Identification
- Summary
Somapacitan is a human growth hormone analog subcutaneous injection indicated for adults with growth hormone deficiency.
- Brand Names
- Sogroya
- Generic Name
- Somapacitan
- DrugBank Accession Number
- DB15093
- Background
Somapacitan, also known as NNC0195-0092,3 is a growth hormone analog indicated to treat adults with growth hormone deficiency.2,6 This human growth hormone analog differs by the creation of an albumin binding site, and prolonging the effect so that it requires weekly dosing rather than daily.5
Somapacitan was granted FDA approval on 28 August 2020.7
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Hormones - Protein Chemical Formula
- C1038H1609N273O319S9
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Somapacitan
- Somapacitan (genetical recombination)
- somapacitan-beco
- External IDs
- NN-8640
- NN8640
- NNC-0195-0092
- NNC0195-0092
Pharmacology
- Indication
Somapacitan is indicated as a replacement for growth hormone in adult patients with growth hormone deficiency.6
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form For therapy Growth hormone (gh) deficiency •••••••••••• ••••• ••••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
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Somapacitan stimulates the growth hormone receptor.6 Somapacitan has a long duration of action as it is given once weekly.6 It has a moderately wide therapeutic window as an acute overdose may cause hypoglycemia followed by hyperglycemia.6 Patients should be counselled regarding the risk of increased mortality in patients with critical illness, risk of neoplasms, glucose intolerance in diabetes mellitus, intracranial hypertension, hypersensitivity, fluid retention, hypoadrenalism, hypothyroidism, pancreatitis, lipohypertrophy, and lipoatrophy.6
- Mechanism of action
Somapacitan binds to the growth hormone receptor and induces intracellular signalling to up-regulate insulin-like growth factor I (IGF-1).1,6 IGF-1 causes growth in bones and muscle tissue.1 Growth hormones more directly cause the fusion of myoblasts and myotubes to cause muscle fibre growth, activate neural stem cells, and induce chondrocyte proliferation.1
Target Actions Organism UGrowth hormone receptor agonistHumans - Absorption
A 0.02mg/kg single dose of somapacitan reaches a Cmax of 14.4 ng/mL, with a Tmax of 11.1 hours, and an AUC of 475 ng*h/mL.3 A 0.04mg/kg single dose of somapacitan reaches a Cmax of 19.8 ng/mL, with a Tmax of 25.6 hours, and an AUC of 777 ng*h/mL.3 A 0.08mg/kg single dose of somapacitan reaches a Cmax of 64.2 ng/mL, with a Tmax of 16.6 hours, and an AUC of 2753 ng*h/mL.3 A 0.12mg/kg single dose of somapacitan reaches a Cmax of 142.5 ng/mL, with a Tmax of 22.5 hours, and an AUC of 6382 ng*h/mL.3
- Volume of distribution
The approximate volume of distribution of somapacitan is 14.6 L.6
- Protein binding
- Metabolism
Studies in humans and rats show that somapacitan is metabolized through cleavage of the albumin-binding moiety and linker sidechain before further non-specific mechanisms.1,6
- Route of elimination
Somapacitan is approximately 81% eliminated in the urine and 13% in the feces.6
- Half-life
The elimination half life of somapacitan is 2-3 days.6
- Clearance
The apparent maximum rate of saturable elimination is estimated to be 0.268 ± 0.03 mg/h.2
- Adverse Effects
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Patients experiencing an acute overdose of somapacitan may present with fluid retention.6 Chronic overdose may resemble gigantism or acromegaly.6 Treat patients with symptomatic and supportive measures to minimize the permanent effects.4
- 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 softwareAbrocitinib The metabolism of Abrocitinib can be decreased when combined with Somapacitan. Acarbose The therapeutic efficacy of Acarbose can be decreased when used in combination with Somapacitan. Acenocoumarol The metabolism of Acenocoumarol can be decreased when combined with Somapacitan. Acetaminophen The metabolism of Acetaminophen can be increased when combined with Somapacitan. Acetohexamide The therapeutic efficacy of Acetohexamide can be decreased when used in combination with Somapacitan. - Food Interactions
- 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.- International/Other Brands
