Drug Database
FS

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

✓ Approved

LG Chem Ltd. · FSHR · Recombinant Proteins

What is FSH?

FSH is a recombinant proteins developed by LG Chem Ltd.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection or subcutaneous injection.

Drug Profile

Brand NamesrFSH, LGLS, LBFS0101, FSH, LG Chem
CompanyLG Chem Ltd.
Drug ClassRecombinant Proteins
Molecular TargetFSHR
RouteInjectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, LG Chem Ltd.

Mechanism of Action

Molecular Targets

FSH 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

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

Therapeutic AreaConditionPhase
Reproductive system and breast disordersInfertility female✓ Approved

Related Research Articles

PubMedBMC women's health2026-10-20

Serum androstenedione levels are associated with dysmenorrhea and pain severity among women without endometriosis: an exploratory cross-sectional study.

Li Tingting T, Yu Sihui S, Shi Peipei P, Yin Sheng S et al.

Dysmenorrhea is a common gynecological condition with heterogeneous etiologies. Endometriosis is an important condition associated with dysmenorrhea, but the serum steroid and reproductive hormone profiles related to dysmenorrhea, and whether these associations differ by endometriosis status, remain unclear. This study aimed to investigate the associations of serum hormone profiles with dysmenorrhea and pain severity. This exploratory cross-sectional study was conducted from October 2022 to January 2024 at Zhongshan Hospital, Fudan University. A total of 139 premenopausal participants were classified into dysmenorrhea (n = 73) and non-dysmenorrhea (n = 66) groups and further stratified by endometriosis status. Serum steroid and reproductive hormones were measured using liquid chromatography-tandem mass spectrometry and immunoassays. Group comparisons were performed according to data distribution, and false discovery rate (FDR) adjustment was applied for multiple hormone comparisons. Multivariable logistic regression was used to evaluate the association between androstenedione (A4) and dysmenorrhea. In the overall cohort, women with dysmenorrhea showed higher A4 levels and a higher luteinizing hormone/follicle-stimulating hormone (LH/FSH) ratio, although these differences did not remain significant after FDR adjustment. After stratification by endometriosis status, these differences were mainly observed among women without endometriosis. In this subgroup, A4 levels were significantly higher in women with dysmenorrhea than in those without dysmenorrhea (0.85 ± 0.36 vs. 0.65 ± 0.28 ng/mL, P = 0.004; FDR-adjusted P = 0.024), as was the LH/FSH ratio (2.11 ± 1.47 vs. 1.44 ± 1.02, P = 0.013; FDR-adjusted P = 0.047). Among women without endometriosis, A4 was modestly correlated with visual analogue scale score (Spearman r = 0.285, P = 0.006) and remained associated with dysmenorrhea after multivariable adjustment (odds ratio = 8.07, 95% confidence interval: 1.60-40.65, P = 0.011). A4 and the LH/FSH ratio showed modest discrimination, with area under the curve values of 0.660 and 0.655, respectively. Serum A4 levels were associated with dysmenorrhea and pain severity, particularly among women without endometriosis. The LH/FSH ratio showed a weaker supportive association. These exploratory findings support further investigation of androgen-related endocrine profiles in dysmenorrhea without endometriosis, but A4 and the LH/FSH ratio showed limited standalone discriminatory value. Chinese Clinical Trial Registry, ChiCTR2400079587, Retrospectively registered on 2024-01-08.

PMID 42897519
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PubMedFrontiers in endocrinology2026-10-20

INSL3: an informative testis biomarker for assessing the HPG axis in men.

Anand-Ivell Ravinder R, Yang Xinyuan X, Tulumcu Bilal B, Ivell Richard R

The male hypothalamo-pituitary-gonadal (HPG) axis is an integrated endocrine system linking hypothalamic GnRH secretion, pituitary gonadotropins (LH and FSH), Leydig cell steroidogenesis, Sertoli cell function, and spermatogenesis. While conventional parameters such as testosterone or LH may be subject to high biological variance due to their pulsatile mode of secretion and multiple stress-related or environmental influences, the Leydig-cell-secreted peptide insulin-like peptide 3 (INSL3) offers a robust and constitutive alternative reflecting Leydig cell number, differentiation status, and long-term functional capacity. This narrative review considers INSL3 across the male life course in relation to other components of the HPG axis, including in fetal development, minipuberty, pubertal development, and male aging. It shows how measuring INSL3 offers important granularity in understanding issues such as the effects of environmental endocrine disruption, childhood, and lifestyle influences on pubertal development as well as on adult Leydig cell capacity, hypogonadism, and age-related morbidity. The presented evidence suggests that INSL3 will prove to be a useful biomarker for the HPG axis in adult life, though the reference range in healthy adults is quite large for yet unknown reasons; associations with BMI as well as early childhood and adolescent influences are described. While INSL3 reflects the GnRH-LH-testosterone arm of the HPG axis and is normally not directly linked to the spermatogenic compartment and male fertility, some studies do suggest a supportive relationship which merits further research. Similarly, other functions of INSL3 in men also remain underexplored.

