Synthetic parathyroid hormone-related protein (PTHrP 1-34) analog; osteoanabolic agent
Abaloparatide
Approvedaka Tymlos, Eladynos, BA058
Abaloparatide is a subcutaneously injected analog of parathyroid hormone-related protein that stimulates new bone formation. Its efficacy was established in the Phase 3 ACTIVE trial, where it lowered the rate of new vertebral and nonvertebral fractures versus placebo in postmenopausal women with osteoporosis. It is approved in the United States, the European Union, and Australia. Regulatory labels cap treatment duration (18 months in the EU; cumulative use of parathyroid hormone analogs limited to two years in the US).
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Mechanism
Abaloparatide is an injected bone-building drug that signals the skeleton to form new bone faster than it is broken down. It is a 34-amino-acid synthetic analog of parathyroid hormone-related protein that selectively activates the PTH type 1 receptor (PTH1R), favoring the transient RG receptor conformation, which drives osteoblast-mediated bone formation with comparatively less bone resorption than continuous PTH exposure.
Regulatory Status by Region
- United States (FDA)Approved. Postmenopausal women with osteoporosis at high risk of fracture (April 2017, brand Tymlos); expanded to men with osteoporosis at high risk of fracture (December 2022).
- Australia (TGA)Registered on the ARTG as a prescription medicine (Eladynos, sponsor Theramex Australia) for postmenopausal osteoporosis, November 2024.
- European Union (EMA)Authorised across the EU (Eladynos) for postmenopausal osteoporosis, December 2022, following an earlier 2018 refusal.
- WADANot listed on the WADA Prohibited List; parathyroid hormone analogs are not among the prohibited peptide-hormone classes.
Key Studies
- ACTIVE trial (Miller PD et al.) (opens in a new tab) (JAMA 2016;316(7):722-733; DOI 10.1001/jama.2016.11136; PMID 27533157; NCT01343004)
- ACTIVE study record (BA058/abaloparatide, Radius Health) (opens in a new tab) (ClinicalTrials.gov NCT01343004; Phase 3; 2463 postmenopausal women; abaloparatide vs teriparatide vs placebo)
- EMA EPAR: Eladynos (abaloparatide) marketing authorisation (opens in a new tab) (European Medicines Agency; EU marketing authorisation granted 12 Dec 2022; postmenopausal osteoporosis)
Related Clinical Trials
- The Effect of Osteoporotic Medications on Vertebral Bone Quality ScorePhase 2 · Not Yet Recruiting
- MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal OsteoporosisN/A · Recruiting
- To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of FracturePhase 3 · Not Yet Recruiting
- A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult SubjectsPhase 1 · Not Yet Recruiting
- Supracondylar Distal Femur Fractures and AbaloparatidePhase 4 · Withdrawn
- Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With OsteoporosisPhase 3 · Unknown
- Sequential Therapies After Osteoanabolic TreatmentN/A · Recruiting
- PTH Analog Type II Odontoid FracturePhase 2 · Terminated
Latest research
- Osteoclast Precursor Membrane-Coated Nanoparticles Loaded With Abaloparatide Enable Dual Modulation of Osteoclast and Osteoblast Differentiation. (opens in a new tab)
Applied biochemistry and biotechnology · Jul 1, 2026
- Biological activation of prolonged delayed fracture healing following abaloparatide under stable circular external fixation: successful limb salvage of a Gustilo type III-C pilon fracture in severe immune thrombocytopenia-a case report. (opens in a new tab)
Journal of medical case reports · Jun 25, 2026
Common Questions
- What is Abaloparatide?
- Abaloparatide (brand names Tymlos and Eladynos) is a synthetic analog of parathyroid hormone-related protein used to build bone in people with osteoporosis at high risk of fracture. It is approved by the FDA, the EMA, and Australia's TGA.
- Is Abaloparatide approved for medical use?
- Abaloparatide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Approved. Postmenopausal women with osteoporosis at high risk of fracture (April 2017, brand Tymlos); expanded to men with osteoporosis at high risk of fracture (December 2022). European Union (EMA): Authorised across the EU (Eladynos) for postmenopausal osteoporosis, December 2022, following an earlier 2018 refusal. Australia (TGA): Registered on the ARTG as a prescription medicine (Eladynos, sponsor Theramex Australia) for postmenopausal osteoporosis, November 2024.
- How does Abaloparatide work?
- Abaloparatide is an injected bone-building drug that signals the skeleton to form new bone faster than it is broken down. It is a 34-amino-acid synthetic analog of parathyroid hormone-related protein that selectively activates the PTH type 1 receptor (PTH1R), favoring the transient RG receptor conformation, which drives osteoblast-mediated bone formation with comparatively less bone resorption than continuous PTH exposure.
- Is Abaloparatide legal in Australia?
- Abaloparatide in Australia (TGA): Registered on the ARTG as a prescription medicine (Eladynos, sponsor Theramex Australia) for postmenopausal osteoporosis, November 2024.
- Is Abaloparatide banned in sport?
- Abaloparatide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List; parathyroid hormone analogs are not among the prohibited peptide-hormone classes.