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.
Background
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
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2011/03/14 | Not Applicable | Withdrawn | |||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 | ||
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 |