Somatropin pegol
Genotropin, Humatrope, Norditropin, Nutropin, NutropinAq, Omnitrope, Serostim, Zomacton (somatropin pegol) is a protein pharmaceutical. Somatropin pegol was first approved as Humatrope on 1986-10-16. It has been approved in Europe to treat growth, pituitary dwarfism, prader-willi syndrome, and turner syndrome.
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Commercial
Therapeutic Areas
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| genotropin | Biologic Licensing Application | 2024-08-28 |
| humatrope | Biologic Licensing Application | 2024-11-13 |
| norditropin | Biologic Licensing Application | 2020-03-09 |
| norditropin norditropin nordiflex | 2008-11-10 | |
| nutropin aq | 2006-07-11 | |
| nutropin aq nuspin 10 nutropin aq nuspin 20 nutropin aq nuspin 5 | Biologic Licensing Application | 2024-11-19 |
| nutropin aq nuspin 10 nutropin aq nuspin 20 nutropin aq nuspin 5 nutropin aq pen 10 nutropin aq pen 20 | New Drug Application | 2019-12-17 |
| nutropin aq nutropin aq nuspin 10 nutropin aq nuspin 20 nutropin aq nuspin 5 nutropin aq pen 10 nutropin aq pen 20 | New Drug Application | 2013-10-29 |
| omnitrope | Biologic Licensing Application | 2024-11-14 |
| serostim | Biologic Licensing Application | 2022-02-02 |
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Indications
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
somatropin, Norditropin, Novo Nordisk Inc. | |||
| 2114-05-31 | Orphan excl. | ||
somatropin, Humatrope, Eli Lilly and Company | |||
| 2113-11-01 | Orphan excl. | ||
somatropin, Genotropin, Pharmacia & Upjohn Company LLC | |||
| 2108-07-25 | Orphan excl. | ||
somatropin, Nutropin, Genentech, Inc. | |||
| 2103-12-30 | Orphan excl. | ||
somatropin, Serostim, EMD Serono, Inc. | |||
| 2103-08-23 | Orphan excl. | ||
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Clinical
Clinical Trials
762 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | 2 | 2 | — | 4 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | — | — | 2 | 1 | — | 3 |
| Gonadal dysgenesis | D006059 | — | — | — | — | 2 | 1 | — | 3 |
| Hypopituitarism | D007018 | EFO_0001380 | E23.0 | — | — | — | 1 | 1 | 2 |
| Hypothyroidism | D007037 | EFO_0004705 | E03.9 | — | — | — | 1 | — | 1 |
| Short bowel syndrome | D012778 | — | K90.82 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | — | 3 | — | 1 | 4 |
| Dwarfism | D004392 | HP_0003510 | E34.31 | — | — | 2 | — | 2 | 4 |
| Pituitary dwarfism | D004393 | EFO_1001109 | E23.0 | — | — | 2 | — | 1 | 3 |
| Growth disorders | D006130 | — | — | — | — | 1 | — | 1 | 2 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | 2 | — | — | 2 |
| Failure to thrive | D005183 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pseudopseudohypoparathyroidism | D011556 | — | — | — | — | — | — | 1 | 1 |
| Pseudohypoparathyroidism | D011547 | — | E20.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Somatropin pegol |
| INN | somatropin pegol |
| Description | Genotropin, Humatrope, Norditropin, Nutropin, NutropinAq, Omnitrope, Serostim, Zomacton (somatropin pegol) is a protein pharmaceutical. Somatropin pegol was first approved as Humatrope on 1986-10-16. It has been approved in Europe to treat growth, pituitary dwarfism, prader-willi syndrome, and turner syndrome. |
| Classification | Protein |
| Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer; tricyclic compounds; growth hormone derivatives; atropine derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108315 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | ZF7544FTQW (ChemIDplus, GSRS) |
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Genotropin – Pfizer
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Safety
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66,216 adverse events reported
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