Abaloparatide: the basics
What is it?
A prescription peptide that activates a parathyroid-hormone receptor to stimulate bone formation.
Research paper ↗What do people claim it helps with?
Reducing fracture risk or increasing bone density in high-risk osteoporosis are supported uses. It is not a routine fitness or injury-recovery supplement.
What has research actually shown?
The ACTIVE human trial found fewer fractures in postmenopausal women with osteoporosis. Studies in men support increases in bone density; these are different outcome types.
Research paper ↗Has this been demonstrated in people?
Demonstrated in people, including controlled clinical trials for the uses described here. Evidence for one diagnosis does not establish benefit for every other claim.
Research paper ↗What side effects, risks and unknowns should I understand?
Dizziness, nausea, palpitations and injection reactions can occur. Calcium and urinary calcium may rise. Label guidance advises avoiding use in people at increased baseline risk of bone cancer.
Prescribing information ↗Is it an approved medicine?
Yes. Tymlos is FDA-approved for certain high-risk osteoporosis patients, with sex-specific indications described in its label.
Prescribing information ↗Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.
How is it used or studied?
Prescription injection with a planned course and subsequent bone-health management.
Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.
A common misunderstanding
A study showing improved bone density should not be described as if it directly proved fewer fractures.
What should I ask a clinician?
- What diagnosis or goal are we trying to address, and what established options are available?
- Was the expected benefit shown in people like me, using this exact product?
- How could my medicines, health conditions or pregnancy plans affect the risks?
- What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
- Peptide
- A short chain of amino acids, the building blocks of proteins.
- Preclinical
- Research in cells, tissues or animals before dependable treatment evidence in people.
- Controlled trial
- A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
- Biomarker
- A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
Abaloparatide Evidence & Clinical Profile
Established Clinical Trials
Abaloparatide has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.
Laboratory & In Vivo Assays
Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.
What is Abaloparatide?
Abaloparatide (Tymlos / PTHrP 1-34 Analogue) is An FDA-approved synthetic 34-amino-acid peptide analogue of parathyroid hormone-related protein (PTHrP 1-34). Engineered with enhanced conformational stability to selectively favor RG-state PTH1R binding, resulting in potent bone formation with lower hypercalcemic incidence. Aliases include: Tymlos, BIM-44058, BA058.
- Sequence (one-letter)
- AVSEHQLLHDKGKSIQDLRRRELLEKLL-Aib-KLHTA-NH2
- Molecular formula
- C174H300N56O49
- Molecular weight
- 3961.0 g/mol
- CAS Number
- 247062-33-5
- UNII Code
- AVK0I6HY2U
- PubChem CID
- 76943386
Identifiers are for the free base; the medicine is formulated as abaloparatide acetate (UNII C4LQA2B9H4).
Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ · PubChem record ↗ See all names and codes in the peptide name index.
Clinical Trials & Human Cohorts
Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.
Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial [1]
What was reported
New morphometric vertebral fractures and nonvertebral fractures were less frequent with abaloparatide than placebo, and BMD gains were greater. Hypercalcemia incidence was lower with abaloparatide (3.4%) than teriparatide (6.4%).
What limits the conclusion
Teriparatide arm was open-label; the authors note further research is needed on clinical importance of the risk differences and comparative efficacy versus other osteoporosis treatments.
How the compound may work
Mechanisms describe how Abaloparatide may affect biological processes. Laboratory findings and patient outcomes answer different questions.
Selective RG Conformation Binding
Binds with greater selectivity to the RG conformation of PTH1R than PTH(1-34) does, producing more transient cAMP responses in receptor-expressing cells. [2]
Proposed Anabolic Rationale
The authors propose that transient, RG-selective signaling may help account for the favorable anabolic bone effects of abaloparatide reported in earlier animal studies; this link was not directly tested in the study. [2]
Areas Being Studied
These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.
Postmenopausal Osteoporosis
Reduced new vertebral and nonvertebral fractures and increased BMD versus placebo over 18 months. [1]
Male Osteoporosis
Greater 12-month BMD gains at lumbar spine, total hip and femoral neck than placebo in men with osteoporosis. [3]
Compare the study designs.
| Study | Design / sample | Outcome type | Key limitation |
|---|---|---|---|
| ACTIVE Phase 3 Trial · 2016 [1] | Phase 3 double-blind RCT (open-label teriparatide arm), 28 sites in 10 countries n = 2463 |
Clinical endpoint evaluation | Teriparatide arm was open-label; the authors note further research is needed on clinical importance of the risk differences and comparative efficacy versus other osteoporosis treatments. |
Regulatory Status & Clinical Safety
Regulatory Classification
FDA approved (NDA 208743) for postmenopausal women and men with osteoporosis at high risk of fracture.
Safety Realities & Impurities
Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.
Clinical Trials Registry Records
Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.
Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women [1]
- Planned enrollment
- 2463 (patients)
- Posted results
- Available
- Sponsor
- Radius Health
- Last updated
- 2017
WADA & Anti-Doping Regulations
WADA Anti-Doping Status
Abaloparatide is not prohibited under current World Anti-Doping Agency (WADA) regulations. However, athletes must ensure unregulated preparations or unverified vendor products do not violate Section S0 (Non-approved substances). Last verified: October 2026.
Research Timeline
What Researchers Still Don't Know
Long-term safety profiles
Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.
Optimal dose-response thresholds
Comparative trials optimizing minimal effective exposure versus adverse event rates.
Formulation bioavailability
Differences between oral, subcutaneous, and modified peptide delivery vehicles.
References
Primary sources verified against PubMed / NLM and regulatory databases.
- Phase 3 Landmark RCT
- Receptor Pharmacology
- Phase 3 Clinical Trial
-
Regulatory
Tymlos (Abaloparatide) Prescribing Information ↗ (external website)