURI?
- You will receive your ZUSDURI dose from your healthcare provider 1 time a week for 6 weeks into your bladder through a tube called a urinary catheter. It is important that you receive all 6 doses of ZUSDURI according to your healthcare provider’s instructions.
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
- During treatment with ZUSDURI, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving ZUSDURI:
- ZUSDURI may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 24 hours.
- To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
- Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
The most common side effects of ZUSDURI include: increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increased or decreased white blood cell counts, urinary tract infection, and blood in your urine.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see ZUSDURI Full Prescribing Information, including the Patient Information, for additional information.
ZUSDURI™ is a trademark and UroGen® is a registered trademark of UroGen Pharma, Ltd.
Copyright©2025 UroGen Pharma, Inc. All rights reserved.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the feasibility of home instillation of ZUSDURI; the potential benefits to patients and opportunities for ZUSDURI, including the potential to administer ZUSDURI at home; the potential benefits of the home instillation of ZUSDURI, including to ease the burden on patients, reduce reliance on hospital or clinic resources and provide effective care with greater comfort and convenience; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs other than mitomycin; the estimated annual U.S. patient population and demographics for LG-IR-NMIBC; and UroGen’s sustained release technology making local delivery potentially more effective as compared to other treatment options. Words such as “can,” “may,” “plan,” “potential,” “will” or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: clinical results may not be indicative of results that may be observed in the future; potential safety and other complications related to UroGen’s products; the ability to maintain regulatory approval; complications associated with commercialization activities; labeling limitations; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s products and product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology and ZUSDURI may not perform as expected; new data relating to ZUSDURI, including from spontaneous adverse event reports and from the ongoing ENVISION trial, may result in changes to the product label and may adversely affect sales, or result in withdrawal of ZUSDURI from the market; the potential for payors to delay, limit or deny coverage for ZUSDURI; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and the impacts of general macroeconomic and geopolitical conditions on UroGen’s business and financial position. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 12, 2025, the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@UroGen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
FAQ
What were the results of UroGen's Phase 3b study for ZUSDURI home administration?
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What were the safety findings for ZUSDURI home administration in the Phase 3b trial?
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What are the limitations of UroGen's ZUSDURI Phase 3b study?
