Announced details
Treatment of pediatric patients with short stature due to growth hormone deficiency
The efficacy and safety of continuous administration of this product at 0.3 mg/kg/week will be comparatively evaluated by testing its superiority over 0.175 mg/kg/week
Launched in Japan in 1995
Trial JR-401G-301, jRCT2051250213
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Tanaka T. Changes, limitations, and prospects of adult height in GH treatment for Japanese GHD patients. Clin Pediatr Endocrinol. 2022;31(4):211-24.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Growject Subcutaneous Injection 12 mg |
| Launch date | The first dose was administered to the first participant on 13 April 2026 (completed) |
| Applicable area | Treatment of pediatric patients with short stature due to growth hormone deficiency |
| Registration number and expiry date | Trial JR-401G-301, jRCT2051250213 |
| Quantitative Effects | The efficacy and safety of continuous administration of this product at 0.3 mg/kg/week will be comparatively evaluated by testing its superiority over 0.175 mg/kg/week |
| Usage history | Launched in Japan in 1995 |
| Source | Tanaka T. Changes, limitations, and prospects of adult height in GH treatment for Japanese GHD patients. Clin Pediatr Endocrinol. 2022;31(4):211-24. |
Items this document does not state (11)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To bridge the gap between the approved dosage and administration regimens in Japan and overseas and develop a regimen that allows dose adjustment in Japan. The company expects this to further improve final height and quality of life.