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rhGH (Norditropine SimpleXx®)
Recombinant human growth hormone (rhGH) binds to growth hormone receptors on target cells to stimulate growth, metabolism, and protein synthesis.
Recombinant human growth hormone (rhGH) binds to growth hormone receptors on target cells to stimulate growth, metabolism, and protein synthesis. Used for Growth hormone deficiency in children, Growth hormone deficiency in adults, Short stature in children born small for gestational age.
At a glance
| Generic name | rhGH (Norditropine SimpleXx®) |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Growth hormone |
| Target | Growth hormone receptor (GHR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
rhGH activates the growth hormone receptor, a transmembrane receptor that triggers intracellular signaling cascades promoting anabolic effects including increased protein synthesis, lipolysis, and insulin-like growth factor-1 (IGF-1) production. This leads to increased linear growth in children, enhanced muscle mass, reduced fat mass, and improved metabolic function in both pediatric and adult populations.
Approved indications
- Growth hormone deficiency in children
- Growth hormone deficiency in adults
- Short stature in children born small for gestational age
- Turner syndrome
- Chronic kidney disease-related growth failure
Common side effects
- Injection site reactions
- Headache
- Hyperglycemia
- Carpal tunnel syndrome
- Fluid retention
- Arthralgia
Key clinical trials
- Study of Growth-promoting and Metabolic Effects of Growth Hormone (rhGH) (PHASE4)
- Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone (PHASE2, PHASE3)
- A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency (PHASE1)
- Liquid Somatropin Formulation in Children With Growth Hormone Deficiency (PHASE4)
- Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx® (PHASE1)
- Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis (PHASE1)
- Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures (PHASE2)
- Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency (PHASE3)
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:
- rhGH (Norditropine SimpleXx®) CI brief — competitive landscape report
- rhGH (Norditropine SimpleXx®) updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI