Abaloparatide

Classification

PTHrP analogue (anabolic bone agent)

Approval status

Approved medicine

Research status

Labelled indications are defined in product information.

Molecular formula

Insufficient reliable evidence identified.

Molecular weight

Insufficient reliable evidence identified.

Sequence

Synthetic analogue of parathyroid hormone-related peptide 1–34 region.

Primary biological target

PTH1 receptor

Half-life

Insufficient reliable evidence identified.

Routes investigated

Subcutaneous

Human evidence level

A — Approved clinical use / strong human evidence

Approved anabolic injection for osteoporosis in postmenopausal women at high fracture risk, as labelled (US).

Established (labelled / textbook receptor pharmacology)

Agonist at PTH1 receptor with anabolic bone-formation signalling, as labelled.

Increases bone mineral density and reduces fractures in labelled osteoporosis trials.

• Postmenopausal osteoporosis

Investigational findings are not proven clinical benefits unless an authority has labelled that indication.

Overall human evidence grade: A · Approved clinical use / strong human evidence

ACTIVE trial programme.

Animal, cell and in-vitro findings are listed separately from human effects.

PTH1R anabolic biology is established.

This section does not provide personalised medical dosing. Values are those reported in papers or protocols. Animal mg/kg doses are not converted to human doses.

Doses reported in human studies

Insufficient reliable evidence identified.

Preclinical / animal study dosing

Insufficient reliable evidence identified.

Reliable human pharmacokinetic data were not identified for this encyclopaedia entry, or are limited to product information for approved presentations.

Hypercalcaemia, dizziness, palpitations; osteosarcoma boxed warning in rodents (USPI).

Unknowns. Absence of a published harm signal is not evidence of safety.

Contraindications. See PI (pre-existing hypercalcaemia; duration limits).

FDA-approved (Tymlos). Confirm EMA/TGA.

Verify ARTG. Not sold here.

1. [1] Abaloparatide versus placebo in postmenopausal osteoporosis (ACTIVE)

   Abaloparatide versus placebo in postmenopausal osteoporosis (ACTIVE)

   Open source