Abaloparatide
Evidence: B — Meaningful Human EvidenceEndocrine / Calcium-Bone Axis Signaling
Evidence Snapshot
What this grade covers
B reflects strong direct phase 3 RCT evidence (ACTIVE) — Abaloparatide is itself the drug/analogue subject, the most conventionally gradable of this family in the classic direct-RCT sense. Covers fracture-reduction/BMD efficacy and current regulatory indication scope. Does not cover, and must never be described as covering, native PTHrP's own therapeutic profile.
Regulatory Context
Abaloparatide (Tymlos) is FDA-approved for postmenopausal women with osteoporosis at high fracture risk and, per current labeling, for men with osteoporosis at high fracture risk. It is a synthetic PTHrP(1-34) analogue, not native PTHrP.
Research Takeaway
Abaloparatide is a synthetic 34-amino-acid analogue of parathyroid hormone-related protein (PTHrP 1-34), sharing 76% sequence homology with native human PTHrP(1-34) and 41% homology with PTH(1-34); it acts as a PTH1 receptor agonist.
See all 4 evidence claims →Quick Summary
Abaloparatide is an FDA-approved osteoporosis drug engineered to resemble part of a natural hormone, PTHrP. As an approved drug, its evidence is strong and direct — but it should not be read as evidence about native PTHrP itself.
Mechanism & Research Overview
Abaloparatide is an FDA-approved osteoporosis drug engineered to resemble part of a natural hormone, PTHrP. As an approved drug, its evidence is strong and direct — but it should not be read as evidence about native PTHrP itself.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
Supported
Abaloparatide is a synthetic 34-amino-acid analogue of parathyroid hormone-related protein (PTHrP 1-34), sharing 76% sequence homology with native human PTHrP(1-34) and 41% homology with PTH(1-34); it acts as a PTH1 receptor agonist.
Sources: TYMLOS (abaloparatide) injection — FDA Prescribing Information
Supported
In the pivotal ACTIVE trial (phase 3, randomized, placebo- and active-comparator-controlled, 28 sites/10 countries, 18 months), abaloparatide 80mcg daily significantly reduced vertebral, nonvertebral, clinical, and major osteoporotic fracture risk and increased bone mineral density versus placebo in postmenopausal women with osteoporosis.
Supported
Abaloparatide (Tymlos) is FDA-approved for postmenopausal women with osteoporosis at high fracture risk, and, per current labeling, for men with osteoporosis at high fracture risk.
Sources: TYMLOS (abaloparatide) injection — FDA Prescribing Information
Supported
Abaloparatide's own clinical-trial and regulatory evidence is specific to this synthetic PTHrP(1-34) analogue; native PTHrP is a distinct, separately-documented native protein and this document's evidence must not be read as evidence about it.
Sources: TYMLOS (abaloparatide) injection — FDA Prescribing Information; A parathyroid hormone-related protein implicated in malignant hypercalcemia: cloning and expression
Safety & Evidence Limitations
Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.
Safety Consideration
ACTIVE trial efficacy and safety data are specific to Abaloparatide and must never be described as evidence about native PTHrP.
Research Areas Being Studied
Research areas discussed on this page reflect the Endocrine / Calcium-Bone Axis Signaling category and the sources cited below.
Findings Reported in Studies
Educational summary only — reported in cited studies, not a claim of proven benefit.
- Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial (2016):
Study Tables by Evidence Type
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis: A Randomized Clinical Trial | 2016 | Phase 3, double-blind RCT (ACTIVE), 28 sites/10 countries, March 2011-Oct 2014, 18 months: placebo (n=821), abaloparatide 80mcg (n=824), open-label teriparatide 20mcg (n=818) | Abaloparatide 80mcg daily significantly reduced vertebral, nonvertebral, clinical, and major osteoporotic fracture risk and increased BMD versus placebo in postmenopausal women with osteoporosis (trial: ACTIVE). This is DIRECT_ANALOGUE_EVIDENCE for Abaloparatide itself; does not cross-grade native PTHrP. |
Animal / Cell / Preclinical Data
No Animal / Cell / Preclinical Data Listed Yet
This section will be updated as sources are added.
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| TYMLOS (abaloparatide) injection — FDA Prescribing Information | Abaloparatide is a synthetic 34-amino-acid analogue of PTHrP(1-34), sharing 76% sequence homology with native human PTHrP(1-34) and 41% homology with PTH(1-34); molecular formula C174H300N56O49; acts as a PTH1 receptor agonist. FDA-approved (Tymlos) for postmenopausal women with osteoporosis at high fracture risk and, per current labeling, for men with osteoporosis at high fracture risk (2025 expansion). ANALOGUE_PROGRAM_CONTEXT relative to native PTHrP — this regulatory/identity evidence is specific to the synthetic analogue and must not be read as native-PTHrP evidence. | No source link available |
Anecdotal Reported Patterns — Not Medical Advice
Anecdotal Reported Patterns — Not Medical Advice
Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.
Lab Markers to Discuss With a Clinician
Educational topics only — not self-monitoring instructions.
FAQ
Disclaimer
Educational information only. This page summarizes published research and official regulatory information about Abaloparatide and does not provide medical advice, an individualized treatment recommendation, or dosing instructions.
Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.
Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.
Content status: Published. Last updated .
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