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Abaloparatide

Parathyroid hormone-related protein (PTHrP) analogue (bone-building agent)

Status

Approved

Approved by FDA (Tymlos) for postmenopausal osteoporosis in 2017 and for men in 2022, and in the EU (Eladynos) for postmenopausal women in 2022; the US label advises against use for more than 2 years in a lifetime.

Evidence

Strong

The 2,463-woman ACTIVE trial showed an 86% relative reduction in new vertebral fractures versus placebo, and the ATOM trial showed bone density gains in men.

Abaloparatide is a lab-designed version of parathyroid hormone-related protein, a natural bone-signalling hormone. Given as a daily injection, it stimulates new bone formation and is approved for osteoporosis in people at high risk of fracture.

Structure

34 residues

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Sequence as text
H-A-V-S-E-H-Q-L-L-H-D-K-G-K-S-I-Q-D-L-R-R-R-E-L-L-E-K-L-L-Aib-K-L-H-T-A-NH2

What it is used for

  • Postmenopausal osteoporosis at high risk of fracture (approved)
  • Osteoporosis in men at high risk of fracture (approved)

How it works

Abaloparatide activates the PTH1 receptor, the same receptor used by parathyroid hormone and teriparatide, switching on cAMP signalling in target cells. Once-daily dosing gives a short burst of stimulation that activates bone-forming cells (osteoblasts) on both the spongy inner and dense outer bone surfaces, increasing bone mineral density and, in animal studies, bone strength.

How strong the evidence is

StrongSeveral large randomised controlled trials in people.

In the 18-month ACTIVE trial, 2,463 postmenopausal women with osteoporosis were randomized to abaloparatide, placebo or open-label teriparatide: new vertebral fractures occurred in 0.6% on abaloparatide versus 4.2% on placebo (86% relative reduction), non-vertebral fractures fell by 43%, and high blood calcium was less common than with teriparatide (3.4% versus 6.4%) (Miller 2016, JAMA; label). In ATOM, 228 men with osteoporosis gained 8.5% in lumbar spine bone density at 12 months versus 1.2% on placebo (Czerwinski 2022).

Risks and side effects

  • Dizziness, palpitations and a drop in blood pressure on standing after early doses
  • Raised blood and urine calcium, with a risk of kidney stones
  • Nausea, headache, fatigue and injection-site reactions
  • Osteosarcoma in rats; avoid in people at increased risk of bone cancer
  • Serious allergic reactions, including anaphylaxis

Label dosing

Label: 80 mcg injected under the skin of the abdomen once daily; use for more than 2 years in a lifetime is not recommended.

Summarised from the official prescribing information. Not a recommendation: dosing is decided with a prescriber.

Regulatory status

RegionYearApproved for
USFDA2017Osteoporosis at high risk for fracture in postmenopausal women (extended to men in 2022)
EUEMA2022Osteoporosis in postmenopausal women at increased risk of fracture

Status by country

JurisdictionStatusSource
USUnited StatesAuthorised medicineSource 2
EUEuropean UnionAuthorised medicineSource 3
UKUnited KingdomAuthorised medicineSource 7
AUAustraliaAuthorised medicineSource 8
CACanadaNo authorised medicineSource 9
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Trials of Abaloparatide to watch

  1. Phase 2Active, not recruiting

    FAST-Healing(opens the source in a new tab)

    Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

    Primary completion expected February 202796 participantsSponsor: Hospital for Special Surgery, New YorkNCT03841058

  2. Phase 3Not yet recruiting

    Abaloparatide vs teriparatide in China(opens the source in a new tab)

    To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture

    Primary completion expected May 2027282 participantsSponsor: Qilu Pharmaceutical Co., Ltd.NCT06898060

All trials to watch

Timeline

  1. 2027

    1. Abaloparatide vs teriparatide in China
    2. FAST-Healing

  2. 2022

    1. Approved, EU (EMA)Osteoporosis in postmenopausal women at increased risk of fracture

  3. 2017

    1. Approved, US (FDA)Osteoporosis at high risk for fracture in postmenopausal women (extended to men in 2022)

Sources

  1. 01TYMLOS (abaloparatide) injection label(opens the source in a new tab) DailyMed, U.S. National Library of Medicine, 2026
  2. 02TYMLOS NDA 208743: approval history(opens the source in a new tab) Drugs@FDA, U.S. Food and Drug Administration, 2026
  3. 03Eladynos (abaloparatide): EPAR(opens the source in a new tab) European Medicines Agency, 2022
  4. 04Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial(opens the source in a new tab) JAMA, 2016
  5. 05The efficacy and safety of abaloparatide-SC in men with osteoporosis: a randomized clinical trial(opens the source in a new tab) J Bone Miner Res, 2022
  6. 06Abaloparatide (CID 76943386)(opens the source in a new tab) PubChem, NCBI, 2026
  7. 07Eladynos 80 micrograms/dose solution for injection in pre-filled pen: Summary of Product Characteristics(opens the source in a new tab) electronic medicines compendium (emc), 2025
  8. 08ELADYNOS abaloparatide 2 mg/mL solution for injection cartridge in a prefilled pen (430937)(opens the source in a new tab) Therapeutic Goods Administration
  9. 09Drug Product Database online query(opens the source in a new tab) Health Canada
  1. ApprovedTeriparatideParathyroid hormone analogue (bone-building agent)34
  2. ApprovedVosoritideC-type natriuretic peptide (CNP) analogue39

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.