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Label indication NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and… FDA label
Also known as Norditropin
somatropin · 22 trials · 17 indications
Height SDS was calculated using the formula: SDS = (height - mean)/SD, where height was the height variable measured, mean and SD of height by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height and negative SDS indicated lesser height than the mean of the reference population. The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline height SDS as a covariate. Positive value in change from baseline indicated that SDS was better than baseline SDS. Missing values were imputed using the last observation carried forward (LOCF) method.
Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
| Arm | Type | Description |
|---|---|---|
| 0.033 mg/kg/day | EXPERIMENTAL | - |
| 0.066 mg/kg/day | EXPERIMENTAL | - |
| hGH:12months treatment | EXPERIMENTAL | - |
| hGH: 6 month un-treatment + 6 month treatment | ACTIVE_COMPARATOR | - |
| Low dose 33 mcg/kg/day | EXPERIMENTAL | - |
| High dose 66 mcg/kg/day | EXPERIMENTAL | - |
| 0.033 mg / NN-220 | EXPERIMENTAL | In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| 0.067 mg / NN-220 | EXPERIMENTAL | In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime |
| No treatment | NO_INTERVENTION | No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period |
| No treatment --> 0.033 mg | EXPERIMENTAL | In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| No treatment --> 0.067 mg | EXPERIMENTAL | In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period |
| Lyophilized | ACTIVE_COMPARATOR | - |
| Liquid | EXPERIMENTAL | - |
| Somatropin | EXPERIMENTAL | - |
| Low dose | EXPERIMENTAL | - |
| High dose | EXPERIMENTAL | - |
| Norditropin® | EXPERIMENTAL | - |
| Genotropin® | ACTIVE_COMPARATOR | - |
| ESRD patients | EXPERIMENTAL | - |
| Healthy subjects | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| somatropin | DRUG | Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks. |
| placebo | DRUG | - |
Inclusion Criteria: * Japanese children with Noonan syndrome clinically diagnosed in one of the following ways: 1. Clinically diagnosed by at least two medical experts using van der Burgt score list, 2. Clinically diagnosed by one medical expert using van der Burgt score list and diagnosed by resul...
Somatropin is a growth hormone receptor agonist developed by Novo Nordisk A/S. It is being studied in growth-related and musculoskeletal conditions, including growth hormone deficiency, idiopathic short stature, Noonan syndrome, Turner syndrome, chronic kidney disease, bone fracture, and fetal growth problems. It is an investigational therapy in Phase 2 development.
Somatropin targets the growth hormone receptor, also known as GHR. It acts as a GHR agonist, meaning it activates this receptor to stimulate growth hormone signaling. This receptor-level activity underlies its investigation in conditions characterized by impaired growth or growth hormone deficiency.
Somatropin is developed by Novo Nordisk A/S, which trades under the ticker NVO. The company has sponsored clinical research of somatropin across multiple growth-related indications, including studies conducted in Japan, South Korea, Israel, and Sweden.
Somatropin is in Phase 2 development and is investigational. It has not been established as approved based on the available development information. Nine clinical trials have been completed, with no active trials currently listed, and total enrollment across those completed studies was 1,134 participants.
Completed somatropin trials include NCT01927861, a Phase 3 study of two doses in short stature due to Noonan syndrome in Japan, and NCT01778023, a Phase 3 study in idiopathic short stature in South Korea. NCT01563926 evaluated a new liquid formulation in children with growth hormone deficiency, and NCT01529944 was an extension study in Noonan syndrome subjects in Sweden.
Somatropin has been studied for growth disorders including growth hormone deficiency in children, idiopathic short stature, Noonan syndrome, and Turner syndrome. Trials have assessed height velocity, long-term efficacy and safety, and acceptance of a new liquid formulation in pediatric patients with these growth-related conditions.