Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Genotonorm (Somatropin)
Genotonorm · 2 trials · 3 indications
Percentage of children with serum IGF-1 \> 2 SD (compared to a child of the same gender and age and without growth hormone (GH) deficiency) 9 months and 12 months after initiation of GH treatment. 9 months and 12 months are combined.
Annual growth rate was expressed as height velocity (centimeter \[cm\]/year). This was derived by substracting annual growth rate at Baseline from 2-year value. (Annual growth rate was calculated each year and rescaled to 1 year if the interval between x and x-1 was not 365 days, as long as a subject remains in the study): ANGRYx = (Height Yx - Height Y{x-1}) / {(Date of Yx - Date of Y{x-1}) /365.25}
| Arm | Type | Description |
|---|---|---|
| Genotonorm (Somatropin) | EXPERIMENTAL | - |
| Genotonorm A | ACTIVE_COMPARATOR | Continuous 0.7 IU/kg/week or 0.03 mg/kg/day |
| Genotonorm B | ACTIVE_COMPARATOR | Continuous, 1.4 IU/kg/week or 0.06 mg/kg/day |
| Genotonorm C | ACTIVE_COMPARATOR | Intermittent, 1.4 IU/kg/week or 0.06 mg/kg/day |
| Name | Type | Description |
|---|---|---|
| Genotonorm (Somatropin) | DRUG | 0.40 mg/kg/week dived in 7 daily subcutaneous injections during 2 years |
| Genotonorm | DRUG | 0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection |
Inclusion Criteria: * Chronological age between 4 and 9 years for a boy and 4 and 7 years for a girl. * Measured Height \< -2.5 Standard Deviation Exclusion Criteria: * Pubertal signs ie: testis volume \> or = 4 ml in boys and breast stage \> or = B2 (Tanner) * Serious chronic disease (diabetes, ...
Genotonorm is used to treat growth disorders and fetal growth retardation, including intrauterine growth retardation in short prepubertal children. It is studied in pediatric patients with growth retardation, with trial participants as young as 3 to 4 years old. The clinical program focuses on improving height in children born small or light for gestational age.
Genotonorm is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company responsible for the clinical development of Genotonorm in the growth disorder and fetal growth retardation indications.
Genotonorm is in Phase 3 clinical development. It is investigational and has not been approved by the FDA for these indications. The Phase 3 program includes completed trials evaluating Genotonorm in children with growth retardation, with a combined enrollment of 208 participants across the reported studies.
Genotonorm has been studied in Phase 3 trials including NCT01073605, titled Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation, which enrolled 208 participants in France, and NCT00174252, a Phase 3 study aimed at improving height in children born little or light with growth retardation. Both trials are completed.
Yes, Genotonorm is also known as Genotonorm (Somatropin). Somatropin is the active ingredient name, and Genotonorm is the brand name used for this product. People searching for Genotonorm somatropin are looking at the same therapy developed by Pfizer for growth disorders and fetal growth retardation.
The Genotonorm Phase 3 program enrolled 208 participants in NCT01073605, the trial in short prepubertal children with intra-uterine growth retardation conducted in France, and 57 participants in NCT00174252, the study in children with fetal growth retardation. Both trials are completed.