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TransCon hGH · 2 trials · 4 indications
Long-term safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
Safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
| Arm | Type | Description |
|---|---|---|
| TransCon hGH | EXPERIMENTAL | Once weekly subcutaneous injection of TransCon hGH |
| Name | Type | Description |
|---|---|---|
| TransCon hGH | DRUG | Once weekly subcutaneous injection of TransCon hGH |
Inclusion Criteria: 1. Children who have completed a prior phase 3 TransCon hGH trial 2. Children who have not permanently discontinued study drug in the prior trial 3. Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by ...
TransCon hGH is an investigational therapy for pediatric growth hormone deficiency, a condition where the pituitary gland does not produce enough growth hormone. It is designed to provide sustained exposure to growth hormone. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
TransCon hGH is a small molecule that works by providing a sustained release of human growth hormone. This mechanism aims to maintain therapeutic levels of growth hormone in the body over a longer period, potentially reducing the frequency of injections needed compared to daily growth hormone therapy. It is being studied specifically for use in children with growth hormone deficiency.
TransCon hGH is being developed by Ascendis Pharma A/S, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ASND. The company is conducting clinical trials to evaluate the safety and efficacy of TransCon hGH in pediatric patients with growth hormone deficiency.
TransCon hGH is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total of 444 participants enrolled. The drug is still investigational and has not received FDA approval. Its safety and efficacy are being evaluated in children with growth hormone deficiency.
TransCon hGH has been studied in two completed Phase 3 trials. NCT03305016 evaluated safety, tolerability, and efficacy in 146 children with growth hormone deficiency across the US, Australia, Canada, and New Zealand. NCT03344458 was a long-term extension trial enrolling 298 children who completed a prior TransCon hGH trial, conducted in multiple countries including the US and Europe.
TransCon hGH is a specific investigational product developed by Ascendis Pharma. It is not known to be the same as other marketed growth hormone therapies. Its unique sustained-release formulation is designed to differentiate it from daily growth hormone injections, though it is still in clinical development and not yet approved.