Mecasermin
updated
Mecasermin is prescription human IGF-1 replacement for children with severe primary IGF-1 deficiency. In the main long-term program, mean growth velocity rose from 2.8 to 8.0 cm per year in year one, then slowed as the observed cohort became smaller. The trials did not test adult height, muscle gain, or IGF-1 LR3.
Recombinant human insulin-like growth factor 1
- Increlex contains native-sequence recombinant human IGF-1
- The US indication starts at age 2 and requires severe primary IGF-1 deficiency or a specific GH-antibody setting
- Hypoglycemia is the central immediate treatment risk
What does severe primary IGF-1 deficiency actually require?
The current US label defines severe primary IGF-1 deficiency with all three of these findings: height standard-deviation score at or below -3.0, basal IGF-1 standard-deviation score at or below -3.0, and normal or elevated growth hormone. The indication is for growth failure in children age 2 or older who meet that definition, or who have a growth-hormone gene deletion and neutralizing antibodies to GH.
A low IGF-1 result alone is not this diagnosis. The label says Increlex is not a substitute for growth hormone and excludes secondary IGF-1 deficiency caused by GH deficiency, malnutrition, hypothyroidism, or chronic pharmacologic anti-inflammatory corticosteroids. The workup matters because the correct treatment depends on why growth and IGF-1 are low.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceIs mecasermin the same thing as IGF-1 LR3, rinfabate, or growth hormone?
No. Mecasermin is recombinant human IGF-1 with the native 70-amino-acid human sequence. Increlex is the preserved 10 mg/mL subcutaneous mecasermin product. Mecasermin rinfabate is a separate complex of recombinant IGF-1 with recombinant IGF-binding protein 3. IGF-1 LR3 is an engineered analog, and growth hormone is a different upstream hormone.
| Name | What the source establishes | Can it inherit Increlex evidence? |
|---|---|---|
| Mecasermin / Increlex | Native-sequence recombinant human IGF-1 in the labeled injection | Yes, when population and product match |
| Mecasermin rinfabate | A distinct IGF-1 and IGFBP-3 complex in FDA substance records | No |
| IGF-1 LR3 | A separately named engineered analog; it is not the Increlex ingredient | No |
| Growth hormone | An upstream pituitary hormone; Increlex is not a GH substitute | No |
FDA substance registration establishes identity, not approval or clinical benefit. The cited Increlex sources do not establish product quality, pharmacokinetics, safety, or efficacy for a vial sold as IGF-1 LR3.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceFDA SRS · mecasermin identity
Official substance identity record
US Food and Drug Administration Substance Registration System. Mecasermin, UNII 7GR9I2683O.
Identifies mecasermin as the recombinant human IGF-1 substance and provides its UNII and identity record.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Regulatory substance registry
Substance registration does not establish approval, clinical efficacy, or product quality.
Read the original sourceFDA SRS · rinfabate identity
Official substance identity record
US Food and Drug Administration Substance Registration System. Mecasermin rinfabate, UNII NZ8M50KKRG.
Identifies mecasermin rinfabate as a distinct complex containing recombinant IGF-1 and recombinant IGFBP-3.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Regulatory substance registry
This identity record does not describe IGF-1 LR3 and does not establish current approval status or outcomes.
Read the original sourceHow did growth velocity change after the first year?
Among 58 treatment-naive children with a pretreatment measurement in the current label analysis, mean height velocity rose from 2.8 cm per year before treatment to 8.0 in year one. It then averaged 5.8 in year two, 5.5 in year three, and roughly 4.3 to 4.8 from years four through eight. The number contributing data fell from 58 in year one to 13 in year eight.
| Period | Mean height velocity | Children with paired data |
|---|---|---|
| Pretreatment | 2.8 cm/year | 58 |
| Year 1 | 8.0 cm/year | 58 |
| Year 2 | 5.8 cm/year | 48 |
| Year 3 | 5.5 cm/year | 38 |
| Year 4 | 4.7 cm/year | 23 |
| Year 5 | 4.7 cm/year | 21 |
| Year 6 | 4.8 cm/year | 20 |
| Year 7 | 4.6 cm/year | 16 |
| Year 8 | 4.3 cm/year | 13 |
Each year is a same-child comparison with that child's pretreatment velocity. Later rows are survivor data from progressively smaller groups, not follow-up on all 58.
