Product Dossier
ELADYNOS
Product Dossier for ELADYNOS (abaloparatide, Theramex). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Theramex
- Active ingredient: abaloparatide
- Therapeutic area: Musculoskeletal
- Same area: NAPROSYN
- Same area: PROXEN
What it is
Eladynos is abaloparatide 2 mg/mL solution for injection supplied in a pre-filled pen cartridge.
Approved indications
— Treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Key safety warnings
The product has a lower incidence of hypercalcaemia compared to teriparatide.
Regulatory history
Eladynos was first listed on the ARTG on 28 November 2024. The TGA approved Eladynos on 6 November 2024 for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. The approval was based on evidence showing a significant reduction in new vertebral fractures and increased bone mineral density. The product was included in the Black Triangle Scheme. In July 2025, the PBAC recommended Eladynos for the treatment of severe established osteoporosis and very high risk of fracture. The recommendation was for first-line treatment, based on similar efficacy to romosozumab and teriparatide, similar safety to teriparatide, and cost-effectiveness if not higher than romosozumab or teriparatide.