Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Genotropin · 3 trials · 3 indications
This was defined as an absolute difference between the 24-month height standard deviation score (SDS) and targeted 24-month height SDS (10th percentile (%), or -1.3 SDS). SDS indicates how similar the participant was to the reference population. These were calculated using 2000 Center for the Disease Control (CDC) growth reference tables (by age and gender).
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
| Arm | Type | Description |
|---|---|---|
| Standard | ACTIVE_COMPARATOR | Standard daily HGH treatment |
| Formula-based | ACTIVE_COMPARATOR | Formula-based dose regimen |
| Sequence 1 | EXPERIMENTAL | Single dose of 4 milligrams (mg) subcutaneous genotropin via marketed genotropin pen 12 (Reference) followed by single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) |
| Sequence 2 | EXPERIMENTAL | Single dose of 4mg subcutaneous genotropin via new genotropin injector pen (Test) followed by single dose of 4mg subcutaneous genotropin via marketed genotropin pen 12 (Reference) |
| Name | Type | Description |
|---|---|---|
| Genotropin | DRUG | Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period. |
| Marketed Genotropin Pen 12 | DEVICE | Growth Hormone Delivery Device for use with Somatropin for injection |
| New Genotropin Injector Pen | DEVICE | Growth Hormone Delivery Device for use with Somatropin for injection |
| Genotropin 4mg | DRUG | 4mg subcutaneous |
Inclusion Criteria: * Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females * Naive to Growth Hormone treatment Exclusion Criteria: * Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | Somapacitan |
| Ascendis Pharma A/S | ASND | 1 | PHASE3 | Lonapegsomatropin, Somatropin Pen Injector |
Genotropin is used for growth disorders, growth hormone deficiency, and idiopathic short stature. It is an endocrine therapy being developed by Pfizer, Inc. for conditions related to growth in children. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.
Genotropin is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in treating growth-related conditions.
Genotropin is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Pfizer has completed multiple Phase 3 trials studying its use in children with growth hormone deficiency and idiopathic short stature.
Genotropin has been studied in several completed clinical trials. NCT00396097 evaluated individualized treatment in 316 children with idiopathic short stature. NCT00965484 assessed an injection pen in 136 patients with growth hormone deficiency or idiopathic short stature. NCT03831880 compared treatment burden in 87 children with growth hormone deficiency.
Genotropin is a brand name for somatropin, which is a recombinant human growth hormone. In clinical trials, it is referred to as Genotropin (somatropin), indicating that somatropin is the active ingredient. The drug is being studied for its effects on growth in children with various growth disorders.