The supporting publication followed 76 children for as long as 12 years under a predominantly open-label design. It found the same 2.8-to-8.0 first-year change and reported that later velocities stayed above baseline for up to eight years. There was no concurrent untreated group for most of this evidence, so maturation, selection, changing exposure, and attrition remain part of the interpretation.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceChernausek cohort · up to 12 years
Predominantly open-label long-term clinical study
Chernausek SD et al. Journal of Clinical Endocrinology and Metabolism. 2007;92(3):902-910. doi:10.1210/jc.2006-1610. PMID: 17192294.
In 76 severely IGF-1-deficient children with GH insensitivity, mean height velocity rose from 2.8 to 8.0 cm/year in year one and remained above baseline for up to eight years; hypoglycemia, injection-site lipohypertrophy, and tonsillar or adenoidal hypertrophy were common.
- Participants / model
- 76 children older than 2 years with severe IGF-1 deficiency and evidence of GH resistance
- Treatment
- Subcutaneous recombinant human IGF-1
- Follow-up
- Up to 12 years; mean treatment duration reported elsewhere as about 4.4 years
- Study design
- Predominantly open-label, multicenter, uncontrolled long-term treatment study
- Funding
- Collaborative sponsor program
The publication's eligibility threshold was broader than the current US label definition, and the lack of a concurrent control plus attrition limits causal and long-term comparisons.
Read the original sourceNCT00571727 · long-term program
Clinical trial registry results record
ClinicalTrials.gov. NCT00571727. Long-Term Treatment With rhIGF-1 in GHIS.
Reports annualized height velocity through as long as 12 years and long-term treatment-emergent adverse-event collection in the integrated mecasermin program.
- Participants / model
- Children in the severe IGF-1 deficiency and GH-insensitivity clinical program
- Treatment
- Subcutaneous mecasermin
- Follow-up
- Annual growth outcomes up to 12 years; adverse-event collection across the longer program
- Study design
- Registry results for a single-group long-term program
- Funding
- Ipsen
The registry entry has no concurrent control. Enrollment and analysis denominators vary by endpoint and year.
Read the original sourceDoes the first-year velocity prove normal adult height?
No. Height velocity is a rate during a measured year, not final adult height. The label's mean height SDS improved from -6.7 at baseline to -5.9 after year one and remained about -5.2 at year eight among those still represented. That is meaningful catch-up growth in an extremely short cohort, but it is not evidence that every child reaches average adult height.
Closed epiphyses are a contraindication. Once growth plates have closed, the pediatric linear-growth rationale no longer applies. The studies also do not answer adult bodybuilding, recovery, or anti-aging questions.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceChernausek cohort · up to 12 years
Predominantly open-label long-term clinical study
Chernausek SD et al. Journal of Clinical Endocrinology and Metabolism. 2007;92(3):902-910. doi:10.1210/jc.2006-1610. PMID: 17192294.
In 76 severely IGF-1-deficient children with GH insensitivity, mean height velocity rose from 2.8 to 8.0 cm/year in year one and remained above baseline for up to eight years; hypoglycemia, injection-site lipohypertrophy, and tonsillar or adenoidal hypertrophy were common.
- Participants / model
- 76 children older than 2 years with severe IGF-1 deficiency and evidence of GH resistance
- Treatment
- Subcutaneous recombinant human IGF-1
- Follow-up
- Up to 12 years; mean treatment duration reported elsewhere as about 4.4 years
- Study design
- Predominantly open-label, multicenter, uncontrolled long-term treatment study
- Funding
- Collaborative sponsor program
The publication's eligibility threshold was broader than the current US label definition, and the lack of a concurrent control plus attrition limits causal and long-term comparisons.
Read the original sourceWhat did the European registry add beyond the original cohort?
The European Increlex Growth Forum Database followed 242 treated children and adolescents enrolled across ten countries from 2008 through 2017. In the treatment-naive prepubertal non-Laron subgroup, 56% met the registry's responder definition of at least a 0.3 increase in height SDS during year one. Younger baseline age predicted response.
The Laron subgroup had 21 children and gained a mean 0.70 height SDS in year one; non-Laron responders gained 0.64. These are observational subgroup results, not randomized estimates. Diagnosis, age, missing follow-up, and treatment selection can change who appears in each comparison. Treatment-emergent adverse events occurred in 65.3% overall, with hypoglycemia most common.
EIGFD registry · 242 treated patients
Prospective observational registry
Bang P et al. Hormone Research in Paediatrics. 2021;93(9-10):531-545. doi:10.1159/000512200. PMID: 33434161.
Among 242 treated children and adolescents from ten European countries, 65.3% reported treatment-emergent adverse events. In the treatment-naive prepubertal non-Laron group, 56% met the study's year-one height-SDS response definition, and younger age predicted response.