- Sogroya (Novo Nordisk)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Sogroya Injection, solution 15 mg/1.5ml Subcutaneous Novo Nordisk 2023-08-02 Not applicable EU 
Sogroya Injection, solution 6.7 mg/1mL Subcutaneous Novo Nordisk 2023-05-01 Not applicable US 
Sogroya Injection, solution 5 mg/1.5ml Subcutaneous Novo Nordisk 2022-07-15 Not applicable EU Sogroya Solution 15 mg / 1.5 mL Subcutaneous Novo Nordisk 2023-11-27 Not applicable Canada 
Sogroya Injection, solution 10 mg/1mL Subcutaneous Novo Nordisk 2023-05-01 Not applicable US
Categories
- ATC Codes
- H01AC07 — Somapacitan
- Drug Categories
- Alcohols
- Amino Acids
- Amino Acids, Cyclic
- Amino Acids, Essential
- Amino Acids, Peptides, and Proteins
- Anterior Pituitary Lobe Hormones and Analogues
- Benzene Derivatives
- Carbohydrates
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 CYP1A2 Inducers (strength unknown)
- Cytochrome P-450 CYP2C19 Inhibitors
- Cytochrome P-450 CYP2C19 inhibitors (strength unknown)
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 Enzyme Inhibitors
- Growth Hormone
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Human Growth Hormone Analogs
- Lipids
- Peptide Hormones
- Peptides
- Phenols
- Pituitary and Hypothalamic Hormones and Analogues
- Pituitary Hormones
- Pituitary Hormones, Anterior
- Somatropin and Somatropin Agonists
- Sugar Alcohols
- 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
- 8FOJ430U94
- CAS number
- 1338578-34-9
References
- General References
- Petersen M, Gandhi PS, Buchardt J, Alanentalo T, Fels JJ, Johansen NL, Helding-Kvist P, Vad K, Thygesen P: Tissue Distribution and Receptor Activation by Somapacitan, a Long Acting Growth Hormone Derivative. Int J Mol Sci. 2020 Feb 11;21(4). pii: ijms21041181. doi: 10.3390/ijms21041181. [Article]
- Juul RV, Rasmussen MH, Agerso H, Overgaard RV: Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5. [Article]
- Rasmussen MH, Janukonyte J, Klose M, Marina D, Tanvig M, Nielsen LF, Hoybye C, Andersen M, Feldt-Rasmussen U, Christiansen JS: Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency. J Clin Endocrinol Metab. 2016 Mar;101(3):988-98. doi: 10.1210/jc.2015-1991. Epub 2016 Jan 4. [Article]
- Adelman DT, Liebert KJ, Nachtigall LB, Lamerson M, Bakker B: Acromegaly: the disease, its impact on patients, and managing the burden of long-term treatment. Int J Gen Med. 2013;6:31-8. doi: 10.2147/IJGM.S38594. Epub 2013 Jan 18. [Article]
- Rasmussen MH, Olsen MW, Alifrangis L, Klim S, Suntum M: A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile. J Clin Endocrinol Metab. 2014 Oct;99(10):E1819-29. doi: 10.1210/jc.2014-1702. Epub 2014 Jul 11. [Article]
- Novo Nordisk: Sogroya FDA Label [Link]
- FDA Approved Drug Products: Sogroya Somapacitan Subcutaneous Injection [Link]
- External Links
- KEGG Drug
- D11194
- 2557394
- Wikipedia
- Somapacitan
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 3 Active Not Recruiting Treatment Growth Hormone Deficiency in Children 1 3 Completed Treatment Adult Onset Growth Hormone Deficiency / Growth Hormone Disorders 3 3 Completed Treatment Growth Hormone Deficiency in Children 1 3 Recruiting Treatment ISS / Noonan Syndrome / SGA / Turner's Syndrome 1 3 Recruiting Treatment SGA, Turner Syndrome, Noonan Syndrome, ISS 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, solution Subcutaneous 10 mg/1mL Injection, solution Subcutaneous 10 MG/1.5ML Injection, solution Subcutaneous 15 mg/1.5ml Injection, solution Subcutaneous 3.3 mg/1mL Injection, solution Subcutaneous 5 mg/1.5ml Injection, solution Subcutaneous 6.7 mg/1mL Solution Subcutaneous 10 mg / 1.5 mL Solution Subcutaneous 15 mg / 1.5 mL Solution Subcutaneous 5 mg / 1.5 mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
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Use our structured and evidence-based datasets to unlock newinsights and accelerate drug research.
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- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- Agonist
- General Function
- Protein kinase binding
- Specific Function
- Receptor for pituitary gland growth hormone involved in regulating postnatal body growth. On ligand binding, couples to the JAK2/STAT5 pathway (By similarity).The soluble form (GHBP) acts as a rese...
