somatrogon 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
growth hormone derivatives 5517 1663481-09-1

Description:

MoleculeDescription

Molfile

Synonyms:

  • somatrogon
  • ngenla
  • MOD-4023
  • somatrogon (genetical recombination)
Somatrogon is a glycoprotein comprised of the amino acid sequence of hGH with one copy of the of C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of somatrogon, which allows for weekly dosing. Somatrogon binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Consistent with GH signalling, somatrogon binding leads to activation of the STAT5b signalling pathway and increases the serum concentration of IGF-1. IGF-1 was found to increase in a dose-dependent manner during treatment with somatrogon partially mediating the clinical effect. As a result, GH and IGF-1 stimulate metabolic changes, linear growth and enhance growth velocity in paediatric patients with GHD.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Feb. 14, 2022 EMA PFIZER EUROPE MA EEIG
June 27, 2023 FDA PFIZER IRELAND PHARMACEUTICALS
Jan. 20, 2022 PMDA PFIZER JAPAN INC.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC H01AC08 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
Somatropin and somatropin agonists

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Growth hormone deficiency indication 397827003
Acute respiratory failure contraindication 65710008 DOID:11162
Active intracranial tumours contraindication 254935002
Multiple accidental trauma contraindication 1163387009
Children with closed epiphyses contraindication
Complications following open heart surgery contraindication
Complications following abdominal surgery contraindication
Tumour growth contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Growth hormone receptor GPCR AGONIST Kd 8.20 SCIENTIFIC LITERATURE DRUG LABEL
Growth hormone receptor, GH receptor Unclassified AGONIST Kd 8.29 IUPHAR

External reference:

IDSource
CHEMBL4297830 ChEMBL_ID
C000723339 MESH_SUPPLEMENTAL_RECORD_UI
C000634267 MESH_SUPPLEMENTAL_RECORD_UI
12013 IUPHAR_LIGAND_ID
DB14960 DRUGBANK_ID
C4726772 UMLSCUI
10402 INN_ID
2644503 RXNORM
6D848RA61B UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ngenla HUMAN PRESCRIPTION DRUG LABEL 1 0069-0505 INJECTION, SOLUTION 24 mg SUBCUTANEOUS BLA 29 sections
Ngenla HUMAN PRESCRIPTION DRUG LABEL 1 0069-0520 INJECTION, SOLUTION 60 mg SUBCUTANEOUS BLA 29 sections