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RE

recombinant FSH (FostiRel)

✓ Approved

Reliance Life Sciences Private Limited · FSHR · Recombinant Proteins

What is recombinant FSH?

recombinant FSH is a recombinant proteins developed by Reliance Life Sciences Private Limited. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.

Drug Profile

Brand NamesFostiRel
CompanyReliance Life Sciences Private Limited
Drug ClassRecombinant Proteins
Molecular TargetFSHR
RouteInjectable (Others), Subcutaneous Injection
StatusApproved

Mechanism of Action

Molecular Targets

recombinant FSH acts on 1 molecular target:

FSHRfollicle stimulating hormone receptor (FSHRO, ODG1)
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Therapeutic Indications

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

Therapeutic AreaConditionPhase
Reproductive system and breast disordersInfertility female✓ Approved

Related Research Articles

PubMedCurrent opinion in urology2026-07-17

The FSH reset hypothesis: optimizing spermatogenesis in azoospermia.

Bedi Nicholas N, Ramasamy Ranjith R

Elevated follicle-stimulating hormone (FSH) in primary hypogonadism is usually read as maximal but failing testicular stimulation, and affected men are often considered poor candidates for hormonal therapy. This is a hypothesis-generating narrative review rather than an evidence-based treatment recommendation. It re-examines that assumption and asks whether FSH bioactivity, rather than concentration alone, might shape the testicular response. Circulating FSH is a mixture of glycosylation-dependent isoforms that differ in receptor-binding efficiency in experimental systems. Chronic gonadotropin excess can downregulate and desensitize the FSH receptor in animal and in vitro models. In principle, these mechanisms could combine to produce a state of functional FSH resistance, in which immunoreactive FSH is high while the effective signal in the testes is weaker. FSH suppression-associated rises in inhibin B, contemporary staged conditioning protocols, and stratification of hypergonadotropic men under the APHRODITE criteria are consistent with a strategy of temporary suppression before stimulation. We outline the FSH reset hypothesis, in which a finite period of pituitary suppression reduces inefficient endogenous hormone and may allow receptor recovery before controlled recombinant FSH. We then present a stepwise treatment algorithm as a model for future investigation in selected men with spermatogenic failure. The hypothesis is speculative and remains unproven in prospective trials.

PubMedAndrology2026-07-17

Follicle-Stimulating Hormone to Inhibin B Ratio Among Primary Infertile Men With Low Testosterone-A Biochemical Marker of Testicular Reserve.

Negri Fausto F, Pozzi Edoardo E, Raffo Massimiliano M, Boeri Luca L et al.

In adult males, Inhibin B (InhB) production depends on follicle-stimulating hormone (FSH)-which stimulates InhB as part of a negative feedback loop on the pituitary gland-and on spermatogenic activity, which reflects the functional state of the seminiferous epithelium. We aimed to (i) investigate the role of the FSH/InhB ratio in a homogeneous cohort of primary infertile men with low testosterone levels and (ii) evaluate its reliability as a marker of impairment severity. Data from 1568 consecutive primary infertile men, defined according to World Health Organization (WHO) criteria, were analyzed. Patients underwent thorough assessments comprising complete demographic, clinical, genetic, and laboratory investigations, including semen analysis and sperm DNA fragmentation index (SDF) testing. Low testosterone was defined as serum total testosterone (tT) < 3.5 ng/mL, according to the EAU threshold. Patients with any chromosomal alteration and history of cryptorchidism were excluded from the analysis. The final cohort was stratified into two groups based on the median FSH/InhB ratio (≤ 0.23 vs. > 0.23). Descriptive statistics were used to summarize baseline characteristics, and linear regression analysis was performed to evaluate the associations between the FSH/InhB ratio and sperm concentration. Overall, 360 men (23%) reported tT < 3.5 ng/mL. Of these, men with higher FSH/InhB ratio levels displayed lower mean testicular volume (TV) [13.5 (10, 20) vs. 17.5 (15, 22.5) mL, p < 0.001], anti-Müllerian hormone (AMH) [0.2 (0.16, 2.7) vs. 6 (3.5, 7.2) ng/mL, p = 0.01] and total motile sperm count (TMSC) [4.4 (0.4, 21.6) vs. 15.7 (2, 55), p < 0.001], along with higher rates of non-obstructive azoospermia (NOA) (31.7% vs. 12.8%, p < 0.001). No additional significant differences were observed between the groups. At multivariable linear regression analysis, smaller TV [β = 2.42 (95% CI 1.41, 2.86); p`0.01], higher BMI [β = -1.24 (95% CI -2.25, -0.23); p = 0.02] and higher FSH/InhB ratio [β = -0.53 (95% CI -1.04, -0.03); p = 0.04] were identified as independent predictors of lower sperm concentration, after adjusting for age and tT. Among primary infertile men with low tT levels, those with a higher FSH/InhB ratio exhibited a more severe phenotype, characterized by reduced TV, lower TMSC, and higher rates of NOA as compared with those with a lower ratio. These findings identify a distinct endocrine phenotype characterized by reduced InhB production at comparable FSH levels, which is associated with impaired gonadal function. The FSH/InhB ratio emerges as a useful biomarker to stratify gonadal dysfunction severity in men with primary infertility and hypogonadism.

PubMedTissue & cell2026-07-17

A review on molecular regulation of male reproductive hormones and signaling pathways: Emerging mechanisms and research gap.

