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urofollitropin (Follegon)

✓ Approved

Merck & Co. · FSHR

什么是 urofollitropin？

urofollitropin 是一种治疗药物，由Merck & Co.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)。

药物档案

商品名Follegon
公司Merck & Co.
分子靶点FSHR
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, Merck & Co.

作用机制

分子靶点

urofollitropin 作用于 1 个分子靶点：

FSHRfollicle stimulating hormone receptor (FSHRO, ODG1)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

urofollitropin 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Reproductive system and breast disordersInfertility female✓ Approved

相关研究文献

PubMedNeurology. Education2026-09-06

Curriculum Innovation: Virtual Reality for Neuroanatomy Education Among Neurology Residents.

Gupta Ayush A, Bass Derek D, Barton Christopher R CR, Zhang Wanyu W et al.

Advanced neuroanatomy knowledge is essential for clinical reasoning in neurology, yet residency training offers limited time to reinforce concepts. This contributes to persistent gaps in topics frequently tested on the Residency In-service Training Examination (RITE). This study evaluated the feasibility and educational impact of a virtual reality (VR) neuroanatomy curriculum intended to enable residents to (1) identify and spatially integrate arterial, venous, and ventricular structures; (2) improve performance on assessments targeting commonly missed RITE concepts; and (3) assess usability, engagement, spatial presence, and perceived educational value. (1) To identify and label key neuroanatomical structures, (2) to describe spatial relationships relevant to clinical localization, (3) to apply neuroanatomy to clinical scenarios modeled after RITE items, and (4) to evaluate usability, engagement, and spatial presence of VR. A single-group, pre-post mixed-methods study among neurology residents at a single academic medical center. Participants completed a faculty-guided 40-minute VR session using Organon VR Anatomy on Meta Quest 3 headsets, focusing on cerebrovascular arterial supply, venous sinuses, ventricular anatomy, and key spatial relationships relevant to clinical localization. Knowledge was assessed using quizzes at baseline, postintervention, and at 2-week follow-up. Learner perceptions were measured using surveys, and data were analyzed using repeated-measures ANOVA and linear mixed-effects models, with mean differences and 95% confidence intervals reported. Thirty residents (mean age 30.5 years, SD 4.6; 50% female) completed all assessments. Mean scores increased from 8.57 (SD 2.75) at baseline to 11.37 (SD 2.27) immediately postintervention and were sustained at 11.20 (SD 3.07) at 2 weeks. The mean increase was 2.80 points (95% CI 1.45-4.15), representing an approximate 33% improvement, with sustained gains at follow-up (2.63 points; 95% CI 1.28-3.99). Participants reported high usability, engagement, and spatial presence. This study demonstrates the feasibility of an instructor-guided VR neuroanatomy curriculum and provides preliminary evidence of improved knowledge and short-term retention. Findings should be interpreted in the context of a single-group design and nonidentical assessments, which limit causal inference. VR seems to be a promising adjunct to traditional instruction, particularly when combined with guided teaching. Future controlled studies are needed to evaluate comparative effectiveness and long-term clinical impact.

PMID 42699696
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PubMedThe European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2026-08-17

Pharmacokinetic bioequivalence between (etonogestrel/ethinylestradiol 11.7/2.7 mg) NuvaRing® and Ornibel Premium® (etonogestrel/ethinylestradiol 8.25/2.6 mg), a novel polymer composition contraceptive vaginal ring.

Pérez de la Cruz María Ángeles MÁ, Diez Carlos C, Urek Sandra S, Matilla Sonia S et al.