PMID 42899007
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PubMedBJUI compass2026-10-20

Does orchidopexy for testicular torsion affect long-term fertility parameters in males: A systematic review.

Rao Avula Aishwarya AA, Rahemtoola Muhammad Shariq MS, Aziz Hassaan H, Grice Peter P et al.

The aim of this study is to investigate long-term fertility outcomes following orchidopexy performed for testicular torsion. This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD420251152057). A literature search was conducted from June 2025 to October 2025 across Scopus, PubMed, Web of Science and the StarPlus Library (University of Sheffield). Studies reporting on male patients with a history of testicular torsion who underwent orchidopexy were included. Eligible study designs comprised case reports/series, cohort studies, case-control studies and randomised controlled trials. Studies involving cryptorchidism, orchidectomy or no intervention following exploration, as well as systematic reviews, meta-analyses, editorials, book chapters, conference proceedings/posters, reviews and commentaries, were excluded. Seventeen articles with 324 patients analysed fertility and hormonal outcomes following detorsion with orchidopexy. Primary outcomes were classified as fertility parameters and semen analysis. Reported pregnancy rates were high, ranging from 90.2% to 91.3% with reported time to pregnancy of 6.6 to 8.9 months. Six studies reported semen parameters with sperm count (11.2-235.4 × 10), motility (51.6-67%) and morphology (3.6-28%) generally within reported reference ranges, although substantial variability existed between studies. Secondary outcomes included hormonal analysis and anti-sperm antibody prevalence. Five studies reported hormonal follicle-stimulating hormone (FSH) and luteinising hormone (LH) levels, eight studies reported testosterone levels and two reported inhibin B levels. Anti-sperm antibodies (ASA) were described in two studies, with positive ASA ranging from 20% to 27.2%. The reported follow-up duration across nine studies was 0.12-11.8 years, although none reported fertility outcomes longitudinally. This review suggests that fertility potential is generally preserved following testicular detorsion with orchidopexy, with the majority of studies reporting favourable semen profiles and pregnancy outcomes. However, the small number of heterogeneous studies and limited long-term data highlight the need for larger, standardised studies to better define the long-term impact of testicular torsion on fertility.

PMID 42898557
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PubMedReproductive toxicology (Elmsford, N.Y.)2026-10-19

"Mirabegron as a Protective Agent in Testosterone-Induced Prostate and Seminal Vesicle Toxicity: Insights into PCNA and TLR-4 Pathways".

Abdel-Hameed Sarah Sameh SS, El-Daly Mahmoud M, Matouk Asmaa I AI

Testosterone is an androgenic hormone and one of the anabolic steroids used in the management of conditions related to hypogonadism as well as to enhance performance in bodybuilders. Prolonged use of testosterone has been linked to adverse outcomes on male reproductive organs. Mirabegron, a β3- adrenergic receptor agonist, is used to alleviate symptoms of overactive bladder and recently, it has shown substantial antioxidant and antinflammmatory effects. This study was designed to investigate the potential protective effects of mirabegron against testosterone induced-toxicity on prostate and seminal vesicle tissues via modulating oxidative stress, inflammation and androgenic activities. Male Wistar rats (200 to 250g) were divided into three groups (n = 8); control; received vehicle, testosterone; received testosterone enanthate (3mg/kg, S.C.), and testosterone + mirabegron; received testosterone (3mg/kg, S.C.) and mirabegron (10mg/kg, P.O.) concurrently. Treatments and vehicle were administrated daily for 4 weeks. Mirabegron attenuated the testosterone-induced changes on serum levels of testosterone, FSH and LH as well as reduced prostatic 5α-reductase 1 (5AR1) (0.9433 ± 0.09597ng/mg) levels. Mirabegron improved the testosterone-induced histopathological alterations of the prostate and seminal vesicle tissues. Further, it reduced prostatic TGF-β1 level (42.93 ± 3.593pg/mg) and increased GSH content in both prostatic and seminal vesicle tissues ((25.59 ± 0.8877 and 31.70 ± 0.895 µmol/mg; respectively. Additionally, mirabegron prophylactic treatment suppressed testosterone-induced increase of oxidative stress, inflammatory and proliferative mediators, including MDA, total nitrite, iNOS, TLR4, IL-1β, PCNA, and procaspase-3. Mirabegron mitigated the damage on prostate and seminal vesicle tissues induced by testosterone through its antioxidant and anti-inflammatory activities.

