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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Commercial
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Genotropin, Humatrope, Norditropin, 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 |
|---|---|---|---|---|---|
| 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 | 2025-07-16 |
| humatrope | Biologic Licensing Application | 2025-11-25 |
| norditropin | Biologic Licensing Application | 2025-07-07 |
| 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 | 2025-07-18 |
| 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 | 2025-07-10 |
| serostim | Biologic Licensing Application | 2022-02-02 |
Show 1 more
Indications
FDA
EMA
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
1190 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 | 3 | 5 | 12 | 4 | 21 | 45 |
| Pituitary dwarfism | D004393 | EFO_1001109 | E23.0 | 2 | 2 | 11 | 3 | 12 | 30 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | 1 | — | 5 | 3 | 8 | 17 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | 1 | — | 3 | 4 | 4 | 12 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | 5 | 1 | 4 | 10 |
| Chronic renal insufficiency | D051436 | — | N18 | 1 | 1 | 1 | 2 | 2 | 7 |
| Syndrome | D013577 | — | — | — | — | 1 | 2 | 2 | 5 |
| Gonadal dysgenesis | D006059 | — | — | — | — | 2 | 2 | 1 | 5 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 1 | 2 | 1 | 5 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 2 | 1 | 3 |
Show 2 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Growth disorders | D006130 | — | — | 3 | — | 2 | — | 3 | 8 |
| Noonan syndrome | D009634 | Orphanet_648 | Q87.19 | — | — | 4 | — | 3 | 7 |
| Dwarfism | D004392 | — | E34.31 | — | — | 2 | — | 4 | 6 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | 1 | 1 | — | — | 3 |
| Metabolic bone diseases | D001851 | — | — | — | 1 | 1 | — | — | 1 |
| Anorexia | D000855 | — | R63.0 | — | 1 | 1 | — | — | 1 |
| Delayed puberty | D011628 | — | E30.0 | — | 1 | 1 | — | — | 1 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypopituitarism | D007018 | EFO_0001380 | E23.0 | — | 1 | — | — | 1 | 2 |
| Spinal muscular atrophy | D009134 | EFO_0003823 | G12.1 | — | 1 | — | — | — | 1 |
| Spinal muscular atrophies of childhood | D014897 | Orphanet_83419 | G12.1 | — | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 1 | — | — | — | 1 |
| Brain concussion | D001924 | — | S06.0 | — | 1 | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | — | 1 | — | — | — | 1 |
| Athletic injuries | D001265 | — | — | — | 1 | — | — | — | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | 1 | — | — | — | 1 |
| Tibial fractures | D013978 | EFO_0003944 | S82.20 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | 1 | 7 |
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | 1 | — | — | — | 2 | 3 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Achondroplasia | D000130 | — | Q77.4 | — | — | — | — | 2 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 2 | 2 |
| Multiple endocrine neoplasia type 1 | D018761 | — | E31.21 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 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) |
Target
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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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No Black-box warning
Adverse Events
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90,763 adverse events reported
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