Delving into the Latest Updates on Menotropins with Synapse

Overview

Basic Info

Drug Type

Chemical drugs

Synonyms

HMG, HP-hMG, Highly Purified Menotrophin

+ [10]

Target

FSHR x LHCGR

Mechanism

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

Therapeutic Areas

Endocrinology and Metabolic DiseaseUrogenital Diseases

Active Indication

Primary Ovarian InsufficiencyAnovulationInfertility+ [1]

Inactive Indication-

Originator Organization

Ferring BV

Active Organization

Huiling Pharmaceutical Consulting (Shanghai) Co., Ltd.Ferring Pharmaceuticals, Inc.

Ferring Pharmaceuticals A/S

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (27 Aug 1999),

Infertility, Female

Regulation-

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Gene Sequence

Sequence Code 83626β

Sequence Code 3253β

Sequence Code 3246α

The purpose of this retrospective observational study is to describe the treatment patterns with MENOPUR and to understand the clinical impact for patients that underwent infertility treatment under real-world setting.
The primary objective is to describe the treatment patterns for the general population and for selected patient profiles.

Start Date01 Sep 2022

Sponsor / Collaborator

Ferring Pharmaceuticals A/S

NCT05103228 / RecruitingNot ApplicableIIT

Cumulative Pregnancy Rate With Lower and Higher Dose of Gonadotropin During Controlled Ovarian Hyperstimulation During IVF Among Expected Poor Responders: a Prospective, Randomized Controlled Trial

Controlled ovarian hyperstimulation (COH) is an important step during in vitro fertilization (IVF). Its aim optimally is to recruit 10-15 oocytes. When deciding on the actual treatment, different stimulation protocols, various stimulating agents and wide range of gonadotropin dose can one choose from. Prior to the decision on the actual stimulation protocol and gonadotropin (Gn) dose the patient's expected response to stimulation is assessed primarily using ovarian reserve markers. Most medications used during stimulation exert their effect in a dose-dependent manner hence with a higher Gn dose one would expect a better response, more oocytes. More oocytes could translate into more embryos and potentially a higher pregnancy rate. The currently available evidence however does not support this practice as randomized controlled trials (RCT) have failed to show that the use of higher Gn dose results in higher pregnancy, live-birth rates. These studies however identified patients based on different criteria, compared different stimulation protocols and various Gn doses. There are only two RCTs that compared cumulative live birth rates (fresh + frozen embryo transfers) and they identified poor responders based on different criteria and used different drug regimens. Therefore, the aim of our study is to compare cumulative IVF clinical pregnancy rates using a lower and a higher gonadotropin dose among poor responders identified based on universally accepted criteria.

Start Date02 Dec 2021

Sponsor / Collaborator-

100 Clinical Results associated with Menotropins

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100 Translational Medicine associated with Menotropins

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100 Patents (Medical) associated with Menotropins

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2,158

Literatures (Medical) associated with Menotropins

01 Jun 2024·European Journal of Pharmaceutical Sciences

The allostery and modification of hGHRH molecules and specific dimer produced significant fertility effect by proliferating and activating in-situ ovarian mesenchymal stem cells

Article

Author: Guo, Xiao-Yuan ; Yu, Li-Cheng ; Tan, Hong-Mei ; Huang, Hui-Xian ; Tang, Jing-Xuan ; Luo, Qun ; Liu, Tao ; Du, Yan ; Yang, Li ; Yue, Feng ; Rao, Dan ; Feng, Lan ; Tang, Song-Shan ; Zhang, Xu-Dong

The negative coordination of growth hormone secretagogue receptor (GHS-R) and growth hormone-releasing hormone receptor (GHRH-R) involves in the repair processes of cellular injury. The allosteric U- or H-like modified GHRH dimer Grinodin and 2Y were comparatively evaluated in normal Kunming mice and hamster infertility models induced by CPA treatment. 1-3-9 µg of Grinodin or 2Y per hamster stem-cell-exhaustion model was subcutaneously administered once a week, respectively inducing 75-69-46 or 45-13-50 % of birth rates. In comparison, the similar mole of human menopausal gonadotropin (hMG) or human growth hormone (hGH) was administered once a day but caused just 25 or 20 % of birth rates. Grinodin induced more big ovarian follicles and corpora lutea than 2Y, hMG, hGH. The hMG-treated group was observed many distorted interstitial cells and more connective tissues and the hGH-treated group had few ovarian follicles. 2Y had a plasma lifetime of 21 days and higher GH release in mice, inducing lower birth rate and stronger individual specificity in reproduction as well as only promoting the proliferation of mesenchymal-stem-cells (MSCs) in the models. In comparison, Grinodin had a plasma lifetime of 30 days and much lower GH release in mice. It significantly promoted the proliferation and activation of ovarian MSCs together with the development of follicles in the models by increasing Ki67 and GHS-R expressions, and decreasing GHRH-R expression in a dose-dependent manner. However, the high GH and excessive estrogen levels in the models showed a dose-dependent reduction in fertility. Therefore, unlike 2Y, the low dose of Grinodin specifically shows low GHS-R and high GHRH-R expressions thus evades GH and estrogen release and improves functions of organs, resulting in an increase of fertility.

