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 I. In addition, it is known to target insulin-like growth factor 1 receptor.
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Commercial
Trade Name
FDA
EMA
Increlex
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)
Mecasermin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Increlex | mecasermin | Ipsen Biopharmaceuticals, Inc. | N-21839 RX | 2005-08-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| increlex | Biologic Licensing Application | 2020-05-07 |
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
HCPCS
Code | Description |
|---|---|
| J2170 | Injection, mecasermin, 1 mg |
Clinical
Clinical Trials
49 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 | — | — | — | 1 | 1 | 2 | ||
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Growth disorders | D006130 | — | 1 | 3 | — | — | 3 | ||
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | 1 | 1 | — | 1 | 2 |
| Burns | D002056 | T30.0 | — | 1 | 1 | — | — | 1 | |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | — | 1 | — | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | — | 3 |
| Hyperinsulinism | D006946 | HP_0000842 | E16.1 | — | 1 | — | — | 2 | 3 |
| X-linked combined immunodeficiency diseases | D053632 | EFO_1001451 | 1 | 1 | — | — | — | 1 | |
| Autism spectrum disorder | D000067877 | F84.0 | — | 1 | — | — | — | 1 | |
| 22q11 deletion syndrome | D058165 | Orphanet_567 | D82.1 | — | 1 | — | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 1 | — | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | 1 | 1 | — | — | — | 1 |
| Duchenne muscular dystrophy | D020388 | 1 | 1 | — | — | — | 1 | ||
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 1 | |
| Myotonic dystrophy | D009223 | G71.11 | 1 | 1 | — | — | — | 1 |
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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 | 2 | — | — | — | — | 2 | |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | C80 | 1 | — | — | — | — | 1 | |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | 1 | — | — | — | — | 1 |
| Hiv-associated lipodystrophy syndrome | D039682 | EFO_1001348 | 1 | — | — | — | — | 1 | |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Igg deficiency | D017099 | D80.3 | — | — | — | — | 2 | 2 | |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | — | 1 | 1 |
| Osteoporotic fractures | D058866 | — | — | — | — | 1 | 1 | ||
| Graves ophthalmopathy | D049970 | EFO_1001466 | — | — | — | — | 1 | 1 | |
| Autoimmune thyroiditis | D013967 | EFO_0006812 | E06.3 | — | — | — | — | 1 | 1 |
| Graves disease | D006111 | EFO_0004237 | E05.0 | — | — | — | — | 1 | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | — | 1 | 1 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Ehlers-danlos syndrome | D004535 | Orphanet_98249 | Q79.6 | — | — | — | — | 1 | 1 |
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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) | — |
Identifiers
| PDB | — |
| CAS-ID | 68562-41-4 |
| RxCUI | 274403 |
| ChEMBL ID | CHEMBL1201716 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01277 |
| UNII ID | 7GR9I2683O (ChemIDplus, GSRS) |
Target
Agency Approved
IGF1
IGF1
Organism
Homo sapiens
Gene name
IGF1
Gene synonyms
IBP1
NCBI Gene ID
Protein name
insulin-like growth factor I
Protein synonyms
insulin-like growth factor 1 (somatomedin C), insulin-like growth factor IB, Mechano growth factor, MGF, Somatomedin-C
Uniprot ID
Mouse ortholog
Igf1 (16000)
insulin-like growth factor I (Q8C4U6)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 353 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,124 adverse events reported
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