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Abaloparatide regulatory status

Current status of Abaloparatide in the United States: FDA approved. In sport: Not WADA prohibited. Details, sources, and the dated timeline follow.

By the PeptideAgent Editorial Team. Draft, pending editorial review.  Last verified

What is the current status of Abaloparatide?

Regulatory: FDA approvedWADA: Not WADA prohibitedVerified: Verified Sep 23, 2026
FDA and compounding
FDA approved as Tymlos in April 2017 for postmenopausal women with osteoporosis at high risk of fracture, with an expanded indication for men with osteoporosis in December 2022. In December 2021 FDA approved removal of the boxed warning for osteosarcoma and the 2 year cumulative use limit. Because an approved product exists, compounding is not permitted except for a documented patient specific need. No generic is available as of the last verified date.
WADA
Not WADA prohibited
Access path
  1. Prescription from a licensed provider filled at a specialty or retail pharmacy.
  2. Prior authorization typically requires a prior fragility fracture, very low bone density, or intolerance to other agents.
  3. Not available through compounding or telehealth peptide clinics.

Full Abaloparatide page: evidence, dosing in the literature, and sources

How has the status of Abaloparatide changed over time?

  1. FDA

    FDA approves Tymlos (abaloparatide) for postmenopausal osteoporosis

    FDA approved abaloparatide injection (Tymlos), a parathyroid hormone-related protein analog, for postmenopausal women with osteoporosis at high risk of fracture.

    Regulatory: FDA approvedSource: Drugs@FDA: Tymlos (abaloparatide) NDA 208743

Sources

Numbered citations in the answers above point here, followed by the regulatory sources on record for Abaloparatide and the source of each dated event.

  1. [1]FDA prescribing information for Tymlos (abaloparatide) injection, via DailyMedFDA, 2026
  2. [2]WADA Prohibited ListWADA, 2026
  3. [3]Drugs@FDA: Tymlos (abaloparatide) NDA 208743FDA, 2017