This was a single-centre, randomised, single-ring insertion, 2-period, 2-sequence, crossover study designed to assess comparative bioavailability and thereby establish bioequivalence of two ethinylestradiol/etonogestrel vaginal rings (delivering 0.015/0.12 mg per day) after a single vaginal ring was inserted and worn for 28 days in healthy female subjects. Forty subjects were randomised for this bioequivalence study. The test product contains etonogestrel/ethinylestradiol 8.25/2.6 mg, compared with etonogestrel/ethinylestradiol 11.00/3.474 mg in the existing Ornibel® formulation, and was compared with NuvaRing (etonogestrel/ethinylestradiol 11.7/2.7 mg) as the reference product. The criteria for bioequivalence between the test and reference products were met. The test-to-reference ratio of geometric LSmeans and corresponding 90% CI for Cmax after Day 1, C504, AUC0-504, C672 and AUC0-672 were all within the acceptance range of 80.00 to 125.00% for ethinylestradiol and etonogestrel. The percentage reduction in residual hormone content remaining in the device after 21 days use, in comparison with NuvaRing®, is as follows: ETO residue after 21 days was reduced by 30%, and EE residue after 21 days was reduced by 4%. The test formulation (ethinylestradiol/etonogestrel vaginal ring delivering 0.015/0.12 mg per day; manufactured by Laboratorios Leon Farma, S.A.) is bioequivalent to the reference formulation (NuvaRing®; manufactured by N.V. Organon) following a single vaginal ring insertion worn for 28 days in healthy adult female subjects. Overall, the products tested were generally safe and well tolerated.

PMID 42605869
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PubMedThe European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2026-08-04

Two cases of pregnancy during the fourth year of 68 mg etonogestrel implant use.

Warling Allysa A, Page Lauren S LS, Nelson Hallie H, Lazorwitz Aaron A

The United States Food and Drug Administration recently expanded approval of the 68 mg radiopaque etonogestrel (ENG) contraceptive implant (Nexplanon, Organon, Oss, The Netherlands) from three years to five years, based on clinical trial data showing no pregnancies in years four or five of use. We present two cases of pregnancy in year four of implant use. Two patients presented to our medical center's emergency department with ENG implants in situ and were found to have positive pregnancy tests. The first patient had her implant placed three years and one month prior to presentation, and had an intrauterine pregnancy. The second patient had her implant placed three years and five months prior to presentation, and had a tubal ectopic pregnancy. The first patient underwent a medical termination of pregnancy and implant removal and replacement three days after initial presentation. Her original implant was removed intact. The second patient underwent a laparoscopic right salpingectomy and implant removal and replacement one day after initial presentation. Her original implant was removed intact. These cases suggest that both intrauterine and ectopic pregnancies can occur in year four of ENG implant use. Further work should be conducted to determine risk factors for implant failure, especially in years four and five of use.

PMID 42549817
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PubMedHuman reproduction open2026-07-11

Predicting natural conception leading to live birth for couples with infertility: a single-centre population-based cohort study of 7086 couples.

Cameron Natalie J NJ, Brian Kate K, McLernon David J DJ, Bhattacharya Siladitya S

