Bones & muscles PTH analog
Teriparatide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Teriparatide (sold as Forteo) is a fragment of parathyroid hormone used to build bone in people at high risk of fracture from osteoporosis. Given as a once-daily injection, it is one of the few drugs that actively stimulates new bone formation rather than just slowing bone loss. It has been FDA-approved in the U.S. since 2002, and a boxed warning about a rat bone-cancer signal was removed by the FDA in 2020.
At a glance
- What it is
- Parathyroid hormone fragment, PTH(1-34), a bone-building (anabolic) agent
- Approved for
- Osteoporosis at high fracture risk in postmenopausal women, men, and glucocorticoid-induced cases
- Key fact
- In the Fracture Prevention Trial it reduced new vertebral fractures by about 65 percent versus placebo
- Route
- Subcutaneous injection, once daily
- Evidence strength
- FDA approved
Summary
Teriparatide (Forteo) is an FDA-approved parathyroid hormone fragment that builds new bone in people at high fracture risk from osteoporosis.
What is teriparatide?
Teriparatide, sold under the brand Forteo (and as Bonsity), is a recombinant version of the first 34 amino acids of human parathyroid hormone, the active portion of the hormone that regulates calcium and bone. Unlike most osteoporosis drugs, which slow the breakdown of bone, teriparatide stimulates the body to lay down new bone. It was developed under the code LY333334 and approved in the United States in 2002.
How does teriparatide work?
Teriparatide binds the PTH-1 receptor on bone-building cells (osteoblasts). The effect of parathyroid hormone on bone depends on how it is delivered: continuously high levels break bone down, but a brief once-daily pulse, which is how teriparatide is given, tips the balance toward bone formation. Each daily injection stimulates osteoblasts more than it stimulates the cells that resorb bone, so bone mineral density and bone strength increase over months of treatment.
That anabolic effect translates into fewer fractures. In the Fracture Prevention Trial in postmenopausal women with prior spine fractures, teriparatide cut the risk of new vertebral fractures by about 65 percent compared with placebo. Because the benefit accrues with daily dosing and treatment is generally limited to a couple of years, it is often followed by an antiresorptive drug to maintain the gains.
Is it FDA-approved?
Editor’s note
Status: Yes. Teriparatide's FDA label has changed since approval: Year | Label status 2002 | Approved for osteoporosis, with a boxed warning because high, lifelong doses caused osteosarcoma (a bone cancer) in rats, along with a 2-year limit on cumulative use 2020 | After years of human data showed no increased osteosarcoma signal, the FDA removed the boxed warning and kept osteosarcoma as a standard warning Now | Use beyond 2 years should be considered only if a person remains at high risk of fracture
Category: FDA-approved · Primary body area: Bones & muscles
Yes. Teriparatide's FDA label has changed since approval:
| Year | Label status |
|---|---|
| 2002 | Approved for osteoporosis, with a boxed warning because high, lifelong doses caused osteosarcoma (a bone cancer) in rats, along with a 2-year limit on cumulative use |
| 2020 | After years of human data showed no increased osteosarcoma signal, the FDA removed the boxed warning and kept osteosarcoma as a standard warning |
| Now | Use beyond 2 years should be considered only if a person remains at high risk of fracture |
What is teriparatide prescribed for?
Teriparatide is prescribed for osteoporosis at high risk of fracture, including in:
- Postmenopausal women
- Men with primary or hypogonadal osteoporosis
- People with glucocorticoid-induced osteoporosis
It is generally used for those at high fracture risk rather than as a first-line drug for mild disease.
What are the side effects?
According to the prescribing information, common side effects include:
- Joint pain
- Pain
- Nausea
- Dizziness and leg cramps
- Transient drop in blood pressure on standing after a dose
More serious considerations include:
- Short-lived increases in blood and urine calcium
- Calcium deposits in the skin, including calciphylaxis
- A historical, now-downgraded concern about osteosarcoma based on rat studies
Teriparatide is avoided in people at increased baseline risk of osteosarcoma, such as those with Paget's disease or prior skeletal radiation.
Sources: FDA prescribing information for Forteo and FDA 2020 label update; the Fracture Prevention Trial (Neer et al., The New England Journal of Medicine, 2001, DOI: 10.1056/NEJM200105103441904), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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