PeptideTrace
ApprovedParathyroid Hormone AnalogueMetabolic

Teriparatide (Forteo, Teriparatide (generic))

A

Evidence Grade A — Regulatory approved. 2953 published studies. 172 registered clinical trials.

172 trials2,953 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Osteoporosis
  • Postmenopausal Osteoporosis

User Experience Reports

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Overview

Teriparatide (sold as Forteo and generics) is a bone-building medication used for severe osteoporosis — it was the first treatment that actually stimulates the formation of new bone, rather than just slowing bone loss. Given as a daily injection, it reduced spinal fractures by 65% in its landmark trial. It is now available as a generic, making it more accessible than ever.

Also Known As

Teriparatide is also known by these brand and alternate names:

Research Activity

2,953studies
Human 2073
Animal 175
In-vitro 82
Reviews 854

2,953 published studies: 2073 human, 175 animal, 82 in-vitro, 854 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Teriparatide is marketed as Forteo (approved November 2002), with generic versions available since 2023. It is indicated for osteoporosis in postmenopausal women and men at high fracture risk. The landmark Fracture Prevention Trial demonstrated a 65% reduction in vertebral fractures and a 53% reduction in non-vertebral fractures compared to placebo.

Treatment is limited to two years due to a preclinical finding of bone tumours in rats given high doses over their lifetime — though this has never been observed in humans over two decades of clinical use. After stopping teriparatide, patients typically transition to an anti-resorptive medication (like a bisphosphonate) to maintain the bone gains. Teriparatide is now facing competition from abaloparatide, which works through a related but distinct mechanism, and romosozumab, a non-peptide monoclonal antibody with dual anabolic and anti-resorptive action.

Mechanism of Action

This is where teriparatide gets counterintuitive: parathyroid hormone continuously elevated in the blood actually breaks bone down (as seen in hyperparathyroidism). But when given as a brief daily pulse — a single injection that spikes then clears — it has the opposite effect: it stimulates bone-building cells (osteoblasts) to form new bone. This intermittent exposure activates growth and survival signals in osteoblasts without triggering the bone-resorption pathway. The result is genuine new bone formation, not just preservation of existing bone.

Research Summary

The Fracture Prevention Trial demonstrated a 65% reduction in vertebral fractures and 53% reduction in non-vertebral fractures compared to placebo — establishing teriparatide as a cornerstone treatment for severe osteoporosis. Over 20 years of use have confirmed its safety and effectiveness. Generic availability since 2023 has significantly improved access. Treatment was historically limited to two years due to a preclinical finding of bone tumours in rats, though this has never been observed in humans despite two decades of monitoring. The standard approach is to follow teriparatide with an anti-resorptive medication (like a bisphosphonate) to maintain the bone gains — the sequential therapy paradigm is now well established. Teriparatide faces competition from abaloparatide (a related bone-builder) and romosozumab (a non-peptide monoclonal antibody with both bone-building and bone-preserving effects).

Clinical Trials

PeptideTrace tracks 172 registered clinical trials for Teriparatide sourced from ClinicalTrials.gov.

NCT02223416Phase ICompleted

A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo

Gedeon Richter Plc.Endpoint: Area under the plasma concentration versus time curve (AUC)
NCT00046137Phase IIICompleted

Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

Eli Lilly and Company
NCT07579936Phase IIRecruiting

A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens

Shenzhen Salubris Pharmaceuticals Co., Ltd.Endpoint: The incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) between each intervention group and the control group during the treatment period,about 10weeksCompletion: 2026-11-30
NCT07497503Phase IRecruiting

A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants

Syneos HealthEndpoint: Maximum Plasma Concentration (Cmax) of B-3E07Completion: 2026-06-24
NCT07242612N/ARecruiting

Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis

Khyber Medical University PeshawarEndpoint: Change in Bone Turnover Markers (BTMs)Completion: 2026-04-15
View all 172 trials on ClinicalTrials.gov →

