Delving into the Latest Updates on Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.) with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

Chorionic gonadotrophin (Merck & Co), chorionic gonadotropin, Pregnyl

+ [1]

Target

FSHR x LHCGR

Action

agonists

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists), LHCGR agonists(Luteinizing hormone/Choriogonadotropin receptor agonists)

Therapeutic Areas

Congenital DisordersEndocrinology and Metabolic DiseaseUrogenital Diseases+ [1]

Active Indication

CryptorchidismHypogonadismInfertility, Female

Inactive Indication-

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization

Organon USA, Inc.

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (20 Oct 1976),

CryptorchidismHypogonadismInfertility, Female

Regulation-

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Structure/Sequence

Sequence Code 51997α

Sequence Code 3246α

This study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with frozen embryo transfer. The study population in frozen embryo transfer cycles receive three doses of human chorionic gonadotropin (HCG) to recognize the effectiveness of HCG on pregnancy outcomes in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Start Date01 Jul 2020

Sponsor / Collaborator

Royan Institute

ChiCTR1900024702

/ SuspendedEarly Phase 1IIT

Clinical study for acupoint injection of chorionic gonadotropin in the treatment of late-onset hypogonadism in males

Start Date22 Oct 2019

Sponsor / Collaborator

Guilin People's Hospital

NCT03423537

/ TerminatedPhase 3IIT

A Prospective, Multicenter, Double-blind, Placebo-controlled, Phase III Clinical Study, on the Efficacy and Safety of Low-dose hCG in a Short Protocol With GnRH Agonist and Ovarian Stimulation With Recombinant FSH (rFSH) During the Follicular Phase in Subfertile Women Undergoing ART

The objective of this prospective randomized clinical trial is to investigate whether the addition of low-dose hCG to a short GnRH-agonist protocol for IVF and ovarian stimulation with rFSH from the onset of the follicular phase and throughout stimulation in sub fertile women undergoing IVF, improves pregnancy rates.

Start Date01 Jun 2018

Sponsor / Collaborator

National & Kapodistrian University of Athens

[+1]

100 Clinical Results associated with Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.)

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100 Translational Medicine associated with Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.)

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100 Patents (Medical) associated with Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.)

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248

Literatures (Medical) associated with Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.)

15 Sep 2023·Analytica chimica acta

A semi-automated hybrid HPLC-MS approach for in-depth characterization of intact non-covalent heterodimer glycoforms of gonadotropin biopharmaceuticals.

Article

Author: Huber, Christian G ; Blöchl, Constantin ; Wuhrer, Manfred ; Di Marco, Fiammetta ; Blümel, Gabriele

BACKGROUNDGonadotropins are a class of heavily glycosylated protein hormones, thus extremely challenging to characterize by mass spectrometry. As biopharmaceuticals, gonadotropins are prescribed for the treatment of infertility and are derived from different sources: either from pooled urine of pregnant women or upon production in genetically modified Chinese Hamster Ovary cells. Human chorionic gonadotropin (hCG) is sold as a biopharmaceutical under the name Pregnyl® (urinary hCG, u-hCG) and Ovitrelle® (recombinant hCG, r-hCG), and recombinant human follicle stimulating hormone (r-hFSH) is marketed as Gonal-f®. Recently, we reported the exhaustive characterization of r-hCG at different structural levels.RESULTSWe implement size exclusion (SE) HPLC-MS to automatize the acquisition of native mass spectra of r-hCG dimer, but also u-hCG and r-hFSH, comparing the drug products up to intact heterodimer level. A hybrid HPLC-MS approach was employed for the characterization of r-hCG, u-hCG and r-hFSH drug products at different structural levels. Released glycans were analyzed by porous graphitized carbon (PGC)-HPLC-MS/MS, glycopeptides by reversed-phase (RP)-HPLC-MS/MS, subunits by RP-HPLC-MS and finally the intact native heterodimers by semi-automated online buffer exchange SE-HPLC-MS. The data were integrated using bioinformatic tools, to finally unravel the composition of 1481 co-existing dimeric glycoforms for r-hCG, 1167 glycoforms for u-hCG, and 1440 glycoforms for r-hFSH, and to compare critical quality attributes of the different drug products such as their degree of sialylation and O-glycosylation.SIGNIFICANCE AND NOVELTYThe strong alliance of bioanalytics and bioinformatics data integration at the different structural levels allowed the identification of more than thousand different glycoforms of r-hCG, u-hCG, and r-hFSH. The results showed that these biopharmaceuticals differ considerably in their glycosylation patterns and highlight the importance of in-depth characterization of biopharmaceuticals for quality control. © 2017 Elsevier Inc. All rights reserved.

