Overview
Mecasermin contains recombinant-DNA-engineered human insulin-like growth factor-1 (rhIGF-1). IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.
Indication
For the long-term treatment of growth failure in pediatric patients with Primary IGFD or with GH gene deletion who have developed neutralizing antibodies to GH . It is not indicated to treat Secondary IGFD resulting from GH deficiency, malnutrition, hypothyroidism or other causes; it is not a substitute for GH therapy.
Associated Conditions
- Primary Insulin-like Growth Factor-1 Deficiency
Research Report
A Comprehensive Monograph on Mecasermin (rhIGF-1): Pharmacology, Clinical Utility, and Safety Profile
Introduction and Drug Profile
Overview of Mecasermin
Mecasermin is a highly purified, biosynthetic form of human insulin-like growth factor-1 (IGF-1), produced through recombinant DNA technology.[1] It is classified pharmacologically as a somatotropin agonist and belongs to the therapeutic class of insulin-like growth factors.[2] Marketed globally under the brand name Increlex, mecasermin has also been identified by other names in research and development contexts, including Myotrophin, FK-780, and Somatomedin-1.[1]
The primary and approved therapeutic application of mecasermin is as a replacement therapy for endogenous IGF-1. It is indicated for the long-term treatment of growth failure in pediatric patients with severe primary IGF-1 deficiency (SPIGFD).[1][ This specific and narrowly defined condition is characterized by an inability to produce sufficient IGF-1 despite normal or elevated levels of growth hormone (GH), rendering GH therapy ineffective. Mecasermin directly addresses this downstream defect, providing the essential mediator for statural growth.]
Physicochemical and Structural Properties
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/04/30 | Early Phase 1 | Recruiting | |||
2015/12/21 | Phase 1 | Completed | |||
2013/10/28 | Phase 2 | Terminated | |||
2012/04/30 | Not Applicable | Completed | Peter Bang | ||
2011/10/05 | Not Applicable | Completed | |||
2011/09/21 | Phase 1 | Completed | |||
2011/04/06 | Phase 1 | Terminated | |||
2011/03/14 | Not Applicable | Withdrawn | |||
2010/09/23 | Phase 1 | Completed | |||
2009/05/15 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ipsen Biopharmaceuticals, Inc. | 15054-1040 | SUBCUTANEOUS | 40 mg in 4 mL | 3/20/2024 | |
| Eton Pharmaceuticals, Inc. | 71863-216 | SUBCUTANEOUS | 40 mg in 4 mL | 5/7/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/2/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| INCRELEX mecasermin 10 mg/mL solution for injection vial | 308494 | Medicine | A | 11/22/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| INCRELEX | ipsen biopharmaceuticals canada inc | 02509733 | Solution - Subcutaneous | 40 MG / 4 ML | 3/1/2021 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| INCRELEX 10 mg/ml SOLUCION INYECTABLE | 07402001 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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