Teriparatide

Also known as: PTH(1-34) · rhPTH(1-34) · Forteo · Forsteo

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 8 applications
Randomized controlled trials 301 of 4,491 publications on PubMed
Registered clinical trials 199 18 active
Adverse event reports 117,891 47,322 classified as serious
  • Teriparatide is an FDA-approved drug, marketed as Forteo, Bonsity, Teriparatide (first approval: November 26, 2002).
  • PubMed lists 4,491 publications mentioning it, including 301 randomized controlled trials and 855 animal-only studies.
  • ClinicalTrials.gov lists 199 registered studies testing it (18 active).
  • FDA's adverse event system (FAERS) holds 117,891 reports mentioning it; 47,322 classified as serious. Reports do not prove causation.

Research topics

  • Bone Density Conservation Agents 65
  • Bone Density 44
  • Osteoporosis 43
  • Parathyroid Hormone 25
  • Osteoporotic Fractures 19
  • Denosumab 15
  • Diphosphonates 14
  • Antibodies, Monoclonal 12
  • Bone Remodeling 12
  • Parathyroid Hormone-Related Protein 11

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA021318 FORTEO Approved, marketed November 26, 2002 LILLY
NDA211939 BONSITY Approved, marketed October 4, 2019 ALVOGEN
ANDA208569 TERIPARATIDE Approved, marketed November 16, 2023 TEVA PHARMS USA
ANDA211097 TERIPARATIDE Approved, marketed November 16, 2023 APOTEX
NDA218771 TERIPARATIDE Approved, marketed June 4, 2024 ALMAJECT
ANDA213641 TERIPARATIDE Approved, marketed December 12, 2025 AMPHASTAR PHARMS INC
ANDA214412 TERIPARATIDE Approved, marketed October 23, 2026 DR REDDYS
NDA019498 PARATHAR Approved, discontinued — SANOFI AVENTIS US

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 4,491
  • Human (MeSH) 2,807
  • Animal only 855
  • Clinical trials 375
  • Randomized controlled trials 301
  • Systematic reviews & meta-analyses 169
  • Case reports 348
  • Retracted 2

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
199
Active
18
With posted results
70

