Drug Database
ES

estradiol (Vagifem)

✓ Approved

Novo Nordisk A/S · ESR1 · Small Molecule

What is estradiol?

estradiol is a small molecule developed by Novo Nordisk A/S. It is approved for therapeutic indications via intravaginal.

Drug Profile

Brand NamesVagifem
CompanyNovo Nordisk A/S
Drug ClassSmall Molecule
Molecular TargetESR1
RouteIntravaginal
StatusApproved
Sources: ClinicalTrials.gov, Novo Nordisk A/S

Mechanism of Action

Molecular Targets

estradiol acts on 1 molecular target:

ESR1estrogen receptor 1 (ER, ESR)
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Therapeutic Indications

estradiol is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Reproductive system and breast disordersAtrophic vulvovaginitis✓ Approved

Related Research Articles

PubMedMicrobiology spectrum2026-07-17

Longitudinal changes in the vaginal microbiome associate with spontaneous preterm birth: a focus on stability and specific taxa in a Chinese cohort.

Yu Yi Y, Zhou Jingwen J, Zhou Qian Q, Li Xu X et al.

Spontaneous preterm birth (sPTB) often results from ascending intra-amniotic infections originating from the vaginal microbiota. This study aimed to characterize vaginal microbial features and identify specific taxa associated with sPTB in a Chinese population. In this prospective cohort study, pregnant women were recruited from Peking Union Medical College Hospital. Vaginal swabs were collected longitudinally at 11-16, 22-28, and 34-37 weeks of gestation. DNA was analyzed using targeted real-time PCR (30 pathogens) and 16S rRNA gene sequencing (V3-V4). Community State Types (CSTs) were defined by enterotype-like clustering. Differential abundance was assessed using MaAsLin3 with Benjamini-Hochberg correction, adjusting for maternal age, BMI, and obstetric history. Among 273 women (26 sPTB, 247 term), no CST was significantly associated with sPTB after multivariable adjustment and false discovery rate (FDR) correction (all q > 0.05). Alpha and beta diversity also showed no significant between-group differences (all q > 0.05). However, longitudinal CST stability was significantly lower in the sPTB group (P < 0.05). Nominally significant associations were observed for Ureaplasma urealyticum (first trimester), Mycoplasma hominis, and Bacteroides fragilis (second trimester), but none survived FDR correction (all q > 0.05). In this Chinese cohort, sPTB was not associated with static CST profiles but with reduced microbial stability over time. Although no single taxon remained significant after correction, several pathogens showed nominal associations, warranting further investigation in larger studies.IMPORTANCEPreterm birth (PTB) is a global maternal and infant health issue affecting approximately 11% of newborns worldwide. In China, the prevalence of PTB was 6.1%. Abnormal vaginal microbiota has been demonstrated to be a risk factor for PTB. Our study is one of the largest studies performed to date to investigate the associations between vaginal microbiome and spontaneous PTB (sPTB) in the Chinese cohort. We found that vaginal microbiome dynamics changes in Community State Types (CSTs) were significantly associated with sPTB. Furthermore, we also found that the microbial risk for sPTB appeared to be the enrichment of specific taxa, suggesting that vaginal dynamics and fine-scale features are important factors to consider in future studies.

PMID 42466879
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PubMedFrontiers in medicine2026-07-17

Identification of key vaginal microbial signatures and immune remodeling associated with HR-HPV clearance following Kushen Gel treatment: a longitudinal analysis.

Wang Ying Y, Pan Shuheng S, Zhang Fengying F, Ma Huimin H et al.

