Delving into the Latest Updates on Somatropin(Eli Lilly & Co.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Hutrope, Somatropin (Lilly), Umatrope

+ [5]

Target

GHR

Action

agonists

Mechanism

GHR agonists(Growth hormone receptor agonists)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [4]

Active Indication

Leri-Weil SyndromeDwarfism, PituitaryDwarfism+ [4]

Inactive Indication-

Originator Organization

Eli Lilly & Co.

Active Organization

Eli Lilly & Co.Eli Lilly Japan KK

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (16 Oct 1986),

DwarfismGrowth DisordersGrowth hormone deficiency+ [2]

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 26401985

The sequence is quoted from: *****

This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] score >=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.

Start Date29 Aug 2023

Sponsor / Collaborator

Columbia University

[+2]

NCT00757393

/ CompletedPhase 3IIT

Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis

The primary objective of this study is to test the hypothesis that growth hormone, administered daily by subcutaneous injection for 2 years will result in a significantly greater BMD Z-score over optimal standard therapy.

Start Date01 Sep 2008

Sponsor / Collaborator

The Hospital for Sick Children

EUCTR2005-001750-25-NL

/ Not yet recruitingNot Applicable

Efficacy and Safety of Somatropin in Combination with Leuprorelin Compared to Somatropin Alone and to an Untreated Control Group in Pubertal Children with Idiopathic Short Stature - PHOENIX

Start Date22 Mar 2007

Sponsor / Collaborator

Lilly France SAS

100 Clinical Results associated with Somatropin(Eli Lilly & Co.)

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100 Translational Medicine associated with Somatropin(Eli Lilly & Co.)

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100 Patents (Medical) associated with Somatropin(Eli Lilly & Co.)

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26

Literatures (Medical) associated with Somatropin(Eli Lilly & Co.)

12 Aug 2022·Cureus

Attenuation of Human Growth Hormone-Induced Rash With Graded Dose Challenge

Author: Rizvi, Khizer ; Hessel, Justina ; Hasan, Zubair ; Khanijo, Sameer ; Lozeau, Daniel ; Neumann, Melissa ; Luo, Evelyn ; Chan, Derek ; Agrawal, Nidhi ; Szema, Anthony M ; Mann, Jake ; Caruana, Dennis ; Donovan, Daniel ; Lee-Wong, Mary ; Gottesman, Eric ; Gunther, Regina

Adult growth hormone (GH) deficiency is rare and requires replacement with extrinsic/synthetic injection. GH hypersensitivity has been reported; specifically, atopic patients may develop rashes from somatotropin therapy. Allergic and non-allergic skin reactions to recombinant human GH are uncommon and infrequently reported. We describe a graded-dose challenge with intravenous Norditropin® in a 65-year-old atopic adult woman who developed a severe whole-body rash with Norditropin FlexPro® administration on several occasions but was negative on skin-prick testing to Norditropin® percutaneously and intradermally, but the patch testing was positive for gold and nickel. The patient was registered as a direct admission to the emergency room at a university hospital for a rapid antigen coronavirus disease 2019 (COVID-19) testing after having received two COVID-19 vaccinations and re-testing four months after vaccination. She was then directly admitted to a non-COVID-19 intensive care unit with direct bedside supervision by a registered nurse and a physician board certified in internal medicine, allergy/immunology, and pulmonary diseases. The patient brought a Norditropin® pen which our pharmacy team attached to a compatible syringe for dilutions. A graded dose challenge at a final dosage of 0.1 mL was performed and the patient was monitored for allergic and other adverse drug reactions, which did not occur. At the time of writing this case report, the patient has been maintained on Norditropin FlexPro® 0.1 mL and has not experienced any adverse reactions, including recurrent skin eruptions. The case presented is the first to describe a patient who successfully tolerated a graded dose challenge of an adult patient to GH replacement therapy (as Norditropin®) under supervision in an intensive care unit, whereas prior to reporting of this case, a graded dose challenge to GH replacement therapy had only been successfully performed in a child using another formulation of somatotropin (Humatrope®). Hence, this case lends support that graded dose challenge with somatotropin analogs may be considered for patients with isolated GH deficiency such as in the case presented here.

