PeptideTrace
ApprovedParathyroid Hormone Analogue

Teriparatide

Forteo, Teriparatide (generic)

A

Evidence Grade A — Regulatory approved. 2914 published studies. 176 registered clinical trials.

176 trials2,914 studiesUSEUCA

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.

Research Activity

2,914studies
Human 2054
Animal 172
In-vitro 81
Reviews 844

2,914 published studies: 2054 human, 172 animal, 81 in-vitro, 844 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

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
NCT07497503Phase INot Yet Recruiting

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

Syneos HealthEndpoint: Maximum Plasma Concentration (Cmax) of B-3E07 and Forsteo®Completion: 2026-06-11
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
NCT06951776N/ANot Yet Recruiting

Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis

Peking University Third HospitalEndpoint: Change of CTX from baseline after administrationCompletion: 2025-12-30
View all 176 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

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.