Skip to content

Bone & calcium

Abaloparatide

A PTHrP-based anabolic peptide for osteoporosis, with labelling extended to men at high fracture risk.

L5Practice-changingApproved medicineApprovedHigh confidenceLast reviewed 2026-08-23
SC injection

Also known as: Tymlos, PTHrP(1-34) analogue

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
84/100
Human safety
80/100
Regulatory status
Approved medicine
Development
Approved
Routes
SC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved osteoporosis medicine

Overview

Human evidence84/100
Preclinical evidence80/100
Human safety evidence80/100

Clinical maturity: Approved osteoporosis medicine

Routes & formulations

Studied / approved routes

SC injection

The approved product is a daily subcutaneous injection under its label.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A synthetic analogue of parathyroid-hormone-related protein (PTHrP), designed for bone-building with a signalling profile distinct from teriparatide.

What people claim

  • Reduces fracture risk and increases bone density in high-risk osteoporosis

What the evidence actually says

Pivotal randomised trials showed fracture reduction in postmenopausal women, with later label expansion supported in men. A second member of the small club of anabolic bone agents.

Human evidence

  • Pivotal randomised fracture-endpoint trials; supporting data in men.

Preclinical evidence

  • PTH1-receptor signalling pharmacology; rodent osteosarcoma findings shared with the class.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • PTH1-receptor activation with a transient signalling profile favouring bone formation.

Safety and unknowns

  • Shares the class-level precautionary labelling rooted in rodent osteosarcoma findings.
  • Labelled effects include hypercalcaemia, dizziness and injection-site reactions.

Cancer relevance

Monitored in trials; not demonstrated in humans

Rodent osteosarcoma findings drive class-level precautionary labelling; a human risk has not been established. Mechanistic precaution, not demonstrated human harm.

Regulatory status

FDA-approved (Tymlos) for osteoporosis in postmenopausal women and, in updated labelling, to increase bone density in men with osteoporosis at high fracture risk. Indication-specific.

Evidence grade

L5Practice-changingHigh confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • Long-term human registry surveillance.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.