- Gene Name
- GHR
- Uniprot ID
- P10912
- Uniprot Name
- Growth hormone receptor
- Molecular Weight
- 71498.885 Da
References
- Petersen M, Gandhi PS, Buchardt J, Alanentalo T, Fels JJ, Johansen NL, Helding-Kvist P, Vad K, Thygesen P: Tissue Distribution and Receptor Activation by Somapacitan, a Long Acting Growth Hormone Derivative. Int J Mol Sci. 2020 Feb 11;21(4). pii: ijms21041181. doi: 10.3390/ijms21041181. [Article]
- Novo Nordisk: Sogroya FDA Label [Link]
Enzymes
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- Inhibitor
- General Function
- 11-beta-hydroxysteroid dehydrogenase [nad(p)] activity
- Specific Function
- Catalyzes reversibly the conversion of cortisol to the inactive metabolite cortisone. Catalyzes reversibly the conversion of 7-ketocholesterol to 7-beta-hydroxycholesterol. In intact cells, the rea...
- Gene Name
- HSD11B1
- Uniprot ID
- P28845
- Uniprot Name
- Corticosteroid 11-beta-dehydrogenase isozyme 1
- Molecular Weight
- 32400.665 Da
References
- Novo Nordisk: Sogroya FDA Label [Link]
- Kind
- Protein
- Organism
- Rat
- Pharmacological action
- Unknown
- Actions
- Inducer
- General Function
- This P450 is active in 15-beta-hydroxylation of steroid sulfates.
- Specific Function
- Arachidonic acid epoxygenase activity
- Gene Name
- Cyp2c12
- Uniprot ID
- P11510
- Uniprot Name
- Cytochrome P450 2C12, female-specific
- Molecular Weight
- 55918.365 Da
References
- Mode A, Tollet P, Strom A, Legraverend C, Liddle C, Gustafsson JA: Growth hormone regulation of hepatic cytochrome P450 expression in the rat. Adv Enzyme Regul. 1992;32:255-63. doi: 10.1016/0065-2571(92)90021-q. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- Inducer
- General Function
- Oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygen
- Specific Function
- Cytochromes P450 are a group of heme-thiolate monooxygenases. In liver microsomes, this enzyme is involved in an NADPH-dependent electron transport pathway. It oxidizes a variety of structurally un...
- Gene Name
- CYP1A2
- Uniprot ID
- P05177
- Uniprot Name
- Cytochrome P450 1A2
- Molecular Weight
- 58293.76 Da
References
- Jurgens G, Lange KH, Reuther LO, Rasmussen BB, Brosen K, Christensen HR: Effect of growth hormone on hepatic cytochrome P450 activity in healthy elderly men. Clin Pharmacol Ther. 2002 Mar;71(3):162-8. doi: 10.1067/mcp.2002.121373. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- Inhibitor
- General Function
- Steroid hydroxylase activity
- Specific Function
- Responsible for the metabolism of a number of therapeutic agents such as the anticonvulsant drug S-mephenytoin, omeprazole, proguanil, certain barbiturates, diazepam, propranolol, citalopram and im...
- Gene Name
- CYP2C19
- Uniprot ID
- P33261
- Uniprot Name
- Cytochrome P450 2C19
- Molecular Weight
- 55930.545 Da
References
- Jurgens G, Lange KH, Reuther LO, Rasmussen BB, Brosen K, Christensen HR: Effect of growth hormone on hepatic cytochrome P450 activity in healthy elderly men. Clin Pharmacol Ther. 2002 Mar;71(3):162-8. doi: 10.1067/mcp.2002.121373. [Article]
Carriers
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- Binder
- General Function
- Toxic substance binding
- Specific Function
- Serum albumin, the main protein of plasma, has a good binding capacity for water, Ca(2+), Na(+), K(+), fatty acids, hormones, bilirubin and drugs. Its main function is the regulation of the colloid...
- Gene Name
- ALB
- Uniprot ID
- P02768
- Uniprot Name
- Serum albumin
- Molecular Weight
- 69365.94 Da
References
- Petersen M, Gandhi PS, Buchardt J, Alanentalo T, Fels JJ, Johansen NL, Helding-Kvist P, Vad K, Thygesen P: Tissue Distribution and Receptor Activation by Somapacitan, a Long Acting Growth Hormone Derivative. Int J Mol Sci. 2020 Feb 11;21(4). pii: ijms21041181. doi: 10.3390/ijms21041181. [Article]
- Novo Nordisk: Sogroya FDA Label [Link]
Drug created at May 20, 2019 14:49 / Updated at August 07, 2021 00:12