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Increlex (MECASERMIN)
Increlex works by mimicking the action of insulin-like growth factor 1 (IGF-1) to stimulate growth in individuals with Laron syndrome.
Increlex (Mecasermin) is a small molecule drug developed by Ipsen Inc, targeting the insulin-like growth factor 1 receptor. It was FDA-approved in 2005 for the treatment of Laron-type isolated somatotropin deficiency. As a commercial product, Increlex remains under patent ownership of Ipsen Inc. Key safety considerations include potential risks of hypoglycemia and fluid retention. The drug's precise pharmacokinetic properties, such as half-life and bioavailability, are not well-documented.
At a glance
| Generic name | MECASERMIN |
|---|---|
| Sponsor | Ipsen Inc |
| Target | Insulin-like growth factor 1 receptor |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2005 |
Mechanism of action
Insulin-like growth factor-1 (IGF-1) is key hormonal mediator on statural growth. Under normal circumstances, growth hormone (GH) binds to its receptor in the liver, and other tissues, and stimulates the synthesis/secretion of IGF-1. In target tissues, the Type IGF-1 receptor, which is homologous to the insulin receptor, is activated by IGF-1, leading to intracellular signaling which stimulates multiple processes resulting in statural growth. The metabolic actions of IGF-1 are in part directed at stimulating the uptake of glucose, fatty acids, and amino acids so that metabolism supports growing tissues.
Approved indications
- Laron-type isolated somatotropin defect
Common side effects
- Hypoglycemia
- Tonsillar hypertrophy
- Otitis media
- Snoring
- Headache
- Dizziness
- Convulsions
- Vomiting
- Hypoacusis
- Fluid in middle ear
- Ear pain
- Abnormal tympanometry
Key clinical trials
- User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate). (NA)
- Biomarkers of Response to SEEG Thermocoagulation (NA)
- 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).
- Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities (NA)
- A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants (PHASE2)
- Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis
- IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency (PHASE1,PHASE2)
- A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Increlex CI brief — competitive landscape report
- Increlex updates RSS · CI watch RSS
- Ipsen Inc portfolio CI