Wanjari Uddesh Ramesh UR

Male infertility is complex, driven by impaired endocrine signalling, germ-somatic cell communication, and epigenetic regulation of spermatogenesis. LH/cAMP/PKA signalling in Leydig cells and FSH-mediated regulation in Sertoli cells have been extensively studied. The combined effects of these pathways on testicular physiology and clinical infertility are unknown. This review integrates hypothalamic-pituitary-gonadal axis signalling, intra-testicular epigenetic oversight, and environmental variables at the systems level. Integrating LH and FSH-dependent signalling with somatic cell activity, epigenetic programming during spermatogenesis, and endocrine disruptor effects on these networks. Despite recent improvements in single-cell and spatial transcriptomics, testicular heterogeneity and its integration processes remain unexplained. This review identifies key barriers that hinder molecular discoveries from becoming clinical diagnoses and therapies. This paradigm links biological pathways to infertility symptoms. It provides new possibilities for biomarker development and targeted therapeutics by including endocrine, epigenetic, and environmental factors on testicular function, prompting future research into translational routes that connect molecular endocrinology and clinical care for infertility.

PubMedMicrobial cell factories2026-07-17

Enhancing recombinant eGFP secretion in P. tricornutum by optimizing culture conditions.

Gargouch Nesrine N, Charrier Aurélie A, Toustou Charlotte C, Bougaran Gaël G et al.

Phaeodactylum tricornutum is a promising candidate for the production of recombinant therapeutic proteins including antibodies. So far, low secretion yields remain a significant bottleneck for pharmaceutical applications. Towards the objective to increase production yield of secreted recombinant protein, this study investigates the optimization of environmental and nutritional parameters, under laboratory conditions, to maximize the production of a model secreted recombinant protein (eGFPsec) under the control of the Nitrate Reductase promoter (PNR). We evaluated the interplay between nitrate availability, Photosynthetic Photon Flux Density (PPFD), and pH level within both natural and artificial seawater matrices. Our results demonstrate that while PNR activity does not increase with nitrate concentrations beyond non-limiting levels, a PPFD of 150 µmol photons m- 2 s- 1 significantly enhances eGFPsec accumulation in the medium. Interestingly, cultures grown in Natural Sea Water under pH-regulated conditions (pH = 8) exhibited markedly higher secreted-eGFP fluorescence compared to those in artificial seawater. These findings highlight the importance of optimizing key environmental and nutritional parameters to improve secretion recombinant protein yields. By identifying key drivers of eGFP fluorescence-based productivity and accumulation in the medium, this work provides actionable insights for process optimization, reinforcing the potential of P. tricornutum as a robust and cost-effective platform for industrial microalgae-based biomanufacturing.

PubMedbioRxiv : the preprint server for biology2026-07-17

An engineered biofactory for efficient production of diverse recombinant superoxide dismutase isozymes loaded with specific metal ions for biochemical characterisation.

Mazgaj Rafał R, Kołpa Agnieszka A, Esmaeeli Mariam M, Pełczyńska Justyna J et al.

Biochemical, biophysical and structural characterisation of isozymes from the ubiquitous family of iron- or manganese-dependent superoxide dismutases (SodFMs) requires the purification of high-quality preparations of recombinant enzymes. Determination of their key biochemical parameter, their catalytic metal-preference, requires the comparison of the catalytic turnover of samples loaded exclusively with iron versus samples loaded exclusively with manganese. Both of these aims are inhibited by the potential contamination of recombinant preparations of SodFMs, prepared by heterologous overexpression inside Escherichia coli cells, by even low levels of endogenous SodFMs from the host, both of which show very high turnover with either manganese ( E. coli MnSOD) or iron (FeSOD). To overcome this problem, we created a strain of E. coli lacking the endogenous SodFMs. Here, we characterised this E. coli BL21 (DE3) Δ sodA Δ sodB strain, determining the physiological effects of SodFM deletion and demonstrating its utility for producing recombinant SodFMs for in vitro characterisation and use. Genomic analysis verified the targeted gene deletions, without off-target effects. Growth, expression, elemental analysis, and proteomic data confirmed a lack of physiological defects of the strain except for a known inability to grow on glucose, which is overcome by heterologous SodFM expression. We demonstrate the utility of the strain for the efficient production of diverse recombinant SodFMs, including highly divergent, understudied isozymes, including the ability to precisely control the metal-loading of the heterologously expressed protein. The E. coli strain described herein is a useful microbial cell factory for production of recombinant SodFMs, which should find widespread utility as expression host of choice, enabling more efficient production of protein for studies of the biochemical, biophysical and structural properties of this remarkable family of metalloenzymes.

PubMedJournal of agricultural and food chemistry2026-07-17

Stereoselective Reproductive and Intergenerational Toxicity of Prothioconazole in Female Zebrafish: Concurrent Ovarian Cytotoxicity and Endocrine Disruption.

Bian Jinhao J, Zhao Hanshuang H, Xu Wenping W, Li Zhong Z et al.

Prothioconazole (PTCZ) is a chiral fungicide generally assessed as a racemate, potentially masking enantiomer-specific hazards. Adult female zebrafish were chronically exposed to environmentally relevant concentrations of racemic PTCZ, R-(-)-PTCZ, or S-(+)-PTCZ. S-(+)-PTCZ caused the strongest reproductive and intergenerational toxicity, whereas Rac-PTCZ showed intermediate effects and R-(-)-PTCZ elicited weaker responses. S-(+)-PTCZ reduced fecundity and GSI, disrupted follicle development, increased follicular atresia, and impaired F1 hatching, survival, and morphology. Ovarian injury was accompanied by increased γ-H2AX, PARP, Caspase-3, and TUNEL staining, mitochondrial abnormalities, ATP depletion, and altered NAD+/NADH status. S-(+)-PTCZ also perturbed HPG-axis end points, including FSH, LH, E2, VTG, and steroidogenesis-related transcripts. These findings reveal pronounced stereoselective reproductive hazards of PTCZ under the tested exposure conditions and support enantiomer-specific ecological risk assessment.

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