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

Stem definitionDrug idCAS RN
growth hormone derivatives 5476 1934255-39-6

Description:

MoleculeDescription

Molfile

Synonyms:

  • lonapegsomatropin
  • lonapegsomatropin-tcgd
  • skytrofa
  • ACP-011
  • TransConPEG hGh
  • rhGH-PEG
Lonapegsomatropin is a pegylated human growth hormone (somatropin) for once-weekly subcutaneous injection. Somatropin binds to the growth hormone (GH) receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Somatropin has direct tissue and metabolic effects, and indirect effects mediated by insulin-like growth factor-1 (IGF-1), including stimulation of chondrocyte differentiation and proliferation, stimulation of hepatic glucose output, protein synthesis and lipolysis. Somatropin stimulates skeletal growth in pediatric patients with growth hormone deficiency (GHD) as a result of effects on the growth plates (epiphyses) of long bones.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 11, 2022 EMA ASCENDIS PHARMA ENDOCRINOLOGY DIVISION A/S
Aug. 25, 2021 FDA ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S

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
FDA CS M0028842 Human Growth Hormone
FDA EPC N0000175606 Recombinant Human Growth Hormone

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Growth failure due to inadequate secretion of endogenous growth hormone (GH) indication 397827003
Active proliferative or severe non-proliferative diabetic retinopathy contraindication 4855003 DOID:8947
Closed epiphyses contraindication 44453008
Acute respiratory failure contraindication 65710008 DOID:11162
Active malignancy contraindication 86049000
Prader-Willi syndrome contraindication 89392001 DOID:11983




🐶 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 OTHER DRUG LABEL DRUG LABEL

External reference:

IDSource
OP35X9610Y UNII
C5421356 UMLSCUI
CHEMBL4298185 ChEMBL_ID
DB16220 DRUGBANK_ID
D11486 KEGG_DRUG
2569562 RXNORM
350054 MMSL
39845 MMSL
39850 MMSL
d09797 MMSL
018839 NDDF
10598 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-003 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-003 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-004 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.60 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-004 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 3.60 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-005 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 4.30 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-005 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 4.30 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-006 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5.20 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-006 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5.20 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-007 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 6.30 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-007 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 6.30 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-008 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 7.60 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-008 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 7.60 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-009 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 9.10 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-009 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 9.10 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-010 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 11 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-010 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 11 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-011 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 13.30 mg SUBCUTANEOUS BLA 32 sections
Skytrofa HUMAN PRESCRIPTION DRUG LABEL 1 73362-011 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 13.30 mg SUBCUTANEOUS BLA 32 sections