- Participants / model
- 242 treated children and adolescents enrolled in ten European countries from 2008 through 2017; prespecified Laron and non-Laron subgroups
- Treatment
- Mecasermin in clinical practice
- Follow-up
- Growth and adverse-event assessments through five years
- Study design
- Open-label observational registry with subgroup and multivariable analyses
- Funding
- Ipsen-sponsored registry; sponsor-affiliated authors
Responder categories were defined after observed height-SDS change and are descriptive. The registry cannot estimate a randomized treatment effect.
Read the original sourceHow large was the hypoglycemia problem in the studied setting?
In the 71-child pooled label safety set, 30 children, or 42%, reported hypoglycemia. Five had severe episodes and four had hypoglycemic seizures or loss of consciousness. Fourteen of the 30 had experienced hypoglycemia before treatment, which matters because severe primary IGF-1 deficiency itself can lower glucose.
Events were most frequent during the first month and in younger children. The label ties every dose to food within about 20 minutes, says to skip it when the child cannot eat, and calls for glucose monitoring at treatment start until a tolerated regimen is established. Insulin or other diabetes medicines can require adjustment because their glucose-lowering effects can overlap.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceChernausek cohort · up to 12 years
Predominantly open-label long-term clinical study
Chernausek SD et al. Journal of Clinical Endocrinology and Metabolism. 2007;92(3):902-910. doi:10.1210/jc.2006-1610. PMID: 17192294.
In 76 severely IGF-1-deficient children with GH insensitivity, mean height velocity rose from 2.8 to 8.0 cm/year in year one and remained above baseline for up to eight years; hypoglycemia, injection-site lipohypertrophy, and tonsillar or adenoidal hypertrophy were common.
- Participants / model
- 76 children older than 2 years with severe IGF-1 deficiency and evidence of GH resistance
- Treatment
- Subcutaneous recombinant human IGF-1
- Follow-up
- Up to 12 years; mean treatment duration reported elsewhere as about 4.4 years
- Study design
- Predominantly open-label, multicenter, uncontrolled long-term treatment study
- Funding
- Collaborative sponsor program
The publication's eligibility threshold was broader than the current US label definition, and the lack of a concurrent control plus attrition limits causal and long-term comparisons.
Read the original sourceWhat does the neoplasia warning establish, and what remains unknown?
Active or suspected malignant neoplasia is a contraindication. The label also describes postmarketing malignant-neoplasia reports in children and adolescents, often in people with predisposing conditions or with exposure above recommended limits or IGF-1 above the age-normal range. It says the relationship to mecasermin is unknown.
In a two-year rat study, adrenal-medullary hyperplasia and pheochromocytoma increased at some exposures below the maximum recommended human exposure; skin and mammary tumors appeared only above the maximum tolerated dose where hypoglycemia caused excess mortality. Animal tumors and spontaneous human reports justify the warning, but they do not calculate a human incidence rate or prove causality.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceWhich product and pharmacokinetic facts should stay narrow?
The label describes Increlex as a preserved 10 mg/mL subcutaneous solution. Its reported 5.8-hour terminal half-life came from only three children with severe primary IGF-1 deficiency after a specified 0.12 mg/kg exposure. That tiny disease-specific pharmacokinetic observation should not be transferred to LR3, rinfabate, an unverified vial, or a different route.
The vial contains benzyl alcohol, so the label warns against use in neonates and infants because large cumulative exposures have caused fatal gasping syndrome. Hypersensitivity including anaphylaxis is also reported. Product concentration, preservative, sterility, and identity therefore matter; a label for Increlex cannot validate a compounded or research-market product.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceWhy can one pathway increase growth and also lower glucose?
IGF-1 receptor activation supports cell growth and growth-plate activity. It also increases peripheral glucose uptake and suppresses hepatic glucose output. In a severely IGF-1-deficient child, replacing that missing signal can accelerate linear growth; the glucose actions explain why meals, monitoring, and hypoglycemia planning sit at the center of treatment.
Mechanistic plausibility does not establish a useful muscle, longevity, or recovery outcome in adults with normal physiology. It also cannot bridge evidence from native recombinant IGF-1 to a modified analog.
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceStudies and sources
Increlex label · severe primary IGF-1 deficiency
FDA prescribing information
Ipsen Biopharmaceuticals. INCRELEX (mecasermin) injection prescribing information. Revised October 2025; DailyMed updated May 18, 2026.
Defines the diagnosis and age boundary, product, supervised dose-with-food safeguards, contraindications, pooled growth trajectory, hypoglycemia counts, growth-related risks, neoplasia language, mechanism, and limited pharmacokinetic sample.
