Advancing women’s health: Key updates and clinical insights from the first half of 2025

Advancing women’s health: Key updates and clinical insights from the first half of 2025 | Image Credit: © terovesalainen - stock.adobe.com.

The first half of 2025 has delivered a wave of clinical advancements, FDA approvals, and expert-driven insights that are reshaping the landscape of obstetrics and gynecology.

From the introduction of first-in-class oral antibiotics for UTIs and gonorrhea to the approval of at-home screening tools for cervical cancer and STIs, this period marked significant progress in improving access, accuracy, and patient-centered care. In parallel, clinical trials revealed promising outcomes for treatments targeting recurrent bacterial vaginosis, vasomotor symptoms, and urinary incontinence, while digital health innovations—including AI and social media platforms—emerged as tools to enhance education and early detection.

In this 6-month recap, Contemporary OB/GYN highlights the most influential regulatory decisions, research findings, and expert commentary from January through June 2025.

Click on each title below for in-depth coverage.

2025 regulatory updates in ob-gyn

FDA approves gepotidacin for uncomplicated UTI treatment

The FDA approved gepotidacin (Blujepa; GSK) for the treatment of uncomplicated urinary tract infections (uUTIs) in female patients aged 12 years and older on March 25, 2025, marking the first oral antibiotic in a new class in over 20 years. Clinical trials demonstrated its superiority over nitrofurantoin, with higher therapeutic success rates and a lower potential for resistance development.

The drug exhibited a favorable safety profile, with gastrointestinal adverse events being the most commonly reported side effects. Given the increasing prevalence of antibiotic-resistant uUTIs, gepotidacin represents a valuable new option for patients in need of effective treatment.

FDA clears Sonio Suspect AI for fetal anomaly detection

The FDA cleared the Sonio Suspect AI model for detecting fetal anomalies on February 24, 2025, offering a 22-point improvement in reader performance and enhancing early and accurate diagnoses. The technology integrates real-time AI quality control with anomaly detection, addressing gaps in prenatal ultrasound screenings, where up to 51% of anomalies go undetected.

Clinical studies demonstrated its efficacy across diverse patient demographics and clinician backgrounds, with the model significantly improving detection rates of brain and heart structures. By enabling earlier identification of congenital malformations, Sonio Suspect supports timely interventions, ultimately improving maternal and fetal health outcomes.

FDA approves Visby’s test for at-home STI identification

The FDA granted marketing authorization for the Visby Medical Women’s Sexual Health Test on March 28, 2025, making it the first at-home, prescription-free test for chlamydia, gonorrhea, and trichomoniasis. Designed for symptomatic and asymptomatic female patients, the test delivers results within approximately 30 minutes through the Visby Medical App.

Clinical evaluations demonstrated high accuracy rates, with sensitivity and specificity exceeding 97% for all 3 infections. While the FDA emphasized the importance of follow-up care, this approval marks a significant advancement in sexual health diagnostics by improving accessibility and reducing barriers to timely testing.

FDA approves Teal Wand for at-home cervical cancer screening

The FDA approved the Teal Wand on May 9, 2025, as the first at-home vaginal self-collection device for cervical cancer screening in U.S. women. Designed for women aged 25 to 65 at average risk, the device demonstrated 96% accuracy in identifying cervical precancer in the SELF-CERV trial and showed strong user preference and ease of use. The Teal Wand offers a comfortable alternative to traditional Pap smears and may help increase screening rates, especially among underserved populations. Nationwide availability is expected to follow its June launch in California, with insurance support aimed at reducing access barriers.

FDA accepts NDA for zoliflodacin to treat gonorrhea

The FDA has accepted a New Drug Application for zoliflodacin, a first-in-class oral antibiotic for uncomplicated gonorrhea in patients aged 12 and older. If approved, it would be the first new oral treatment for gonorrhea in decades and a critical option against rising antibiotic resistance. Clinical trials showed that a single oral dose of zoliflodacin was non-inferior to the standard ceftriaxone plus azithromycin regimen, with a favorable safety profile and no severe adverse events. As global resistance to cephalosporins and azithromycin grows, zoliflodacin may address a significant public health need.

2025 trial announcements in ob-gyn

Revi System demonstrates positive two-year results for treating urgency urinary incontinence

The OASIS study, published on February 7, 2025, confirms the long-term efficacy and safety of BlueWind Medical’s Revi System, a minimally invasive Tibial NeuroModulation device for urgency urinary incontinence (UUI). Over 24 months, 79% of participants experienced at least a 50% reduction in UUI episodes, with 28% achieving complete dryness, while patient satisfaction remained high at 97%.

The Revi System offers a patient-friendly alternative to traditional neuromodulation devices, eliminating the need for frequent battery replacements and invasive surgeries. Supported by updated clinical guidelines, these findings highlight Revi’s potential as a durable, non-pharmacologic solution for UUI, improving both symptom management and quality of life.

Elinzanetant found safe and effective for VMS linked to breast cancer treatment

A phase 3 study published by Bayer on January 9, 2025, confirms the safety and efficacy of elinzanetant for treating moderate to severe vasomotor symptoms (VMS) associated with breast cancer therapy. As a dual neurokinin-1 and 3 receptor antagonist, elinzanetant offers a non-hormonal option for women experiencing VMS because of adjuvant endocrine therapy, a population with no approved treatment options.

The OASIS 4 trial demonstrated significant reductions in VMS frequency and severity by weeks 4 and 12, along with improvements in sleep and menopause-related quality of life. These findings support elinzanetant’s potential as a breakthrough therapy for managing VMS in women with or at high risk of hormone-receptor positive breast cancer.

