FDA Approved Healing & Recovery

Teriparatide

also known as: Forteo, Bonsity, rhPTH(1-34), PTH 1-34

The FDA-approved anabolic osteoporosis drug (Forteo, 2002; Bonsity biosimilar 2019) — the recombinant N-terminal PTH fragment (PTH 1-34) that builds bone rather than slowing resorption. Daily subcutaneous injection; 2-year lifetime-exposure limit.

A recombinant version of the biologically active N-terminal 34 amino acids of human parathyroid hormone, delivered as a daily subcutaneous injection to produce intermittent PTH receptor exposure that shifts the bone remodeling balance toward formation; the first anabolic (bone-building) agent approved for osteoporosis, in contrast to antiresorptive agents like bisphosphonates that slow bone loss rather than rebuild mass.

Mechanism of action

Binds the PTH1 receptor (PTHR1), a class B GPCR on osteoblasts and osteocytes. Intermittent, pulsatile receptor activation (from once-daily injection followed by rapid clearance) favors osteoblast lifespan and bone formation, whereas sustained PTH elevation (as in hyperparathyroidism or continuous infusion) predominantly stimulates osteoclast activity via RANKL and produces net bone loss. The anabolic-vs-catabolic duality is a key pharmacological principle for the PTH analog class.

Primary uses

Postmenopausal osteoporosis at high risk of fracture
Osteoporosis in men (primary or hypogonadal)
Glucocorticoid-induced osteoporosis

Typical dosing

20 mcg once daily (subcutaneous (thigh or abdomen, prefilled pen))

Lifetime exposure limited to 2 years (24 months) based on rat osteosarcoma data. Sequential therapy with an antiresorptive (e.g. bisphosphonate, denosumab) after the teriparatide course is standard to preserve the BMD gains.

Regulatory status

FDA-approved as Forteo (2002, Eli Lilly) for osteoporosis in postmenopausal women at high risk of fracture, primary or hypogonadal osteoporosis in men, and glucocorticoid-induced osteoporosis. The Bonsity biosimilar was approved in 2019. Carries a boxed warning for osteosarcoma risk based on rat carcinogenicity data, which is the basis for the 2-year lifetime-exposure limit.

References

[fda-pi] Forteo (teriparatide) Prescribing Information. Eli Lilly and Company.
[pubmed] Neer RM, et al. "Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis (Fracture Prevention Trial)." N Engl J Med, 2001;344:1434-1441.
[pubmed] Kendler DL, et al. "Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO)." Lancet, 2018;391:230-240.

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Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.