- Participants / model
- Pediatric patients age 2 years and older with growth failure from severe primary IGF-1 deficiency or GH-gene deletion with neutralizing GH antibodies
- Treatment
- Increlex 10 mg/mL subcutaneous mecasermin
- Follow-up
- Label program includes yearly growth observations through eight years and 274 subject-years of pooled safety exposure
- Study design
- Regulatory prescribing information summarizing five studies, four open-label and one double-blind placebo-controlled
- Funding
- Sponsor regulatory program
The label pool contains only 71 subjects and later annual denominators are small. Product and indication facts do not transfer to LR3 or rinfabate.
Read the original sourceChernausek cohort · up to 12 years
Predominantly open-label long-term clinical study
Chernausek SD et al. Journal of Clinical Endocrinology and Metabolism. 2007;92(3):902-910. doi:10.1210/jc.2006-1610. PMID: 17192294.
In 76 severely IGF-1-deficient children with GH insensitivity, mean height velocity rose from 2.8 to 8.0 cm/year in year one and remained above baseline for up to eight years; hypoglycemia, injection-site lipohypertrophy, and tonsillar or adenoidal hypertrophy were common.
- Participants / model
- 76 children older than 2 years with severe IGF-1 deficiency and evidence of GH resistance
- Treatment
- Subcutaneous recombinant human IGF-1
- Follow-up
- Up to 12 years; mean treatment duration reported elsewhere as about 4.4 years
- Study design
- Predominantly open-label, multicenter, uncontrolled long-term treatment study
- Funding
- Collaborative sponsor program
The publication's eligibility threshold was broader than the current US label definition, and the lack of a concurrent control plus attrition limits causal and long-term comparisons.
Read the original sourceNCT00571727 · long-term program
Clinical trial registry results record
ClinicalTrials.gov. NCT00571727. Long-Term Treatment With rhIGF-1 in GHIS.
Reports annualized height velocity through as long as 12 years and long-term treatment-emergent adverse-event collection in the integrated mecasermin program.
- Participants / model
- Children in the severe IGF-1 deficiency and GH-insensitivity clinical program
- Treatment
- Subcutaneous mecasermin
- Follow-up
- Annual growth outcomes up to 12 years; adverse-event collection across the longer program
- Study design
- Registry results for a single-group long-term program
- Funding
- Ipsen
The registry entry has no concurrent control. Enrollment and analysis denominators vary by endpoint and year.
Read the original sourceEIGFD registry · 242 treated patients
Prospective observational registry
Bang P et al. Hormone Research in Paediatrics. 2021;93(9-10):531-545. doi:10.1159/000512200. PMID: 33434161.
Among 242 treated children and adolescents from ten European countries, 65.3% reported treatment-emergent adverse events. In the treatment-naive prepubertal non-Laron group, 56% met the study's year-one height-SDS response definition, and younger age predicted response.
- Participants / model
- 242 treated children and adolescents enrolled in ten European countries from 2008 through 2017; prespecified Laron and non-Laron subgroups
- Treatment
- Mecasermin in clinical practice
- Follow-up
- Growth and adverse-event assessments through five years
- Study design
- Open-label observational registry with subgroup and multivariable analyses
- Funding
- Ipsen-sponsored registry; sponsor-affiliated authors
Responder categories were defined after observed height-SDS change and are descriptive. The registry cannot estimate a randomized treatment effect.
Read the original sourceFDA SRS · mecasermin identity
Official substance identity record
US Food and Drug Administration Substance Registration System. Mecasermin, UNII 7GR9I2683O.
Identifies mecasermin as the recombinant human IGF-1 substance and provides its UNII and identity record.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Regulatory substance registry
Substance registration does not establish approval, clinical efficacy, or product quality.
Read the original sourceFDA SRS · rinfabate identity
Official substance identity record
US Food and Drug Administration Substance Registration System. Mecasermin rinfabate, UNII NZ8M50KKRG.
Identifies mecasermin rinfabate as a distinct complex containing recombinant IGF-1 and recombinant IGFBP-3.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Regulatory substance registry
This identity record does not describe IGF-1 LR3 and does not establish current approval status or outcomes.
Read the original sourceWhy is Mecasermin in S tier?
S reflects an approved replacement medicine with long-term growth data in children with severe primary IGF-1 deficiency. The studies do not cover ordinary short stature, closed growth plates, bodybuilding, IGF-1 LR3, or mecasermin rinfabate.
read Mecasermin in the reptides guide, chapter 17: 10 pages, free to read.