Drug Database
UR

urofollitropin (Follegon)

✓ Approved

Merck & Co. · FSHR

What is urofollitropin?

urofollitropin is a therapeutic agent developed by Merck & Co.. It is approved for therapeutic indications via injectable (others).

Drug Profile

Brand NamesFollegon
CompanyMerck & Co.
Molecular TargetFSHR
RouteInjectable (Others)
StatusApproved
Sources: ClinicalTrials.gov, Merck & Co.

Mechanism of Action

Molecular Targets

urofollitropin acts on 1 molecular target:

FSHRfollicle stimulating hormone receptor (FSHRO, ODG1)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

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

Therapeutic AreaConditionPhase
Reproductive system and breast disordersInfertility female✓ Approved

Related Research Articles

PubMedHuman reproduction (Oxford, England)2026-10-09

Ovarian reserve after chemotherapy in premenopausal women with breast cancer undergoing fertility preservation counselling with and without unilateral ovarian tissue cryopreservation.

Yde Anna Mathilde AM, Colmorn Lotte Berdiin LB, Pinborg Anja A, Forman Julie Lyng JL et al.

What is the impact of chemotherapy on the ovarian reserve in premenopausal women diagnosed with breast cancer, and how is this impacted by fertility preservation (FP) strategy and age at diagnosis? Chemotherapy reduces ovarian reserve in women with breast cancer, with the greatest reductions observed among women who underwent ovarian tissue cryopreservation (OTC) and those of advanced reproductive age (≥35 years). Breast cancer is the most prevalent cancer among women of reproductive age, and in recent decades increasing emphasis has been placed on FP, including ovarian tissue, embryo, and oocyte cryopreservation. However, few large prospective studies have evaluated the effect of chemotherapy on ovarian reserve in patients with breast cancer using both anti-Müllerian hormone (AMH) and antral follicle count (AFC), and no large studies have assessed the impact by choice of FP. In this combined retro and prospective cohort study, we included 152 premenopausal women diagnosed with breast cancer who received FP counselling at Rigshospitalet, Copenhagen University Hospital, between 1 January 2018 and 31 August 2023. Women aged 18-42 years scheduled for FP counselling before chemotherapy were included. Exclusion criteria were previous chemotherapy, oophorectomy, and death or emigration within 2 years of inclusion. Medical and gynecological history, and oncological treatment plans were recorded. Ovarian reserve was assessed using AMH and AFC at baseline and at 6, 12, and 24 months after chemotherapy. Changes over time were analyzed using linear mixed models adjusted for age at baseline and hormonal contraceptive use. Of 152 women, 57 underwent OTC, while 41 underwent oocyte/embryo cryopreservation and 54 had no FP. Baseline median AMH was 13.9 [95% CI: 10.7, 18.1] pmol/l among women who did not undergo OTC and 13.3 [10.9, 16.3] pmol/l among those who did. A marked reduction in both AMH and AFC was observed after chemotherapy, with partial recovery within 2 years after treatment. The reduction was more pronounced, and recovery more limited, in women with OTC and in those of advanced reproductive age (≥35 years). Compared to baseline, the adjusted reduction in median AMH was 90% [95% CI: 85%, 93%] at 6 months and 75% [95% CI: 63%, 83%] at 24 months in women without OTC and 93% [95% CI: 85%, 95%] and 85% [95% CI: 78%, 90%] in women with OTC, respectively. Similar patterns, however, not as profound, were seen for AFC. Not all women completed assessments at all three follow-up visits, likely reflecting emotional exhaustion, hospital fatigue, reluctance to attend additional appointments, or changes in reproductive intentions. Furthermore, the observed reduction in ovarian reserve may, to some extent, also reflect the natural age-related decline in ovarian reserve. These findings may support counselling women with breast cancer about chemotherapy-related ovarian damage and thus the need for FP. The study is funded by the Independent Research Fund Denmark (Grant ID 10.46540/4308-00130B). A.P. has received grants (paid to the institution) and consulting fees from Gedeon Richter, Ferring Pharmaceuticals, Merck A/S, and Cryos; honoraria from Gedeon Richter, Ferring Pharmaceuticals, Merck A/S, and Organon; and support for meeting attendance and/or travel (paid to the institution) from Gedeon Richter. A.T.P. received speaker fees from Astellas, Gedeon-Richter, and Novo Nordisk. These companies had no role in the study. The other authors have no conflicts or interests to declare. N/A.

PMID 42853979
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PubMedHuman reproduction (Oxford, England)2026-09-25

The two-shot protocol. A randomized controlled trial of a novel two-injection ovarian stimulation strategy.