PMID 42896680
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PubMedEnvironmental toxicology2026-10-19

Protective Effects of Trigonella foenum-graecum Extract Against Lead Toxicity: Integrated Redox, Endocrine, and Spermatogenic Responses.

Kayri Veysi V, Sahin Emre E, Irmak Mehmet M, Ozmen Ramazan R et al.

Lead (Pb) exposure remains an important environmental health concern because of its bioaccumulation and toxicity to multiple organs, including the liver, kidneys, and male reproductive system. This study evaluated the protective effects of a standardized Trigonella foenum-graecum L. (fenugreek; TFG) seed extract against subchronic lead acetate-induced toxicity in rats. An integrated experimental design assessed biochemical, oxidative, molecular, endocrine, histopathological, and sperm functional parameters. Animals were assigned to control, TFG extract (50 or 100 mg/kg), lead acetate, and combined lead plus TFG extract groups. Lead exposure caused hepatorenal dysfunction and histopathological injury, accompanied by increased malondialdehyde (MDA), reduced antioxidant defenses, increased nuclear factor kappa B (NF-κB) protein expression, and reduced nuclear factor erythroid 2-related factor 2 (Nrf2) and heme oxygenase-1 (HO-1) protein expression. Lead exposure also decreased circulating follicle-stimulating hormone (FSH) and luteinizing hormone (LH) concentrations and impaired sperm motility, density, morphology, viability, and testicular architecture. Coadministration of the TFG extract significantly attenuated these alterations, improved biochemical and antioxidant indices, reduced NF-κB expression, increased Nrf2 and HO-1 expression, improved gonadotropin concentrations and sperm quality, and ameliorated hepatic and testicular histopathology. For most endpoints, the 100 mg/kg/day dose produced greater numerical improvement than 50 mg/kg/day, although between-dose differences were not consistently significant. These findings indicate that the chemically characterized fenugreek extract attenuates lead-induced systemic and reproductive toxicity in this preclinical rat model, with effects associated with improved redox balance, inflammation-related protein expression, gonadotropin concentrations, and spermatogenic outcomes. Further studies are required before therapeutic or translational conclusions can be drawn.

PMID 42894270
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PubMedCureus2026-10-19

Efficacy and Safety of Vitex Extract on Menopausal Symptoms and Quality of Life in Postmenopausal Women: A Randomized Placebo-Controlled Trial.

Reddy Prasanna A PA, Aluri Srilakshmi S, Ca Anzar A, Mv Joseph J et al.

Postmenopausal women often experience vasomotor and hormonal symptoms due to a decline in estradiol levels, which affects their quality of life (QOL). Botanical extracts like Vitexextract, known for their estrogen- and progesterone-like actions, may offer a safe and effective approach for alleviating postmenopausal symptoms and improving overall quality of life. The current study was a prospective, randomized, double-blind, placebo-controlled, monocenter clinical study to evaluate the safety and efficacy of Vitex extract in postmenopausal women aged 40-65 years. Sixty eligible participants were randomized to either the Vitex extract or placebo group equally and instructed to take one capsule daily after breakfast for 60 days. The primary endpoints included changes in the Blatt-Kupperman Index (BKI), Menopause-Specific Quality of Life Questionnaire (MENQOL), Menopause Rating Scale (MRS), and overall QOL scores. The study was prospectively registered with the Clinical Trials Registry of India (CTRI/2025/03/082025). After 60 days, Vitex extract supplementation led to clinically and statistically significant improvements compared with placebo in all primary outcomes. Notable reductions were observed in BKI, MENQOL, and MRS scores, reflecting better control of vasomotor, psychosocial, physical, and sexual symptoms. Improvements were also seen in the reduction in joint and muscle pain, stress levels, and serum cortisol. Hormonal regulation of luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol, and thyroid function, along with reduced rheumatoid factor, indicated anti-inflammatory and endocrine benefits. No adverse effects or lab abnormalities were reported. In this single-center study, Vitex extract appeared effective and was well tolerated, suggesting its potential as a safe, non-hormonal option for relieving menopausal symptoms and improving quality of life in postmenopausal women. However, these findings should be confirmed in larger, multi-center trials before broader clinical recommendations can be made.

PMID 42894752
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