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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
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
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 10 mg/1.5ml Subcutaneous Novo Nordisk 2021-04-20 Not applicable EU Sogroya Solution 10 mg / 1.5 mL Subcutaneous Novo Nordisk 2023-11-27 Not applicable Canada 
Sogroya Injection, solution 3.3 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
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
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Enrolling by Invitation Not Available Adult Onset Growth Hormone Deficiency 2 somestatus stop reason just information to hide Not Available Enrolling by Invitation Not Available Growth Hormone Deficiency in Children 1 somestatus stop reason just information to hide 3 Active Not Recruiting Treatment Growth Hormone Deficiency in Children 1 somestatus stop reason just information to hide 3 Completed Treatment Adult Onset Growth Hormone Deficiency / Growth Hormone Disorders 3 somestatus stop reason just information to hide 3 Completed Treatment Growth Hormone Deficiency in Children 1 somestatus stop reason just information to hide
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.
Use our structured and evidence-based datasets to unlock new insights and accelerate drug research.
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- Agonist
- General Function
- Receptor for pituitary gland growth hormone (GH1) involved in regulating postnatal body growth (PubMed:1549776, PubMed:2825030, PubMed:8943276). On ligand binding, couples to the JAK2/STAT5 pathway (PubMed:1549776, PubMed:15690087, PubMed:2825030, PubMed:8943276)
- Specific Function
- cytokine binding
- 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
- Controls the reversible conversion of biologically active glucocorticoids such as cortisone to cortisol, and 11-dehydrocorticosterone to corticosterone in the presence of NADP(H) (PubMed:10497248, PubMed:12460758, PubMed:14973125, PubMed:15152005, PubMed:15280030, PubMed:17593962, PubMed:21453287, PubMed:27927697, PubMed:30902677). Participates in the corticosteroid receptor-mediated anti-inflammatory response, as well as metabolic and homeostatic processes (PubMed:10497248, PubMed:12414862, PubMed:15152005, PubMed:21453287). Plays a role in the secretion of aqueous humor in the eye, maintaining a normotensive, intraocular environment (PubMed:11481269). Bidirectional in vitro, predominantly functions as a reductase in vivo, thereby increasing the concentration of active glucocorticoids (PubMed:10497248, PubMed:11481269, PubMed:12414862, PubMed:12460758). It has broad substrate specificity, besides glucocorticoids, it accepts other steroid and sterol substrates (PubMed:15095019, PubMed:15152005, PubMed:17593962, PubMed:21453287). Interconverts 7-oxo- and 7-hydroxy-neurosteroids such as 7-oxopregnenolone and 7beta-hydroxypregnenolone, 7-oxodehydroepiandrosterone (3beta-hydroxy-5-androstene-7,17-dione) and 7beta-hydroxydehydroepiandrosterone (3beta,7beta-dihydroxyandrost-5-en-17-one), among others (PubMed:17593962). Catalyzes the stereo-specific conversion of the major dietary oxysterol, 7-ketocholesterol (7-oxocholesterol), into the more polar 7-beta-hydroxycholesterol metabolite (PubMed:15095019, PubMed:15152005). 7-oxocholesterol is one of the most important oxysterols, it participates in several events such as induction of apoptosis, accumulation in atherosclerotic lesions, lipid peroxidation, and induction of foam cell formation (PubMed:15095019). Mediates the 7-oxo reduction of 7-oxolithocholate mainly to chenodeoxycholate, and to a lesser extent to ursodeoxycholate, both in its free form and when conjugated to glycine or taurine, providing a link between glucocorticoid activation and bile acid metabolism (PubMed:21453287). Catalyzes the synthesis of 7-beta-25-dihydroxycholesterol from 7-oxo-25-hydroxycholesterol in vitro, which acts as a ligand for the G-protein-coupled receptor (GPCR) Epstein-Barr virus-induced gene 2 (EBI2) and may thereby regulate immune cell migration (PubMed:30902677)
- Specific Function
- 11-beta-hydroxysteroid dehydrogenase (NADP+) activity
- Gene Name
- HSD11B1
- Uniprot ID
- P28845
- Uniprot Name
- 11-beta-hydroxysteroid dehydrogenase 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