Can a model be developed to predict natural conception leading to live birth over a period of 12 months in couples with different causes of infertility? We developed and validated a novel clinical prediction model that can be used to provide individualized estimates of the chance of a natural conception (leading to live birth) over a 12-month period for couples with different causes of infertility, including tubal factor, anovulation, male factor, unexplained, other (cervical, uterine, or sexual factor), and endometriosis. Existing prediction models for natural conception are primarily aimed at infertile couples with no identified cause (unexplained), mild male factor, or minimal endometriosis. Currently, there is no available model that is applicable across a wide range of fertility diagnoses at the point of initial assessment. A population-based cohort study based on data from a single large tertiary UK fertility centre serving the entirety of the North of Scotland, including all 9757 couples who registered at the clinic for the first time from 1998 to 2015. Using a Cox proportional hazards survival model, we estimated the chance of conception within the first year from diagnosis of infertility leading to live birth. The predictive accuracy of the model was assessed using discrimination and calibration measures in an internal validation. The clinical utility of the model was assessed using decision curve analysis. After exclusions, 7086 couples with infertility were included, of whom 891 (13%) had a natural conception within 1 year of diagnosis leading to live birth. Longer duration of infertility [hazard ratio (HR): 0.64 (95% CI: 0.57-0.72)], increasing female age [0.62 (0.55-0.70)], and tubal infertility [0.62 (0.47-0.81)] had the strongest influence on reducing the chance of natural conception within 1 year leading to live birth. Conversely, previous pregnancy [1.30 (1.12-1.50)] and unexplained infertility [1.29 (1.00-1.67)] were most strongly associated with increased chances of live birth. For example, a 25-year-old woman with 1 year of secondary unexplained infertility has a 33.8% predicted chance of having a baby resulting from natural conception within a year of diagnosis. In contrast, a 35-year-old woman with tubal infertility and 1 year of primary infertility has an estimated 6.0% predicted chance of live birth over a similar time horizon. The model demonstrated acceptable discrimination (optimism-corrected C-statistic 0.645) and good calibration in internal validation. Decision curve analysis demonstrated that applying the model at a 20% probability threshold would correctly identify an additional 7.2 couples per 100 as being likely to benefit from fertility treatment when compared against a 'treat-all' policy, which incorrectly assumes that all couples would benefit from fertility treatment. A freely available online calculator was constructed from the model formula to generate individual estimates of the chance of live birth following natural conception. The data used to inform this model were collected from a single centre until 2016, limiting generalizability. Any information not collected in this dataset, such as markers of ovarian reserve, severity of endometriosis, or subtype of ovulatory disorder, could not be included and may have improved the accuracy of the model predictions. As we have demonstrated that couples diagnosed with infertility can conceive on their own, knowledge of their individual chances of having a baby can clarify the net value of active treatment, including assisted reproduction. Use of this model via the online calculator could improve the quality of decision-making around the nature and timing of initiating fertility treatment. This work was funded in part by an NHS Grampian Charities Small Research Grant awarded to N.J.C, grant number SRG 24-30. We acknowledge the associated financial support of NHS Research Scotland, through NHS Grampian investment in the Grampian DaSH. N.J.C has no conflict of interest to declare. K.B. declares a previous role as Founder of the Fertility Alliance (charity) and receipt of speaker fees/honoraria from Merck and IBSA (paid to the Fertility Alliance). D.J.M. reports consulting fees from the Society for Assisted Reproductive Technology (SART) (paid to institution), honoraria from Merck for a fertility prediction modelling workshop, and financial support from ESHRE, Merck and IVIRMA to present at scientific conferences. S.B. reports royalties/licenses from Cambridge University Press, consulting fees from Merck, Ferring and Organon (paid to S.B. and to the institution), speaker fees/honoraria from Merck (paid to S.B. and to the institution), support for attending meetings/travel from Merck, and a leadership role as Board Member of the Fertility Alliance (charity). N/A.

PMID 42433287
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PubMedHuman reproduction (Oxford, England)2026-07-08

ESHRE position paper: international limits on the number of offspring per gamete donor.

Frith Lucy L, Tassot Johanna J, Ahlstrom Aisling A, Baldani Dinka Pavičić DP et al.

