Identification
- Summary
Somatrogon is a long-acting recombinant human growth hormone used as the long-term treatment of pediatric patients who have growth failure due to growth hormone deficiency.
- Generic Name
- Somatrogon
- DrugBank Accession Number
- DB14960
- Background
Somatrogon is a long-acting recombinant human growth hormone. Growth hormone is a peptide hormone secreted by the pituitary gland that plays a crucial role in promoting longitudinal growth during childhood and adolescence and regulating metabolic function in adulthood.2 Recombinant growth hormone therapy for growth hormone deficiency and other conditions has been available since 1985, with daily administration being the standard treatment for many years. More recently, longer-acting forms of growth hormone were developed to improve patient adherence and thus, improve the therapeutic efficacy of treatment.1 Somatrogon was produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. It is a chimeric product generated by fusing three copies of the C-terminal peptide (CTP), or 28 carboxy-terminal residues, from the beta chain of human chorionic gonadotropin (hCG) to the N-terminus and C-terminus of human growth hormone.2,6 The glycosylation and the presence of CTPs in the protein sequence prolongs the half-life of somatrogon and allows its once-weekly dosing.6
In October 2021, Health Canada approved somatrogon under the market name NGENLA as the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone caused by growth hormone deficiency, marking Canada as the first country to approve this drug.4 It is available as a once-weekly subcutaneous injection.5
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Hormones - Protein Chemical Formula
- C1359H2125N361O420S7
- Protein Average Weight
- 30465.1 Da (Aglycosylated)
- Sequences
>Somatrogon amino acid sequence SSSSKAPPPSLPSPSRLPGPSDTPILPQFPTIPLSRLFDNAMLRAHRLHQLAFDTYQEFE EAYIPKEQKYSFLQNPQTSLCFSESIPTPSNREETQQKSNLELLRISLLLIQSWLEPVQF LRSVFANSLVYGASDSNVYDLLKDLEEGIQTLMGRLEDGSPRTGQIFKQTYSKFDTNSHN DDALLKNYGLLYCFRKDMDKVETFLRIVQCRSVEGSCGFSSSSKAPPPSLPSPSRLPGPS DTPILPQSSSSKAPPPSLPSPSRLPGPSDTPILPQ
Download FASTA FormatReferences:
- Health Canada Approved Drug Products: NGENLA (Somatrogon) subcutaneous injection [Link]
- Synonyms
- Somatrogon
- External IDs
- MOD-4023
Pharmacology
- Indication
Somatrogon is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency).6
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- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
Somatrogon mimics the physiological actions of endogenous growth hormone, such as cell proliferation, metabolism, and growth. It was also shown to increase the serum concentration of insulin-like growth factor (IGF-1).6
- Mechanism of action
Growth hormone is a key hormone that promotes body growth and regulates carbohydrate, protein and lipid metabolism.3 Somatrogon is a hormone replacement therapy that aims to restore deficient levels of growth hormone (GH). Like endogenous growth hormone, somatrogon binds to the GH receptor, which leads to the binding of JAK2 to GH receptor and activation of JAK2. Activation of JAK2 and phosphorylation of both JAK2 and GHR initiates the recruits various signalling proteins and facilitates multiple signalling pathways responsible for growth and metabolism.3 One of the activated signalling pathways is the STAT5b signalling pathway, which is critical for the effect of GH on body height.6
- Absorption
Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, Cmax of somatrogon was 690 ng/mL. Tmax was 8 hours and the AUC was 21800 ng x h/mL. Over the dose range of 0.25-0.66 mg/kg/week, somatrogon exposure increased in a dose-proportional manner.6
- Volume of distribution
Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the apparent central volume of distribution (Vc) was 0.812 L/kg and the apparent peripheral volume of distribution (Vt) was 0.169 L/kg. Somatrogon does not accumulate after once-weekly administration.6
- Protein binding
There is no information available.
- Metabolism
Somatrogon is expected to undergo protein catabolism, with subsequent reclamation of the amino acids and return to the systemic circulation.6
- Route of elimination
There is no information available.
