IGF-1
Recombinant human Insulin-like Growth Factor-1 (rhIGF-1, Mecasermin). Marketed as INCRELEX. FDA-approved strictly for severe primary IGF-1 deficiency (Laron syndrome) and GH gene deletion with neutralizing antibodies. Crucially distinct from unapproved research variants such as IGF-1 LR3 and IGF-1 DES, which have modified IGFBP binding and no approved human indications. Banned in sports by WADA (S2).
60-Second Scientific Briefing
Mecasermin (Increlex) is an FDA-approved recombinant human insulin-like growth factor-1 (rhIGF-1) indicated specifically for severe primary IGF-1 deficiency (IGFD) or growth hormone gene deletion in pediatric patients. It is NOT identical to unregulated research analogues such as IGF-1 LR3 or IGF-1 DES, which are unapproved.
What is IGF-1?
Pharmacological Classification & Molecular IdentityRecombinant human insulin-like growth factor-1 produced by recombinant DNA technology in E. coli, identical in amino acid sequence to native human IGF-1.
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Binds the IGF-1 receptor (IGF-1R), a receptor tyrosine kinase, stimulating intracellular Akt/mTOR signaling to promote systemic protein synthesis, chondrocyte proliferation, and bone elongation.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsFDA Approved under NDA 021839 (Increlex) strictly for treatment of growth failure in pediatric patients with severe primary IGFD or GH gene deletion. NOT approved for adults, athletic use, or anti-aging.
IGF-1 has received regulatory approval for specific medical indications. Commercial distribution and medical usage require appropriate prescription and adherence to approved labeling.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesClinical trials demonstrated sustained increases in height velocity in children with severe primary IGFD refractory to growth hormone therapy.
Clinical Evidence
Clinical trials demonstrated sustained increases in height velocity in children with severe primary IGFD refractory to growth hormone therapy.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesSevere hypoglycemia (most common, requires glucose monitoring and dietary carbohydrates), lymphoid tissue hypertrophy (tonsillar hypertrophy), intracranial hypertension, and slipped capital femoral epiphysis.
Mitogenic and tumor promotion risks associated with unmonitored supra-physiological IGF-1 exposure in adult non-deficient populations.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesFDA-approved pediatric dose: 0.04 to 0.08 mg/kg twice daily by subcutaneous injection, titrated up to a maximum of 0.12 mg/kg twice daily, given shortly before or after meals.
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Recombinant human insulin-like growth factor-1 produced by recombinant DNA technology in E. coli, identical in amino acid sequence to native human IGF-1.
- Targets & Selectivity: Binds the IGF-1 receptor (IGF-1R), a receptor tyrosine kinase, stimulating intracellular Akt/mTOR signaling to promote systemic protein synthesis, chondrocyte proliferation, and bone elongation.
- Clinical trials demonstrated sustained increases in height velocity in children with severe primary IGFD refractory to growth hormone therapy.
- Safety considerations: Severe hypoglycemia (most common, requires glucose monitoring and dietary carbohydrates), lymphoid tissue hypertrophy (tonsillar hypertrophy), intracranial hypertension, and slipped capital femoral epiphysis.
? Unknown / Under Ongoing Investigation
- Mitogenic and tumor promotion risks associated with unmonitored supra-physiological IGF-1 exposure in adult non-deficient populations.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysIGF-1 is classified as a Human Insulin-Like Growth Factor-1 Agonist. Molecular structure: Recombinant human insulin-like growth factor-1 produced by recombinant DNA technology in E. coli, identical in amino acid sequence to native human IGF-1..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
IGF-1 exerts biological activity via Binds the IGF-1 receptor (IGF-1R), a receptor tyrosine kinase, stimulating intracellular Akt/mTOR signaling to promote systemic protein synthesis, chondrocyte proliferation, and bone elongation..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
Regulatory status: FDA Approved under NDA 021839 (Increlex) strictly for treatment of growth failure in pediatric patients with severe primary IGFD or GH gene deletion. NOT approved for adults, athletic use, or anti-aging.
Prescription use requires a verified medical diagnosis and adherence to approved labeling.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
Clinical evaluation status: Clinical trials demonstrated sustained increases in height velocity in children with severe primary IGFD refractory to growth hormone therapy.
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
- Near-Adult Height Outcomes in Patients Treated With rhIGF-1 for Severe Growth Failure: Real-World IGFD Registry Data (The Journal of Clinical Endocrinology & Metabolism, 2026-01-21)
Reported safety profile: Severe hypoglycemia (most common, requires glucose monitoring and dietary carbohydrates), lymphoid tissue hypertrophy (tonsillar hypertrophy), intracranial hypertension, and slipped capital femoral epiphysis.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
Key scientific uncertainties: Mitogenic and tumor promotion risks associated with unmonitored supra-physiological IGF-1 exposure in adult non-deficient populations.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
FDA-approved pediatric dose: 0.04 to 0.08 mg/kg twice daily by subcutaneous injection, titrated up to a maximum of 0.12 mg/kg twice daily, given shortly before or after meals.
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
Storage status: Store multi-dose vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from direct light. Stable for 30 days after initial puncture.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
Athletic status depends on WADA category classification; peptide hormones, growth factor mimetics, and related substances are prohibited under WADA Section S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
- FDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling (U.S. Food and Drug Administration, 2005-08-30)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesFDA Drugs@FDA Database: INCRELEX (Mecasermin [rDNA origin] Injection) Approval History and Labeling ↗
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021839
Near-Adult Height Outcomes in Patients Treated With rhIGF-1 for Severe Growth Failure: Real-World IGFD Registry Data ↗
https://doi.org/10.1210/clinem/dgaf390