Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Genotropin Somatropin · 1 trial · 1 indication
Height SDS was calculated at the relevant visit by means of the following formula: Height SDS = (participant height) - (normal height)/normal height standard deviation. Where participant height refers to the participant's height at the relevant visit, and normal height and the normal height standard deviation equals the population mean and standard deviation values for participants of a similar age and gender. The change from Baseline value for height SDS was calculated as the difference between the parameter values at a specific visit, and the Baseline parameter values. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | The active treatment arm |
| Control | EXPERIMENTAL | Control |
| Name | Type | Description |
|---|---|---|
| Genotropin (PN-180,307) Somatropin | DRUG | Injectable Genotropin |
| Control-no treatment | DRUG | Control-no treatment |
Inclusion Criteria: Caucasian male or female subjects aged between 19-29 months at Screening Visit 1. Born SGA (birth length and/or weight \<-2 SD for gestational age, using country-specific standards). Height below -2.5 SD at screening (19-29 months of age). At least one measurement of length be...
Genotropin Somatropin is a small molecule developed by Pfizer, Inc. (PFE) for the treatment of infants born small for gestational age. It is also known as Genotropin (PN-180,307) Somatropin. The drug has been studied in a Phase 3 clinical trial and is intended for use in very young children.
Genotropin Somatropin is used for the treatment of infants born small for gestational age. This condition refers to babies who are smaller than expected for the number of weeks of pregnancy. The drug is being developed by Pfizer, Inc. (PFE) and has been evaluated in a Phase 3 trial in this indication.
Genotropin Somatropin is made by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the developer responsible for the clinical development of this drug for infants born small for gestational age.
Genotropin Somatropin is in Phase 3 clinical development. The only trial listed for this drug is a completed Phase 3 study. It is an investigational therapy and has not been approved by the FDA for the studied indication.
Genotropin Somatropin has been studied in one completed Phase 3 clinical trial, NCT00627523, titled "Genotropin Treatment In Very Young Children Born Small For Gestational Age." The trial enrolled 43 participants across Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, Sweden, and Switzerland.
Yes, Genotropin Somatropin is also known as Genotropin (PN-180,307) Somatropin. These names refer to the same drug candidate developed by Pfizer, Inc. (PFE) for infants born small for gestational age.