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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Study first post date
Last update post date
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Completion date
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Commercial
Therapeutic Areas
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 | 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 | 2025-08-05 |
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
329 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 | 1 | 1 | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dwarfism | D004392 | — | E34.31 | — | 1 | 2 | — | 1 | 3 |
| Growth disorders | D006130 | — | — | — | 1 | 3 | — | — | 3 |
| Failure to thrive | D005183 | — | — | — | — | 3 | — | — | 3 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | 1 | 2 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | 1 | 1 | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | — | 1 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | 1 | — | — | 1 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 1 | 1 | — | — | — | 1 |
| Delayed puberty | D011628 | — | E30.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | — | 1 | 1 |
| Apnea | D001049 | — | R06.81 | — | — | — | — | 1 | 1 |
| Igg deficiency | D017099 | — | D80.3 | — | — | — | — | 1 | 1 |
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 | — |
| RxCUI | — |
| 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)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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€
£
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Increlex – Eton Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,272 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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932 adverse events reported
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