mitomycin intravesicular (UGN-103) / UroGen - LARVOL DELTA

Next-generation novel mitomycin-based formulation for urothelial cancers (The Manila Times) - "The FDA agreed with the regulatory plan to submit an NDA based on the data from the single-arm Phase 3 UTOPIA trial to support potential approval of UGN-103. UroGen anticipates submitting an NDA for UGN-103 in the second half of 2026 with potential approval anticipated in 2027."

FDA approval • FDA filing • Bladder Cancer

UroGen Reports 77.8% Three-Month Complete Response Rate from Phase 3 UTOPIA Trial of UGN-103 and Receives FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Based on UTOPIA Trial (GlobeNewswire) - "...the U.S. Food and Drug Administration (FDA) agreed that CR and durability results from the UTOPIA trial can support the submission of a New Drug Application (NDA) for UGN-103 for recurrent LG-IR-NMIBC....'We look forward to working closely with the FDA as we complete the UTOPIA trial and prepare for an NDA submission in 2026.'"

FDA filing • P3 data • Bladder Cancer

Next-generation novel mitomycin-based formulations for urothelial cancers (GlobeNewswire) - "Enrollment is now complete in the ongoing Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with recurrent LG-IR-NMIBC."

Enrollment closed • Bladder Cancer • Urothelial Cancer

UroGen Announces Completion of Enrollment in the Phase 3 UTOPIA Clinical Trial of UGN-103 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (GlobeNewswire) - "UroGen Pharma...announced that it has completed patient enrollment in its Phase 3 UTOPIA clinical trial of UGN-103 (mitomycin) for intravesical solution, a next-generation formulation in development for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The UTOPIA trial enrolled 99 patients across multiple centers globally....The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103. All enrolled patients receive 75 mg of UGN-103 via intravesical instillation once weekly for six weeks."

Enrollment closed • Bladder Cancer

UroGen Pharma Reports First Quarter 2025 Financial Results and Provides a Business Update (Businesswire) - "Enrollment is ongoing in the Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC and enrollment is expected to be completed by mid-2025....UroGen plans to initiate a Phase 3 trial to explore the safety and efficacy of UGN-104 by mid-2025. UGN-104 is a next generation investigational product for LG-UTUC."

Enrollment status • New P3 trial • Urothelial Cancer

UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=87 | Recruiting | Sponsor: UroGen Pharma Ltd. | Trial completion date: Mar 2026 ➔ Jul 2026 | Trial primary completion date: Mar 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

First Patient Dosed in Phase 3 Clinical Trial of UGN-103, a Next Generation Mitomycin-Based Formulation in Development for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (Businesswire) - "UroGen Pharma Ltd...announced that the first patient was dosed in the Phase 3 clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in development for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)."

Trial status • Bladder Cancer

UroGen Receives New U.S. Patent Allowance for Next-Generation Mitomycin-Based Products Expected to Provide Protection Until December 2041 (Businesswire) - "UroGen Pharma Ltd...announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/535,108 entitled 'Material and Method for Treating Cancer'. The allowed claims relate to the combination of UroGen’s RTGel technology with medac’s licensed proprietary lyophilized mitomycin formulation and cover the use of UroGen’s UGN-103 and UGN-104 development programs in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively. The U.S. patent, once issued, will have an expiration date in December 2041."

Patent • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=87 | Recruiting | Sponsor: UroGen Pharma Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

UroGen Pharma…Reports 2024 Second Quarter Financial Results and Business Highlights (Businesswire) - "JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC): Generated net product revenue of $21.8 million in the second quarter of 2024, compared to $21.1 million in the second quarter of 2023....UroGen has initiated the Phase 3 study and has onboarded three clinical sites to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC. UroGen plans to initiate a Phase 3 study of UGN-104 in LG-UTUC early next year."

New P3 trial • Sales • Trial status • Bladder Cancer • Urothelial Cancer

UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (Businesswire) - "UroGen Pharma Ltd...today announced the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)....UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 for the treatment of LG-IR-NMIBC, a highly recurrent disease....UroGen intends to complete the rolling new drug application (NDA) submission for UGN-102 in September 2024, with a potential FDA decision as early as the first quarter of 2025 if priority review is granted by FDA."

IND • NDA • New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

UTOPIA: A Phase 3 Single-arm Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P3 | N=87 | Not yet recruiting | Sponsor: UroGen Pharma Ltd.

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

UroGen Pharma Delivers Double Digit JELMYTO Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102 (Businesswire) - "UGN-102 (mitomycin) for intravesical solution:...The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA. The company plans to complete the submission in September 2024....Next-generation novel mitomycin-based formulation for urothelial cancers:...UroGen plans to initiate Phase 3 studies to explore the safety and efficacy of UGN-103 and UGN-104 in LG-IR-NMIBC and LG-UTUC, respectively, in 2024."

NDA • New P3 trial • Bladder Cancer • Urothelial Cancer

UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers (Businesswire) - "UroGen Pharma Ltd...today announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers....UGN-103 UroGen’s RTGel technology combined with medac’s licensed mitomycin, is a next-generation formulation that is planned to follow the anticipated U.S. Food and Drug Administration approval and launch of UGN-102. UGN-103 is expected to provide advantages related to production, cost, supply, and product convenience if approved. UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC....With medac's intellectual property protection for this next-generation mitomycin formulation lasting until June 2035 and our pending U.S. patent applications, we foresee potential intellectual property protection until December 2041."

Launch US • Licensing / partnership • NDA • New P3 trial • Patent expiry • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer