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Iplex, Increlex(mecasermin rinfabate)
Increlex, Iplex (mecasermin rinfabate) is a protein pharmaceutical. Mecasermin rinfabate was first approved as Iplex on 2005-12-12. It has been approved in Europe to treat laron syndrome.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
hereditary congenital and neonatal diseases and abnormalitiesD009358
endocrine system diseasesD004700
Trade Name
FDA
EMA
No data
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 rinfabate
Tradename
Proper name
Company
Number
Date
Products
Iplexmecasermin rinfabateInsmedN-21884 DISCN2005-12-12
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
increlexBiologic Licensing Application2020-05-07
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
mecasermin rinfabate, Iplex, Insmed Incorporated
2112-12-12Orphan 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
— H01AC05: Mecasermin rinfabate
HCPCS
No data
Clinical
Clinical Trials
2 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471C6111———2
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMECASERMIN RINFABATE
INNmecasermin rinfabate
Description
Mecasermin rinfabate (INN, USAN) (brand name Iplex), also known as rhIGF-1/rhIGFBP-3, is a drug consisting of recombinant human insulin-like growth factor 1 (IGF-1) and recombinant human insulin-like growth factor binding protein-3 (IGFBP-3) which is used for the treatment of amyotrophic lateral sclerosis (Lou Gehrig's disease).
Classification
Protein
Drug classgrowth factors: insulin-like growth factors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1201717
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDNZ8M50KKRG (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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