Humatrope, Nutropinaq(somatropin)
Genotropin, Humatrope, Norditropin, Nutropin, NutropinAq, Omnitrope, Serostim, Zomacton (somatropin) is a protein pharmaceutical. Somatropin was first approved as Humatrope on 1986-10-16. It is used to treat cachexia, dwarfism, heart failure, noonan syndrome, and prader-willi syndrome amongst others in the USA. It has been approved in Europe to treat growth, pituitary dwarfism, prader-willi syndrome, and turner syndrome. The pharmaceutical is active against growth hormone receptor.
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Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Serostim, Zomacton (discontinued: Accretropin, Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Zomacton)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Somatropin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Nutropin AQ | somatropin | Genentech | N-20522 RX | 2008-01-03 | 3 products |
| Serostim | somatropin | EMD Serono | N-20604 RX | 1996-08-23 | 3 products |
| Humatrope | somatropin | Eli Lilly | N-19640 RX | 1999-02-04 | 3 products |
| Zomacton | somatropin | Ferring Pharmaceuticals | N-19774 RX | 2002-01-04 | 2 products |
| Norditropin | somatropin | Novo Nordisk | N-21148 RX | 2010-03-01 | 4 products |
| Genotropin | somatropin | Pharmacia & Upjohn Company LLC | N-20280 RX | 1995-08-24 | 12 products |
| Omnitrope | somatropin | Sandoz | N-21426 RX | 2006-05-30 | 3 products |
Show 11 discontinued
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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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. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2941 | Injection, somatropin, 1 mg |
Clinical
Clinical Trials
2107 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | 2 | 1 | 4 |
| Syndrome | D013577 | — | — | — | — | 2 | 2 | — | 4 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | — | — | 2 | 1 | — | 3 |
| Gonadal dysgenesis | D006059 | — | — | — | — | 2 | 1 | — | 3 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | 1 | — | 2 |
| Hypopituitarism | D007018 | EFO_0001380 | E23.0 | — | — | — | 1 | 1 | 2 |
| Neoplasms | D009369 | — | C80 | — | — | — | 1 | — | 1 |
| 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
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
| Extranodal nk-t-cell lymphoma | D054391 | — | C86.0 | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | — | 1 | — | — | — | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | — | 1 | — | — | — | 1 |
Show 1 more
Indications Phases 1
No data
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 |
| INN | somatropin |
| Description | Accretropin, Genotropin, Humatrope, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive/Serostim, NutropinAq (somatropin) is a protein pharmaceutical. Somatropin was first approved as Accretropin on 2001-02-15. It is used to treat cachexia, dwarfism, heart failure, noonan syndrome, and prader-willi syndrome amongst others in the USA. It has been approved in Europe to treat pituitary dwarfism, prader-willi syndrome, and turner syndrome. The pharmaceutical is active against growth hormone receptor. |
| Classification | Protein |
| Drug class | 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 | CHEMBL1201621 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | NQX9KB6PCL (ChemIDplus, GSRS) |
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Genotropin – Pfizer
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Somatropin
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Trends
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Safety
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72,990 adverse events reported
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