Recombinant IGF-1 protein medicine · Fact sheet
Mecasermin
Also known as Increlex · Recombinant human IGF-1
Mecasermin is recombinant human IGF-1 approved as Increlex for defined pediatric growth-failure disorders. It is different from IGF-1 LR3 and DES; its approval and schedule do not validate experimental analogs or bodybuilding.
What is Mecasermin?
The medicine replaces IGF-1 in selected severe deficiency settings. It is not a substitute for growth hormone in ordinary approved GH indications.
Sequence, formulation and binding-protein interactions matter when comparing native IGF-1 with modified research analogs.
Benefits & claims
Interest centers on growth signaling, but correction of severe pediatric deficiency is a narrow medical use.
What the evidence supports
- Growth outcomes in severe deficiency support the approved treatment context.
- The controlled Rett-syndrome trial found no overall improvement and some measures worsened. It does not support a general neuroprotective indication.
- Native IGF-1 evidence cannot establish the pharmacology or safety of LR3 or DES analogs.
Research areas
- Severe primary IGF-1 deficiency
- GH-gene deletion with neutralizing antibodies
- Investigational Rett syndrome
Dosage & frequency
Product-specific label informationThe Increlex pediatric deficiency label provides a specialist titration reference, not an enhancement regimen.
Increlex mecasermin injection
Children aged at least two with the label-defined severe IGF-1-deficiency or GH-gene-deletion disorder
- Amount
- Starting 0.04–0.08 mg/kg per administration; label maximum 0.12 mg/kg per administration
- Frequency
- Twice daily; increases of 0.04 mg/kg per dose only after at least a week of tolerability
- Route studied or labeled
- Subcutaneous prescription treatment
The label requires individualized supervision, glucose monitoring and administration within 20 minutes of a meal or snack; omitted food changes administration eligibility. This partial reference omits full contraindication and monitoring details and specifies no fixed duration.
How to read these amounts
An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.
Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences
Formulations, interactions & practical context
- Identity and pharmacology
- The medicine replaces IGF-1 in selected severe deficiency settings. It is not a substitute for growth hormone in ordinary approved GH indications.
Formulation differences
- Sequence, formulation and binding-protein interactions matter when comparing native IGF-1 with modified research analogs.
Interactions & precautions
- The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.
What is still unresolved
- Outcomes outside the defined deficiency conditions
- Long-term safety in unapproved populations
- Equivalence of experimental IGF-1 analogs
Side effects & risks
- Severe hypoglycemia, including seizures, can occur; the label links administration to food intake and glucose monitoring.
- Hypersensitivity, intracranial hypertension, lymphoid-tissue growth, orthopedic complications and malignant-neoplasia concerns are material label warnings.
- It is contraindicated with closed growth plates or malignant neoplasia, and is not indicated for children younger than two.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research
Moderate human evidenceThe label supports the defined growth-failure use. Exploratory Rett-syndrome studies were a different indication, and the controlled crossover study did not establish overall efficacy.
Studies
Early mecasermin Rett-syndrome study; separate indication.
Controlled crossover Rett study; did not establish overall benefit.
Personal experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.
No attributable personal accounts were found in the sources reviewed.
Approval status
Increlex is approved for growth failure in children aged at least two with severe primary IGF-1 deficiency, or GH-gene deletion with neutralizing GH antibodies. It is not approved for athletic enhancement or general anti-aging.
Approved uses
- Increlex for label-defined growth failure in children aged at least two with severe primary IGF-1 deficiency or GH-gene deletion with neutralizing antibodies.
FDA approved for a specific product and use
Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.
Open questions
- Outcomes outside the defined deficiency conditions
- Long-term safety in unapproved populations
- Equivalence of experimental IGF-1 analogs
Summary
Native IGF-1 evidence cannot establish the pharmacology or safety of LR3 or DES analogs.
Sources
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- nihIncrelex prescribing information
Current mecasermin indication, age limit, titration, hypoglycemia, neoplasia and other warnings.
- pubmedSafety, pharmacokinetics, and preliminary assessment of efficacy of mecasermin (recombinant human IGF-1) for the treatment of Rett syndrome.
Early mecasermin Rett-syndrome study; separate indication.
- pubmedPlacebo-controlled crossover assessment of mecasermin for the treatment of Rett syndrome.
Controlled crossover Rett study; did not establish overall benefit.