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AMIRAVOResearch Library
Hormonal

Teriparatide

Also known as Forteo · Forsteo · Bonsity · rhPTH(1-34) · hPTH(1-34) · LY333334

FDA-approvedAHuman trial evidenceWhat this means

Teriparatide is recombinant human parathyroid hormone (1-34), FDA-approved as Forteo and as generic and 505(b)(2) products for osteoporosis at high fracture risk in postmenopausal women, men, and people on long-term glucocorticoids.

US status
FDA-approved
Evidence
Grade A
Half-life
Approximately 1 hour in serum after subcutaneous injection; peak at about 30 minutes, declining to non-quantifiable concentrations within 3 hours 1.
Class
Parathyroid hormone analog (PTH 1-34)
More
Log a sample
Dosing referenceCycle-length evidence
Unbranded reference vial illustrating Teriparatide; 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

  • Teriparatide is recombinant human PTH(1-34), approved for osteoporosis at high fracture risk in postmenopausal women, men and glucocorticoid-treated patients 1.
  • In the pivotal trial, new vertebral fractures occurred in 5.0% versus 14.3% with placebo 1,2.
  • Once-daily exposure preferentially stimulates osteoblastic over osteoclastic activity, whereas continuous PTH excess can be detrimental to bone 1.
  • Osteosarcoma occurred in rats; the label advises avoiding use in people at increased baseline risk and considering use beyond 2 years only if fracture risk remains high 1.
  • PTH analogs were not mentioned on the WADA 2026 Prohibited List page reviewed 6.

Development stage

Where Teriparatide 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

Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. Teriparatide binds the same high-affinity cell-surface receptors as the 34 N-terminal amino acids of PTH with the same affinity and physiological actions 1.

Exposure pattern

  • Once-daily administration stimulates new bone formation on trabecular and cortical surfaces by preferential stimulation of osteoblastic over osteoclastic activity 1.
  • In monkeys it improved trabecular microarchitecture and increased bone mass and strength; in humans it increased skeletal mass and bone formation and resorption markers 1.
  • Continuous excess of endogenous PTH, as in hyperparathyroidism, may stimulate resorption more than formation 1.

Pharmacokinetics

Absolute bioavailability is about 95%; clearance exceeds liver plasma flow, consistent with hepatic and extra-hepatic clearance 1.

Molecular structure

PubChem CID 16133850 ↗
2D chemical structure of Teriparatide

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

Formula
C181H291N55O51S2
Molecular weight
4117.8 g/mol
CAS
52232-67-4
InChIKey
OGBMKVWORPGQRR-UMXFMPSGSA-N

Research overview

Human research

Placebo-controlled trials in postmenopausal women (1,637) and men (437), an active-controlled glucocorticoid-induced osteoporosis trial (428), and the VERO comparison with risedronate (1,360) evaluated fractures and bone mineral density 1,2,3.

Animal research

In Fischer 344 rats, teriparatide caused dose- and duration-dependent osteosarcoma, osteoblastoma and osteoma; no bone tumors were detected in an 18-month ovariectomized monkey study with 3 years of follow-up 1.

In-vitro research

Teriparatide was not genotoxic in the Ames test, mouse lymphoma assay or CHO chromosomal aberration assay 1.

Key studies

  1. Neer et al., N Engl J Med (2001)
    Randomized, placebo-controlled, median 21 months of observation
    Model: Humans (1,637 postmenopausal women with prior vertebral fractures)

    New vertebral fractures 14% placebo versus 5% and 4% with the two teriparatide doses (RR 0.35 and 0.31); nonvertebral fragility fractures 6% versus 3% 2.

  2. Kendler et al., Lancet (VERO, NCT01709110) (2018)
    Double-blind, double-dummy randomized trial versus oral risedronate, 24 months
    Model: Humans (1,360 postmenopausal women with severe osteoporosis)

    New vertebral fractures 5.4% versus 12.0% (RR 0.44); clinical fractures 4.8% versus 9.8%; non-vertebral fragility fractures 4.0% versus 6.1% (not significant) 3.

  3. Forteo prescribing information, Section 14.2 (men) (2026)
    Double-blind, placebo-controlled, median exposure 10 months
    Model: Humans (437 men with primary or hypogonadal osteoporosis)

    Lumbar spine BMD +5.9% versus +0.5% with placebo 1.

  4. Forteo prescribing information, Section 14.3 (glucocorticoid-induced osteoporosis) (2026)
    Randomized, double-blind, active-controlled, 18 months
    Model: Humans (428 adults on at least 5 mg/day prednisone equivalent)

    Mean BMD change of 7.2% at the lumbar spine, 3.6% at total hip and 3.7% at femoral neck with teriparatide 1.

  5. Forteo prescribing information, Section 13.1 (rat carcinogenicity) (2026)
    Two 2-year carcinogenicity bioassays
    Model: Animals (Fischer 344 rats)

