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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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, Nutropin, 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
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

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Labels

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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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
heart failure	HP_0001635	D006333	I50
prader-willi syndrome	Orphanet_739	D011218	Q87.11
cachexia	HP_0004326	D002100	R64
turner syndrome	Orphanet_881	D014424	Q96
noonan syndrome	Orphanet_648	D009634	Q87.19
dwarfism	HP_0003510	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

2089 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101	—	C90.0	159	327	144	10	16	571
Plasma cell neoplasms	D054219	—	—	154	316	138	10	15	550
Laron syndrome	D046150	Orphanet_633	E34.321	17	42	59	27	90	226
Breast neoplasms	D001943	EFO_0003869	C50	46	95	29	4	37	191
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	27	97
Syndrome	D013577	—	—	7	23	21	15	31	89
Dwarfism	D004392	HP_0003510	E34.31	3	15	17	14	37	83
Lymphoma	D008223	—	C85.9	28	48	13	1	2	76
Macular edema	D008269	—	—	4	16	22	18	9	64

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Prostatic neoplasms	D011471	—	C61	18	40	5	—	—	52
Colorectal neoplasms	D015179	—	—	11	30	11	—	2	49
Growth disorders	D006130	—	—	4	4	10	—	30	47
B-cell lymphoma	D016393	—	—	16	27	5	—	—	38
Large b-cell lymphoma diffuse	D016403	—	C83.3	12	24	5	—	—	34
Plasmacytoma	D010954	—	C90.3	7	22	6	—	—	32
Recurrence	D012008	—	—	10	19	2	—	2	31
Amyloidosis	D000686	EFO_1001875	E85	8	23	1	—	2	28
Carcinoma	D002277	—	C80.0	9	12	5	—	1	23
Triple negative breast neoplasms	D064726	—	—	4	14	1	—	1	19

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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	—	—	15	23
Non-hodgkin lymphoma	D008228	—	C85.9	14	14	—	—	—	20
Immunoglobulin light-chain amyloidosis	D000075363	—	—	5	16	—	—	2	20
Rectal neoplasms	D012004	—	—	4	7	—	—	2	12
Ovarian neoplasms	D010051	EFO_0003893	C56	7	6	—	—	—	11
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	5	9	—	—	—	10
Non-alcoholic fatty liver disease	D065626	EFO_0003095	K75.81	4	3	—	—	3	10
Aging	D000375	GO_0007568	R41.81	2	6	—	—	3	10
Primary myelofibrosis	D055728	—	D47.4	1	7	—	—	—	8
Hematologic diseases	D006402	EFO_0005803	D75.9	4	5	—	—	2	8

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Endometriosis	D004715	EFO_0001065	N80	1	—	—	—	2	3
Overweight	D050177	—	E66.3	1	—	—	—	2	3
Pancreatic ductal carcinoma	D021441	—	—	3	—	—	—	—	3
Prediabetic state	D011236	EFO_1001121	R73.03	3	—	—	—	—	3
Anemia	D000740	HP_0001903	D64.9	1	—	—	—	1	2
T-cell lymphoma cutaneous	D016410	—	—	2	—	—	—	—	2
Headache	D006261	HP_0002315	R51	1	—	—	—	1	2
Disease	D004194	EFO_0000408	R69	1	—	—	—	1	2
Hepatocellular carcinoma	D006528	—	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	—	—	—	—	—	7	7
Metabolic diseases	D008659	EFO_0000589	E88.9	—	—	—	—	4	4
Pre-eclampsia	D011225	EFO_0000668	O14	—	—	—	—	3	3
Central serous chorioretinopathy	D056833	—	H35.71	—	—	—	—	2	2
Eclampsia	D004461	HP_0100601	O15	—	—	—	—	2	2
Tissue adhesions	D000267	—	—	—	—	—	—	2	2
Gestational diabetes	D016640	HP_0009800	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)	—