- Half-life
Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the half-life was 28.3 hours. Somatrogon was detected in the circulation for about 6 days after the last dose.6
- Clearance
Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the clearance was 0.0336 L/h/kg.6
- Adverse Effects
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Subcutaneous doses of somatrogon higher than 0.66 mg/kg per week have not been studied. Based on existing clinical data of other growth hormone products, short-term overdosage from somatrogon could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term overdosage could result in signs and symptoms of gigantism or acromegaly consistent with the effects of excess growth hormone. Overdose with somatrogon should be treated with general supportive measures.6
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your software1,2-Benzodiazepine The metabolism of 1,2-Benzodiazepine can be increased when combined with Somatrogon. Abemaciclib The metabolism of Abemaciclib can be increased when combined with Somatrogon. Abiraterone The metabolism of Abiraterone can be increased when combined with Somatrogon. Acalabrutinib The metabolism of Acalabrutinib can be increased when combined with Somatrogon. Acarbose The therapeutic efficacy of Acarbose can be decreased when used in combination with Somatrogon. Acenocoumarol The metabolism of Acenocoumarol can be increased when combined with Somatrogon. Acetaminophen The metabolism of Acetaminophen can be increased when combined with Somatrogon. Acetohexamide The therapeutic efficacy of Acetohexamide can be decreased when used in combination with Somatrogon. Acyclovir The metabolism of Acyclovir can be increased when combined with Somatrogon. Adagrasib The metabolism of Adagrasib can be increased when combined with Somatrogon. 
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- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Ngenla Injection, solution 24 mg/1.2ml Subcutaneous Pfizer Europe Ma Eeig 2022-05-04 Not applicable EU 
Ngenla Solution 50 mg / mL Subcutaneous Pfizer Canada Ulc 2022-02-22 Not applicable Canada 
Ngenla Injection, solution 60 mg/1.2ml Subcutaneous Pfizer Europe Ma Eeig 2022-05-04 Not applicable EU Ngenla Solution 20 mg / mL Subcutaneous Pfizer Canada Ulc 2022-02-22 Not applicable Canada
Categories
- ATC Codes
- H01AC08 — Somatrogon
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Anterior Pituitary Lobe Hormones and Analogues
- Growth Hormone
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Peptide Hormones
- Peptides
- Pituitary and Hypothalamic Hormones and Analogues
- Pituitary Hormones
- Pituitary Hormones, Anterior
- Recombinant Human Growth Hormone
- Somatropin and Somatropin Agonists
- Systemic Hormonal Preparations, Excl. Sex Hormones and Insulins
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 6D848RA61B
- CAS number
- 1663481-09-1
References
- General References
- Lal RA, Hoffman AR: Perspectives on long-acting growth hormone therapy in children and adults. Arch Endocrinol Metab. 2019 Nov-Dec;63(6):601-607. doi: 10.20945/2359-3997000000190. [Article]
- Bidlingmaier M, Strasburger CJ: Growth hormone. Handb Exp Pharmacol. 2010;(195):187-200. doi: 10.1007/978-3-540-79088-4_8. [Article]
- Carter-Su C, Schwartz J, Argetsinger LS: Growth hormone signaling pathways. Growth Horm IGF Res. 2016 Jun;28:11-5. doi: 10.1016/j.ghir.2015.09.002. Epub 2015 Sep 10. [Article]
- Pfizer: HEALTH CANADA APPROVES NGENLA (SOMATROGON) INJECTION FOR PEDIATRIC GROWTH HORMONE DEFICIENCY [Link]
- OPKO: About Somatrogon [Link]
- Health Canada Approved Drug Products: NGENLA (Somatrogon) subcutaneous injection [Link]
- External Links
- Not Available
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 3 Active Not Recruiting Treatment Childhood-onset Growth Hormone Deficiency 1 3 Completed Other Human Growth Hormone Deficiency 2 3 Terminated Treatment Adult Onset Growth Hormone Deficiency 1 2 Active Not Recruiting Treatment Human Growth Hormone Deficiency 1 2 Completed Treatment Adult Onset Growth Hormone Deficiency 1 2 Completed Treatment Childhood-onset Growth Hormone Deficiency 1 1 Completed Other Healthy Male Volunteers 1 1 Completed Other Human Growth Hormone Deficiency 1 1 Completed Treatment Healthy Subjects (HS) 1 Not Available Not Yet Recruiting Not Available Childhood-onset Growth Hormone Deficiency 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Subcutaneous 24 mg/1.2ml Injection, solution Subcutaneous 60 mg/1.2ml Solution Subcutaneous 20 mg / mL Solution Subcutaneous 50 mg / mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Drug created at May 20, 2019 14:38 / Updated at December 07, 2021 13:41