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Drug ReportsMecasermin rinfabate
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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Financial
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Events Timeline
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6M
YTD
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5Y
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Events
FDA approval date
EMA approval date
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Study first post date
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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 Application2024-03-20
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
250 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AcromegalyD0001723861128
Laron syndromeD046150Orphanet_633E34.3212744418
DwarfismD004392HP_0003510E34.311422411
Pituitary dwarfismD004393EFO_1001109E23.0143411
Failure to thriveD005183112126
Cognitive dysfunctionD060825HP_0001268G31.84145
Heart failureD006333HP_0001635I5012125
Wounds and injuriesD014947T14.81135
Endocrine system diseasesD004700EFO_0001379E34.921115
Chronic kidney failureD007676EFO_0003884N18.9224
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Indications Phases 3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8053310
OsteoporosisD010024HP_0000939M81.01134
SarcomaD012509224
Insulin resistanceD007333HP_00008552214
Rectal neoplasmsD01200433
Healthy volunteers/patients123
Liver neoplasmsD008113EFO_1001513C22.0213
Chromosome disordersD025063EFO_0003831Q99.933
Chromosome deletionD00287233
Retinopathy of prematurityD012178EFO_1001158H35.133
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E84213
Colorectal neoplasmsD015179112
AgingD000375GO_0007568R41.81112
LipodystrophyD008060HP_0009125E88.1112
GliomaD005910EFO_000052011
Brain stem neoplasmsD020295EFO_100176711
PinealomaD01087111
Squamous cell carcinoma of head and neckD00007719511
Joint instabilityD00759311
TendinopathyD052256EFO_1001434M77.911
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Indications Without Phase
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)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL1201717
ChEBI ID
PubChem CID
DrugBank
UNII IDNZ8M50KKRG (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,031 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,669 adverse events reported
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