Mecasermin
Somatropin and Somatropin Agonists
Sold as GUNA-IGF · INCRELEX
- Drug class
- Somatropin and Somatropin Agonists
- Availability
- Over-the-counter
- Routes
- Oral, Subcutaneous
- Markets covered
- 4
- Products on record
- 4
- FDA reports (12 mo)
- 44
Overview
Mecasermin is an active pharmaceutical ingredient in the Somatropin and Somatropin Agonists group (H01AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | November 15, 2022 |
| CA Canada | Health Canada | 1 | June 1, 2026 |
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
| EU European Union | EMA | 1 | March 30, 2026 |
USUnited States· FDA
1 product
Uses
INDICATIONS & USAGE
Neuroendocrine Support
How to take
CACanada· Health Canada
1 product
Uses
Increlex® (mecasermin) is indicated for the treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (SPIGFD). 5th percentile for age and gender and; • GH sufficiency.
• Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. SPIGFD can include patients with mutations in the GH receptor (GHR) gene/Laron’s syndrome, post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
1 Pediatrics Pediatrics (2-18 years): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Increlex in pediatric patients has been established; therefore, Health Canada has authorized an indication for pediatric use.
GBUnited Kingdom· MHRA
1 product
Uses
For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (Primary IGFD). 5th percentile for age and gender and • GH sufficiency.
• Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
EUEuropean Union· EMA
1 product
Uses
For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (Primary IGFD). 5th percentile for age and gender and • GH sufficiency.
• Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
Drug interactions
Known interactions involving Mecasermin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 06e9b066-8118-47… · revised November 15, 2022 [PDF]
- [2]Health Canada (DPD) · 02509733 · revised June 1, 2026
- [3]MHRA (UK) · PL084980041 · revised May 15, 2026
- [4]European Medicines Agency · EMEA/H/C/000704 · revised March 30, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.