teriparatide
PeptideapprovedOrphan Drug FDA
Approved
Nov 26, 2002
Teriparatide was manufactured under the brand name FORTEO. FORTEO contains recombinant human parathyroid hormone (1-34), [rhPTH(1-34)], which has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone, that regulates calcium and phosphate in the body. FORTEO is indicated for the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy. In addition, Forteo is used for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture. The biological actions of teriparatide is mediated through binding to specific high-affinity cell-surface receptors. Teriparatide is not expected to accumulate in bone or other tissues. — NCATS
Clinical trial activity
155 trials · 113 clinical orgs · 8 marketing orgs
Phase 1
20
Phase 2
76
Phase 3
38
Phase 4
45
Earliest trial started Sep 1, 1987 (NCT00005006)
Timeline
1980s
- Jan 1, 1987
Earliest Phase 2 Sponsor(trial)
- Jan 9, 1987
Orphan Drug Designation
2000s
2010s
- Oct 4, 2019
Pfenex, Inc — Marketing Organization
- Oct 4, 2019
Alvogen — Marketing Organization
- Oct 4, 2019
Alvogen — NDA Secondary Org
2020s
- Nov 16, 2023
Apotex — Marketing Organization
- Nov 16, 2023
Teva — Marketing Organization
- Jun 4, 2024
Almaject — Marketing Organization
- Dec 12, 2025
Amphastar Pharmaceuticals — Marketing Organization
Indications
Studied for
- Alveolar Bone Loss · Phase 4
- Ankle Fractures · Phase 4
- Anorexia Nervosa · Phase 2
- Arthritis, Rheumatoid · Phase 4
- Back Pain · Phase 3
- Bone Diseases · Phase 4
- Bone Diseases, Endocrine · Phase 1
- Bone Diseases, Metabolic · Phase 3
- Bone Marrow Diseases · Phase 4
- Bone Regeneration · Phase 4
- Cartilage Diseases · Phase 2
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Colles' Fracture · Phase 2
- Diabetes Mellitus · Phase 2
- Diabetes Mellitus, Type 2 · Phase 4
- Dialysis · Phase 3
- DiGeorge Syndrome · Phase 3
- Disease · Phase 1/Phase 2
- Education · Phase 4
- Femoral Fractures · Phase 3
- Femoral Neck Fractures · Phase 3
- Fracture Healing · Phase 4
- Fractures, Bone · Phase 4
- Fractures, Stress · Phase 4
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 4
- Hip Fractures · Phase 2
- Humeral Fractures · Phase 4
- Hyperparathyroidism · Phase 1
- Hyperparathyroidism, Secondary · Phase 3
- Hypocalcemia · Phase 3
- Hypoparathyroidism · Phase 3
- Intervertebral Disc Degeneration · Phase 2
- Menopause · Phase 2/Phase 3
- Neoplasms · Phase 1
- Osteoarthritis, Knee · Phase 2
- Osteogenesis Imperfecta · Phase 4
- Osteoporosis, Postmenopausal · Phase 4
- Osteoporotic Fractures · Phase 2
- Parathyroid Hormone · Phase 3
- Periodontitis · Phase 1
- Pharmacological and Toxicological Phenomena · Phase 1
- Prostheses and Implants · Phase 2
- Psoriasis · Phase 2
- Quality of Life · Phase 4
- Renal Insufficiency, Chronic · Phase 4
- Shoulder Fractures · Phase 2
- Spinal Cord Injuries · Phase 4
- Spinal Fractures · Phase 3
- Spinal Fusion · Phase 2
- Spinal Injuries · Phase 4
- Spinal Stenosis · Phase 4
Mechanism of action
Approval history
- approvedNov 26, 2002
Chemistry & pharmacology
Loading structure…
SMILES
CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C(=O)N[C@@H](Cc1cnc[nH]1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1ccccc1)C(=O)O)C(C)C)C(C)C- Mol. weight
- 4117.79 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaTeriparatide ↗
- NCATS10T9CSU89I ↗
- ChEMBLCHEMBL525610 ↗
- ChEMBLCHEMBL1201549 ↗
Also known as
- ak159
- forsteo
- forsteo
- forsteo
- forteo
- forteo
- forteo
- hpth 1-34
- hpth 1-34
- hpth 1-34
- hpth 1-34 (acetate salt)
- hpth 1-34 (acetate salt)
- parathar
- parathar
- parathar
- parathyroid hormone-related peptide (1-36)
- pth (1-34)
- pth (1-34)
- pth-related protein (1-36)
- pthrp (1-36)
- pthrp (1-36)
- rhpth (1-34)
- teriparatide
- teriparatide
- teriparatide
- teriparatide
- teriparatide
- teriparatide
- teriparatide
- teriparatide
