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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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| genotropin | Biologic Licensing Application | 2024-08-28 |
| humatrope | Biologic Licensing Application | 2023-12-08 |
| 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 | 2021-12-13 |
| 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 | 2024-03-01 |
| serostim | Biologic Licensing Application | 2022-02-02 |
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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
758 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | 17 | 42 | 59 | 27 | 90 | 226 |
| Pituitary dwarfism | D004393 | EFO_1001109 | E23.0 | 8 | 29 | 46 | 19 | 47 | 144 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | 5 | 21 | 40 | 8 | 28 | 98 |
| Dwarfism | D004392 | HP_0003510 | E34.31 | 3 | 14 | 17 | 13 | 37 | 81 |
| Syndrome | D013577 | — | — | 3 | 14 | 21 | 11 | 26 | 69 |
| Acromegaly | D000172 | — | — | 1 | 6 | 10 | 7 | 24 | 48 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | 1 | 7 | 9 | 8 | 18 | 43 |
| Gonadal dysgenesis | D006059 | — | — | 1 | 7 | 9 | 7 | 16 | 40 |
| Healthy volunteers/patients | — | — | — | 16 | 1 | — | 3 | 11 | 31 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | 6 | 2 | 3 | 18 | 31 |
Show 51 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Growth disorders | D006130 | — | — | 4 | 3 | 10 | — | 27 | 43 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 4 | 4 | 1 | — | 5 | 13 |
| Fibrosis | D005355 | — | — | 1 | 6 | 5 | — | 3 | 11 |
| Pituitary neoplasms | D010911 | — | — | — | 3 | 1 | — | 5 | 9 |
| Noonan syndrome | D009634 | Orphanet_648 | Q87.19 | — | 1 | 5 | — | 3 | 9 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 3 | 3 | — | 3 | 7 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | 3 | 2 | — | 2 | 7 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 1 | 3 | 4 | — | 1 | 6 |
| Abdominal obesity | D056128 | HP_0001956 | — | — | 3 | 1 | — | 2 | 6 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 3 | 1 | — | 2 | 5 |
Show 51 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Insulin resistance | D007333 | HP_0000855 | — | 6 | 4 | — | — | 14 | 22 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 4 | 3 | — | — | 3 | 10 |
| Aging | D000375 | GO_0007568 | R41.81 | 2 | 5 | — | — | 3 | 9 |
| Neoplasms | D009369 | — | C80 | 3 | 1 | — | — | 2 | 5 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 1 | — | — | 2 | 4 |
| Nervous system neoplasms | D009423 | — | — | 1 | 1 | — | — | 2 | 4 |
| Hiv | D006678 | — | — | 1 | 1 | — | — | 2 | 4 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | — | 1 | 1 | — | — | 3 | 4 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | 1 | — | — | 1 | 3 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | 1 | — | — | 1 | 3 |
Show 49 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | — | — | — | 1 | 3 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | 1 | — | — | — | 2 | 3 |
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | 2 | 3 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 3 | — | — | — | — | 3 |
| Carcinoid tumor | D002276 | — | D3A.00 | 2 | — | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | 1 | 2 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | 1 | 2 |
| Hyperinsulinism | D006946 | HP_0000842 | E16.1 | 2 | — | — | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | — | 1 |
Show 12 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 4 | 4 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 4 | 4 |
| Precocious puberty | D011629 | — | E22.8 | — | — | — | — | 3 | 3 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 3 | 3 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 2 | 2 |
| Pseudopseudohypoparathyroidism | D011556 | — | — | — | — | — | — | 2 | 2 |
| Pseudohypoparathyroidism | D011547 | — | E20.1 | — | — | — | — | 2 | 2 |
| Hyperplasia | D006965 | EFO_0000536 | — | — | — | — | — | 2 | 2 |
| Congenital adrenal hyperplasia | D000312 | — | E25.0 | — | — | — | — | 2 | 2 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | — | — | — | 2 | 2 |
Show 66 more
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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59,553 adverse events reported
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