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Context, anatomy, and key evidence

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PTHrP analog

Abaloparatide

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

In this source, abaloparatide is classified among anabolic agents used pharmacologically to treat osteoporosis after menopause. As a PTHrP(1-34) analog, abaloparatide binds and activates PTH1R, leading to downstream cAMP pathway activation in responsive cells. In this PLO position statement, teriparatide/abaloparatide is categorized among the preferred pharmacologic options (along with romosozumab). A contraindication is documented for prior severe hypersensitivity to the active peptide (abaloparatide) or any inactive component in the product.

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

Identity

In this source, abaloparatide is classified among anabolic agents used pharmacologically to treat osteoporosis after menopause.

Sources[4]pubmedEfficacy and safety of abaloparatide, denosumab, teriparatide, oral bisphosphonates, and intravenous bisphosphonates in the treatment of postmenopausal osteoporosis: a systematic review and Bayesian network meta-analysis.Pharmacological interventions include anabolic agents (abaloparatide [ABA], teriparatide [TER])
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Pharmacological interventions include anabolic agents (abaloparatide [ABA], teriparatide [TER])”

    Efficacy and safety of abaloparatide, denosumab, teriparatide, oral bisphosphonates, and intravenous bisphosphonates in the treatment of postmenopausal osteoporosis: a systematic review and Bayesian network meta-analysis. · BACKGROUND

    pubmed:42494861:edd11c98dfb8:edd11c98dfb8

How does it work?

Target, response, and disposition.

Mechanism

As a PTHrP(1-34) analog, abaloparatide binds and activates PTH1R, leading to downstream cAMP pathway activation in responsive cells.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017Abaloparatide is a PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Abaloparatide is a PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 12.1 Mechanism of Action

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Mechanism

In a cell assay, CHEMBL3301581 activated the human PTH1 receptor with an EC50 of 0.02 nM.

Sources[1]chembl-activitiesChEMBL activities for CHEMBL3301581Molecule: CHEMBL3301581 Target: Parathyroid hormone/parathyroid hormone-related peptide receptor (CHEMBL1793) Assay: Agonist activity at human PTH1 receptor expressed in human GP2.3 cells assessed as induction of cAMP after 12 to 20 mins by luciferase reporter gene assay Assay format: cell-based format Standard result: EC50 = 0.02 nM pChEMBL value: 10.70 Document: CHEMBL4024754
Reported result
EC50 = 0.02 nM; pChEMBL value: 10.70
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Molecule: CHEMBL3301581 Target: Parathyroid hormone/parathyroid hormone-related peptide receptor (CHEMBL1793) Assay: Agonist activity at human PTH1 receptor expressed in human GP2.3 cells assessed as induction of cAMP after 12 to 20 mins by luciferase reporter gene assay Assay format: cell-based format Standard result: EC50 = 0.02 nM pChEMBL value: 10.70 Document: CHEMBL4024754”

    ChEMBL activities for CHEMBL3301581 · Activity 18120915

    chembl-activities:chembl3301581:3ba6bb527699:3ba6bb527699

What has been studied?

What the evidence says.

Comparative evidence

In this PLO position statement, teriparatide/abaloparatide is categorized among the preferred pharmacologic options (along with romosozumab).

Sources[3]pubmedPregnancy- and lactation-associated osteoporosis: A position statement of the IAPM, IOF, ECTS, ESCEO, IMS, and EMAS.Preferred treatment options are teriparatide/abaloparatide or romosozumab.
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Preferred treatment options are teriparatide/abaloparatide or romosozumab.”

    Pregnancy- and lactation-associated osteoporosis: A position statement of the IAPM, IOF, ECTS, ESCEO, IMS, and EMAS. · Abstract

    pubmed:42464584:47630e9a5e17:47630e9a5e17

Study findings

In a luciferase reporter assay that quantifies cAMP induction in human GP2.3 cells expressing human PTH1 receptor, CHEMBL3301581 acted as an agonist with EC50 = 0.02 nM after 12 to 20 mins.

Sources[1]chembl-activitiesChEMBL activities for CHEMBL3301581Standard result: EC50 = 0.02 nM
Reported result
EC50 = 0.02 nM
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Standard result: EC50 = 0.02 nM”

    ChEMBL activities for CHEMBL3301581 · Activity 18120915

    chembl-activities:chembl3301581:3ba6bb527699:3ba6bb527699

Risks and interactions

Risks, organized for scanning.

