Drug Database
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
Sources: ClinicalTrials.gov, Reliance Life Sciences Private Limited

Mechanism of Action

Molecular Targets

recombinant 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

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

Therapeutic AreaConditionPhase
Reproductive system and breast disordersInfertility female✓ Approved

Related Research Articles

PubMedFrontiers in allergy2026-09-19

Severe anaphylactic shock suspectedly induced by injection of recombinant humanized type III collagen lyophilized fiber for facial skin improvement: a case report.

Liu Junjie J, Yan Wenjing W, Liu Jing J, Yang Bowen B et al.

Recombinant humanized type III collagen is widely used in facial rejuvenation due to its excellent biocompatibility and overall favorable safety profile; however, severe systemic hypersensitivity reactions are exceedingly rare. We report a case of a 47-year-old woman with no prior history of allergy who received topical lidocaine to the face, followed by injection of recombinant humanized type III collagen lyophilized fibers for skin texture improvement. Immediately after the injection, she developed suspectedly severe anaphylactic shock temporally associated with the recombinant collagen injectionpresenting with confusion, respiratory distress, followed by marked bradycardia (33 beats/min), and loss of palpable arterial pulse. Emergency protocols were activated immediately, including cardiopulmonary resuscitation, intravenous adrenaline, corticosteroids, and fluid resuscitation. The patient's vital signs gradually recovered, and she was discharged after complete recovery two days later after complete recovery. This case suggests that recombinant humanized collagen, as a macromolecular protein, inherently carries the risk of triggering immediate-type anaphylactic shock despite its favorable safety profile. Clinicians should perform rigorous preoperative assessment, adhere to standardized procedures, and be proficient in the emergency management of anaphylactic shock to minimize the risk of severe adverse reactions and ensure medical safety.

PMID 42760965
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PubMedSignal transduction and targeted therapy2026-09-19

A randomized, double-blind, active-controlled phase 3 multicenter trial of rHSA for cirrhotic ascites.

Jia Jidong J, An Yajun Y, Ou Xiaojuan X, Duan Weijia W et al.

In this multicenter, randomized, double-blind, active-controlled phase 3 trial (NCT06553456), we assessed the equivalence of recombinant human serum albumin (rHSA) expressed in Pichia pastoris to plasma-derived human serum albumin (pHSA) for elevating serum albumin (ALB) levels and non-inferiority regarding ascites improvement in patients with cirrhotic ascites. Using a rigorous dual-endpoint design, the primary endpoint was the change from baseline in serum ALB immediately after the final intravenous infusion. The key secondary endpoint was the ascites improvement rate after the final administration. Ultimately, 364 out of 390 patients completed the study. Statistical equivalence was established for the primary endpoint, with least-squares mean ALB changes of 11.16 ± 0.364 g/L (rHSA) and 10.95 ± 0.395 g/L (pHSA) (LSM difference: 0.21 g/L [95% CI: -0.75, 1.16]). For the secondary endpoint, ascites improvement was non-inferior, demonstrating a 58.0% response rate for rHSA versus 48.7% for pHSA (difference: 9.4% [95% CI: -0.56%, 19.10%]). Both endpoints of the trial were successfully achieved. The overall incidence of adverse events was similar in the two groups; crucially, no anti-drug antibodies were detected in the rHSA group. Exploratory analysis revealed that rHSA significantly reduced glycated ALB (-12.24%), whereas pHSA increased it ( + 12.52%) (P < 0.001). Corroborated by LC‒MS characterization, silver-staining purity assessment, and four biochemical quality attributes (free thiol, Hcy, AGEs, and carbonyl levels), this divergence highlights the preserved molecular integrity of rHSA. This trial demonstrated that in patients with cirrhotic ascites, rHSA was statistically equivalent to pHSA in elevating serum ALB and non-inferior in ascites improvement, with a favorable safety profile.

PMID 42760319
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PubMedAAPS PharmSciTech2026-09-19

Comprehensive Stability Assessment of Squalene in a Nanoemulsion Adjuvant and the SpiN-Tec Vaccine: HPLC Quantification, Stress Testing, and Stability Studies.

Gomes Isabela Pereira IP, Rivelli Graziella Gomes GG, Bagno Flávia Fonseca FF, Hojo-Souza Natália Satchiko NS et al.

