Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 for growth disorders and fetal growth retardation, specifically in children born small or light with growth retardation. It is being studied to improve height in these children. The drug is currently in Phase 3 clinical development.
Genotonorm is developed by Pfizer, Inc., a company listed on the 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.
Genotonorm is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Clinical trials are ongoing to assess its effectiveness in improving height in children with growth retardation.
Genotonorm has been studied in two Phase 3 clinical trials. One trial, NCT00174252, enrolled 57 children with fetal growth retardation in France. Another trial, NCT01073605, enrolled 208 children with growth disorders and intrauterine growth retardation, also in France. Both trials are completed.
Genotonorm is associated with Genotropin, as one clinical trial is titled 'Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation.' This suggests Genotonorm may be a brand name or formulation related to Genotropin, though the exact relationship is not specified.