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| Stem definition | Drug id | CAS RN |
|---|---|---|
| growth hormone derivatives | 5476 | 1934255-39-6 |
| Molecule | Description |
|---|---|
|
Synonyms:
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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.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 25, 2021 | FDA | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S | |
| Jan. 11, 2022 | EMA | ASCENDIS PHARMA ENDOCRINOLOGY DIVISION A/S |
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| 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 |
| 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 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Growth hormone receptor | Membrane receptor | OTHER | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| OP35X9610Y | UNII |
| C5421356 | UMLSCUI |
| CHEBI:757592 | CHEBI |
| CHEMBL4298185 | ChEMBL_ID |
| DB16220 | DRUGBANK_ID |
| CHEMBL4297687 | ChEMBL_ID |
| D11486 | KEGG_DRUG |
| 10598 | INN_ID |
| C000723007 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4044243 | VANDF |
| 4044244 | VANDF |
| 350054 | MMSL |
| 39845 | MMSL |
| 39850 | MMSL |
| d09797 | MMSL |
| 018839 | NDDF |
| 2569562 | RXNORM |
| 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 | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-004 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3.60 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-005 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 4.30 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-006 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5.20 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-007 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 6.30 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-008 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 7.60 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-009 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 9.10 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-010 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 11 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-011 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 13.30 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-012 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 0.70 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-013 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1.40 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-014 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1.80 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-015 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2.10 mg | SUBCUTANEOUS | BLA | 35 sections |
| Skytrofa | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73362-016 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2.50 mg | SUBCUTANEOUS | BLA | 35 sections |