New HPV vaccine shows promise in treating high-grade cervical lesions

A phase 2 clinical trial published on January 24, 2025, highlights the potential of Vvax001, a therapeutic vaccine targeting HPV16, in reducing advanced precancerous cervical lesions. The study involved 18 patients with HPV16-related grade 3 cervical intraepithelial neoplasia (CIN3), a precancerous condition that can progress to cervical cancer if untreated.

Results showed a complete response in 50% of participants, with 63% clearing HPV16. Among those with disease regression, some avoided surgery altogether. The vaccine was well tolerated, with no serious adverse effects reported. Researchers emphasize the need for larger trials to confirm Vvax001’s efficacy as a non-surgical alternative for HPV16-related CIN3.

Oral sulopenem demonstrates non-inferiority to amoxicillin/clavulanate in phase 3 uUTI trial

Oral sulopenem (ORLYNVAH; Iterum Therapeutics) was found non-inferior to amoxicillin/clavulanate for treating uncomplicated urinary tract infections in adult women, based on results from the phase 3 REASSURE trial. Among 2,222 participants, sulopenem showed a 60.9% overall success rate vs 55.6% for amoxicillin/clavulanate, meeting the noninferiority threshold. Sulopenem also showed statistical superiority in patients with susceptible pathogens but had higher rates of mild adverse events. With demonstrated activity against multidrug-resistant organisms, sulopenem offers a promising oral alternative for uUTIs, especially amid rising antibiotic resistance and limited treatment options.

Tebipenem HBr cUTI trial ends early after meeting efficacy goals

The phase 3 PIVOT-PO trial evaluating tebipenem HBr for complicated urinary tract infections (cUTIs) will stop early due to efficacy, according to GSK and Spero Therapeutics. Tebipenem HBr met its primary endpoint of noninferiority to IV imipenem-cilastatin, making it a potential first oral carbapenem for cUTIs in the U.S. The trial included 1690 adults, with no new safety concerns reported. Common adverse events were mild and included diarrhea and headache. GSK plans to submit the data to regulators later in 2025 and present findings at an upcoming scientific meeting.

Secnidazole shows promise for recurrent BV treatment in new clinical trial

New data presented at the 2025 ACOG Annual Clinical and Scientific Meeting support the long-term use of secnidazole oral granules for recurrent bacterial vaginosis (BV), a condition affecting nearly 1 in 3 reproductive-aged women in the U.S. In a small trial, once-weekly 2 g doses showed comparable or improved efficacy to CDC-recommended suppressive regimens. Lead investigator Chemen M. Neal, MD, emphasized the potential for simplified dosing to improve adherence and reduce recurrence. The findings also underscore the need for accurate diagnosis and sustained management of BV, which carries both physical and psychosocial burdens.

2025 expert perspectives in ob-gyn

In this section, click the "play" button on each video interview to watch.

Tia Welsh, MD, highlights breakthroughs in cervical cancer screening

In this interview, Tia Welsh, MD, MPH, discussed recent advancements in cervical cancer screening, including primary HPV screening and extended genotyping. She emphasized that these tools, particularly self-collection in clinical settings, can expand screening access by over 30%, reaching underserved groups such as those with disabilities, LGBTQ+ individuals, and patients facing socioeconomic barriers. Welsh also highlighted BD’s FDA-approved Onclarity Assay, which enables extended genotyping and supports self-collection, marking a key evolution in cervical cancer screening and patient-centered care.

How gepotidacin offers new option for uncomplicated UTIs, with Ryan Haumschild, PharmD

The approval of gepotidacin marks a major advancement in treating uncomplicated urinary tract infections (uUTIs) in female adults and adolescents, offering a long-awaited alternative to older antibiotics. Ryan Haumschild, PharmD, MS, MBA, CPEL, vice president of pharmacy at Emory Healthcare, emphasized the importance of this new option, noting that prolonged use of existing treatments has led to antibiotic resistance.

Developed by GSK, gepotidacin is the first in a new class of oral antibiotics for uUTIs in over 20 years and has shown promising results in phase 3 trials, demonstrating non-inferiority and even superiority over nitrofurantoin in some cases. Haumschild highlighted the value of having another effective option with a different side effect profile, which could help reduce resistance and improve patient outcomes.

New pSNM system empowers patients in urge urinary incontinence treatment

In a recent interview with Contemporary OB/GYN, Jannah Thompson, MD, FPMRS, from Trinity Health Urogynecology, discussed the Neuspera sacral neuromodulation system's ability to address patient involvement in their care. Thompson highlighted that the system requires patients to use an external stimulator for 2 hours each day, fostering active participation and long-term commitment to treatment.

While the study initially targeted urge urinary incontinence, the therapy showed potential benefits for a broader range of patients, including those with mixed incontinence. The device is currently under FDA review, with Thompson expressing excitement over its potential to improve patient outcomes.

Ciera Kirkpatrick, PhD, shows how TikTok is transforming cervical cancer awareness

In this video interview, Ciera Kirkpatrick, PhD, highlighted the growing role of TikTok and other short-form video platforms in promoting cervical cancer screening among young women. She noted that providers are using these tools to deliver visual, approachable education on Pap tests, helping demystify the procedure and reduce anxiety. While visuals can be helpful, Kirkpatrick cautioned against focusing on pain or discomfort, which may deter viewers. Instead, empathetic, clear messaging can boost awareness and intent to screen, particularly for uninsured or underserved audiences with limited access to traditional health care.