Delving into the Latest Updates on Somatropin (genetical recombination)(JCR) with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

rhGH, 遺伝子組換えヒト成長ホルモン

+ [4]

Target

GHR

Action

agonists

Mechanism

GHR agonists(Growth hormone receptor agonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [4]

Active Indication

Short Stature Homeobox DeficiencyDwarfismSmall-for-dates baby+ [2]

Inactive Indication-

Originator Organization

JCR Pharmaceuticals Co., Ltd.

Active Organization

JCR Pharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Author: Stanimirovic, Aleksandar ; Djukic, Aleksandar ; Savic, Dragan ; Miljic, Dragana ; Vukovic, Rade ; Todorovic, Sladjana ; Soldatovic, Ivan ; Petakov, Milan ; Milenkovic, Tatjana ; Grujicic, Danica ; Stojanovic, Marko ; Manojlovic-Gacic, Emilija ; Pekic, Sandra ; Milicevic, Mihajlo ; Jesic, Maja ; Zdravkovic, Vera ; Doknic, Mirjana ; Mitrovic, Katarina ; Bogosavljevic, Vojislav

ObjectiveTo analyze metabolic parameters, body composition (BC), and bone mineral density (BMD) in childhood-onset GH deficiency (COGHD) patients during the transition period (TP).DesignSingle- center, retrospective study was performed on 170 consecutive COGHD patients (age 19.2 ± 2.0 years, range 16–25) transferred after growth completion from two pediatric clinics to the adult endocrine unit. Two separate analyses were performed: (i) cross-sectional analysis of hormonal status, metabolic parameters, BC, and BMD at first evaluation after transfer from pediatrics to the adult department; (ii) longitudinal analysis of BC and BMD dynamics after 3 years of GH replacement therapy (rhGH) in TP.ResultsCOGHD was of a congenital cause (CONG) in 50.6% subjects, tumor-related (TUMC) in 23.5%, and idiopathic (IDOP) in 25.9%. TUMC patients had increased insulin and lipids levels (P < 0.01) and lower Z score at L-spine (P < 0.05) compared to CONG and IDOP groups. Patients treated with rhGH in childhood demonstrated lower fat mass and increased BMD compared to the rhGH-untreated group (P < 0.01). Three years of rhGH after growth completion resulted in a significant increase in lean body mass (12.1%) and BMD at L-spine (6.9%), parallel with a decrease in FM (5.2%).ConclusionThe effect of rhGH in childhood is invaluable for metabolic status, BC, and BMD in transition to adulthood. Tumor-related COGHD subjects are at higher risk for metabolic abnormalities, alteration of body composition, and decreased BMD, compared to those with COGHD of other causes. Continuation of rhGH in transition is important for improving BC and BMD in patients with persistent COGHD.

01 Jan 2021·Clinical Pediatric Endocrinology

Newly formulated GROWJECT<sup>®</sup> is bioequivalent to the prior GROWJECT<sup>®</sup> formulation and causes less injection-associated pain

Article

Author: Namba, Noriyuki ; Yasukawa, Hidehito ; Mita, Yoko ; Owada, Yasuko ; Yamaoka, Mariko ; Hanada, Takashi ; Asano, Yuuka

Daily treatment with subcutaneous injections of recombinant human GH can be physically and emotionally stressful for children and their caregivers owing to the pain caused by injection. In this study, 52 healthy male subjects were randomized to investigate the bioequivalence and compare the safety and injection-associated pain between the prior GROWJECT^® sc formulation and the new formulation, which contains less phosphate buffer. Single subcutaneous doses of each formulation were administered in a crossover manner. Adverse events were monitored throughout the study and subjects rated injection site pain on a 5-point scale. The 90% confidence intervals of the geometric least square means ratio for the area under the human GH concentration-time curve from 0 to 24 h and maximum concentration were 1.002-1.049 and 0.971-1.075 following 6 mg and 0.992-1.038 and 0.973-1.058 following 12 mg, respectively. No severe adverse events were observed. The mean pain score was significantly higher (i.e., less painful) with the new formulation than with the prior formulation regardless of the order of treatment. The new GROWJECT^® sc formulation was bioequivalent to the prior formulation and associated with less injection site pain.