    Marked dose-related increase in osteosarcoma, reaching 40-50% in high-dose groups; dependent on dose and duration 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 20 micrograms subcutaneously once a day, with supplemental calcium and vitamin D if dietary intake is inadequate 1.
  • Use for more than 2 years during a patient's lifetime should only be considered if the patient remains at or has returned to high fracture risk 1.
  • Not approved for intravenous or intramuscular use; initial doses should be given where the patient can sit or lie down in case of orthostatic hypotension. 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 teriparatide or inactive ingredients, including anaphylaxis and angioedema 1. 1
  • Osteosarcoma: increased incidence in rats; postmarketing cases reported in humans, though observational studies have not shown increased risk. Avoid in open epiphyses, Paget's disease or other metabolic bone disease, bone metastases or skeletal malignancy, prior skeletal radiation, or hereditary predisposition. Limited data beyond 2 years 1. 1
  • Hypercalcemia (avoid in hypercalcemic disorders such as primary hyperparathyroidism) and cutaneous calcification including calciphylaxis 1. 1
  • Urolithiasis risk, orthostatic hypotension with initial doses, and digoxin toxicity risk from transient serum calcium increases 1. 1
  • Avoid use during breastfeeding; consider discontinuing when pregnancy is recognized; not approved in pediatric patients 1. 1
  • Arthralgia
    10.1% versus 8.4% placebo
    Two principal osteoporosis trials, women and men (n=691 each arm) 1 · Shown without attribution of causality
  • Nausea
    8.5% versus 6.7%
    Same trials 1 · Not graded
  • Dizziness
    8.0% versus 5.4%
    Same trials 1 · Not graded
  • Asthenia
    8.7% versus 6.8%
    Same trials 1 · Not graded
  • Leg cramps
    2.6% versus 1.3%
    Same trials 1 · Not graded
  • Syncope
    2.6% versus 1.4%
    Same trials 1 · Not graded
  • Transient hypercalcemia 4-6 hours post-dose
    11% of women and 6% of men versus 2% and 0% with placebo
    Clinical trials 1 · Verified on consecutive measurements in 3% of women and 1% of men
  • Symptomatic orthostatic hypotension
    5% of volunteers
    Short-term studies in healthy volunteers 1 · Transient; began within 4 hours of dosing

Emerging safety signals

  • In two U.S. claims-database surveillance studies, three and zero osteosarcoma cases were identified among 379,283 and 153,316 users; the label notes data limitations 1. 1 (2026)
  • Antibodies cross-reacting with teriparatide were detected in 3% of treated postmenopausal women, without evident effects on calcium or BMD response 1. 1 (2026)

What is not known: Data on osteosarcoma risk beyond 2 years of use are limited 1. No metabolism or excretion studies have been performed, and no studies exist in hepatic impairment 1. It is unknown whether teriparatide alters the metabolic bone disease of chronic renal impairment, and whether it is excreted in human milk 1.

Background viewing

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

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; the Forteo label gives initial U.S. approval 1987. As of 2026-10-24 Drugs@FDA lists Forteo (NDA 021318), Bonsity and several generic teriparatide products with prescription marketing status; Parathar is discontinued 1,4.
United States (FDA)
FDA-approved (label initial U.S. approval 1987). Drugs@FDA lists Forteo (NDA 021318), Bonsity (NDA 211939), NDA 218771 and generic ANDAs from Apotex, Amphastar and Teva with prescription marketing status as of 2026-10-24 1,4.
Sport (WADA)
Parathyroid hormone analogs, including teriparatide, were not mentioned on the WADA 2026 Prohibited List page reviewed 6.

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

Quality and testing notes

A certificate of analysis for teriparatide material would be expected to show HPLC purity, identity by mass spectrometry against the label's molecular weight of 4117.8 Da and the PTH(1-34) sequence, net peptide content and endotoxin level [1, 5, 7].

How purity testing works · Reading a certificate of analysis

Check a Teriparatide certificate of analysis against its expected mass (4,117.8 Da)

Storage and handling

The Forteo label directs storage under refrigeration at 2-8°C at all times except during administration, protected from light, not frozen; the pen is discarded 28 days after first use [1].

Frequently asked questions

What is teriparatide?
Recombinant human parathyroid hormone (1-34), the biologically active N-terminal region of PTH 1.
What is it approved for?
Osteoporosis at high fracture risk in postmenopausal women, men with primary or hypogonadal osteoporosis, and glucocorticoid-induced osteoporosis 1.
How much did it reduce fractures?
In the pivotal trial, new vertebral fractures occurred in 5.0% versus 14.3% with placebo 1.
Why is there a 2-year consideration?
Rats developed osteosarcoma, and data beyond 2 years in humans are limited; the label advises longer use only if fracture risk remains high 1.
How does it build bone when hyperparathyroidism weakens bone?
The label explains that once-daily exposure favors osteoblastic activity, while continuous PTH excess may favor resorption 1.
What are common adverse events?
Arthralgia, nausea, dizziness, asthenia, leg cramps and transient increases in serum calcium 1.
How long does it last in the body?
Serum half-life is approximately 1 hour after subcutaneous injection 1.

Latest indexed research

Search all studies on Teriparatide (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: Teriparatide.

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 Teriparatide; not an actual product

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

Specifications

Molecular formula
C181H291N55O51S2
Molecular weight
4,117.8 g/mol
CAS number
52232-67-4
PubChem CID
16133850
FDA UNII
10T9CSU89I
Sequence
Ser-Val-Ser-Glu-Ile-Gln-Leu-Met-His-Asn-Leu-Gly-Lys-His-Leu-Asn-Ser-Met-Glu-Arg-Val-Glu-Trp-Leu-Arg-Lys-Lys-Leu-Gln-Asp-Val-His-Asn-Phe
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
3,065
Indexed as human research
2,136
Animal-only research
181
Randomized controlled trials
258
Registered trials
182
Trials with posted results
63
FDA adverse-event reports (FAERS)
7,248
NIH-funded projects naming it
477
2006: 742007: 532008: 662009: 772010: 1062011: 1392012: 1322013: 1322014: 1412015: 1812016: 1802017: 2002018: 1792019: 2022020: 2102021: 2302022: 1992023: 1782024: 1892025: 2652026: 24320062026
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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