Regulatory Timeline

2002
Regulatory

FDA ORIG 1

2004
Regulatory

FDA SUPPL 2

2004
Regulatory

Health Canada Market Authorisation

2004
Regulatory

FDA SUPPL 4

2007
Regulatory

FDA SUPPL 9

2008
Regulatory

FDA SUPPL 15

2008
Regulatory

FDA SUPPL 16

2009
Regulatory

FDA SUPPL 12

2011
Regulatory

FDA SUPPL 26

2012
Regulatory

FDA SUPPL 27

2013
Regulatory

FDA SUPPL 32

2013
Regulatory

FDA SUPPL 33

2013
Regulatory

FDA SUPPL 35

2013
Regulatory

FDA SUPPL 36

2014
Regulatory

FDA SUPPL 38

2014
Regulatory

FDA SUPPL 37

2014
Regulatory

FDA SUPPL 39

2014
Regulatory

FDA SUPPL 40

2014
Regulatory

FDA SUPPL 41

2015
Regulatory

FDA SUPPL 44

2017
Regulatory

FDA SUPPL 51

2019
Regulatory

FDA SUPPL 52

2019
Regulatory

FDA ORIG 1

2020
Regulatory

FDA SUPPL 53

2020
Regulatory

FDA SUPPL 54

2021
Regulatory

FDA SUPPL 56

2023
Regulatory

FDA ORIG 1

2023
Regulatory

FDA SUPPL 4

2023
Regulatory

FDA ORIG 1

2024
Regulatory

FDA SUPPL 57

2024
Regulatory

FDA SUPPL 6

2024
Regulatory

FDA SUPPL 1

2025
Regulatory

FDA SUPPL 17

2025
Regulatory

FDA ORIG 1

Scientific Detail

Overview (Scientific)

Teriparatide is the recombinant 34-amino-acid N-terminal fragment of human parathyroid hormone, PTH(1-34). This fragment retains full biological activity at the PTH1 receptor. It was the first anabolic agent approved for osteoporosis.

Mechanism of Action (Scientific)

Teriparatide activates the PTH1 receptor (PTH1R) on osteoblasts. The anabolic effect depends on intermittent exposure: brief, daily receptor activation produces transient cAMP signaling that upregulates genes promoting osteoblast differentiation, survival, and bone formation (Wnt signaling, RUNX2). This contrasts with continuous PTH exposure (as in hyperparathyroidism), which upregulates RANKL on osteoblasts, stimulating osteoclastogenesis and net bone resorption.

Summary (Scientific)

Teriparatide is marketed as Forteo (approved November 26, 2002). Generic teriparatide became available in 2023 (Teva, Ambio). Indicated for osteoporosis in postmenopausal women and men at high fracture risk. The Fracture Prevention Trial (N=1,637; NEJM 2001) demonstrated a 65% reduction in vertebral fractures (RR 0.35), 53% reduction in nonvertebral fractures (RR 0.47), and lumbar spine BMD increase of 9%. The original 24-month treatment limit (based on osteosarcoma in Fischer 344 rats at near-lifetime exposure) has been relaxed—the post-marketing registry showed no increased human osteosarcoma risk, and the boxed warning has been removed.

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Related Compounds

Linaclotide

Approved
Guanylate Cyclase-C Agonist

Linaclotide is marketed as Linzess (approved August 2012). It is taken as a daily oral capsule on an empty stomach, at least 30 minutes before the first meal. The recommended dose is 290 mcg for IBS-C and 72 or 145 mcg for chronic constipation. In clinical trials, approximately 34% of IBS-C patients met the composite improvement endpoint compared to 17% on placebo. Diarrhoea is the most common side effect (approximately 20%) and the leading reason for discontinuation. Linaclotide has a boxed warning against use in children under 6 years due to deaths in young mice, though no such events have been reported in humans. It competes with plecanatide (which targets the same pathway) and other IBS-C treatments.

Elamipretide

Approved
Mitochondria-Targeted Tetrapeptide (Approved)

Elamipretide (Forzinity) was approved by the FDA for Barth syndrome based on the TAZPOWER trial. The randomised crossover phase (12 patients) did not meet its primary endpoints, but the open-label extension (168 weeks) demonstrated durable improvements in walking distance and muscle strength that formed the basis for approval. Barth syndrome affects approximately 1 in 300,000–400,000 births. A larger Phase III trial in primary mitochondrial myopathy (218 patients, MMPOWER-3) did not meet its primary endpoint, and the drug was not approved for that broader indication. Elamipretide remains approved exclusively for Barth syndrome. See also SS-31 (#158) for the research compound context.

Glucagon

Approved
Counter-Regulatory Peptide Hormone

Glucagon has been available as an emergency injection since the 1960s and remains the standard rescue treatment for severe hypoglycaemia. Recent innovation has focused on making it easier to administer in emergencies. Baqsimi, approved in 2019, was the first needle-free option as a nasal powder. Gvoke, also approved in 2019, eliminated the need to mix and reconstitute the medication before injection — a significant advance since severe hypoglycaemia often impairs the ability to follow complex preparation steps. Dasiglucagon (Zegalogue), a next-generation stable liquid glucagon approved in 2021, further improved on the convenience of rescue administration. Beyond emergency rescue, glucagon's receptor is now a major research target — dual and triple agonists combining glucagon receptor activity with GLP-1 (such as survodutide and retatrutide) are in advanced clinical trials for obesity and metabolic disease.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.