01 Apr 2017·American Journal of Physiology-Regulatory, Integrative and Comparative PhysiologyQ2 · MEDICINE

Oxygen-sensitive regulation and neuroprotective effects of growth hormone-dependent growth factors during early postnatal development

Q2 · MEDICINE

Article

Author: Doerr, Helmuth-Guenther ; Jung, Susan ; Trollmann, Regina ; Boie, Gudrun

Perinatal hypoxia severely disrupts metabolic and somatotrophic development, as well as cerebral maturational programs. Hypoxia-inducible transcription factors (HIFs) represent the most important endogenous adaptive mechanisms to hypoxia, activating a broad spectrum of growth factors that contribute to cell survival and energy homeostasis. To analyze effects of systemic hypoxia and growth hormone (GH) therapy (rhGH) on HIF-dependent growth factors during early postnatal development, we compared protein (using ELISA) and mRNA (using quantitative RT PCR) levels of growth factors in plasma and brain between normoxic and hypoxic mice (8% O2, 6 h; postnatal day 7, P7) at P14. Exposure to hypoxia led to reduced body weight ( P < 0.001) and length ( P < 0.04) compared with controls and was associated with significantly reduced plasma levels of mouse GH ( P < 0.01) and IGF-1 ( P < 0.01). RhGH abrogated these hypoxia-induced changes of the GH/IGF-1 axis associated with normalization of weight and length gain until P14 compared with controls. In addition, rhGH treatment increased cerebral IGF-1, IGF-2, IGFBP-2, and erythropoietin mRNA levels, resulting in significantly reduced apoptotic cell death in the hypoxic, developing mouse brain. These data indicate that rhGH may functionally restore hypoxia-induced systemic dysregulation of the GH/IGF-1 axis and induce upregulation of neuroprotective, HIF-dependent growth factors in the hypoxic developing brain.

1

News (Medical) associated with Somatropin (genetical recombination)(JCR)

20 Dec 2024

·pipelinereview.com

JCR Pharmaceuticals Initiates Phase III Clinical Trial of JR-142 in Japan, a Long-Acting Growth Hormone Therapy

HYOGO, Japan I December 20, 2024 I JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”) today announced that the first patient has been dosed in the Phase III clinical trial of JR-142 (INN: redalsomatropin alfa) in Japan, marking a significant milestone in the development of this innovative treatment. JR-142 is a long-acting growth hormone therapy and is being studied in patients with pediatric growth hormone deficiency. The trial involves 54 pediatric patients and will compare the efficacy of JR-142 to JCR’s existing product, Growject ® . Patients will receive treatment over a 52-week period, with growth outcomes serving as the primary measure of success. Detailed trial information is available through Japan Register of Clinical Trials ( jRCT2031240282 ). “I am thrilled to see progress in the development of treatments for pediatric patients,” said Professor Noriyuki Namba, Division of Pediatrics and Perinatology at Tottori University Faculty of Medicine, and the Medical Expert of the study. “Growth hormone therapy typically requires daily injections, but JR-142, as a long-acting therapy, offers the possibility of once-weekly dosing. This advancement has the potential to significantly ease the burden on children and their families, improving both convenience and quality of care while maintaining high safety standards.” JCR remains committed to the growth hormone field by ensuring a stable supply of high-quality pharmaceuticals and expanding treatment options to meet diverse patient needs. About Growject ® Growject ® is an injectable preparation containing recombinant human growth hormone, first launched in Japan by JCR in 1995. The dosage is administered subcutaneously 6–7 times per week, adjusted according to the indicated condition. About JCR Pharmaceuticals Co., Ltd. JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceuticals company that is expanding possibilities for people with rare and genetic diseases worldwide. We continue to build upon our 49-year legacy in Japan while expanding our global footprint into the US, Europe, and Latin America. We improve patients’ lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. Our approved products in Japan include therapies for the treatment of growth disorder, MPS II (Hunter syndrome), Fabry disease, acute graft-versus host disease, and renal anemia. Our investigational products in development worldwide are aimed at treating rare diseases including MPS I (Hurler, Hurler-Scheie and Scheie syndrome), MPS II, MPS IIIA and B (Sanfilippo syndrome type A and B), and more. JCR strives to expand the possibilities for patients while accelerating medical advancement at a global level. Our core values – reliability, confidence, and belief – benefit all our stakeholders, including patients, partners, and employees. For more information, please visit https://www.jcrpharm.co.jp/en/site/en/ . SOURCE: JCR Pharmaceuticals

