All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
growth hormone derivatives	5476	1934255-39-6

Description:

Molecule

Description

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:

Date	Agency	Company	Orphan
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:

Source	Code	Description
ATC	H01AC09	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES Somatropin and somatropin agonists
FDA CS	M0028842	Human Growth Hormone
FDA EPC	N0000175606	Recombinant Human Growth Hormone

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

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Growth hormone receptor	GPCR	P10912	GHR_HUMAN	OTHER				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
OP35X9610Y	UNII
C5421356	UMLSCUI
CHEMBL4298185	ChEMBL_ID
DB16220	DRUGBANK_ID
D11486	KEGG_DRUG
CHEMBL4297687	ChEMBL_ID
10598	INN_ID
C000723007	MESH_SUPPLEMENTAL_RECORD_UI
018839	NDDF
2569562	RXNORM
350054	MMSL
39845	MMSL
39850	MMSL
d09797	MMSL

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-003	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-003	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-003	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-004	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.60 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-004	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.60 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-004	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.60 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-005	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	4.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-005	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	4.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-005	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	4.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-006	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5.20 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-006	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5.20 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-006	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5.20 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-007	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	6.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-007	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	6.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-007	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	6.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-008	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	7.60 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-008	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	7.60 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-008	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	7.60 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-009	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	9.10 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-009	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	9.10 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-009	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	9.10 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-010	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	11 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-010	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	11 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-010	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	11 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-011	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	13.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-011	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	13.30 mg	SUBCUTANEOUS	BLA	33 sections
Skytrofa	HUMAN PRESCRIPTION DRUG LABEL	1	73362-011	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	13.30 mg	SUBCUTANEOUS	BLA	33 sections