Donno Valeria V, Sachs-Guedj Noemie N, Devesa Marta M, García-Martinez Sandra S et al.

Is the number of MII (metaphase II) oocytes comparable in the two-shot protocol versus the conventional corifollitropin alfa (CFA) followed by follitropin-beta protocol? Although the mean number of MII oocytes did not differ significantly between the two-shot protocol and the control group, non-inferiority was not statistically met. Controlled ovarian stimulation (COS) protocols are often associated with significant side effects, largely due to the burden of multiple daily injections. Efforts to develop more patient-friendly protocols include the shift from GnRH-agonist to antagonist protocols and the introduction of progestin protocol for pituitary suppression (PPS). While such patient-friendly approaches benefit infertile patients, they are even more appealing for women undergoing COS for elective fertility preservation. The current study aims to compare a novel ovarian stimulation protocol involving two sequential CFA injections (two-shot protocol) with a conventional approach using CFA and follitropin-beta in elective fertility preservation. Phase III, randomized, controlled, single-center, non-inferiority clinical trial conducted at a Fertility Unit within a University-Affiliated Hospital between December 2023 and July 2025. A total of 194 women were enrolled with a 1:1 allocation. Eligible participants were ≤40, with antral follicular count <20, and anti-Mullerian hormone (AMH) ≤ 3 ng/ml. Participants were randomized to receive either two sequential shots of CFA (150 mcg on Day 1 + 100 mcg on Day 5) or CFA (150 mcg) on Day 1, followed by recombinant FSH (200 IU/day) from Day 8. In both groups, the LH surge was suppressed using a PPS protocol with daily oral desogestrel 75 mcg from the beginning of stimulation until the trigger day. Final oocyte maturation was triggered with GnRH-agonist (triptorelin 0.2 mg). The primary outcome was to compare the two ovarian stimulation protocols in terms of the number of MII oocytes. Comparisons will be made using the estimated mean difference (MD) and corresponding 95% CI. A total of 194 patients were assessed for eligibility and randomized into two groups: 97 patients were assigned to the two-shot protocol (Group A), while 97 patients followed the conventional protocol involving CFA followed by rFSH (Group B). No statistically significant differences were found in the mean number of oocytes nor MII oocytes between the two-shot protocol and the control group, respectively, 8.09 ± 5.87 vs 9.11 ± 6.86; MD -1.02 [95% CI: -2.83; 0.79] and 6.14 ± 4.59 vs 7.19 ± 5.67, MD -1.04 [95% CI: -2.27; 0.18]. However, because the lower bound of the CI for the primary endpoint (-2.27) exceeded the pre-specified non-inferiority margin of -1.5 MII oocytes, non-inferiority of the two-shot protocol could not be demonstrated. Duration of stimulation (10.27 ± 1.69 vs 10.19 ± 1.47 days; MD 0.09 [95% CI -0.39; 0.56]) and number of follicles ≥14 mm on trigger day (10.67 ± 5.36 vs 11.14 ± 5.46; MD -0.47 [95% CI -2.11; 1.17]) were comparable between groups. The hormonal assessment performed during the stimulation revealed no clinically meaningful differences, except for the FSH concentrations, which were markedly higher in Group A on Day 8 (53.43 ± 13.28 vs 24.60 ± 8.33 IU/l; MD 28.82 [95% CI: 25.39; 32.25]) and remained higher on the day of ovulation trigger (31.28 ± 9.50 vs 24.46 ± 5.01 IU/l; MD 6.82 [95% CI: 4.32; 9.32]). The current study focused only in elective fertility preservation women, preventing conclusions on embryological differences between the protocols. Furthermore, since the sample size was powered to detect differences in the number of MII oocytes, findings for secondary outcomes, such as the hormonal profile, should be interpreted with caution. The two-shot protocol yielded a comparable number of MII oocytes to conventional stimulation; however, the pre-specified non-inferiority margin was not met, as the CI could not exclude a true reduction exceeding 1.5 MII oocytes. The point estimate of approximately one fewer MII oocyte is unlikely to be clinically meaningful, but larger studies are required before the protocol can be formally established as non-inferior. The study was supported by Fundación Santiago Dexeus Font and an unrestricted grant by Organon. N.P.P. has received research grant funding paid to the institution and personal honoraria for lectures from Organon. V.D. has received payment or honoraria for lectures from Organon. N.S.-G., M.D., S.G.-M., and I.R. have not conflict of interest to declare. NCT06134479. 18 November 2023. 18 December 2023.

PMID 42786378
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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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