Somatropin - PharmaKB

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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Patent expiration date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
musculoskeletal diseases	D009140
nervous system diseases	D009422
urogenital diseases	D000091642
cardiovascular diseases	D002318
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
nutritional and metabolic diseases	D009750
endocrine system diseases	D004700
signs and symptoms pathological conditions	D013568
physiological phenomena	D010829

Trade Name

FDA

EMA

Genotropin, Humatrope, Norditropin, Omnitrope, Serostim, Zomacton (discontinued: Accretropin, Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Zomacton)

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable 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

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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

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	EFO_0003144	D006333	I50
prader-willi syndrome	Orphanet_739	D011218	Q87.11
cachexia	—	D002100	R64
turner syndrome	Orphanet_881	D014424	Q96
noonan syndrome	Orphanet_648	D009634	Q87.19
dwarfism	—	D004392	E34.31

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

ATC Codes

H: Systemic hormonal preparations, excl. sex hormones and insulins

— H01: Pituitary and hypothalamic hormones and analogues

— H01A: Anterior pituitary lobe hormones and analogues

— H01AC: Somatropin and somatropin agonists

— H01AC01: Somatropin

HCPCS

Code	Description
J2941	Injection, somatropin, 1 mg

Clinical

Clinical Trials

1189 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	22	45	62	27	94	239
Pituitary dwarfism	D004393	EFO_1001109	E23.0	12	34	50	25	63	177
Breast neoplasms	D001943	EFO_0003869	C50	40	76	28	4	38	171
Endocrine system diseases	D004700	EFO_0001379	E34.9	2	11	29	6	23	68
Dwarfism	D004392	—	E34.31	2	14	12	8	29	60
Acromegaly	D000172	—	—	1	7	10	7	24	49
Turner syndrome	D014424	Orphanet_881	Q96	1	7	10	9	18	45
Syndrome	D013577	—	—	1	5	11	6	24	44
Infertility	D007246	EFO_0000545	—	5	10	4	9	19	42
Obesity	D009765	EFO_0001073	E66.9	6	7	2	3	20	36

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Growth disorders	D006130	—	—	4	4	10	—	30	47
Prostatic neoplasms	D011471	—	C61	11	22	4	—	—	28
Triple negative breast neoplasms	D064726	—	—	8	14	2	—	1	21
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	1	9	4	—	3	14
Lymphoma	D008223	—	C85.9	2	7	2	—	1	11
Noonan syndrome	D009634	Orphanet_648	Q87.19	—	1	6	—	3	10
Diabetes mellitus	D003920	EFO_0000400	E08-E13	3	1	1	—	3	8
Fibrosis	D005355	—	—	—	4	4	—	3	8
Cystic fibrosis	D003550	EFO_0000390	E84	1	3	2	—	3	8
Carcinoma	D002277	—	C80.0	1	3	3	—	1	7

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	4	3	—	—	3	10
Aging	D000375	GO_0007568	R41.81	2	5	—	—	4	10
Non-small-cell lung carcinoma	D002289	—	—	5	5	—	—	2	9
Ovarian neoplasms	D010051	EFO_0003893	C56	6	3	—	—	—	7
Liver diseases	D008107	EFO_0001421	K70-K77	—	1	—	—	5	6
Metabolic diseases	D008659	EFO_0000589	E88.9	—	1	—	—	5	6
Central nervous system neoplasms	D016543	—	—	1	2	—	—	2	5
Osteoarthritis	D010003	EFO_0002506	M15-M19	1	1	—	—	3	5
Hiv	D006678	—	O98.7	1	1	—	—	3	5
Medulloblastoma	D008527	—	—	2	2	—	—	1	4

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Lung neoplasms	D008175	—	C34.90	2	—	—	—	2	4
Sarcoma	D012509	—	—	2	—	—	—	1	3
Prediabetic state	D011236	EFO_1001121	R73.03	3	—	—	—	—	3
Hyperinsulinism	D006946	—	E16.1	3	—	—	—	—	3
Leiomyoma	D007889	—	D25	1	—	—	—	1	2
Myofibroma	D047708	—	—	1	—	—	—	1	2
Nervous system neoplasms	D009423	—	—	1	—	—	—	1	2
Hepatocellular carcinoma	D006528	—	C22.0	1	—	—	—	1	2
Liver neoplasms	D008113	EFO_1001513	C22.0	1	—	—	—	1	2
Adrenal insufficiency	D000309	—	—	1	—	—	—	1	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inflammation	D007249	MP_0001845	—	—	—	—	—	6	6
Tissue adhesions	D000267	—	—	—	—	—	—	3	3
Pre-eclampsia	D011225	EFO_0000668	O14	—	—	—	—	2	2
Assisted reproductive techniques	D027724	—	—	—	—	—	—	2	2
Dental caries	D003731	EFO_0003819	K02	—	—	—	—	2	2
Endometriosis	D004715	EFO_0001065	N80	—	—	—	—	2	2
Gestational diabetes	D016640	—	O24.4	—	—	—	—	2	2
Cardiomyopathies	D009202	EFO_0000318	I42	—	—	—	—	2	2
Pseudopseudohypoparathyroidism	D011556	—	—	—	—	—	—	2	2
Pseudohypoparathyroidism	D011547	—	E20.1	—	—	—	—	2	2

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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)	—