What urologists can expect in Q4 of 2025

As we enter the final months before the end of 2025, we reflect on the notable advances that have already shifted the landscape in urologic care. Looking back at this year, we saw notable approvals across bladder cancer, prostate cancer, and benign conditions.

Specifically, approvals such as perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC); mitomycin intravesical solution (Zusduri, formerly UGN-102) for low-grade, intermediate-risk non–muscle invasive bladder cancer; and gemcitabine intravesical system for BCG-unresponsive NMIBC continue to move the needle in bladder cancer care. The prostate cancer space also saw key advances with the approval of an expanded indication for ¹⁷⁷Lu-PSMA-617 (Pluvicto) in the pre-taxane setting, as well as the approval of darolutamide (Nubeqa) without the need for chemotherapy in the metastatic castration-sensitive setting.

For those treating patients with benign urologic conditions, significant developments included an approval for an integrated sacral neuromodulation system for urge urinary incontinence and approval of an expanded label for the Rezūm System in benign prostatic hyperplasia (BPH).

These advances reflect the continued evolution of treatments and technology in these disease spaces.

Thus, with the first 3 quarters of 2025 in the rearview, we now look ahead to the regulatory actions and conferences poised to further advance urologic care. Although regulatory decisions are not quite as frequent, urologists can, as expected, anticipate a packed conference schedule throughout the last few months of the year.

Take a look through the key regulatory decisions and meetings slated for Q4 of 2025.

Regulatory Decisions

Flibanserin (Addyi, 100 mg)

PDUFA: Unknown

Indication: Hypoactive sexual desire disorder (HSDD) in postmenopausal women

The FDA is considering an expanded indication for flibanserin (Addyi, 100 mg) to treat hypoactive sexual desire disorder (HSDD) in postmenopausal women. The non-hormonal medication, initially approved in 2015, is currently indicated for use in certain premenopausal women with acquired, generalized HSDD.

The agency granted priority review to the supplemental application for flibanserin in July 2025.¹ The expanded indication has already been approved in Health Canada.

The safety and efficacy of flibanserin in postmenopausal women were established in the SNOWDROP and PLUMERIA (NCT01057901) trials.²

Gepotidacin

PDUFA: December 11, 2025

Indication: Uncomplicated urogenital gonorrhoea in patients 12 years of age and older (weighing ≥45 kg)

Urologists can expect a decision on the supplemental new drug application (sNDA) for gepotidacin for uncomplicated urogenital gonorrhea on or by December 11, 2025. The application was granted priority review in August 2025.³

The sNDA is backed by data from the phase 3 EAGLE-1 trial (NCT04010539), which showed that gepotidacin was non-inferior to combined treatment with intramuscular ceftriaxone plus oral azithromycin in regard to the treatment success rates (microbiological response) at the urogenital site. Specifically, treatment with gepotidacin led to a 92.6% (95% CI, 88.0 to 95.8) success rate at the urogenital site compared with a rate of 91.2% (95% CI, 86.4 to 94.7) in the intramuscular ceftriaxone plus oral azithromycin arm (treatment difference, -0.1; 95% CI, -5.6 to 5.5; P = .5072).

Gepotidacin (Blujepa) was previously approved in March 2025 for female adult and pediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection (uUTI).

Zoliflodacin

PDUFA: December 15, 2025

Indication: adult and pediatric patients 12 years and older with uncomplicated gonorrhea

Shortly thereafter, the FDA will issue a decision on an application for a second agent for uncomplicated gonorrhea—zoliflodacin. The FDA granted priority review to the NDA in June 2025, issuing a PDUFA target action date of December 15, 2025.⁴

The NDA for zoliflodacin is supported by data from several clinical trials, including a pivotal phase 3 trial (NCT03959527) that evaluated zoliflodacin vs a standard of care (SOC) regimen (500 mg ceftriaxone intramuscular plus 1g oral azithromycin) in patients with uncomplicated gonorrhea.⁵

Overall, the trial met its primary end point by demonstrating that zoliflodacin was non-inferior to the SOC regimen regarding microbiological response at the urogenital site at the test of cure visit (6 +/- 2 days following treatment). Specifically, the microbiological cure rate was 90.9% in the zoliflodacin arm vs 96.2% in the ceftriaxone/azithromycin arm (treatment difference, -5.3%; 95% CI, 1.4% to 8.7%).