Contraindications

A contraindication is documented for prior severe hypersensitivity to the active peptide (abaloparatide) or any inactive component in the product.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017TYMLOS is contraindicated in patients with a history of severe hypersensitivity to abaloparatide or any of the inactive ingredients of TYMLOS.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “TYMLOS is contraindicated in patients with a history of severe hypersensitivity to abaloparatide or any of the inactive ingredients of TYMLOS.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 4 CONTRAINDICATIONS

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Safety findings

Post-dose blood pressure drops consistent with orthostatic hypotension are reported with TYMLOS, with typical onset within 4 hours after injection.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Orthostatic hypotension may occur with TYMLOS, typically within 4 hours of injection.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 5.3 Orthostatic Hypotension

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Safety findings

Because safety/efficacy data are lacking beyond 2 years, lifetime treatment duration with abaloparatide (TYMLOS) above 2 years is not recommended.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017The safety and efficacy of TYMLOS have not been evaluated beyond 2 years of treatment. Use of the drug for more than 2 years during a patient's lifetime is not recommended.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The safety and efficacy of TYMLOS have not been evaluated beyond 2 years of treatment. Use of the drug for more than 2 years during a patient's lifetime is not recommended.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 2.3 Treatment Duration

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Products and regulatory status

Same ingredient. Different records.

Regulatory status

In men with osteoporosis who are at high fracture risk (e.g., prior fracture or multiple risk factors) or who have failed/intolerant to other available osteoporosis therapy, TYMLOS is indicated to increase bone density.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017TYMLOS is indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “TYMLOS is indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 1.2 Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Regulatory status

In postmenopausal women with osteoporosis who are at high fracture risk (e.g., prior fracture or multiple risk factors) or who have failed/intolerant to other osteoporosis therapy, TYMLOS is an indicated treatment option.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or patients who have failed or are intolerant to other available osteoporosis therapy.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Administration context

The practical clinical context.

Administration

Dosage form information states a single-patient-use prefilled pen containing abaloparatide solution, delivering 30 subcutaneous doses; each dose is 80 mcg in 40 microliters.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017The prefilled pen delivers 30 doses of TYMLOS, each containing 80 mcg of abaloparatide in 40 mcL.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The prefilled pen delivers 30 doses of TYMLOS, each containing 80 mcg of abaloparatide in 40 mcL.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 3 DOSAGE FORMS AND STRENGTHS

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Dose records

Recommended dosing for abaloparatide (TYMLOS) is 80 mcg by subcutaneous administration once per day.

Sources[2]dailymedThese highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017The recommended dosage of TYMLOS is 80 mcg administered subcutaneously once daily.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The recommended dosage of TYMLOS is 80 mcg administered subcutaneously once daily.”

    These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 · 2.1 Recommended Dosage

    dailymed:712143d9-e21e-4013-bb3b-3426a21060a8:11cf37e182c2:11cf37e182c2

Research status + gaps

What still needs better answers?

  • No publishable claim yet for: interaction
  • 191 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (128), assurance_score_below_0.72 (57), current_regulatory_source_required (36), extraction_ambiguity (120), high_risk_requires_regulatory_or_two_independent_sources (60), no_direct_support (182), proposal_not_staged (1)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. ChEMBL activities for CHEMBL3301581 ↗

    chembl-activities · published 2026-08-25 · retrieved 2026-08-25T22:30:24Z

  2. These highlights do not include all the information needed to use TYMLOS safely and effectively. See full prescribing information for TYMLOS.TYMLOS®(abaloparatide) injection, for subcutaneous useInitial U.S. Approval: 2017 ↗

    dailymed · published 2026-08-11 · retrieved 2026-09-04T19:08:07Z

  3. Pregnancy- and lactation-associated osteoporosis: A position statement of the IAPM, IOF, ECTS, ESCEO, IMS, and EMAS. ↗

    pubmed · published 2026-07-16 · retrieved 2026-08-25T08:39:52Z

  4. Efficacy and safety of abaloparatide, denosumab, teriparatide, oral bisphosphonates, and intravenous bisphosphonates in the treatment of postmenopausal osteoporosis: a systematic review and Bayesian network meta-analysis. ↗

    pubmed · published 2026-01-01 · retrieved 2026-08-28T12:18:09Z

Publication history and provenance

Version 11 · Automated assessment · 2026-09-04T19:08:07Z

9c03575f04456cf49db6acb217a0e7f97c07ffe8f8118be4939f8576d5720291