- Asahi Kasei Therapeutics opened a Phase III trial in Japan to test extended Teribone (teriparatide acetate) beyond the 24‑month limit for high‑fracture‑risk osteoporosis patients.
- The trial enrolls patients who have completed 24 months of teriparatide treatment and still require continued therapy.
- Teribone dosing in the trial: once weekly 56.5 μg or twice weekly 28.2 μg.
- Trial ID jRCT2031260049; Japan currently restricts teriparatide to a 24‑month maximum based on non‑clinical data.
Phase III trial initiated in Japan
Asahi Kasei Therapeutics has started a domestic Phase III study to assess extended administration of Teribone (teriparatide acetate) in patients with severe osteoporosis at high risk of fracture who require treatment beyond the current duration limit.
Patient population and objectives
The trial enrolls patients who have completed 24 months of teriparatide treatment and still demonstrate a clinical need; its primary aim is to evaluate the efficacy and safety of continued Teribone dosing in this population.
Drug profile and dosing
Teribone is a human parathyroid hormone (PTH) preparation that promotes bone formation and increases bone mass; dosing in the program is once weekly 56.5 μg or twice weekly 28.2 μg.
Background and rationale
In Japan, teriparatide preparations are currently limited to a maximum of 24 months based on non‑clinical findings; this restriction creates a treatment gap for patients needing sustained bone formation, which the trial seeks to address. Trial ID: jRCT2031260049