09 Apr 2024·Translational Vision Science & Technology

Quantitative Assessment of Fundus Tessellated Density in Highly Myopic Glaucoma Using Deep Learning

Article

Author: Xiao, Yue ; Huang, Shaofen ; Chen, Jianqi ; Zhuo, Yehong ; Lu, Lin ; Chen, Xiaohong ; Shen, Xinyue ; Zhu, Yingting ; Wu, Zhenquan ; Li, Zhidong ; Chen, Xuhao

PurposeTo characterize the fundus tessellated density (FTD) in highly myopic glaucoma (HMG) and high myopia (HM) for discovering early signs and diagnostic markers.MethodsThis retrospective cross-sectional study included hospital in-patients with HM (133 eyes) and HMG (73 eyes) with an axial length ≥26 mm at Zhongshan Ophthalmic Center. Using deep learning, FTD was quantified as the average exposed choroid area per unit area on fundus photographs in the global, macular, and disc regions. FTD-associated factors were assessed using partial correlation. Diagnostic efficacy was analyzed using the area under the curve (AUC).ResultsHMG patients had lower global (0.20 ± 0.12 versus 0.36 ± 0.09) and macular FTD (0.25 ± 0.14 vs. 0.40 ± 0.09) but larger disc FTD (0.24 ± 0.11 vs. 0.19 ± 0.07) than HM patients in the tessellated fundus (all P < 0.001). In the macular region, nasal FTD was lowest in the HM (0.26 ± 0.13) but highest in the HMG (0.32 ± 0.13) compared with the superior, inferior, and temporal subregions (all P < 0.05). A fundus with a macular region nasal/temporal (NT) FTD ratio > 0.96 (AUC = 0.909) was 15.7 times more indicative of HMG than HM. A higher macular region NT ratio with a lower horizontal parapapillary atrophy/disc ratio indicated a higher possibility of HMG than HM (AUC = 0.932).ConclusionsFTD differs in degree and distribution between HMG and HM. A higher macular NT alone or with a lower horizontal parapapillary atrophy/disc ratio may help differentiate HMG.Translational RelevanceDeep learning-based FTD measurement could potentially assist glaucoma diagnosis in HM.

22 Mar 2024·Medicine

Mechanisms underlying the therapeutic effects of Xiaoyaosan in treating hyperplasia of mammary glands based on network pharmacology

Article

Author: Tai, Yuxing ; Liu, Mingjun ; Guan, Qifan ; Wang, Sixian ; Li, Xin ; Zhang, Long ; Liu, Shaowei ; Li, Peizhe

This study utilized network pharmacology to investigate the effects of Xiaoyaosan (XYS) on the intervention of hyperplasia of mammary glands (HMG) by targeting specific genes and signaling pathways. The active ingredients and targets of XYS, which consisted of 8 traditional Chinese medicines (TCM), were identified using TCMSP. The gene targets associated with HMG were obtained from the GeneCards Database, and the intersection data between the 2 was integrated. Cytoscape 3.8.1 software was used to construct a network diagram illustrating the relationship between compounds, drug active ingredients, target proteins, and the disease. The protein-protein interaction network diagram was generated using STRING, and the core targets were analyzed. A total of 133 active ingredients in XYS and 7662 active ingredient targets were identified. Among them, 6088 targets were related to HMG, and 542 were common targets between the active ingredients and the disease. The protein-protein interaction (PPI) core network contained 15 targets, with 5 key targets playing a crucial role. Gene ontology (GO) and Kyoto encyclopedia of genes and genomes (KEGG) enrichment analyses have indicated that XYS has the potential to treat HMG by interfering with the AGE-RAGE signaling pathway in diabetic complications, the MAPK signaling pathway, and the PI3K-Akt signaling pathway. Additionally, molecular docking studies have shown excellent binding properties between the drug components and key targets. Thus, this study provides a theoretical foundation for a better understanding of the pharmacological mechanism and clinical application of XYS in the comprehensive treatment of HMG.