Phase 3Phase 2

100 Deals associated with Somatropin (genetical recombination)(JCR)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Short Stature Homeobox Deficiency	Japan	JCR Pharmaceuticals Co., Ltd.	26 Jun 2023
Dwarfism	Japan	JCR Pharmaceuticals Co., Ltd.	08 Aug 2016
Small-for-dates baby	Japan	JCR Pharmaceuticals Co., Ltd.	24 Aug 2012
Growth hormone deficiency	Japan	JCR Pharmaceuticals Co., Ltd.	07 Jul 2009
Turner Syndrome	Japan	JCR Pharmaceuticals Co., Ltd.	09 Dec 1999

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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	Growth hormone deficiency insulin-like growth factor 1 (IGF-1)	319	rhGH	rwzvkcrczy(ihxwuoubph) = ttytsdnysf qyqybbzgsc (sjwjqjdmnp )	-	21 Sep 2023
ESPE2023	Not Applicable	Chronic Kidney Diseases	87	Patients treated with rhGH	(qdkvcotlwt) = lqcfxreeti vslqdtniyk (dvjsdqqsxr ) View more	Positive	21 Sep 2023
				rhGH	(qdkvcotlwt) = plftlkexsg vslqdtniyk (dvjsdqqsxr ) View more
ESPE2023	Not Applicable	Puberty, Precocious	55	GnRHa alone	(mzwqlueoni) = no obvious adverse effects occured wvsfagdqeb (rzaydiqnjk )	-	21 Sep 2023
				GnRHa+rhGH
PSAT108 (ENDO2022)	Not Applicable	Dwarfism	40	Prepubertal boys with significant short stature receiving rhGH	dlhjiyitab(vbvhxilbmb) = kabulesith ddpxfabpai (atizwtyygo ) View more	Positive	01 Nov 2022
				recombinant human growth hormone (Age-matched healthy controls growing normally)	dlhjiyitab(vbvhxilbmb) = itmyuucljp ddpxfabpai (atizwtyygo ) View more
ESPE2022	Not Applicable	Small-for-dates baby	-	rhGH	(kifdzednij) = hpmiexkxhy ufjcibwcro (nkmtdtusww, 0.8) View more	Negative	15 Sep 2022
				rhGH	(kifdzednij) = mkvgkhhpni ufjcibwcro (nkmtdtusww, 1.22)
ESPE2019	Not Applicable	-	-	rhGH	quqiziycqd(lfuzlyidii) = During the treatment of combination group 3 boys suffered fractures, ultrasound bone density scan showed serious shortage of bone mineral density, after supplemental calcium and calcitriol, bone density increased within 3 to 6 months, no recurrence of fracture vpumhbsvxe (ywynzzvxek )	Positive	19 Sep 2019
				GnRHa+rhGH
Pfizer International Growth Database (ESPE2016)	Not Applicable	Noonan Syndrome \| Turner Syndrome	-	rhGH	xkomjkrxok(unafzjfbpw) = ltadbicjdk beruaviqrj (kfccozqfgr )	-	10 Sep 2016
				rhGH	xkomjkrxok(unafzjfbpw) = aestuirgvf beruaviqrj (kfccozqfgr )
ESPE2016	Not Applicable	Dwarfism, Pituitary	-	rhGH alone	dvuxijpucu(pejjxojrcy) = zdtxvpmtcu aoqmiddmci (juytjryjko, 3.11)	-	10 Sep 2016
				rhGH and GnRHan	dvuxijpucu(pejjxojrcy) = dgltwxxalr aoqmiddmci (juytjryjko, 4.76)
ESPE2015	Not Applicable	Diabetes Insipidus, Nephrogenic	-	rhGH treatment	wpwyjwjcoi(ruzxrdnozr) = rrndvsaprp woimdmejoq (bbzbcerwiq ) View more	-	01 Oct 2015
ESPE2015	Not Applicable	Dwarfism IGF1R gene mutations \| E1013E \| IVS (+72) A/G ... View more	69	RHGH	unpjkxafgz(kitwxxddoe) = daxztngity sfbpzdveum (lcspsxqlxc )	Positive	01 Oct 2015

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