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FS

FSH (rFSH, LGLS / LBFS0101 / FSH, LG Chem)

✓ Approved

LG Chem Ltd. · FSHR · 重组蛋白

什么是 FSH？

FSH 是一种重组蛋白，由LG Chem Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection、Subcutaneous Injection。

药物档案

商品名rFSH, LGLS, LBFS0101, FSH, LG Chem
公司LG Chem Ltd.
药物类别重组蛋白
分子靶点FSHR
给药途径Injectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
状态Approved
来源： ClinicalTrials.gov, LG Chem Ltd.

作用机制

分子靶点

FSH 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

FSH 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

PubMedInternational journal of fertility & sterility2026-10-26

Therapeutic Potential of Bone Marrow-Derived Mesenchymal Stem Cells in A Letrozole-Induced Rat Model of Polycystic Ovary Syndrome.

M Abou-El-Naga Amoura A, Younes Elarby Nada N, El-Dusoky Sara S, Fayad Eman E et al.

Polycystic ovary syndrome (PCOS) is a prevalent metabolic and reproductive disorder and one of the leading causes of infertility. Bone marrow-derived mesenchymal stem cells (BM-MSCs) possess anti-inflammatory properties and have shown potential in alleviating PCOS manifestations in experimental models. This study aimed to evaluate the therapeutic efficacy of transplanted BM-MSCs and BM-MSC-derived culture media in a letrozole (LTZ)- induced PCOS rat model. The experimental study was conducted on 50 female Sprague Dawley rats aged (4-6 weeks) and weighing (100-120 g), using a LTZ-induced PCOS model. Animals were randomly assigned to 4 groups, including control, PCOS, BM-MSC-treated, and BM-MSC culture media-treated groups. BM-MSCs were isolated from (bone marrow) and administered via (tail vain) at a dose of (1×106 BM-MSC). Blood samples were collected to measure hormonal and metabolic parameters (insulin, androgen, progesterone, estrogen, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) using [enzyme-linked immunosorbent assay (ELISA) technique). Ovarian tissues were analyzed by for histopathological and immunohistochemical methods to assess [key markers, e.g., follicular development, tumor necrosis factor-alpha (TNF), and vascular endothelial growth factor (VEGF)]. The PCOS group exhibited hormonal imbalance, metabolic disturbance, and ovarian dysfunction. BMMSC treatment significantly reduced insulin (P=0.003) and androgen levels (P=0.040), while restoring progesterone (P=0.003), estrogen (P=0.007), FSH (P=0.009), and LH (P=0.001) to near-normal levels. BM-MSCs markedly improved both metabolic and reproductive parameters, effectively restoring fertility in the PCOS model. Treatment with BM-MSC-derived culture media produced partial improvement but did not fully reverse PCOS manifestations. BM-MSCs improved ovarian structure and function, ameliorating both metabolic and reproductive dysfunction in the PCOS rat model. BM-MSC transplantation yielded the most favorable outcomes, whereas BM-MSCderived culture media alone provided incomplete therapeutic benefits.

PMID 42929028
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PubMedJournal of pediatric endocrinology & metabolism : JPEM2026-10-23

FSH-secreting pituitary adenomas presenting with spontaneous ovarian hyperstimulation syndrome in children and adolescents: two cases, a literature review, and long-term follow-up.

Mammadova Jamala J, Kara Cengiz C, Çelebi Bitkin Eda E, Akın Leyla L et al.

Functioning FSH-secreting pituitary adenomas (FSHomas) are exceedingly rare in children; only nine pediatric patients, seven girls and two boys, have been reported previously. In girls, they commonly present with spontaneous ovarian hyperstimulation syndrome (sOHSS). The clinical presentation, management, and long-term outcomes of these tumors remain incompletely characterized. We report two girls aged 10.1 and 16 years with prolonged menstrual bleeding and bilateral multicystic ovarian enlargement due to FSHoma-associated sOHSS. Both demonstrated markedly elevated estradiol, suppressed LH, and nonsuppressed (inappropriately normal) FSH, with pituitary adenomas of 14 × 11 × 13 mm and 9 × 9 mm on MRI; immunohistochemistry was FSHβ-positive in both. Case 1 underwent transsphenoidal adenectomy after medical treatment with letrozole and cabergoline; despite residual tumor tissue, she remained stable over 10 years of follow-up. Case 2 underwent transsphenoidal resection but developed recurrent hyperestrogenism and ovarian enlargement 5 years later despite radiological stability of the residual adenoma, and subsequently required emergency surgery for ovarian torsion (excision of the left ovary, right ovarian cystectomy). All 11 pediatric patients, including the present two, were compared for presentation, treatment, and long-term outcome. These cases provide 10 and 9 years of follow-up after diagnosis. Biochemical recurrence may occur independently of radiological tumor progression, and persistent ovarian stimulation from residual adenoma tissue may cause irreversible complications, including ovarian torsion. Long-term multidisciplinary surveillance with serial hormonal assessment, pelvic imaging, and pituitary MRI is essential, and early pituitary-directed intervention may prevent unnecessary gynecological surgery.