Conditions studied

  • Osteoporosis 90
  • Osteoporosis, Postmenopausal 19
  • Hypoparathyroidism 15
  • Postmenopausal Osteoporosis 15
  • Bone Loss 5
  • Osteoporosis, Post-Menopausal 5
  • Endocrine System Diseases 4
  • Parathyroid Diseases 4
  • Spinal Cord Injury 4
  • Osteopenia 4
  • Postmenopausal Women With Osteoporosis 3
  • Osteoporotic Fractures 3
Study Status Phase Start
PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)
NCT06303284 University of Calgary
Not yet recruiting Phase 1, Phase 2 March 15, 2027
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
NCT07081997 Ascendis Pharma Bone Diseases A/S
Recruiting Phase 3 May 7, 2026
A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens
NCT07579936 Shenzhen Salubris Pharmaceuticals Co., Ltd.
Recruiting Phase 2 April 30, 2026
A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
NCT07497503 Syneos Health
Recruiting Phase 1 April 10, 2026
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
NCT06898060 Qilu Pharmaceutical Co., Ltd.
Not yet recruiting Phase 3 Jun 2025
Chronotherapeutic Optimization of Teriparatide Administration in Postmenopausal Osteoporosis
NCT06951776 Peking University Third Hospital
Not yet recruiting N/A May 1, 2025
Combined Anabolic Therapy
NCT06558188 Massachusetts General Hospital
Recruiting Phase 4 February 3, 2025
Precision Medicine Approach for Osteoporosis - Follow Up Study
NCT06264609 Paul F Netzel
Enrolling by invitation Phase 4 February 1, 2024
Sequential Therapies After Osteoanabolic Treatment
NCT06164795 424 General Military Hospital
Recruiting — November 25, 2023
Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
NCT05866029 Peking Union Medical College Hospital
Recruiting N/A May 26, 2023
Show 40 more studies
Study Status Phase Start
Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures
NCT06842758 University of Palermo
Active, not recruiting — May 1, 2023
Fracture Recovery for Returning to Duty (Teriparatide STRONG)
NCT04589819 University of South Carolina
Enrolling by invitation Phase 4 December 8, 2022
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
NCT05151484 Madhumathi Rao
Active, not recruiting Phase 4 March 21, 2022
Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
NCT04522622 Ditte Hansen
Recruiting Phase 4 December 15, 2021
Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery
NCT03770338 The University of Hong Kong
Active, not recruiting N/A March 1, 2019
Comparation of Treatment Strategies for OVF: Teriparatide Injection and PVP
NCT03692143 Nanfang Hospital, Southern Medical University
Active, not recruiting — January 1, 2017
Teriparatide (PTH) and Bone Strength in Postmenopausal Women
NCT01155245 University Health Network, Toronto
Active, not recruiting — Jun 2008
Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis
NCT01155232 University Health Network, Toronto
Active, not recruiting — Nov 2004
Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis
NCT07242612 Khyber Medical University Peshawar
Completed N/A October 1, 2025
A Study of TeriQ Patch in Healthy Adult Female Participants
NCT06644040 QuadMedicine
Completed Phase 1 October 25, 2024
Teriparatide on Maxillary Sinus Floor Osseointegration
NCT06061354 Universidad de Valparaiso
Unknown status Phase 4 August 23, 2023
Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo
NCT05965167 Entera Bio Ltd.
Completed Phase 1 May 11, 2023
Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule
NCT05164614 RANI Therapeutics
Completed Phase 1 February 21, 2022
To Evaluate the Efficacy and Safety of SAL056 for Postmenopausal Women With Osteoporosis at High Fracture Risk
NCT07028320 Shenzhen Salubris Pharmaceuticals Co., Ltd.
Completed Phase 3 December 3, 2021
PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
NCT05387070 Visen Pharmaceuticals (Shanghai) Co., Ltd.
Completed Phase 3 July 28, 2021
Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women
NCT04974723 Radius Health, Inc. Results posted
Completed — July 1, 2021
Study and Follow-up of the Clinical Effectiveness and Comparative Safety of Biosimilar Teriparatide in the Management of Postmenopausal or Senile.
NCT05369013 STADA, Spain
Unknown status — June 15, 2021
Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture
NCT04473989 Peking University Third Hospital
Unknown status Phase 2 June 1, 2021
Pharmacokinetic and PHarmacodynamic Analysis and Evaluation of Teriparatide (PTH 1-34) Between Sexes
NCT04921124 Norfolk and Norwich University Hospitals NHS Foundation Trust
Completed Phase 3 May 24, 2021
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
NCT04750460 Saint Petersburg State University, Russia
Completed Phase 3 March 1, 2021
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism
NCT04701203 Ascendis Pharma Bone Diseases A/S Results posted
Completed Phase 3 February 16, 2021
Effect of Vitamin K Supplementation on Circulating Levels of Osteocalcin on the Bone Metabolism and Aging
NCT04669782 University of Milano Bicocca
Terminated N/A November 24, 2020
Post-fracture Medication and Mortality
NCT05366621 National Cheng-Kung University Hospital
Completed — November 1, 2020
Replication of the VERO Osteoporosis Trial in Healthcare Claims Data
NCT04879420 Brigham and Women's Hospital
Completed — October 29, 2020
Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture
NCT05018637 Inbo Han
Unknown status Phase 2 September 1, 2020
Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults
NCT04747392 Shenzhen Salubris Pharmaceuticals Co., Ltd.
Completed Phase 1 August 19, 2020
Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis
NCT03217513 Edward Fox
Withdrawn — January 1, 2020
Study of Teriparatide in Stress Fracture Healing
NCT04196855 University of East Anglia
Unknown status Phase 3 December 23, 2019
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
NCT04026256 Massachusetts General Hospital Results posted
Completed Phase 4 September 2, 2019
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
NCT04009291 Ascendis Pharma A/S Results posted
Completed Phase 2 August 27, 2019
Novel Combination Therapy for Osteoporosis in Men
NCT03994172 VA Office of Research and Development Results posted
Completed Phase 4 July 1, 2019
A Six-month Phase 2 Study of Oral hPTH(1-34) (EBP05) in Postmenopausal Women With Low Bone Mass
NCT04003467 Entera Bio Ltd.
Completed Phase 2 June 30, 2019
Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism
NCT04126941 Hospices Civils de Lyon
Unknown status — June 1, 2019
Circulating Myokine Levels and Bone Metabolism
NCT04206618 424 General Military Hospital
Completed — June 1, 2019
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
NCT03702140 Shinshu University
Unknown status Phase 2 October 9, 2018
G56W1 in Women With Postmenopausal Osteoporosis
NCT03720886 Shenzhen Salubris Pharmaceuticals Co., Ltd.
Unknown status Phase 1, Phase 2 October 1, 2018
Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption
NCT03710889 Radius Health, Inc. Results posted
Completed Phase 3 September 20, 2018
Oral PTH(1-34) PK and PD Study in Patients With Hypoparathyroidism
NCT03516773 Entera Bio Ltd.
Completed Phase 2 June 17, 2018
Medication-related Osteonecrosis of the Jaw (MRONJ) Registry
NCT02932501 AO Clinical Investigation and Publishing Documentation
Unknown status — August 14, 2017
Effect of Mechanical Loading With PTH on Cortical Bone
NCT03232476 Massachusetts General Hospital
Withdrawn Phase 4 Jul 2017

All 199 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
117,891
Serious
47,322
With death outcome
6,093

Most reported reactions

  • Nausea 9,220
  • Arthralgia 8,819
  • Dizziness 8,551
  • Pain in extremity 8,548
  • Fall 8,442
  • Pain 7,744
  • Fatigue 7,378
  • Back pain 6,091
  • Muscle spasms 5,818
  • Malaise 5,817
  • Headache 5,635
  • Asthenia 5,578

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

  • Forteo HUMAN PRESCRIPTION DRUG Eli Lilly and Company August 3, 2026
  • Teriparatide HUMAN PRESCRIPTION DRUG BluePoint Laboratories March 12, 2026
  • Teriparatide HUMAN PRESCRIPTION DRUG Amphastar Pharmaceuticals, Inc. December 22, 2025
  • Teriparatide HUMAN PRESCRIPTION DRUG Prasco Laboratories June 16, 2025

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.