At a glance
FDA approval FDA-approved 2 applications
Randomized controlled trials 17 of 315 publications on PubMed
Registered clinical trials 40 5 active
Adverse event reports 821 440 classified as serious
- Mecasermin (recombinant IGF-1) is an FDA-approved drug, marketed as Increlex (first approval: August 30, 2005).
- PubMed lists 315 publications mentioning it, including 17 randomized controlled trials and 48 animal-only studies.
- ClinicalTrials.gov lists 40 registered studies testing it (5 active).
- FDA's adverse event system (FAERS) holds 821 reports mentioning it; 440 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
| BLA021839 | INCRELEX | Approved, marketed | August 30, 2005 | IPSEN INC |
| BLA021884 | IPLEX | Approved, discontinued | December 12, 2005 | INSMED |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
- All publications 315
- Human (MeSH) 224
- Animal only 48
- Clinical trials 21
- Randomized controlled trials 17
- Systematic reviews & meta-analyses 3
- Case reports 25
- Retracted 1
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 40
- Active
- 5
- With posted results
- 22
| Study | Status | Phase | Start |
| Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities NCT06915428 University of North Carolina, Chapel Hill | Not yet recruiting | N/A | October 1, 2026 |
| Biomarkers of Response to SEEG Thermocoagulation NCT07399327 Assistance Publique Hopitaux De Marseille | Recruiting | N/A | June 19, 2026 |
| Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis NCT06602869 University Hospital, Montpellier | Recruiting | — | September 17, 2024 |
| A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants NCT03253263 OHB Neonatology Ltd. | Active, not recruiting | Phase 2 | May 9, 2019 |
| Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD). NCT00903110 Esteve Pharmaceuticals, S.A. | Recruiting | — | December 9, 2008 |
| User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate). NCT06526637 Imperial College London | Completed | N/A | September 26, 2024 |
| Gender Differences in Renal Functioning and Disease NCT04085094 Centre Hospitalier Universitaire Vaudois | Completed | — | May 30, 2017 |
| A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS NCT02847481 Beth Israel Deaconess Medical Center | Completed | Phase 1 | May 2016 |
| IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency NCT02636270 Children's Hospital Medical Center, Cincinnati Results posted | Completed | Phase 1, Phase 2 | December 21, 2015 |
| Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP) NCT02386839 Shire Results posted | Completed | Phase 2 | March 26, 2015 |
Show 30 more studies
| Study | Status | Phase | Start |
| A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder NCT01970345 Icahn School of Medicine at Mount Sinai Results posted | Terminated | Phase 2 | May 2014 |
| Treatment of Rett Syndrome With Recombinant Human IGF-1 NCT01777542 Boston Children's Hospital Results posted | Completed | Phase 2 | Jan 2013 |
| Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome) NCT01525901 Icahn School of Medicine at Mount Sinai Results posted | Completed | Phase 2 | Feb 2012 |
| IGF-1 and Bone Loss in Women With Anorexia Nervosa NCT01406444 Massachusetts General Hospital Results posted | Completed | N/A | Oct 2011 |
| Evaluation of the Safety and Efficacy of Using Insulin-like Growth Factor-1 in Patients With a Heart Attack NCT01438086 University College Cork | Completed | Phase 1, Phase 2 | Oct 2011 |
| IGF-I Stimulation of Collagen Synthesis in Ehlers-Danlos Patients NCT01446783 Bispebjerg Hospital | Completed | N/A | Sep 2011 |
| Effects of IGF-I in HIV Metabolic Disease NCT01329744 University of Texas Southwestern Medical Center | Terminated | Phase 1 | Jun 2011 |
| Increlex Treatment of Children With Chronic Liver Disease and Short Stature NCT01314508 University of California, Los Angeles | Withdrawn | N/A | Jun 2011 |
| IGF-I Induced Muscle Glucose Uptake and Interstitial IGF-I Concentrations NCT01588093 Peter Bang | Completed | N/A | Apr 2011 |
