TheraRadar
Data updated: May 26, 2026

FORTEO (teriparatide)

Trial Activity: Mature 5 active trials
Musculoskeletal Approved 2002-11-26

FORTEO is indicated for the treatment of Osteoporosis.

Source: FDA Label • Eli Lilly • Parathyroid Hormone Analog
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How FORTEO Works

Teriparatide is a recombinant human parathyroid hormone (PTH 1-34) that binds to specific high-affinity cell-surface receptors to regulate bone metabolism. When administered via intermittent once-daily injection, it stimulates osteoblastic (bone-forming) activity more than osteoclastic (bone-resorbing) activity. This "anabolic window" results in the formation of new bone on both trabecular and cortical surfaces, leading to increased skeletal mass and improved bone strength.

Source: FDA Label

Development Insights

Eli Lilly and Company conducting 8 trials (15%)
49 indications explored (Broad Platform)
→ osteoporosis (19 trials)
→ postmenopausal osteoporosis (8 trials)
→ spinal cord injury (3 trials)
3
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-11-26
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Eli Lilly
Active Ingredient: TERIPARATIDE

FORTEO Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
50 FDA actions from 2002 to 2024 · 2 indication expansions
Jul 2024 SUPPL
Label · Labeling
Label
Sep 2021 SUPPL
Label · Labeling
FDA Letter Label
Nov 2020 SUPPL
Efficacy
FDA Letter Label

What FORTEO Treats

1 indications

FORTEO is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Osteoporosis
Source: FDA Label

FORTEO Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BONCRESA
AMNEAL PHARMS
2025 3 indic.
CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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SHANGHAI HENLIUS BIOTECH
Shared indications:
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Clinical Trial Registry

53 trials
Trial Sponsor ID Phase Status Title
NCT06558188 CAT 2024P002279 1R21AR083567-01A1 Ph 4 recruiting Combined Anabolic Therapy
NCT06264609 91026 Ph 4 enrolling by invitation Precision Medicine Approach for Osteoporosis - Follow Up Study
NCT01225055 results posted STU00033380 CDMRP-SC090010 Ph 2 completed Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury
NCT05151484 70781 R01AG072797 Ph 4 active not recruiting Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
NCT03133195 ORTHCU-2017-01 Ph 3 completed The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA
NCT04522622 DANDYNAMIC BONE 2018-003888-56 Ph 4 recruiting Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease
NCT04026256 results posted 2018P002537 5R01AR073191-04 Ph 4 completed Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
NCT03072147 Forteo 65996 Ph 2 completed Teriparatide as a Chondroregenerative Therapy in OA
NCT02025179 results posted A1195 Ph 2 completed 12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI)
NCT04589819 19-08190 Ph 4 enrolling by invitation Fracture Recovery for Returning to Duty (Teriparatide STRONG)
NCT03472846 MIDETE Ph 4 completed MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis
NCT01796301 STRUCTURE results posted 20080289 2012-002948-24 Ph 3 completed An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
NCT04750460 TeriCa TeriCa Ph 3 completed Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
NCT05164614 CP-0004 Ph 1 completed Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule
NCT00896532 results posted 20060326 2008-005991-28 Ph 2 completed Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density
NCT04921124 PHAB PHAB01 Ph 3 completed Pharmacokinetic and PHarmacodynamic Analysis and Evaluation of Teriparatide (PTH 1-34) Between Sexes
NCT02023411 results posted ABAR-1072013 Ph 2 completed Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot
NCT02824718 ACTICAS P150911 PHRC-15-549, 2016-000500-29 Ph 2 completed Recombinant Human rhPTH(1-34) VS Association Alfacalcidol/Hydrochlorothiazide in Severe Primary Hypoparathyroidism
NCT01679080 TreatOI Ph 2 terminated The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
NCT01292252 results posted UCSFSpineForteo Ph 4 completed Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
NCT02176382 DATA-HD results posted 2014P000853 Ph 4 completed Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
NCT01440803 results posted AAAF2251 R01FD003902-01 Ph 2 completed Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
NCT00887354 MOVE results posted 12400 B3D-EW-GHDK Ph 4 completed A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
NCT01709110 VERO results posted 14536 B3D-EW-GHDW, 2012-000123-41 Ph 4 completed VERtebral Fracture Treatment Comparisons in Osteoporotic Women
NCT02090244 PTH spinal stenosis 2011-002917-12 Ph 4 completed Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
NCT00926380 DATA results posted 20080723 2009P000525 Ph 2 completed Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis
NCT01279187 results posted HUM00042770 Ph 2 terminated The Impact of Parathyroid Hormone (PTH) on Craniofacial Osseous Regeneration in Bone
NCT02571140 ENT-02-2013 Ph 1 completed A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
NCT01705587 FiX-IT results posted PRO12040560 (FiX-IT) Ph 4 completed Fracture (FX) Improvement With Teriparatide: FiX-IT Study
NCT01153425 TERIZOL results posted 803763 R01AR041443 Ph 4 completed µMRI of Therapeutic Intervention in Postmenopausal Osteoporosis
NCT00759772 results posted 829 Ph 2 completed The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa
NCT01293292 Forsteo STH15466 2010-021009-19 Ph 4 completed Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action
NCT01400516 TERA results posted 2010P002691 Ph 4 completed Teriparatide for Joint Erosions in Rheumatoid Arthritis: The TERA Trial
NCT01343004 ACTIVE results posted BA058-05-003 ACTIVE Trial Ph 3 completed Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women
NCT02478879 CP-2015-005 Ph 1 completed A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
NCT02656810 PF708-101 Ph 1 completed A Comparison Study of PF708 and Forteo in Healthy Subjects
NCT01753856 results posted 14592 B3D-US-GHDV Ph 4 completed Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis
NCT02202603 0020-11-HMO-EnteraBio Ph 1 completed A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects
NCT01360424 HUS-LTO-PTH 2010-019297-32 Ph 4 completed Teriparatide Treatment in Patients With Inherited Osteoporosis
NCT01734824 Vinforce-012 Bone marrow edema Ph 4 suspended Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo
NCT02091492 TERAFRAP Vinforce_006 # 317.276.2000 Ph 3 withdrawn Teriparatide for Fracture Repair in Humans
NCT01473589 results posted 13467 B3D-MC-GHDN Ph 3 completed Effect of Teriparatide on Hip Fracture Healing
NCT01473602 results posted 14125 B3D-MC-GHDQ Ph 3 completed Second Study of the Effect of Teriparatide on Hip Fracture Healing
NCT01171690 results posted 10-000901 Ph 2 terminated Teriparatide for Postsurgical Hypoparathyroidism
NCT01105832 2009-017320-29 Ph 4 completed Does Teriparatide (rhPTH 1-34) Promote Fracture Healing in Proximal Humeral Fractures?
NCT01166958 results posted H-2010-0064 Ph 4 completed Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?
NCT00826228 results posted STU00003009 Ph 4 completed Effect of Parathyroid Hormone (PTH) and Weight-Bearing on Bone in Spinal Cord Injury (SCI)
NCT01063504 PTHKnee Ph 2 completed Teriparatide for Improved Knee Prosthesis Fixation
NCT00927186 results posted 13032 B3D-US-GHDL Ph 4 completed Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women
NCT01430104 results posted 14454 B3D-JE-GHDT Ph 4 completed A Study of Teriparatide in Japanese Osteoporosis Patients

Showing 50 of 53 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FORTEO FDA Label Details

Indications & Usage

FDA Label (PDF)

FORTEO is indicated for the treatment of Osteoporosis.

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Data Sources

FDA Approval: NDA021318 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment