Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Once weekly of TransCon hGH · 1 trial · 5 indications
Annualized height velocity (AHV) at 52 weeks for weekly lonapegsomatropin (TransCon hGH) and daily hGH treatment groups
| Arm | Type | Description |
|---|---|---|
| TransCon hGH | EXPERIMENTAL | Once weekly subcutaneous injection of TransCon hGH |
| human growth hormone (Genotropin) | ACTIVE_COMPARATOR | Once daily subcutaneous injection of Genotropin |
| Name | Type | Description |
|---|---|---|
| Once weekly subcutaneous injection of TransCon hGH | DRUG | Once weekly subcutaneous injection |
| Once daily subcutaneous injection of Genotropin | DRUG | Once daily subcutaneous injection |
Inclusion Criteria: * Prepubertal children with GHD (either isolated or as part of a multiple pituitary hormone deficiency) in Tanner stage 1 (Tanner 1982) aged: * Boys: 3-12 years, inclusive * Girls: 3-11 years, inclusive * Impaired height (HT) defined as at least 2.0 standard deviations (SD)...
TransCon hGH is an investigational once-weekly human growth hormone being developed for pediatric growth hormone deficiency (GHD). It is designed to provide a weekly alternative to daily growth hormone injections in children with GHD. The drug is currently in Phase 3 clinical development and is not yet approved.
TransCon hGH is being developed by Ascendis Pharma A/S, a biopharmaceutical company listed on the NASDAQ under the ticker ASND. The company is conducting clinical trials to evaluate the safety and efficacy of this once-weekly growth hormone therapy for children with growth hormone deficiency.
TransCon hGH is in Phase 3 clinical development. A Phase 3 trial has been completed, evaluating the safety, tolerability, and efficacy of once-weekly TransCon hGH compared to daily human growth hormone in children with growth hormone deficiency. The drug remains investigational and has not received regulatory approval.
TransCon hGH has one completed Phase 3 clinical trial, registered as NCT02781727. This trial enrolled 162 children with growth hormone deficiency and compared once-weekly TransCon hGH against daily human growth hormone. The study was active-controlled, randomized, and open-label, with participants aged 3 years and older.
TransCon hGH is a long-acting form of human growth hormone designed to be administered once weekly. It works by providing sustained release of growth hormone to treat growth hormone deficiency in children. The drug is engineered to maintain therapeutic levels of growth hormone over a longer period compared to daily injections.