Mecasermin - PharmaKB

Increlex(mecasermin)

Increlex (mecasermin) is a protein pharmaceutical. Mecasermin was first approved as Increlex on 2005-08-30. It has been approved in Europe to treat laron syndrome. The pharmaceutical is active against insulin-like growth factor 1; insulin-like growth factor I. In addition, it is known to target insulin-like growth factor 1 receptor.

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
musculoskeletal diseases	D009140
hereditary congenital and neonatal diseases and abnormalities	D009358
endocrine system diseases	D004700

Trade Name

FDA

EMA

Increlex

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Mecasermin

Tradename	Proper name	Company	Number	Date	Products
Increlex	mecasermin	Eton Pharmaceuticals	N-21839 RX	2005-08-30	1 products

Labels

FDA

EMA

Brand Name	Status	Last Update
aqua de folli hair booster	unapproved drug other	2020-10-05
aqua de folli hair booster mini	unapproved drug other	2020-10-05
aqua de folli hair booster pro	unapproved drug other	2020-10-05
hucord hscm-100 ampoule	unapproved drug other	2019-12-23
increlex	Biologic Licensing Application	2025-07-23

Indications

FDA

EMA

No data

Agency Specific

FDA

EMA

Expiration	Code
mecasermin, Increlex, Ipsen Biopharmaceuticals, Inc.
2112-08-30	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

— H01AC03: Mecasermin

— H01AC05: Mecasermin rinfabate

HCPCS

Code	Description
J2170	Injection, mecasermin, 1 mg

Clinical

Clinical Trials

326 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Acromegaly	D000172	—	—	—	4	10	6	13	33
Laron syndrome	D046150	Orphanet_633	E34.321	2	6	3	4	5	18
Dwarfism	D004392	—	E34.31	1	5	2	2	6	14
Pituitary dwarfism	D004393	EFO_1001109	E23.0	1	4	—	3	4	11
Heart failure	D006333	EFO_0003144	I50	1	2	—	1	3	6
Failure to thrive	D005183	—	—	1	1	2	1	2	6
Cognitive dysfunction	D060825	—	G31.84	—	—	—	1	4	5
Wounds and injuries	D014947	—	T14.8	—	1	—	1	3	5
Endocrine system diseases	D004700	EFO_0001379	E34.9	—	2	1	1	1	5
Chronic kidney failure	D007676	EFO_0003884	N18.6	—	—	—	2	2	4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	5	6	1	—	5	13
Carcinoma	D002277	—	C80.0	3	8	2	—	1	12
Syndrome	D013577	—	—	2	7	2	—	3	12
Obesity	D009765	EFO_0001073	E66.9	—	2	1	—	9	11
Graves ophthalmopathy	D049970	EFO_1001466	—	—	1	7	—	3	11
Eye diseases	D005128	EFO_0003966	H44	—	1	7	—	3	11
Thyroid diseases	D013959	—	E00-E07	—	1	7	—	2	10
Anorexia	D000855	—	R63.0	2	4	3	—	2	8
Anorexia nervosa	D000856	EFO_0004215	F50.0	2	4	3	—	2	8
Covid-19	D000086382	—	U07.1	1	4	2	—	1	8

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369	—	C80	10	5	—	—	3	16
Sarcoma	D012509	—	—	1	5	—	—	2	7
Colorectal neoplasms	D015179	—	—	2	3	—	—	1	5
Hepatocellular carcinoma	D006528	—	C22.0	2	2	—	—	2	5
Liver neoplasms	D008113	EFO_1001513	C22.0	1	3	—	—	2	5
Ovarian neoplasms	D010051	EFO_0003893	C56	3	4	—	—	—	5
Squamous cell carcinoma of head and neck	D000077195	—	—	2	3	—	—	—	4
Pancreatic neoplasms	D010190	EFO_0003860	C25	2	4	—	—	—	4
Osteoporosis	D010024	EFO_0003882	M81.0	1	1	—	—	3	4
Insulin resistance	D007333	EFO_0002614	E88.819	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
Glioma	D005910	EFO_0000520	—	3	—	—	—	—	3
Cystic fibrosis	D003550	EFO_0000390	E84	2	—	—	—	1	3
Aging	D000375	GO_0007568	R41.81	1	—	—	—	2	3
Brain neoplasms	D001932	EFO_0003833	C71	1	—	—	—	1	2
Tendinopathy	D052256	EFO_1001434	M77.9	1	—	—	—	1	2
Metabolic diseases	D008659	EFO_0000589	E88.9	1	—	—	—	1	2
Lipodystrophy	D008060	—	E88.1	1	—	—	—	1	2
Gastrointestinal neoplasms	D005770	—	C26.9	1	—	—	—	—	1
Urogenital neoplasms	D014565	EFO_0003863	D07	1	—	—	—	—	1
Female genital neoplasms	D005833	—	—	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Metabolic bone diseases	D001851	—	—	—	—	—	—	3	3
Igg deficiency	D017099	—	D80.3	—	—	—	—	3	3
Alzheimer disease	D000544	EFO_0000249	F03	—	—	—	—	2	2
Dementia	D003704	EFO_0003862	F03	—	—	—	—	2	2
Bone fractures	D050723	EFO_0003931	T14.8	—	—	—	—	2	2
Graves disease	D006111	EFO_0004237	E05.0	—	—	—	—	2	2
Alopecia areata	D000506	EFO_0004192	L63	—	—	—	—	2	2
Alopecia	D000505	—	L64	—	—	—	—	2	2
Schizophrenia	D012559	EFO_0000692	F20	—	—	—	—	2	2
Stroke	D020521	EFO_0000712	I63.9	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Mecasermin
INN	mecasermin
Description	Mecasermin (INN) (brand name Increlex), also known as recombinant human insulin-like growth factor-1 (rhIGF-1), is a recombinant form of human insulin-like growth factor 1 (IGF-I) which is used in the long-term treatment of growth failure and short stature in children with severe primary IGF-I deficiency, for instance due to growth hormone deficiency or Laron syndrome (growth hormone insensitivity).
Classification	Protein
Drug class	growth factors: insulin-like growth factors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	—