- Asahi Kasei Therapeutics has launched a domestic Phase III trial in Japan to assess extended teriparatide acetate (Teribone) therapy beyond the 24‑month limit
- The trial targets patients at high risk of fracture who have completed 24 months of teriparatide and still require continued treatment to evaluate efficacy and safety
- Teribone dosing in the study includes once‑weekly 56.5 μg or twice‑weekly 28.2 μg regimens
- Japanese labeling currently limits teriparatide to a maximum of 24 months based on non‑clinical findings, prompting the need for clinical evidence for prolonged use
Trial overview
Asahi Kasei Therapeutics has initiated a domestic Phase III trial in Japan to evaluate continued administration of teriparatide acetate (Teribone) in patients with severe osteoporosis at high risk of fracture who have completed 24 months of teriparatide treatment and continue to require therapy; the trial will assess efficacy and safety of extended use beyond the current treatment limit.
Investigational drug and dosing
Teribone is a human parathyroid hormone (PTH) preparation administered either once weekly (56.5 μg) or twice weekly (28.2 μg) to stimulate bone formation, increase bone mass and reduce fracture risk.
Rationale
Japanese labeling currently limits teriparatide preparations to a maximum of 24 months based on non‑clinical findings; the trial aims to generate clinical evidence to address the unmet need for sustained bone‑forming therapy in patients requiring prolonged treatment.
