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
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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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| increlex | Biologic Licensing Application | 2024-03-20 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
mecasermin rinfabate, Iplex, Insmed Incorporated | |||
| 2112-12-12 | Orphan excl. | ||
Patent Expiration
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HCPCS
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Acromegaly | D000172 | — | — | — | 1 | 1 | 1 | 1 | 4 |
| Dwarfism | D004392 | HP_0003510 | E34.31 | — | 2 | 2 | 1 | — | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Growth disorders | D006130 | — | — | — | 1 | 3 | — | — | 3 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | 1 | 2 |
| Failure to thrive | D005183 | — | — | — | — | 2 | — | — | 2 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | 1 | 1 | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | 1 | — | — | 1 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | 1 | — | — | 1 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | — | — | 1 | — | — | 1 |
| Gonadal dysgenesis | D006059 | — | — | — | — | 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 |
| Muscular dystrophies | D009136 | HP_0003560 | G71.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep apnea syndromes | D012891 | HP_0010535 | G47.3 | — | — | — | — | 1 | 1 |
| Apnea | D001049 | HP_0002104 | R06.81 | — | — | — | — | 1 | 1 |
| Igg deficiency | D017099 | HP_0004315 | D80.3 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Mecasermin rinfabate |
| INN | mecasermin 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).
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| 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 | CHEMBL1201717 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | NZ8M50KKRG (ChemIDplus, GSRS) |
Target
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Safety
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Adverse Events
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1,686 adverse events reported
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