| Effects of Anorexia Nervosa on Peak Bone Mass NCT01301183 Massachusetts General Hospital Results posted | Completed | Phase 3 | Feb 2011 |
| Treatment of Rett Syndrome With rhIGF-1 (Mecasermin [rDNA]Injection) NCT01253317 Boston Children's Hospital Results posted | Completed | Phase 1 | Dec 2010 |
| Safety and Efficacy Study of IGF-1 in Duchenne Muscular Dystrophy NCT01207908 Children's Hospital Medical Center, Cincinnati Results posted | Completed | Phase 1, Phase 2 | Nov 2010 |
| IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity NCT01096784 Shire Results posted | Completed | Phase 2 | June 18, 2010 |
| Metabolic Effects of GH and IGF-I in Growth Hormone Deficient(GHD) and Diabetes and Impaired Glucose Tolerance(IGT) NCT01020955 Karolinska University Hospital | Completed | Phase 3 | Oct 2009 |
| Growth Hormone Feedback to Insulin-like Growth Factor-I (IGF-1) and Oral Glucose Tolerance Test (OGTT) NCT00915954 Cedars-Sinai Medical Center Results posted | Completed | N/A | Dec 2008 |
| Effect of Increlex® on Children With Crohn Disease NCT00764699 Nationwide Children's Hospital Results posted | Terminated | Phase 2, Phase 3 | Oct 2008 |
| Effects of rhIGF-1 on Bone Metabolism in Adolescent Girls With Anorexia Nervosa NCT00720122 Massachusetts General Hospital Results posted | Completed | Phase 2 | Jul 2008 |
| IGF-1 Therapy in Patients With Cystic Fibrosis NCT00566241 Stony Brook University | Terminated | Phase 1 | Jun 2008 |
| Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors NCT00684957 Columbia University Results posted | Terminated | Phase 1, Phase 2 | Jan 2008 |
| rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency NCT00572156 Ipsen Results posted | Terminated | Phase 2 | Dec 2007 |
| Treatment for Growth Failure in Patients With X-Linked Severe Combined Immunodeficiency: Phase 2 Study of Insulin-Like Growth Factor-1 NCT00490100 National Institute of Allergy and Infectious Diseases (NIAID) Results posted | Terminated | Phase 1, Phase 2 | Jun 2007 |
| Safety Profile of Insulin Like Growth Factor-1 (IGF-I) Administration in Adolescents NCT00516386 Massachusetts General Hospital Results posted | Completed | Phase 1, Phase 2 | Mar 2007 |
| IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex NCT00747604 Ipsen | Terminated | — | Jun 2006 |
| Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency NCT00330668 Ipsen Results posted | Terminated | Phase 3 | Nov 2005 |
| Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency NCT00125190 Ipsen Results posted | Completed | Phase 2, Phase 3 | Jul 2005 |
| Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency NCT00125164 Ipsen Results posted | Completed | Phase 3 | Mar 2004 |
| Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial NCT00035815 Mayo Clinic Results posted | Completed | Phase 3 | Jun 2003 |
| A 48-Week (24-Week Baseline Followed by a 24-Week Treatment) Phase II Pilot Study of the Tolerability and Effect/Efficacy of Subcutaneously Administered Insulin-Like Growth Factor-1 (rhIGF) (CEP-151) in Multiple Sclerosis (MS) Patients NCT00001669 National Institute of Neurological Disorders and Stroke (NINDS) | Completed | Phase 2 | Jul 1997 |
| Long-Term Treatment With rhIGF-1 in GHIS NCT00571727 Ipsen Results posted | Completed | Phase 2, Phase 3 | May 20, 1991 |
| Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome NCT00351221 Insmed Incorporated | Terminated | Phase 2 | — |
All 40 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 821
- Serious
- 440
- With death outcome
- 24
Most reported reactions
- Off label use 132
- Headache 68
- Hypoglycaemia 62
- Vomiting 44
- Injection site pain 41
- Drug dose omission 40
- Blood glucose decreased 36
- Pyrexia 36
- Tonsillar hypertrophy 36
- Fatigue 34
- Product dose omission issue 30
- Decreased appetite 27
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Increlex HUMAN PRESCRIPTION DRUG Eton Pharmaceuticals, Inc. May 18, 2026
- Increlex HUMAN PRESCRIPTION DRUG Ipsen Biopharmaceuticals, Inc. August 5, 2025
- GUNA-IGF HUMAN OTC DRUG Guna spa November 15, 2022
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.