OBGYN Updates: Q4 2023 Recap & New Advances

Landmark Advancements in Women’s Health Mark a Transformative 2025

A surge of FDA approvals, promising clinical trial data, and evolving technologies are reshaping the landscape of gynecologic care, offering new hope for women’s health across multiple fronts.

As 2025 draws to a close, the fourth quarter has witnessed significant progress in areas ranging from menopause management and infectious disease treatment to improved screening and a growing understanding of disparities in women’s healthcare. These developments, highlighted by Contemporary OB/GYN, signal a period of robust innovation poised to impact millions of women.

New Hope for Menopause Relief with Elinzanetant

The FDA recently approved elinzanetant (Lynkuet), a 60 mg capsule developed by Bayer, for the treatment of moderate to severe vasomotor symptoms associated with menopause. This marks a pivotal moment as the first FDA-approved dual neurokinin-1 and neurokinin-3 receptor antagonist for this indication. Phase 3 data from the OASIS program, specifically the OASIS-3 trial, demonstrated that elinzanetant reduced the frequency and severity of hot flashes by over 73% at 12 weeks, compared to a 47% reduction observed in the placebo group. Furthermore, the treatment showed improvements in sleep disturbance and menopause-specific quality of life. “Safety findings were consistent across trials, with no treatment-related serious adverse events reported,” stated a company release, positioning elinzanetant as a valuable nonhormonal option for patients who cannot utilize estrogen therapy.

Addressing Female Sexual Dysfunction: DARE to PLAY Now Available

DARE to PLAY, a topical sildenafil cream formulated for women, is now commercially available in select US states through a Section 503B outsourcing facility, according to Daré Bioscience. Designed to increase genital blood flow and enhance arousal sensations, the nonhormonal formulation has demonstrated onset within 10 to 15 minutes in clinical studies. While compounded products are not FDA approved, the launch is supported by robust toxicology testing and randomized clinical trials, including a phase 2b study that revealed meaningful improvements in sexual arousal and reduced distress among women experiencing female sexual arousal disorder. The company continues to pursue full regulatory approval.

New Oral Treatment for Gonorrhea Approved

In a significant step forward in combating antimicrobial resistance, the FDA has approved a supplemental new drug application for gepotidacin (Blujepa), manufactured by GSK, as an oral treatment for uncomplicated urogenital gonorrhea in adolescents and adults aged 12 and older. Phase 3 EAGLE-1 trial data showed noninferior microbiological cure rates compared to the standard injectable treatment of ceftriaxone plus azithromycin, with no reported treatment-related serious adverse events. This approval represents the first new class of oral antibiotics for gonorrhea in over 30 years, offering a crucial non-injectable alternative in the face of growing resistance and the lack of a licensed vaccine.

Zoliflodacin Shows Promise as a Gonorrhea Alternative

Further bolstering the fight against gonorrhea, Innoviva Specialty Therapeutics announced the publication of multicountry phase 3 trial results in The Lancet demonstrating that investigational oral zoliflodacin was noninferior to ceftriaxone plus azithromycin in treating uncomplicated urogenital gonorrhea in adolescents and adults. The findings revealed comparable microbiological cure rates and safety profiles, even at extragenital sites, supporting zoliflodacin as a potential single-dose oral alternative. The agent has received a Qualified Infectious Disease Product designation from the FDA, with a PDUFA target date of December 2025, positioning it as a promising addition to treatment options.

Maternal Vaccine Shows Immunogenicity in Phase 2 Trial

A phase 2 randomized, placebo-controlled study revealed promising results for the investigational maternal vaccine GBS-AlpN, designed to protect newborns from Group B Streptococcus (GBS) infection. The vaccine demonstrated immunogenicity when administered during pregnancy, leading to high concentrations of vaccine-specific antibodies in infants at birth, with an acceptable safety profile for both mothers and infants. Vaccinated groups achieved substantially higher cord blood IgG levels compared to the placebo group, indicating effective transplacental antibody transfer. Investigators concluded that these findings support the advancement of GBS-AlpN into phase 3 trials as a potential strategy to reduce early- and late-onset neonatal GBS disease.

Addressing the Perimenopause Misdiagnosis Crisis

A recent survey from Biote revealed a concerning trend: nearly 40% of women seeking care for perimenopause symptoms report being misdiagnosed, often receiving diagnoses of anxiety or depression instead of receiving care addressing underlying hormonal changes. The findings underscore a critical gap in provider engagement and menopause education, with less than half of respondents reporting that their clinician initiated discussions about perimenopause. Many women are relying on nonmedical sources for information. “Improved clinician education and earlier, accurate diagnosis—along with evidence-based interventions such as cognitive behavioral therapy—may help address unmet needs during perimenopause,” investigators noted, particularly as awareness and regulatory shifts around hormone therapy continue to evolve.

These advancements collectively represent a significant leap forward in women’s health, offering new tools and insights to improve care and address long-standing challenges.