Persistent high-risk human papillomavirus (HR-HPV) infection drives cervical carcinogenesis, often exacerbated by vaginal dysbiosis and localized immune dysfunction. Kushen Gel shows clinical promise, yet its impact on microbial-immune crosstalk during HR-HPV clearance remains unclear. This study elucidates the microbial remodeling and immune shifts associated with Kushen Gel-mediated HR-HPV regression. A retrospective analysis of 230 vaginal swabs (130 pre-treatment, 100 post-treatment) via 16S rRNA sequencing characterized community structural shifts. Subsequently, a prospective cohort of 35 patients with persistent HR-HPV infection (defined as laboratory-confirmed positive HR-HPV DNA for ≥12 months) validated clinical outcomes (HR-HPV clearance, vaginal pH, Nugent scores) alongside paired 16S rRNA sequencing and ELISA-based quantification of cervicovaginal cytokines (IL-8, IL-6, TNF-α, IFN-γ). Kushen Gel intervention significantly decreased microbial alpha diversity and was associated with a distinct beta-diversity shift toward a stable, Lactobacillus-dominant state. Models (LEfSe, Random Forest) identified a marked reduction in pathobionts (Gardnerella, Sneathia, Prevotella) post-treatment. In the prospective cohort, the HR-HPV clearance rate reached 82.9% (29/35) after three menstrual cycles, synchronized with significant reductions in mean vaginal pH (4.85 ± 0.42 to 4.12 ± 0.35, p < 0.001) and an 85.7% Nugent score normalization rate. Crucially, Kushen Gel treatment was associated with a profound shift from a pro-inflammatory to an anti-viral immune microenvironment. Pro-inflammatory markers (IL-8, IL-6, TNF-α) plummeted significantly (p < 0.0001), while anti-viral IFN-γ exhibited a robust increase (3.2 ± 1.1 to 18.6 ± 5.4 pg./mL, p < 0.0001), particularly in responders. Lactobacillus abundance positively correlated with IFN-γ (r = 0.68) and inversely with IL-8 (r = -0.54). Kushen Gel is associated with HR-HPV clearance and concurrent vaginal microenvironment remodeling, marked by suppressed anaerobic-driven inflammation and an enhanced IFN-γ-associated anti-viral niche dominated by Lactobacillus. These findings biologically support using Kushen Gel to manage vaginal dysbiosis and HR-HPV regression.

PMID 42465087
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PubMedArchives of sexual behavior2026-07-17

Adapting and Validating the Indonesian Version of the Masturbatory Premature Ejaculation Diagnostic Tool: A Questionnaire for Masturbation-Related Ejaculatory Symptoms.

Lionardi Samuel S, Handini Lika Putri LP, Utomo Natasha Susanto NS, Hartanto Markus Christian MC et al.

Objectively diagnosing premature ejaculation remains a challenge as it has traditionally been defined only through diagnostic criteria based on vaginal-penetrative activity. However, male sexual activity is diverse, ranging from penile-vaginal intercourse to solitary practices such as masturbation. Masturbation is highly prevalent in the general population, particularly among younger men who often report premature ejaculation. This presents a specific challenge in diagnosing premature ejaculation in men who do not engage in vaginal-penile intercourse and rely solely on solitary sexual activity, such as masturbation. Therefore, we translated and psychometrically validated the Indonesian version of the Masturbatory Premature Ejaculation Diagnostic Tool (MPEDT) in Bahasa Indonesia to facilitate and expand the application of sexual assessment in sexual healthcare, thereby enabling more comprehensive management of premature ejaculation. The Indonesian version demonstrated good construct validity, internal consistency (Cronbach's α = 0.88), and good temporal stability and reliability (intraclass correlation coefficient = 0.76), supporting its potential use as a screening instrument for masturbation-related ejaculatory symptoms in clinical and research settings. Furthermore, based on our analysis, an MPEDT cut-off score of ≥ 9 may help identify individuals who may benefit from further clinical evaluation.

PMID 42463927
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PubMedStem cell research2026-07-17

Generation of a human induced pluripotent stem cell line (hiPSC) from a patient with DLG4-related synaptopathy (AOUMEYi004-A) and a novel heterozygous de novo nonsense DLG4 variant c.2155A > T p.(Arg719*).

Feo Federica F, Falliano Silvia S, Caciotti Anna A, Rinaldi Marina M et al.

DLG4-related synaptopathy, also known as SHINE-syndrome, is a rare neurodevelopmental disorder caused by heterozygous de novo pathogenic variants in the DLG4 gene. DLG4 encodes the PSD-95 protein, which plays a crucial role in regulating the postsynaptic domain (PSD) of glutamatergic neurons. We established the diagnosis in a 37-year-old man, by whole exome sequencing, heterozygous for the novel variant c.2155A > T; p.(Arg719*), then generated and characterized the iPSC line derived from the patient in order to model the neurodevelopmental disorder. The AOUMEYi004-A line exhibits a normal karyotype and a positive expression of pluripotency markers and originates cells representing the three embryonic germ layers.

PMID 42462545
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PubMedPediatric quality & safety2026-07-17

Improving Skin-to-Skin Contact During the Golden Hour for Neonates ≥34 Weeks: Single-Site Quality-Improvement Initiative Study.