Conferences

26th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America

Dates: October 9-12

Location: Grapevine, Texas

In addition to the usual array of scientific abstracts spanning the whole of sexual medicine, this year’s SMSNA meeting also includes multiple educational courses and symposia, including (but not limited to):

• Basic Science Symposium - Novel and Innovative Techniques for Sexual Medicine Research

• Instructional Course - BPH Surgery in Sexual Medicine Practice

• SMSNA Symposium Sexual Medicine: Fellowship to Practice

• ISSWSH Fundamentals Course in Women's Sexual Health

• Instructional Course - Androgens and Peptides - Part 1

• Basic Science Symposium - SMSNA Funding Opportunities

• Instructional Course - Office Based Procedures in Sexual Medicine

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Society of Urologic Nurses & Associates 2025 uroLogic Conference

Dates: October 10-13

Location: Louisville, Kentucky

Sessions to be featured at this year’s meeting include “Renal Basics,” “Elevated PSA/Prostate Cancer Across the Spectrum,” with “CAUTI Prevention,” along with urology-themed “escape rooms.”

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European Society for Medical Oncology Congress 2025

Dates: October 17-21

Location: Berlin, Germany

The German capital is set to host ESMO 2025, with no fewer than 21 late-breaking abstracts on genitourinary cancers. Among the presentations to watch for are LBA108 (Durvalumab [D] in combination with bacillus Calmette-Guérin [BCG] for BCG-naïve, high-risk non-muscle-invasive bladder cancer [NMIBC]: final analysis of the phase 3, open-label, randomised POTOMAC trial), LBA112 (Neoadjuvant gemcitabine intravesical system [TAR-200] + cetrelimab [CET] or CET alone in patients [pts] with muscle-invasive bladder cancer [MIBC]: SunRISe-4 [SR-4] primary analysis and biomarker results), and LBA2 (Perioperative [periop] enfortumab vedotin [EV] plus pembrolizumab [pembro] in participants [pts] with muscle-invasive bladder cancer [MIBC] who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study).

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45th Congress of the Société Internationale d'Urologie

Dates: October 29-November 1

Location: Edinburgh, Scotland

Another international highlight this fall is the annual gathering of the Société Internationale d'Urologie, which will host symposia for urology organizations from across the globe.

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LUGPA Annual Meeting

Dates: November 6-8

Location: Chicago, Illinois

Independent-practice urologists will descend upon the Windy City in early November for the LUGPA Annual Meeting. This year’s continuing medical education (CME) program includes sessions on both non–muscle invasive and muscle-invasive bladder cancer, stone disease, testosterone therapy, prostate cancer, and more. Non-CME sessions to watch for this year include “Building a Successful Advanced Bladder Cancer Program to Support New Technologies,” “Rapid Access Clinic to Improve Patient Care,” “Best Practices for Hospital Partnerships and Call Coverage,” and more.

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26th Annual Meeting of the Society of Urologic Oncology

Dates: December 2-5, 2025

Location: Phoenix, Arizona

Closing out the urology conference year is the SUO’s yearly gathering. Among the sessions to expect from this year’s event are “State of the Art Session I: From Patients to Practice: Harnessing PROs to Improve Cancer Outcomes,” “State of the Art Session II: Incorporating Minimal Residual Disease in ctDNA Testing/Assays in Clinical Practice in Bladder Cancer: Are We There Yet?” “State of the Art Session III: Health Policy Impact of the 2024 Election,” and more.

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REFERENCES

1. FDA grants priority review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in postmenopausal women. News release. Sprout Pharmaceuticals. July 24, 2025. Accessed September 29, 2025. https://www.prnewswire.com/news-releases/fda-grants-priority-review-for-addyi-flibanserin-paving-the-way-for-expanded-access-to-treat-low-sexual-desire-in-postmenopausal-women-302512883.html

2. Portman DJ, Brown L, Yuan J, et al. Flibanserin in postmenopausal women with hypoactive sexual desire disorder: Results of the PLUMERIA study. J Sex Med. 2017;14(6):834-842. Doi:10.1016/j.jsxm.2017.03.258

3. Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea. News release. GSK. August 11, 2025. Accessed September 29, 2025. https://www.gsk.com/en-gb/media/press-releases/gepotidacin-accepted-for-priority-review-by-the-us-fda-for-the-oral-treatment-of-uncomplicated-urogenital-gonorrhoea/

4. FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhea and assigns target PDUFA date of December 15, 2025. News release. Innovia Specialty Therapeutics, Inc. June 12, 2025. Accessed September 29, 2025. https://www.businesswire.com/news/home/20250612432209/en/FDA-Grants-Priority-Review-for-Zoliflodacin-New-Drug-Application-for-the-Treatment-of-Uncomplicated-Gonorrhea-and-Assigns-Target-PDUFA-Date-of-December-15-2025

5. Luckey A, Broadhurst H, Daram P, et al. Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomised controlled trial. Presented at: European Society of Clinical Microbiology and Infectious Disease Global Congress. April 27-30, 2024. Barcelona, Spain. https://gardp.org/wp-content/uploads/2024/04/Zoli001-Topline-ECCMID2024_final_V1.0_23Apr2024_.pdf