2

News (Medical) associated with Menotropins

11 Apr 2023

·www.fiercebiotech.com

Ferring's research site closure signals shift from internal to external R&D, CSO says

Ferring Pharma's CSO says the company's commitment to reproductive and maternal health products is unchanged even as R&D priorities shift. After more than 25 years, Ferring Pharmaceuticals suddenly shuttered a San Diego research institute in March just months after finishing a major renovation. It's all part of the plan, says Chief Scientific Officer Armin Metzger, Ph.D. The research executive, now in his seventh year with Ferring, said that the company is making a concerted pivot toward external innovation to make the best use of capital following two FDA approvals at the end of 2022. It's a shift that Metzger describes as a "fundamental" change. "We will still have internal discovery, but [be] much, much more external focused, giving more flexibility of allocating funds," he said in an interview with Fierce Biotech. The clear-eyed assessment of the company’s priorities set the record straight as to why the Ferring Research Institute, one of the company’s three main R&D hubs, closed after 27 years. The move resulted in nearly 90 staffers being laid off and came after Ferring finished renovations on the institute just last year. “[T]he turning point was that we got two FDA approvals of two first-in-class assets in one year,” said Metzger. “And this leads to the adaptation, again of the strategy—how we deliver innovation to the patients—and it is not an easy decision-making process.” In November 2022, Ferring nabbed FDA approval for the first fecal microbiota product, Rebyota, for adults with C. difficile following antibiotic treatment or recurrent infection. Just a few weeks later, gene therapy Adstiladrin was approved for bladder cancer. The new strategy is not a complete departure from Ferring’s existing work, as those now-approved assets originated from deals. Ferring acquired Rebiotix in April 2018, tacking on the C. difficile treatments, and then a month later, the Swiss pharma signed a commercialization agreement with FKD Therapies for the bladder cancer treatment. “I think a company of our size, with the investment needed now on the later stage, we can't entertain technology platforms in-house,” said Metzger, who added that Ferring will instead rely on "partnerships across the globe.” Ferring’s main therapeutic areas are remaining unchanged, however, including maternal and reproductive health, which Metzger called “the core” of the company. One of the priorities is bringing the infertility treatment Rekovelle to the U.S. after it nabbed approval in Europe and Switzerland. He expects feedback from the FDA in the second half of the year. In addition to Rekovelle, infertility treatments LutrePulse and Menopur are under development, along with Pabal, a med for postpartum hemorrhage. But the clinical-stage work is in limbo. A phase 2 trial for a treatment to address inadequate milk production, merotocin, was shuttered earlier this year due to low enrollment and a phase 2 infertility treatment is now absent from the company’s pipeline. A spokesperson for Ferring did not immediately respond to a request for comment on the missing program. Regardless, Metzger says that in the next year, the company hopes to bolster its portfolio, including potentially boosting the indications for merotocin. This could also mean combination opportunities and female and male infertility assets from Ferring's reproductive medicine pipeline.

Drug ApprovalPhase 2AcquisitionGene TherapyLicense out/in

09 Mar 2023

·www.businesswire.com

Approval of New Medicines in 2022 Sets Ferring on Course for Future Growth and Diversification