Chittethu Shaji Jithin J, Amuji Nalina N, Krishna Vilasam Reghunath Tinu T, Rao Pn Suman S

Early skin-to-skin contact (SSC) during the golden hour after birth offers multiple benefits for newborns and mothers. Despite World Health Organization and United Nations Children's Fund recommendations, baseline SSC rates in our unit were only 7% for vaginal deliveries and 10% for cesarean deliveries. We therefore aimed to increase the early SSC rate to more than 80% from baseline within 10 weeks. A multidisciplinary team of doctors and nurses conducted this quality improvement initiative in Southern India over 10 months (September 2023-June 2024) using the point-of-care quality improvement model (POCQI_learner_manual_ver 03_2020.pdf). Stable neonates of 34weeks or older included, measured baseline rates during 4 weeks, and tested 4 change ideas during the next 10 weeks. We assessed sustainability for 6 months after the intervention. Out 1312 neonates of gestation age 34 weeks or older, 854 were eligible (513 vaginal deliveries and 341 cesarean deliveries). The mean gestational age was 37 ± 1 weeks (mean ± SD), and the mean birth weight was 2,929 ± 445 g (mean ± SD). Implementation of change ideas-including standardized documentation, simulation-based training, and task-sharing with nursing students and aides-improved SSC rates to 85% for vaginal deliveries and 91% for cesarean deliveries. We sustained these gains, with rates consistently remaining more than 85% during the sustainability period. This quality improvement initiative enhanced healthcare providers' knowledge, competence, and confidence in facilitating SSC, resulting in a marked and sustained change in practice. Future studies should explore scalability across diverse healthcare settings.

PMID 42466160
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PubMedBMC microbiology2026-07-17

Vaginal PRA1 identifies clinically relevant Candida albicans vaginitis and excludes asymptomatic colonization: an exploratory study.

Roselletti Elena E, Kozma Barbara B, Ratonyi David D, Kunkli Alexandra A et al.

Accurate interpretation of Candida detection in women with vulvovaginal symptoms remains difficult, because organism recovery may reflect either clinically relevant infection or nonpathogenic colonization. We have recently demonstrated that the secreted fungal zinc-binding protein, Pra1 is responsible for driving the inflammatory immunopathology of VVC. We therefore reasoned that PRA1 expression by Candida albicans in the vagina may act as a diagnostic tool to discriminate between commensal colonisation and active disease. We conducted a 12-week prospective, single-center exploratory biomarker analysis nested within a registered parent clinical trial. Nine women with vulvovaginal symptoms provided cervicovaginal lavage samples and clinical data at baseline and at weeks 4, 8, and 12. This report does not present the primary efficacy analysis of the randomized trial. At each visit, Candida culture status and clinical severity score (CSS) were recorded. Symptomatic Candida vaginitis was defined as Candida culture positivity with CSS ≥ 3 at the same visit. Species identification of fungal isolates was performed by MALDI-TOF mass spectrometry, and vaginal PRA1 was quantified by SYBR Green real-time qPCR. Vaginal PRA1 concentrations were assessed as a time-varying same-visit biomarker using repeated-measures approaches, non-parametric comparisons, correlation analyses, and receiver operating characteristic (ROC) curves. PRA1 concentrations were substantially higher in Candida culture-positive than in culture-negative samples (median 4,011 vs. 21.5 pg/µL, p = 3.99 × 10⁻⁵). PRA1 was also higher in samples meeting criteria for symptomatic Candida vaginitis than in asymptomatic culture-negative samples (median 11,762 vs. 21.5 pg/µL, p = 8.15 × 10⁻⁵). Among culture-positive observations, PRA1 was associated with symptom severity (Spearman rho = 0.67; Pearson r = 0.56 after log10 transformation). Same-visit discrimination was high in this cohort for both Candida culture positivity and symptomatic Candida vaginitis (AUC approximately 0.95 for each outcome). In this small exploratory cohort, lower PRA1 thresholds achieved 100% sensitivity and negative predictive value for clinically significant Candida vaginitis. These estimates require validation in larger studies. These preliminary findings suggest that vaginal PRA1 may help distinguish symptomatic Candida-associated disease from clinically insignificant Candida detection and may be particularly useful as a rule-out biomarker. Given the small sample size and exploratory design, these results should be regarded as hypothesis-generating and require validation in larger, independent cohorts. The study protocol was approved by the Hungarian National Institutional Review Medical Research Council (approval No. 3282-7/2023/EUIG). The parent trial is registered at ClinicalTrials.gov (NCT05895162; 2023-06-08).

PMID 42464124
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