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Increlex
Increlex, marketed by Children's Hospital Medical Center, Cincinnati, is the only approved treatment for Laron-type isolated somatotropin defect. The drug holds a unique position in this niche market, with a key composition patent expiring in 2028, providing a strong barrier to entry. The primary risk lies in the limited patient population, which may constrain revenue growth.
At a glance
| Generic name | Increlex |
|---|---|
| Also known as | rhIGF-1 |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Target | Insulin receptor, Insulin-like growth factor 1 receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Laron-type isolated somatotropin defect
Common side effects
- Hypoglycemia
- Tonsillar hypertrophy
- AST elevation
- LDH elevation
- Renal length increase
- Splenic length increase
- Cholesterol elevation
- Triglyceride elevation
- ALT elevation
- Soft tissue thickening of face
- Cardiomegaly/valvulopathy
Serious adverse events
- Hypoglycemic seizures/loss of consciousness
- Severe hypoglycemia
- Intracranial hypertension
- Anaphylaxis
- Angioedema
- Generalized urticaria
- Dyspnea
- Obstructive sleep apnea
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)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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
- Children's Hospital Medical Center, Cincinnati portfolio CI