01 Jan 2017·Clinical Pediatric Endocrinology

Incidence of diabetes mellitus and neoplasia in Japanese short-statured children treated with growth hormone in the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)

Article

Author: Seino, Yoshiki ; Tanaka, Hiroyuki ; Hasegawa, Tomonobu ; Funai, Jumpei ; Chihara, Kazuo ; Yokoya, Susumu ; Iwamoto, Noriyuki ; Jia, Nan ; Kanzaki, Susumu ; Ozono, Keiichi ; Ihara, Katsuichiro ; Child, Christopher J. ; Tanaka, Toshiaki

The primary goal of the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) was to assess the safety and effectiveness of Humatrope^®, a GH preparation, in the treatment of pediatric patients with short stature. We report our findings in the GH-treated Japanese pediatric population focusing on the incidence of type 2 diabetes (T2D) and occurrence of neoplasms. A total of 2,345 Japanese patients were assessed for safety. During a mean observation period of 3.2 yr, T2D occurred in 3 patients (0.13%) and slowly progressive insulin-dependent diabetes mellitus (SPIDDM) related to underlying mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) in 1 patient (0.04%). Neoplasms were reported in 13 patients (0.56%), including 1 patient with brain tumor (germinoma) and 5 with craniopharyngiomas (4 recurrences); the remainder were benign, typically dermatological, neoplasms. The incidence of diabetes mellitus determined in the study did not differ from previous reports in GH-treated pediatric patients, and there was no apparent increase in the risk of new neoplastic lesions or malignant tumors.

01 Jan 2013·Endocrine JournalQ4 · MEDICINE

An observational study of the effectiveness and safety of growth hormone (Humatrope<sup>®</sup>) treatment in Japanese children with growth hormone deficiency or Turner syndrome

Q4 · MEDICINE

Article

Author: Tanaka, Toshiaki ; Ozono, Keichi ; Tai, Shigeru ; Seino, Yoshiki ; Tanaka, Hiroyuki ; Yokoya, Susumu ; Chihara, Kazuo ; Fujieda, Kenji ; Hasegawa, Tomonobu ; Kanzaki, Susumu

This study assessed the effectiveness and safety of growth hormone (GH; Humatrope(®)) therapy in Japanese children with GH deficiency (GHD) or Turner syndrome (TS) enrolled in the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS). GeNeSIS is an open-label, multinational, multicenter, observational study conducted in 30 countries. In this interim report, there were 1129 GH treatment-naïve children with GHD, with a mean chronological age (± standard deviation) of 8.75 (3.32) years, and 90 girls with TS, with a mean chronological age of 8.93 (3.67) years. The mean height standard deviation score (SDS) increased from -2.73 (0.63) SD and -2.71 (0.63) SD at study entry to -2.22 (0.68) SD and -2.20 (0.60) SD after 1 year of treatment in the GHD and TS groups, respectively. In both groups, mean height SDS increased further with each year of treatment to 4 years; however, the magnitude of change in height SDS declined with time. The mean insulin-like growth factor-I SDS increased from below the mean of the reference population at study entry to a level similar to (GHD group) or higher than (TS group) the mean of the reference population during the 4-year treatment period. The incidence of serious adverse events (AEs), treatment-related AEs, and AEs related to glucose intolerance was low in both groups (0.1% to 3.0%). In conclusion, GH treatment in Japanese children with GHD or TS resulted in increased growth over a 4-year treatment period with a favorable safety profile; however, the improvements in growth declined with time.

100 Deals associated with Somatropin(Eli Lilly & Co.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Leri-Weil Syndrome	United States	Eli Lilly & Co.	01 Nov 2006
Dwarfism, Pituitary	Japan	Eli Lilly Japan KK	28 Feb 1989
Dwarfism	United States	Eli Lilly & Co.	16 Oct 1986
Growth Disorders	United States	Eli Lilly & Co.	16 Oct 1986
Growth hormone deficiency	United States	Eli Lilly & Co.	16 Oct 1986
Idiopathic short stature	United States	Eli Lilly & Co.	16 Oct 1986
Turner Syndrome	United States	Eli Lilly & Co.	16 Oct 1986

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Growth hormone deficiency	Phase 1	Italy	Eli Lilly & Co.	01 Mar 2004

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00001305 (CTgov)	Phase 3	Growth hormone deficiency	42	Humatrope	lkkqyqxlub(gjtxbrguxt) = jxuoeuwjwx tsufimkkgb (gmckqttdcn, lxdogbyigz - erqrtwddio) View more	-	29 Jan 2019
NCT00191165 (CTgov)	Phase 3	Growth hormone deficiency	27	Somatropin (High Dose Somatropin)	godsgdgtaw(jcsgvxxjux) = uscirfxvpx lxbvkhrflc (qldgbwcait, ytcxefdhqc - ivbuszygno) View more	-	08 Jun 2009
NCT00191165 (CTgov)	Phase 3	Growth hormone deficiency	27	Somatropin (Label Dose Somatropin)	godsgdgtaw(jcsgvxxjux) = seyhqjhaja lxbvkhrflc (qldgbwcait, otneqabapx - ejrbqtmxsd) View more	-	08 Jun 2009

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Somatropin(Eli Lilly & Co.)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation