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Hormonal

Abaloparatide

Also known as Tymlos · BA058 · BA-058 · BIM-44058 · PTHrP(1-34) analog · Abaloparatide-SC

FDA-approvedAHuman trial evidenceWhat this means

Abaloparatide is a synthetic 34-amino-acid analog of parathyroid hormone-related peptide, FDA-approved in 2017 as Tymlos for osteoporosis at high fracture risk in postmenopausal women and, to increase bone density, in men.

US status
FDA-approved
Evidence
Grade A
Half-life
Approximately 1 hour; median time to peak about 0.5 hours after subcutaneous injection 1.
Class
Parathyroid hormone-related peptide (PTHrP) analog; PTH1 receptor agonist
More
Log a sample
Dosing referenceCycle-length evidence
Unbranded reference vial illustrating Abaloparatide; not an actual product
Research reference, not advice. Label quotes, not a recommendation. Amiravo sells nothing; some links are referrals.Read the full notice

Key takeaways

  • Abaloparatide is a PTHrP(1-34) analog approved as Tymlos for postmenopausal osteoporosis at high fracture risk and to increase bone density in men with osteoporosis 1.
  • In ACTIVE, new vertebral fractures occurred in 0.6% versus 4.2% with placebo over 18 months 1,2.
  • The label states that use for more than 2 years during a lifetime is not recommended 1.
  • Common adverse reactions included hypercalciuria, dizziness, nausea, headache and palpitations; orthostatic hypotension may occur within 4 hours of injection 1.
  • PTH and PTHrP analogs were not mentioned on the WADA 2026 Prohibited List page reviewed 5.

Development stage

Where Abaloparatide sits between laboratory work and regulatory approval.

  1. Preclinical
  2. Phase 1
  3. Phase 2
  4. Phase 3
  5. Approved (current)

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Abaloparatide acts as an agonist at the PTH1 receptor (PTH1R), activating cAMP signaling in target cells 1.

Bone effects

  • Once-daily administration stimulates new bone formation on trabecular and cortical surfaces through osteoblastic activity 1.
  • In rats and monkeys it increased BMD and bone mineral content, correlating with bone strength 1.
  • In postmenopausal women, the formation marker sPINP peaked at 93% above baseline at month 1, while the resorption marker sCTX peaked at 26% above baseline at month 3 1.

Heart rate

A dose-dependent heart-rate increase developed within 15 minutes of injection and resolved in about 6 hours 1.

Molecular structure

PubChem CID 76943386 ↗
2D chemical structure of Abaloparatide

2D depiction generated from the PubChem record. Depictions are schematic and do not show salt form, counter-ions or conformation.

Formula
C174H300N56O49
Molecular weight
3961 g/mol
CAS
247062-33-5
InChIKey
BVISQZFBLRSESR-XSCWXTNMSA-N

Research overview

Human research

An 18-month placebo-controlled fracture trial in 2,463 postmenopausal women (ACTIVE, with an open-label teriparatide arm and an alendronate extension) and a 12-month placebo-controlled BMD trial in 228 men (ATOM) support the labeled indications 1,2,3.

Animal research

In 2-year Fischer rat studies, abaloparatide caused marked dose-dependent increases in osteosarcoma and osteoblastoma; in rats and monkeys it increased BMD and bone strength 1.

In-vitro research

Abaloparatide is a PTH1R agonist that activates cAMP signaling in target cells 1.

Key studies

  1. Miller et al., JAMA (ACTIVE, NCT01343004) (2016)
    Phase 3, double-blind, placebo-controlled RCT with open-label teriparatide arm, 18 months
    Model: Humans (2,463 postmenopausal women with osteoporosis)

    New vertebral fractures lower than placebo; nonvertebral fracture event rate lower; hypercalcemia 3.4% versus 6.4% with teriparatide 2.

  2. Tymlos prescribing information, Section 14.1 (Studies 003 and 005) (2026)
    18-month RCT followed by open-label alendronate extension
    Model: Humans (postmenopausal women; mITT 690 vs 711)

    New vertebral fractures 0.6% versus 4.2% at 18 months (RRR 86%) and 0.6% versus 4.4% at 25 months after alendronate (RRR 87%); lumbar spine BMD +9.2% versus +0.5% 1.

  3. Czerwinski et al., J Bone Miner Res (ATOM, NCT03512262) (2022)
    Randomized 2:1, double-blind, placebo-controlled, 12 months
    Model: Humans (228 men aged 40-85 with osteoporosis)

    Lumbar spine BMD +8.48% versus +1.17%; total hip +2.14% versus +0.01%; femoral neck +2.98% versus +0.15% 3.

  4. Tymlos prescribing information, Section 13.1 (rat carcinogenicity) (2026)
    2-year carcinogenicity study
    Model: Animals (Fischer rats)

    Marked dose-dependent increases in osteosarcoma and osteoblastoma in all dose groups at 4 to 28 times human exposure 1.

Dosing as stated on the FDA label

Quoted from the prescribing information for reference. Prescribing decisions belong to a licensed clinician; this is not a recommendation or instruction for use.

Full dosing reference, study durations and vial arithmetic →
  • The recommended dosage is 80 micrograms subcutaneously once daily, with supplemental calcium and vitamin D if dietary intake is inadequate 1.
  • Safety and efficacy have not been evaluated beyond 2 years; use for more than 2 years during a patient's lifetime is not recommended 1.
  • Do not administer intravenously or intramuscularly; give the first several doses where the patient can sit or lie down. Other administration instructions are in the label and are not reproduced here 1.

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

Label warnings

  • Contraindicated with a history of severe hypersensitivity to abaloparatide or inactive ingredients; reactions have included anaphylaxis, angioedema, dyspnea and urticaria 1. 1
  • Risk of osteosarcoma: dose-dependent osteosarcoma in rats; unknown whether it occurs in humans. Avoid in open epiphyses, Paget's disease or other metabolic bone disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary predisposition 1. 1
  • Orthostatic hypotension, typically within 4 hours of injection; first several doses where the patient can sit or lie down 1. 1
  • Hypercalcemia (not recommended with pre-existing hypercalcemia or hypercalcemic disorders such as primary hyperparathyroidism), and hypercalciuria and urolithiasis 1. 1
  • Hypercalciuria
    11% versus 9% placebo
    Postmenopausal women, 18-month trial (n=822 vs 820) 1 · Not graded in table
  • Dizziness
    10% versus 6%
    Same trial 1 · Among reactions leading to discontinuation (1%)
  • Nausea
    8% versus 3%
    Same trial 1 · Leading cause of discontinuation (2%)
  • Headache
    8% versus 6%
    Same trial 1 · Not graded in table
  • Palpitations
    5% versus 0.4%
    Same trial 1 · Not graded in table
  • Injection site redness
    58% versus 28%
    Daily assessment during the first month 1 · Severe redness in 2.9%
  • Hypercalcemia (corrected calcium 10.7 mg/dL or higher at 4 hours)
    3% versus 0.1%
    Postmenopausal women trial 1 · 2 patients (0.2%) discontinued
  • Elevated serum uric acid
    25% versus 6% with at least one value above normal
    Patients with normal baseline uric acid 1 · Not associated with increased gout or arthralgia

Emerging safety signals

  • Tachycardia was reported in 2% versus 1% with placebo, and a mean peak heart-rate increase of 15 bpm was measured 15 minutes after an 80-microgram dose in a thorough QT study 1. 1 (2026)
  • Osteosarcoma has been reported postmarketing with a PTH analog, though observational studies have not shown increased risk; data beyond 2 years are limited 1. 1 (2026)

What is not known: Safety and efficacy beyond 2 years have not been evaluated 1. Whether abaloparatide causes osteosarcoma in humans is unknown 1. It is unknown whether it may exacerbate urolithiasis 1. Fracture outcomes in men were not the primary endpoint of ATOM, which measured BMD 3.

Background viewing

We haven't found a clinician video focused on Abaloparatide yet. Meanwhile, this widely watched talk covers the science of aging in general. It does not discuss Abaloparatide.

David Sinclair, PhD (Harvard Medical School) on the biology of aging
The Diary Of A CEO · 6.9M views · 2026

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status
FDA-approved (initial U.S. approval 2017) as Tymlos, NDA 208743, listed with prescription marketing status as of 2026-10-24 1,4.
United States (FDA)
FDA-approved (initial U.S. approval 2017) as Tymlos, NDA 208743, with prescription marketing status per Drugs@FDA as of 2026-10-24 1,4.
Sport (WADA)
Parathyroid hormone and PTHrP analogs, including abaloparatide, were not mentioned on the WADA 2026 Prohibited List page reviewed 5.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

A certificate of analysis for abaloparatide material would be expected to show HPLC purity, identity by mass spectrometry against the label's molecular weight of 3961 Da, confirmation of the Aib residue and C-terminal amide, net peptide content and endotoxin level [1, 6].

How purity testing works · Reading a certificate of analysis

Check a Abaloparatide certificate of analysis against its expected mass (3,961 Da)

Storage and handling

The label directs refrigerated storage (2-8°C) before first use; after first use, up to 30 days at 20-25°C; do not freeze or expose to heat [1].

Frequently asked questions

What is abaloparatide?
A synthetic analog of parathyroid hormone-related peptide (PTHrP 1-34) that acts at the PTH1 receptor 1.
What is it approved for?
Postmenopausal women with osteoporosis at high fracture risk, and to increase bone density in men with osteoporosis at high fracture risk 1.
How much did it reduce fractures?
In ACTIVE, new vertebral fractures occurred in 0.6% versus 4.2% with placebo over 18 months 1.
How does it differ from teriparatide?
Teriparatide is PTH(1-34); abaloparatide is a PTHrP(1-34) analog. In ACTIVE, hypercalcemia was less frequent with abaloparatide than with open-label teriparatide 1,2.
Is there a time limit on use?
The label states use for more than 2 years during a patient's lifetime is not recommended 1.
What are common adverse reactions?
Hypercalciuria, dizziness, nausea, headache, palpitations and injection-site redness 1.
How long does it last in the body?
Half-life is approximately 1 hour 1.

Latest indexed research

Search all studies on Abaloparatide (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 24, 2026. Typo and layout fixes are not listed.

  • New section· entryOct 24, 2026

    New research reference added: Abaloparatide.

Last reviewed October 24, 2026 by the Amiravo editorial team.

Read our editorial policy · Report an error on this page

Need the math?

Laboratory arithmetic with every formula shown.

For research use only. Not for human or veterinary use. Not a drug, food, or dietary supplement. This page is educational and is not medical advice.

Unbranded reference vial illustrating Abaloparatide; not an actual product

Unbranded reference image. Amiravo does not produce, supply or sell this compound.

Specifications

Molecular formula
C174H300N56O49
Molecular weight
3,961 g/mol
CAS number
247062-33-5
PubChem CID
76943386
FDA UNII
AVK0I6HY2U
ChEMBL
CHEMBL4084894
Sequence
Ala-Val-Ser-Glu-His-Gln-Leu-Leu-His-Asp-Lys-Gly-Lys-Ser-Ile-Gln-Asp-Leu-Arg-Arg-Arg-Glu-Leu-Leu-Glu-Lys-Leu-Leu-Aib-Lys-Leu-His-Thr-Ala-NH2
Type
Single compound

Identifiers from PubChem. Verify against the supplier’s documentation for your lot.

Research stats

How much has been published, not how good it is.

PubMed records
407
Indexed as human research
266
Animal-only research
44
Randomized controlled trials
31
Registered trials
25
Trials with posted results
11
FDA adverse-event reports (FAERS)
439
NIH-funded projects naming it
71
2006: 02007: 02008: 02009: 02010: 02011: 02012: 02013: 02014: 42015: 62016: 182017: 332018: 352019: 442020: 412021: 392022: 422023: 492024: 482025: 552026: 5220062026
PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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