01 May 2021·F&S Science

Superovulation with gonadotropin-releasing hormone agonist or chorionic gonadotropin for ovulation trigger differentially affects leukocyte populations in the peri-implantation mouse uterus

Article

Author: Sam Mesiano ; Rachel Weinerman ; Valerie R. Libby ; Cheryl Cameron ; Rachel Wilson ; Adam Kresak ; Raymond Redline

OBJECTIVETo investigate the effect of superovulation with human chorionic gonadotropin (hCG) or gonadotropin-releasing hormone agonist (GnRHa) trigger on leukocyte density and expression of leukocyte-specific genes in the peri-implantation period in the mouse uterus.DESIGNLaboratory research.SETTINGUniversity laboratory facility.INTERVENTIONSFemale mice were mated to fertile male mice in one of three protocols: (1) natural mating or mating following injection with pregnant mare serum gonadotropin followed by trigger with (2) GnRHa or (3) hCG. Female mice were killed prior to implantation, 3 days after ovulation (E3.5), and the ovaries and uterine tissue were collected. Total RNA was isolated and assayed using quantitative reverse transcription polymerase chain reaction, and the uterine tissue was stained for histologic analysis of immune cell markers.MAIN OUTCOME MEASURESEndometrial leukocyte (CD45) and vessel density (CD31) by immunohistochemical staining; expression of leukocyte markers CD11b, CD335, and CD22, by quantitative reverse transcription polymerase chain reaction in the whole uterine tissue.RESULTSSuperovulation decreased (compared with controls) the endometrial leukocyte density, based on the number of cells staining for CD45, and endometrial vessel density, based on the number of cells staining for CD31. Leukocyte density was additionally decreased in the GnRHa trigger group compared with that in the hCG trigger group. Superovulation with hCG and GnRHa triggers decreased the uterine expression of the B-cell marker CD22 compared with controls. The expression of the natural killer cell marker CD11b was decreased by the hCG trigger but not by the GnRHa. Abundance of mRNA encoding the CD335 natural killer cell marker was not affected by superovulation or trigger agent.CONCLUSIONSIn mice, superovulation with the GnRHa trigger compared with that with the hCG trigger differentially alters key immunologic factors in the uterine peri-implantation. These altered immunologic factors have roles in angiogenesis that may assist in elucidating the effects of assisted reproductive technologies on implantation efficiency and fetal growth and development.

01 Jan 2020·TalantaQ2 · CHEMISTRY

Development of Immobilized Enzyme Reactors for the characterization of the glycosylation heterogeneity of a protein

Q2 · CHEMISTRY

Article

Author: Fournier, Thierry ; Delaunay, Nathalie ; Giangrande, Chiara ; Vinh, Joëlle ; Pichon, Valérie ; Eskenazi, Nicolas ; Camperi, Julien ; Perchepied, Stan

The mapping of post-translational modifications (PTMs) of proteins can be addressed by bottom-up proteomics strategy using proteases to achieve the enzymatic digestion of the biomolecule. Glycosylation is one of the most challenging PTM to characterize due to its large structural heterogeneity. In this work, two Immobilized Enzyme Reactors (IMERs) based on trypsin and pepsin protease were used for the first time to fasten and improve the reliability of the specific mapping of the N-glycosylation heterogeneity of glycoproteins. The performance of the supports was evaluated with the digestion of human Chorionic Gonadotropin hormone (hCG), a glycoprotein characterized by four N- and four O-glycosylation sites, prior to the analysis of the digests by nanoliquid chromatography coupled to tandem mass spectrometry (nanoLC-MS/MS). Firstly, the repeatability of the nanoLC-MS/MS was evaluated and a method to control the identification of the identified glycans was developed to validate them regarding the retention time of glycopeptides in reversed phase nanoLC separation. The repeatability of the digestion with trypsin-based IMER was evaluated on the same hCG batch and on three independent batches with common located glycans up to 75%. Then, the performance of the IMER digestions was compared to in-solution digestions to evaluate the qualitative mapping of the glycosylation. It has given rise to 42 out of 45 common glycans between both digestions modes. For the first time, the complementarity of trypsin and pepsin was illustrated for the glycosylation mapping as trypsin led to identifications on 2 out of 4 glycosylation site while pepsin was informative on the 4 glycosylation site. The potential of IMERs for the study of the glycosylation of a protein was illustrated with the comparison of two hCG-based drugs, Ovitrelle® and Pregnyl®.

100 Deals associated with Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.)

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External Link

KEGG	Wiki	ATC	Drug Bank
D06457	-	G03GA01	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Cryptorchidism	United States	Organon USA, Inc.	20 Oct 1976
Hypogonadism	United States	Organon USA, Inc.	20 Oct 1976
Infertility, Female	United States	Organon USA, Inc.	20 Oct 1976

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01607203 (CTgov)	Phase 4	Infertility	120	PREGNYL SC (hCG TRIGGERING)	dvlqiqljzp(xsppobbufw) = useeypyofx fdbqvfnccw (hgmbwemlle, cxqzhilnoa - qebetzqsnt) View more	-	19 Feb 2015
				DECAPEPTYL(GONAPEPTYL)+PREGNYL (hCG and GnRH Agonist Triggering)	dvlqiqljzp(xsppobbufw) = wdoiflhalt fdbqvfnccw (hgmbwemlle, pnvjsvfhvm - cnrvsvneiu) View more
NCT00627406 (CTgov)	Phase 4	Ovarian Hyperstimulation Syndrome	384	GnRHa (A: >14 Follicles; GnRHa Trigger + 1500 hCG)	klqjvxmaln(uqgdbqqrqy) = yfzhtugnjd boropuvfco (qugwrmqcsb, lwlvoqrobf - ocrqcusuds) View more	-	27 Nov 2013
				hCG (Pregnyl)+Pregnyl (B: >14 Follicles; hCG Trigger)	klqjvxmaln(uqgdbqqrqy) = eoytomrmsp boropuvfco (qugwrmqcsb, jkevdbdlek - aehuggdujk) View more

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Biosimilar

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Gonadotropin, Chorionic(Merck Sharp & Dohme Corp.)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation