Mitomycin Intravesical Solution: First Approval.

IF 2.7 3区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical Drug Investigation Pub Date : 2025-08-31 DOI:10.1007/s40261-025-01475-2

Susan J Keam

引用次数: 0

Abstract

Mitomycin intravesical solution (ZUSDURI^TM), a hydrogel formulation of the DNA synthesis inhibitor mitomycin, has been developed by UroGen Pharma, Inc. for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) via intravesical instillation. In June 2025, mitomycin intravesical solution was approved for the treatment of recurrent LG-IR-NMIBC in the USA. This article summarizes the milestones in the development of mitomycin intravesical solution leading to this first approval for LG-IR-NMIBC.

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丝裂霉素膀胱内溶液：首次批准。

丝裂霉素膀胱内溶液（ZUSDURITM）是一种DNA合成抑制剂丝裂霉素的水凝胶制剂，由UroGen Pharma， Inc.开发，用于通过膀胱内滴注治疗低级别中危非肌肉浸润性膀胱癌（LG-IR-NMIBC）。2025年6月，丝裂霉素膀胱内溶液在美国被批准用于治疗复发性LG-IR-NMIBC。本文总结了丝裂霉素膀胱内滴注液的发展历程，并由此首次批准了LG-IR-NMIBC。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Drug Investigation 医学-药学

CiteScore

5.90

自引率

3.10%

发文量

108

审稿时长

6-12 weeks

期刊介绍： Clinical Drug Investigation provides rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. The Journal includes: -Clinical trials, outcomes research, clinical pharmacoeconomic studies and pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs. -Clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice. -Pharmacodynamic and pharmacokinetic studies in healthy volunteers in which significant implications for clinical prescribing are discussed. -Studies focusing on the application of drug delivery technology in healthcare. -Short communications and case study reports that meet the above criteria will also be considered. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Clinical Drug Investigation may be accompanied by plain language summaries to assist readers who have some knowledge, but non in-depth expertise in, the area to understand important medical advances.