How should the number of offspring per gamete donor be regulated at an international level? The European Society of Human Reproduction and Embryology (ESHRE) recommends introducing a European Union (EU)-wide limit on the number of families per gamete donor, starting at 50 families and gradually reducing it to a maximum of 15 families or lower, supported by an EU-wide donor registry to monitor compliance. Most European countries impose national limits on the number of offspring or families per donor, but these limits vary widely and are not always enforced. Cross-border movement of patients and the export of donor gametes between countries mean that large donor sibling groups can still emerge despite these restrictions. What matters to donor-conceived people is the total number of donor siblings, regardless of which country they are in, making a transnational limit the only relevant mechanism that can address this issue. This position paper sets out principles relevant to international donor offspring limits and the position and policy recommendations of ESHRE, focusing on the EU level. This ESHRE position paper was developed by a multidisciplinary expert working group. Recommendations are supported by data from the literature, where available. The first version was published for stakeholder review in November 2025, with 45 completed review forms received from organizations representing donor-conceived people, families built through donor conception and infertility patients, national fertility societies, researchers, professionals from different disciplines, and gamete banks. The paper was then revised on the basis of the stakeholder review. ESHRE considers that the wellbeing of donor-conceived people should have the highest priority when determining limits, while also balancing the wellbeing of prospective parents. Limits should be set for the number of families rather than individual children. ESHRE proposes a phased introduction starting at 50 families per donor, being reduced to a maximum of 15 families or lower, alongside a 20-year cap on distributing gametes to new families after the first donation. National limits should still be upheld where they are lower, and donors should be able to set their own lower personal limit. Compliance should be monitored through an EU-wide donor registry or, failing that, national registries, with gamete banks (including non-EU banks exporting into the EU) obliged to enforce the limit, donors required to declare all previous donations, and families counted as potential live births unless confirmed otherwise. The evidence base on the psychosocial impact of large donor sibling groups is small and developing, and definitive evidence of harm is limited. Research on the preferences of donor-conceived people, donors, and recipients regarding offspring limits is scarce and inconclusive. These recommendations therefore take a precautionary approach, and the proposed 15-family limit should be reviewed in light of developing knowledge during the transition period. An EU-wide limit would represent a feasible first step towards an international limit. An EU-wide donor registry could potentially serve secondary purposes such as supporting tracing in case of the diagnosis of a serious genetic condition and giving access to information to donors and donor-conceived people. Support for the working group was provided by ESHRE. L.F. and C.C.-J. report travel support from ESHRE. D.P.B. reports speakers' fees from Merck, Ferring, Gedeon Richter and MSD, travel support from ESHRE, and a position as the president of the Croatian Society for Gynaecological Endocrinology and Human Reproduction. A.A. reports speakers' fees from Merck Healthcare KGaA and Ferring, travel support from ESHRE, passive shareholder interest in Inception Midco 1. S.à r.l., membership in a subgroup of the European Medical Devices Coordination Group, and a position as vice chair of the EXPAMED panel on obstetrics, gynaecology and reproductive medicine. G.N. reports speakers' fees from Gedeon-Richter and Organon, travel support from ESHRE, and a position as past chairman and member of the Executive Committee of the Bulgarian Association for Human Reproductive Embryology. P.T. reports speakers' fees and travel support from Ferring and Gedeon Richter and a position as a board member on the Arbeitskreis donogene Insemination. J.K.-B. reports speakers' fees from Ferring, IBSA, Merck and CooperSurgical, travel support from Merck and ESHRE, an associate editor position for the journal Andrology, and a position as chair of the scientific advisory committee of the Association for Reproductive and Clinical Scientists (ARCS). The remaining authors (J.T. and N.V.) have nothing to declare. n/a.

PMID 42415539
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PubMedJAMA psychiatry2026-06-24

Assessing Drug Efficacy After Multiple Negative Trials-Gepirone's Journey Through the FDA.

Turner Erick H EH, Powers John H JH, Ahn-Horst Rosa Y RY, Kesselheim Aaron S AS

Surveys have indicated that patients and clinicians can overestimate the efficacy and safety of drugs approved by the US Food and Drug Administration (FDA). In recent years, only approximately half of new drug approvals have been based on 2 or more adequate and well-controlled trials; furthermore, regulations do not limit how many trials can be conducted or provide clear guidance on how the FDA should consider a drug with conflicting evidence of benefit from multiple trials. To understand how the FDA evaluated a single investigational drug with positive and negative preapproval trials. The case of gepirone extended release (ER), approved for major depressive disorder, was reviewed. The FDA based its efficacy evaluation of gepirone ER on 13 trials: 12 acute treatment trials and 1 maintenance or relapse prevention trial. The FDA judged 2 acute treatment trials as positive. In the others, gepirone ER did not demonstrate superiority to placebo; and for 3, the FDA found evidence of statistical inferiority to an active comparator. Concerned that the positive trials might have occurred by chance and the amount of countervailing evidence, the FDA rejected the New Drug Application from the sponsor 4 times (Organon in 1999, 2002, and 2004, and Fabre-Kramer Pharmaceuticals, Inc in 2007). In 2014, the sponsor filed a dispute resolution request, leading to intervention by senior FDA leaders. In 2015, an FDA Advisory Committee voted that drug efficacy had not been demonstrated. Nevertheless, FDA leaders came to agree with the sponsor's arguments that the 2 positive trials had not occurred by chance and that the drug satisfied the FDA statutory standard for efficacy, and the drug was approved. The case of gepirone shows how the FDA evaluated an investigational drug with conflicting evidence. The FDA sometimes exercises "regulatory flexibility" and focuses on statistical (as opposed to clinical) significance in a few trials, allowing the approval of drugs with scant benefits. Product labeling should transparently report on all adequate and well-controlled trials relating to an FDA-approved indication, not just those with positive outcomes, so that clinicians can make better-informed prescribing decisions.

PMID 42340691
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