SAINT-PREX, Switzerland--( BUSINESS WIRE )--Ferring has today published its 2022 Annual Report. The company reported revenues of €2.3 billion, an increase of +5% on the previous year at actual exchange rates, but a slight decrease of -1% at constant exchange rates. The main highlights of the year were the approvals by the US Food and Drug Administration (FDA) for two pioneering new medicines, Rebyota™ (fecal microbiota, live – jslm), a new microbiome treatment, and Adstiladrin ® (nadofaragene firadenovec-vncg), a novel gene-based therapy for bladder cancer. These were approved in November and December 2022 respectively. This means Ferring was responsible for two out of the eight biological medicine products approved by the US FDA’s Center for Biologics Evaluation and Research in 2022. 1 The ground-breaking approvals of Rebyota™ and Adstiladrin ® will provide new options for patients and important mid- to long-term growth and diversification opportunities for Ferring, reflecting our strategy to progress late-stage opportunities and demonstrating our ongoing commitment to scientific innovation. We also continue to demonstrate leadership in reproductive medicine and maternal health. Carbetocin Ferring (carbetocin, room temperature-stable formulation) became our first-ever product to gain prequalification status from the World Health Organization. This will make it easier for more women in low- and lower middle-income countries to access treatment for the prevention of PPH. For the year, revenues showed a slight decrease of -1% at constant exchange rates, after a strong first three quarters of the year. However, in the fourth quarter, Ferring faced challenges when we were made aware of changes in the manufacturing process of the drug substance for Menopur ® (menotropins for injection), one of our leading products used for ovarian stimulation in women undergoing assisted reproductive technologies. Whilst Ferring’s data reviewed to date indicates that the safety and efficacy of the product remain unaltered, this has resulted in supply constraints as we work with health authorities to resolve the situation. Thus, for the year, the reproductive medicine and maternal health portfolio decreased by -2% at constant exchange rates but was largely offset by the solid growth in the rest of the portfolio. The appreciation of several currencies against the euro resulted in revenues achieving growth of +5% at actual exchange rates. In 2022, expenditure increased as business activity returned to normal following the COVID-19 pandemic. We also invested in the field of microbiome in anticipation of the Rebyota™ launch, alongside increased research and development costs as the pipeline evolved and clinical studies were conducted. Despite inflation, we were able to partly mitigate the increase in operating expenses through disciplined cost management. Nevertheless, operating profit decreased to reach €231 million for the year. “ In 2022, we continued to demonstrate the qualities that make Ferring such an enduring force in the world of healthcare: the inspiration and passion to develop pioneering medicines, a consistent focus on the unmet needs of patients, and the resilience to overcome challenges as they arise,” said Per Falk, President of Ferring Pharmaceuticals. “ Our newly approved products provide important avenues for exploration and growth, built upon our established strength in reproductive medicine and maternal health, where we have a long-standing reputation for innovation and remain committed to building families of every shape and size.” About Ferring Pharmaceuticals Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries. Learn more at www.ferring.com , or connect with us on Twitter , Facebook , Instagram , LinkedIn and YouTube . References: 1 U.S. Food and Drug Administration. 2022 Biological License Application Approvals. Available at https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2022-biological-license-application-approvals . Last accessed 24 February 2023. 2 Trends in Maternal Mortality 2000 to 2017: Estimates by WHO, UNICEF, UNFPA, World Bank Group and the United Nations Population Division. World Health Organization 2019. Available at: https://www.unfpa.org/sites/default/files/pub-pdf/Maternal_mortality_report.pdf Last accessed 24 February 2023. # # #

