Tymlos
Evidence Grade A — Regulatory approved. 373 published studies. 0 registered clinical trials.
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Abaloparatide (sold as Tymlos) is an injectable medication that actively builds new bone, prescribed for people at high risk of breaking bones due to osteoporosis. Unlike treatments that simply slow bone loss, abaloparatide stimulates the body to form new bone tissue, making bones stronger and denser. In a major clinical trial, it cut the risk of spinal fractures by 86% compared to a placebo over 18 months.
373 published studies: 245 human, 39 animal, 17 in-vitro, 145 reviews
Abaloparatide is marketed as Tymlos (approved April 2017 for postmenopausal osteoporosis; December 2022 for male osteoporosis). In the ACTIVE trial, it reduced vertebral fractures by 86% and non-vertebral fractures by 43% compared to placebo over 18 months. Bone density gains at the hip were numerically greater than with teriparatide.
The ACTIVExtend follow-up study showed that patients who transitioned from abaloparatide to the anti-resorptive alendronate maintained their bone gains over an additional two years — the fracture reduction benefit persisted long after the bone-building treatment ended. Like teriparatide, treatment duration is limited to two years. Abaloparatide carries the same preclinical bone tumour warning as teriparatide, though a transdermal patch formulation is in development that could offer a needle-free alternative.
Abaloparatide targets the same receptor as teriparatide (the PTH1 receptor) but engages it differently. The receptor exists in two configurations — one linked to bone building and one linked to bone breakdown and calcium release. Abaloparatide was specifically designed to preferentially activate the bone-building configuration, producing a brief, transient signal that strongly stimulates new bone formation. This selective activation means it builds bone comparably to teriparatide but with less calcium elevation in the blood — a safety advantage.
Abaloparatide has strong clinical evidence from well-designed trials. The ACTIVE trial demonstrated an 86% reduction in vertebral fractures and a 43% reduction in non-vertebral fractures over 18 months, with bone density gains at the hip that were numerically better than those seen with the older bone-building drug teriparatide. A follow-up study (ACTIVExtend) showed that patients who transitioned to a standard anti-resorptive medication maintained their bone gains for at least two additional years. The main limitations are a two-year cap on treatment duration (shared with all drugs in this class) and a preclinical warning about bone tumours observed in animal studies. Direct head-to-head fracture data against teriparatide are limited — the comparison arm in the ACTIVE trial was not designed to detect differences between the two drugs. A transdermal patch version that could have eliminated the need for daily injections did not succeed in development.
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