Squalene-based nanoemulsions are widely used as adjuvants in vaccine formulations, but their stability can be affected by environmental factors such as pH, oxidative stress, temperature, and light. We have produced a squalene nanoemulsion (CTVad1) to support the clinical development of new vaccines. This study aimed to develop and validate an HPLC method for squalene quantification in SpiN-Tec, a recombinant protein vaccine against COVID-19. We also aimed to evaluate the stability of the CTVad1 adjuvant and SpiN-Tec under controlled storage conditions. A reversed-phase HPLC method was developed and validated, and comprehensive forced degradation studies were performed on the raw material and SpiN-Tec under acidic, basic, oxidative, thermal, and photolytic conditions to demonstrate the stability-indicating capability of the method. Physicochemical, morphological, and biological characteristics were assessed, and stability studies of both the vaccine and the CTVad1 adjuvant were performed under accelerated and long-term conditions. The HPLC method was selective, precise, accurate, linear, and robust. Squalene raw material degraded under all tested conditions, whereas formulation in nano-sized globules improved its stability, with degradation observed only under hydrogen peroxide and light exposure. CTVad1 remained stable over time, exhibiting only minor, non-critical changes within the specification limits in both accelerated and long-term stability studies, regardless of the glass packaging used (clear or amber). In addition, the SpiN-Tec vaccine maintained its physicochemical and biological integrity under all tested conditions, with all evaluated parameters remaining within the established specification ranges. Our findings demonstrate that proper formulation, packaging, and storage conditions can preserve squalene stability in nanoemulsion-based vaccines, ensuring the quality, safety, and efficacy of the SpiN-Tec vaccine and its adjuvant throughout shelf life.

PMID 42760453
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PubMedFrontiers in plant science2026-09-19

Root-TransUNet enables high-throughput phenotyping of Arabidopsis thaliana roots as a parameter in Heterodera schachtii parasitism.

Zhou Jie J, Moura de Souza Victor Hugo VH, Ju Lei L, Eves-van den Akker Sebastian S et al.

Plant parasitism by sedentary plant-parasitic nematodes is a dynamic and continuously evolving process, accompanied by profound remodelling of host root system architecture across distinct infection stages. However, the physiology and anisotropic growth of Arabidopsis thaliana roots under Heterodera schachtii infection, together with complex lateral root proliferation and increasingly dense, overlapping morphology, pose substantial challenges for accurate image segmentation. Here, we introduce Root-TransUNet, an optimised segmentation architecture that extends TransUNet by incorporating a composite loss function to improve boundary precision and structural continuity, as well as dual-stage strip-pooling (SP) modules to enhance elongated and directional root features. These adaptations address the unique morphological complexity of the infected root system. Additionally, we integrated Root-TransUNet into a high-throughput phenotyping pipeline and applied it to an existing dataset of ~120,000 images of 362 A. thaliana MAGIC recombinant inbred lines collected over several months of infection. By extracting root system architecture traits, including root surface area and estimated root volume across infection stages, we enabled stage-specific association analyses between host root growth and nematode performance across these genotypes. Root-TransUNet achieved strong segmentation performance, demonstrating improved structural continuity and boundary precision compared with widely used CNN- and Transformer-based baselines, including UNet++. Stage-specific analyses revealed that the relationship between host root traits and nematode performance changed as infection progressed. During establishment, nematode number was largely independent of initial root size and varied strongly among genotypes, whereas during the reproductive phase (10-30 dpi), greater root expansion coincided with reduced estimated nematode volume accumulation. Notably, nematode burden was largely independent of host root size before infection, indicating that root quantity was generally not a limiting factor for infection in this experiment. These results demonstrate that Root-TransUNet can robustly segment infected root systems across a wide range of nematode infection densities, providing a scalable image-analysis framework for studying plant-parasitic nematode parasitism in combination with host root phenotyping.

PMID 42761003
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PubMedBiotechnology letters2026-09-18

Design and functional characterization of recombinant chimeras as vaccine candidates against Lawsonia intracellularis.

Costa Ana Vitória AV, Conrad Neida L NL, Greco João Pedro G JPG, Kremer Frederico S FS et al.

Proliferative enteropathy is a gastrointestinal disease caused by the intracellular bacterium Lawsonia intracellularis, affecting swine populations worldwide and leading to significant economic losses due to reduced growth performance, increased mortality, and treatment expenses. Current vaccines present limitations related to production processes, stability, and overall cost. This study aimed to design and evaluat chimeric proteins containing immunogenic epitopes of L. intracellularis. A recombinant chimera, designated Li_full, was rationally designed in silico by integrating predicted B-cell and MHC epitopes relevant to swine immunity. To further investigate the immunogenic potential of distinct regions, Li_full was subdivided into three fractions (Li_1, Li_2, and Li_3). All constructs were cloned into an Escherichia coli expression system, allowing efficient production and biochemical characterization of the recombinant proteins. Antigenicity was confirmed by strong reactivity with sera from naturally infected pigs. Immunogenicity was assessed through vaccination in mice, which developed significantly (p < 0.05) elevated antibody titers, demonstrating the ability of the chimeras to elicit robust humoral immune responses. The integration of bioinformatics-driven epitope prediction with recombinant DNA technology represents a promising and innovative strategy for controlling proliferative enteropathy. This study underscores the value of in silico design strategies for the development of targeted veterinary immunogens and provides a foundation for further research aimed at evaluating protective efficacy under field conditions.

PMID 42758400
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PubMedThe Journal of infection2026-09-18

Corrigendum to "Immunogenicity and safety of co-administration of a recombinant shingles vaccine with an mRNA COVID-19 or adjuvanted influenza vaccine: A randomised controlled trial" [J Infect 93 (2026) 106784].

Harris Rosie R, Thirard Russell R, Iftikhar Hina H, Middleditch Alexander A et al.

PMID 42759230
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