PMID 42912446
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PubMedFrontiers in endocrinology2026-10-23

First-morning urinary luteinizing hormone and bone age decomposition for diagnosis of central precocious puberty in girls: a two-step prediction model study.

Huang Miao M, Lu Xiyan X, Liu Peipei P, Dong Guoqing G et al.

The diagnosis of central precocious puberty (CPP) in girls relies on the invasive gonadotropin-releasing hormone (GnRH) stimulation test. Urinary luteinizing hormone (LH) is a noninvasive candidate biomarker, but evidence from Chinese populations and its integration into multivariable prediction frameworks remain limited. We evaluated the diagnostic accuracy of first-morning urinary LH for CPP, established sex- and pubertal stage-specific reference intervals, and developed a two-step prediction model based on a bone age decomposition. In this single-center retrospective diagnostic accuracy study, we enrolled 808 children: 295 girls with early breast development (146 CPP, 149 non-CPP), 271 healthy girls, and 242 healthy boys (reference intervals only). First-morning urine was assayed for LH, follicle-stimulating hormone (FSH), and creatinine. Diagnostic performance was evaluated primarily in the 295 symptomatic girls, with an extended analysis in 566 girls including healthy controls; multivariable logistic regression decomposed bone age into chronological age (CA) and the BA-CA difference as separate predictors. Urinary LH showed moderate accuracy for CPP in the primary symptomatic cohort (AUC 0.692, 95% CI 0.630-0.752), peaking in girls aged 7-8 years (AUC 0.708, 95% CI 0.621-0.785); the extended cohort gave similar results (AUC 0.712; secondary, spectrum-extended estimate). The LH-to-creatinine ratio offered no improvement. Basal serum LH was the superior single marker (AUC 0.868 vs 0.692, P < 0.001). The noninvasive Model 1 (CA + BA-CA + urinary LH + breast Tanner stage + uterine length) achieved a C-statistic of 0.853 (sensitivity 73.3%, specificity 83.2%), with CA, BA-CA, and urinary LH as independent predictors. Adding basal serum LH and FSH (Model 2) improved the C-statistic to 0.909; urinary LH retained independent significance (aOR 1.280, P = 0.024), whereas basal FSH was inversely associated with CPP. Bootstrap-corrected C-statistics were 0.838 (Model 1) and 0.893 (Model 2). Pubertal-onset cutoffs were >1.02 mIU/mL in girls and >0.95 mIU/mL in boys. Decomposing bone age into CA and BA-CA enables tiered CPP risk stratification: the noninvasive model supports initial screening without blood sampling, and the complete model refines risk once serum gonadotropins become available. Urinary LH is a clinically useful component of tiered diagnostic algorithms for CPP.

PMID 42910289
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PubMedFood and chemical toxicology : an international journal published for the British Industrial Biological Research Association2026-10-23

Alterations in Kiss1-Gnrh1 and testicular steroidogenic gene expression following α-terpineol exposure in male rats.

Goravara Pakkiresha P, Handi Rahul M RM, Yenagi Vijay A VA, Malashetty Vijaykumar B VB