Drug ApprovalFinancial Statement

100 Deals associated with Menotropins

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External Link

KEGG	Wiki	ATC	Drug Bank
D02692	-	G03GA02	DB00032

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Primary Ovarian Insufficiency	US	Ferring Pharmaceuticals, Inc.	19 Feb 2014
Anovulation	US	Ferring Pharmaceuticals, Inc.	29 Oct 2004
Infertility	US	Ferring Pharmaceuticals, Inc.	29 Oct 2004
Infertility, Female	CN	Huiling Pharmaceutical Consulting (Shanghai) Co., Ltd.	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility	Phase 1	BE	Ferring Pharmaceuticals A/S	01 Jul 2009
Infertility	Phase 1	SE	Ferring Pharmaceuticals A/S	01 Jul 2009
Infertility	Phase 1	ES	Ferring Pharmaceuticals A/S	01 Jul 2009
Infertility	Phase 1	PL	Ferring Pharmaceuticals A/S	01 Jul 2009
Infertility	Phase 1	TR	Ferring Pharmaceuticals A/S	01 Jul 2009
Infertility	Phase 1	DK	Ferring Pharmaceuticals A/S	01 Jul 2009
Infertility	Discovery	CZ	Ferring Pharmaceuticals A/S	01 Jul 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESPE2023	Not Applicable	Hypogonadism luteinising hormone (LH) \| follicle-stimulating hormone (FSH)	-	hCG	lfapacddme(icoyjcycla) = ehnamcvxnb hmwbhffumh (rdacjpqeep, 25.0 - 56.1)	-	21 Sep 2023
				hCG + FSH	lfapacddme(icoyjcycla) = fkszrwaivy hmwbhffumh (rdacjpqeep, 80.2% - 88.4%)
Pubmed \| Fertil Steril	Not Applicable	-	242	Luteal-phase ovarian stimulation with hMG and letrozole	(ivnpoknior) = looxgrilga uwjizdieum (hrfogamkxh ) View more	-	01 Jan 2014
NCT02738580 (CTgov)	Phase 4	Infertility \| Ovarian Hyperstimulation Syndrome	112	rFSH (rFSH)	ohcjqvlwsv(qnpgjnncyl) = sskxbeqojt dydhtaugpm (ididxtqduf, uknomlojqk - kdczrywfee) View more	-	03 Mar 2020
				HP-HMG+GnRH antagonists (HP-HMG)	ohcjqvlwsv(qnpgjnncyl) = hwdcphbxwt dydhtaugpm (ididxtqduf, jppmaxmtop - rlvvwebgue) View more
NCT02554279 (CTgov)	Phase 4	Infertility	620	menotropin (Menotropin)	mhqgfsgohe(irbvlneloh) = omqwyjlxbh vibwtzviou (zvplrijfls, bcyfsaqqja - hkjuvgxksd) View more	-	02 Mar 2018
				recombinant FSH (Recombinant FSH)	mhqgfsgohe(irbvlneloh) = wdsvgmnrth vibwtzviou (zvplrijfls, cjfgldvqrg - hmqhrvvaej) View more
NCT02458768 (CTgov)	Phase 4	Infertility, Female \| Ovarian Hyperstimulation Syndrome	112	IVF-M HP Inj. (IVF-M HP Inj.)	(ssbwbhzdwn) = xqitdekhpo qacvmykbdx (dvjwvseckc, wzxqvrgqaz - jnysswtblc) View more	-	03 Feb 2016
				Menopur® Inj. (Menopur® Inj.)	(ssbwbhzdwn) = ynocpeacnn qacvmykbdx (dvjwvseckc, lzcmsynytr - hhcsgpyriz) View more
NCT01921166 (CTgov)	Phase 4	Infertility	23	Menopur+Clomid+Bravelle+Follistim+Gonal f (Clomiphene Plus Gonadotropins)	hyfsrcruen(jnulgsqroe) = ytqdxvkzoc orsirjnfwh (onzkipcrdm, cnhpgzmavc - lsbwuamjup) View more	-	23 Feb 2018
				Leuprolide flare (Leuprolide Flare)	hyfsrcruen(jnulgsqroe) = orxidsmmoc orsirjnfwh (onzkipcrdm, qppdmwzlbi - lbnubvjtlf) View more
NCT02554279 (MEGASET HR, Pubmed \| Fertil Steril) Manual	Phase 4	Ovarian Stimulations	619	highly purified human menotropin	yocglwtnax(axjgzlpvip) = dvjhkynscv zlahspuiug (xllnqbmler ) View more	Negative	01 Aug 2020
				recombinant follicle-stimulating hormone	yocglwtnax(axjgzlpvip) = lvayxboxej zlahspuiug (xllnqbmler ) View more
ChiCTR-INR-16008220 (Pubmed \| Hum Reprod)	Not Applicable	-	819	Depot GnRHa	ibbztcyuax(zmiqxfivzq) = lpfcfzcokx utkhgqouva (fcfynrucli )	-	01 Jun 2020
				Long GnRHaLong GnRHaLong GnRHa	ibbztcyuax(zmiqxfivzq) = ozcpqnsxmp utkhgqouva (fcfynrucli )
Pubmed \| Reprod Biomed Online	Not Applicable	-	-	recombinant FSH	nhxzaqpqnk(octupihsrs) = noahfglbmy dractyaknw (tvcpcrdgoa )	-	01 Oct 2012
				HMG	nhxzaqpqnk(octupihsrs) = spytzposdp dractyaknw (tvcpcrdgoa )
NCT04163458 (CTgov)	Phase 3	Infertility	405	Placebo (for MENOPUR powder+MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL (MENOPUR Liquid)	zakutrzloj(ijlmgmnqbi) = izlamrwjnq vjmrspzamz (sjekwzfvvk, rcmoasteib - dpvnlsjeue) View more	-	07 Nov 2023
				Placebo (for MENOPUR solution for injection in pre-filled pen)+solvent for solution for injection, 75 IU (MENOPUR Powder)	zakutrzloj(ijlmgmnqbi) = lkfpazpbkg vjmrspzamz (sjekwzfvvk, isotdvwfcj - fubztdaisa) View more