- A cytochrome P450 monooxygenase involved in the metabolism of various endogenous substrates, including fatty acids, steroid hormones and vitamins (PubMed:10681376, PubMed:11555828, PubMed:12865317, PubMed:19965576, PubMed:9435160). Mechanistically, uses molecular oxygen inserting one oxygen atom into a substrate, and reducing the second into a water molecule, with two electrons provided by NADPH via cytochrome P450 reductase (NADPH--hemoprotein reductase) (PubMed:10681376, PubMed:11555828, PubMed:12865317, PubMed:19965576, PubMed:9435160). Catalyzes the hydroxylation of carbon-hydrogen bonds (PubMed:11555828, PubMed:12865317). Exhibits high catalytic activity for the formation of hydroxyestrogens from estrone (E1) and 17beta-estradiol (E2), namely 2-hydroxy E1 and E2 (PubMed:11555828, PubMed:12865317). Metabolizes cholesterol toward 25-hydroxycholesterol, a physiological regulator of cellular cholesterol homeostasis (PubMed:21576599). May act as a major enzyme for all-trans retinoic acid biosynthesis in the liver. Catalyzes two successive oxidative transformation of all-trans retinol to all-trans retinal and then to the active form all-trans retinoic acid (PubMed:10681376). Primarily catalyzes stereoselective epoxidation of the last double bond of polyunsaturated fatty acids (PUFA), displaying a strong preference for the (R,S) stereoisomer (PubMed:19965576). Catalyzes bisallylic hydroxylation and omega-1 hydroxylation of PUFA (PubMed:9435160). May also participate in eicosanoids metabolism by converting hydroperoxide species into oxo metabolites (lipoxygenase-like reaction, NADPH-independent) (PubMed:21068195). Plays a role in the oxidative metabolism of xenobiotics. Catalyzes the N-hydroxylation of heterocyclic amines and the O-deethylation of phenacetin (PubMed:14725854). Metabolizes caffeine via N3-demethylation (Probable)
- Specific Function
- aromatase activity
- Gene Name
- CYP1A2
- Uniprot ID
- P05177
- Uniprot Name
- Cytochrome P450 1A2
- Molecular Weight
- 58406.915 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
- A cytochrome P450 monooxygenase involved in the metabolism of polyunsaturated fatty acids (PUFA) (PubMed:18577768, PubMed:19965576, PubMed:20972997). Mechanistically, uses molecular oxygen inserting one oxygen atom into a substrate, and reducing the second into a water molecule, with two electrons provided by NADPH via cytochrome P450 reductase (NADPH--hemoprotein reductase) (PubMed:18577768, PubMed:19965576, PubMed:20972997). Catalyzes the hydroxylation of carbon-hydrogen bonds. Hydroxylates PUFA specifically at the omega-1 position (PubMed:18577768). Catalyzes the epoxidation of double bonds of PUFA (PubMed:19965576, PubMed:20972997). Also metabolizes plant monoterpenes such as limonene. Oxygenates (R)- and (S)-limonene to produce carveol and perillyl alcohol (PubMed:11950794). 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 imipramine. Hydroxylates fenbendazole at the 4' position (PubMed:23959307)
- Specific Function
- (R)-limonene 6-monooxygenase activity
- Gene Name
- CYP2C19
- Uniprot ID
- P33261
- Uniprot Name
- Cytochrome P450 2C19
- Molecular Weight
- 55944.565 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
- Binds water, Ca(2+), Na(+), K(+), fatty acids, hormones, bilirubin and drugs (Probable). Its main function is the regulation of the colloidal osmotic pressure of blood (Probable). Major zinc transporter in plasma, typically binds about 80% of all plasma zinc (PubMed:19021548). Major calcium and magnesium transporter in plasma, binds approximately 45% of circulating calcium and magnesium in plasma (By similarity). Potentially has more than two calcium-binding sites and might additionally bind calcium in a non-specific manner (By similarity). The shared binding site between zinc and calcium at residue Asp-273 suggests a crosstalk between zinc and calcium transport in the blood (By similarity). The rank order of affinity is zinc > calcium > magnesium (By similarity). Binds to the bacterial siderophore enterobactin and inhibits enterobactin-mediated iron uptake of E.coli from ferric transferrin, and may thereby limit the utilization of iron and growth of enteric bacteria such as E.coli (PubMed:6234017). Does not prevent iron uptake by the bacterial siderophore aerobactin (PubMed:6234017)
- Specific Function
- antioxidant activity
- Gene Name
- ALB
- Uniprot ID
- P02768
- Uniprot Name
- 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