The present study investigated whether repeated oral exposure to α-terpineol is associated with alterations in Kiss1-GnRH-related HPG-axis signaling and testicular steroidogenesis in male Sprague-Dawley rats. Adult male rats received α-T (75, 150, or 300 mg/kg/day) by oral gavage for 28 days. Reproductive hormone levels, sperm characteristics, organ weights, testicular histopathology and ultrastructure, oxidative stress biomarkers, DNA damage, Nrf2 immunoreactivity, and expression of genes involved in HPG-axis regulation and steroidogenesis were evaluated. Repeated α-T exposure associated with dose-dependent reproductive toxicity characterized by significant reductions in reproductive organ weights, circulating GnRH, LH, FSH, and testosterone levels (T), impaired sperm count, motility and viability, increased sperm abnormalities, and marked testicular histopathological and mitochondrial ultrastructural alterations. α-T was associated with oxidative stress, evidenced by increased lipid peroxidation (MDA), depletion of antioxidant defenses (SOD, CAT, GSH), enhanced Nrf2 immunoreactivity, and increased testicular DNA damage. Molecular analyses revealed significant downregulation of Kiss1, Gnrh1, Lhb, Star, Hsd3b, and Cyp11a1, accompanied by enrichment of pathways associated with GnRH signaling, steroidogenesis, and reproductive endocrine regulation. Together, these findings demonstrate male reproductive toxicity following repeated α-terpineol exposure and identify accompanying changes in selected Kiss1-GnRH-associated, steroidogenic, and oxidative-stress endpoints; however, the causal contribution of these pathways remains to be established.

PMID 42913779
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PubMedJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society2026-10-23

Impact of female CFTR variant carrier status on reproductive outcomes.

Jia Miaomiao M, Xue Xia X

This study aimed to investigate the impact of carrying a single pathogenic or likely pathogenic CFTR variant on reproductive outcomes in women undergoing assisted reproductive technology (ART). In this single-center retrospective study, 4479 vitro fertilization (IVF) /intracytoplasmic sperm injection (ICSI) cycles from 3398 patients who had undergone expanded carrier screening (ECS) between January 2022 and November 2024 were analyzed. Cycles were categorized into a control group (n = 4089 cycles) and a CF carrier group (n = 390 cycles) based on the presence of a pathogenic/likely pathogenic CFTR variant in the female partner. The CF carrier group was propensity-score matched to controls at a 1:4 ratio. Subgroup analysis was stratified by variant loci (5T allele or non-5T variants). Compared with controls, female CF carriers showed lower baseline FSH levels (6.7 ± 2.9 vs. 7.8 ± 4.3, p < 0.05) and a reduced mature oocyte rate (78.4%vs. 84.1%, p < 0.05). In single blastocyst transfer cycles, clinical outcomes were comparable between 5T allele carriers and the control group. Carriers of non-5T CFTR variants had significantly lower clinical pregnancy (34.1%vs. 57.3%, p < 0.05) and live birth rates (25.0%vs. 44.7%, p < 0.05). No significant between-group differences were observed in other ovarian reserve parameters and embryo development. Women carrying a single pathogenic or likely pathogenic CFTR variant (excluding the 5T allele) may exhibit reduced fertility potential and poorer ART outcomes. These results support recommending that women be informed of the possible reproductive implications of CFTR carrier status prior to ART treatment.

PMID 42919705
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PubMedFrontiers in endocrinology2026-10-23

Serum miRNA expression profile in responders to acupuncture treatment for diminished ovarian reserve: a study protocol for a nested case-control study.

An Dongxue D, Yang Li L, Li Jiashan J, Hang Tian T et al.

Diminished ovarian reserve (DOR) leads to subfertility, infertility, and premature menopause, significantly compromising women's reproductive health. Although clinical evidence supports the effectiveness of acupuncture in improving ovarian reserve, treatment responses vary considerably among DOR patients, and the factors associated with favorable outcomes remain unclear. Serum microRNAs may serve as potential biomarkers for distinguishing acupuncture responders, warranting further investigation. This prospective nested case-control study will enroll women with DOR who undergo acupuncture treatment. Treatment response will be evaluated based on changes in anti-Müllerian hormone (AMH) levels, antral follicle count (AFC), serum follicle stimulating hormone (FSH) levels and clinical pregnancy. According to their response, participants demonstrating greater improvement will be assigned to the experimental group (responders), while non-responders will be matched in a 1:1 ratio to form the control group. Serum microRNA profiles from both groups will be analyzed using high-throughput sequencing to identify differentially expressed microRNAs. Candidate microRNAs will subsequently be validated via real-time quantitative PCR (RT-qPCR), and receiver operating characteristic (ROC) curve analysis will be performed to evaluate their predictive value for acupuncture treatment response. This is the first clinical study to characterize the serum miRNA expression profiles of DOR patients who benefit from acupuncture. The findings are expected to provide evidence supporting the precise identification of acupuncture-responsive individuals within this patient population. https://itmctr.ccebtcm.org.cn/mgt/project/view/-4614215526207679163, identifier ITMCTR2025000004.

PMID 42908727
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