- teriparatide
- teriparatide acetate
- teriparatide acetate
- teriparatide acetate
- teriparatide acetate
- teriparatide recombinant human
- teriparatide recombinant human
- teriparatide recombinant human
- teriparatide recombinant human
- teriparatide recombinant human
- teriparatide recombinant human
- teriparatide recombinant human
- zt-034
- zt-034
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07242612 | N/A | Oct 1, 2025 | Khyber Medical University Peshawar |
| NCT06898060 | Phase 3 | Jun 30, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06558188 | Phase 4 | Apr 1, 2025 | Harvard University, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| NCT06303284 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2025 | University of Calgary |
| NCT06644040 | Phase 1 | Oct 25, 2024 | QuadMedicine |
| NCT06264609 | Phase 4 | Feb 1, 2024 | University of Kentucky |
| NCT06061354 | Phase 4 | Aug 23, 2023 | Fluminense Federal University, Universidad de Valparaiso |
| NCT05866029 | N/A | Jun 2, 2023 | Chinese Academy of Medical Sciences |
| NCT05965167 | Phase 1/Phase 2 (Phase 2) | May 11, 2023 | Entera Bio Ltd. |
| NCT05164614 | Phase 1 | Mar 1, 2022 | RANI Therapeutics |
| NCT05151484 | Phase 4 | Dec 15, 2021 | National Institute on Aging (NIA), University of Kentucky |
| NCT07028320 | Phase 3 | Dec 3, 2021 | Jiao Tong University, Shenzhen Salubris Pharmaceuticals Co., Ltd. |
| NCT04473989 | Phase 2 | Jun 1, 2021 | Peking University |
| NCT04921124 | Phase 3 | May 24, 2021 | Government of United Kingdom, University of East Anglia |
| NCT04750460 | Phase 3 | Mar 31, 2021 | Saint-Petersburg State Medical University |
| NCT04669782 | N/A | Nov 24, 2020 | University of Milano Bicocca |
| NCT04589819 | Phase 4 | Nov 1, 2020 | Department of Defense, United States Army, University of South Carolina |
| NCT04533984 | Phase 4 | Oct 1, 2020 | University of South Carolina, Washington University in St. Louis |
| NCT04522622 | Phase 4 | Sep 30, 2020 | Steno Diabetes Center Copenhagen, University of Antwerp, University of Copenhagen, University of Southern Denmark |
| NCT05018637 | Phase 2 | Sep 1, 2020 | Cha Medical University |
Showing 20 of 155 trials
Page 1 / 8
Organizations
Research & Development (113)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eli Lilly | For profit | 49 | 33 | 5 | 1996 |
| Harvard University | Academic/Hospital | 9 | 8 | 2 | 2004 |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Government | 9 | 0 | 4 | 1987 |
| Columbia University | Academic/Hospital | 5 | 4 | 2 | 2003 |
| Entera Bio Ltd. | For profit | 5 | 5 | 2 | 2011 |
| Helen Hayes Hospital | Academic/Hospital | 5 | 3 | 3 | 1987 |
| University of California, San Francisco | Academic/Hospital | 5 | 4 | 4 | 1999 |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Government | 4 | 1 | 3 | 2004 |
| Novartis | For profit | 4 | 3 | 3 | 2006 |
| Amgen | For profit | 3 | 2 | 2 | 2009 |
| Department of Veteran Affairs | Government | 3 | 2 | 2 | 1998 |
| GlaxoSmithKline | For profit | 3 | 2 | 2 | 2007 |
| Health Research, Inc. | Academic/Hospital | 3 | 2 | 3 | 2005 |
| Hebrew University | Academic/Hospital | 3 | 0 | 2 | 2011 |
| Linkoping University | Academic/Hospital | 3 | 3 | 2 | 2010 |
| Northwestern University | Academic/Hospital | 3 | 3 | 2 | 2009 |
| Shenzhen Salubris Pharmaceuticals Co., Ltd. | For profit | 3 | 3 | 3 | 2018 |
| University of Copenhagen | Academic/Hospital | 3 | 2 | 3 | 2008 |
| University of Kentucky | Academic/Hospital | 3 | 3 | 2 | 2015 |
| University of Pittsburgh | Academic/Hospital | 3 | 3 | 2 | 2008 |
113 organizations
Page 1 / 6
Marketing (9)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Almaject | For profit | MKTG | Jun 4, 2024 |
| Alvogen | For profit | MKTG | Oct 4, 2019 |
| Alvogen | For profit | NDA2 | Oct 4, 2019 |
| Amphastar Pharmaceuticals | For profit | MKTG | Dec 12, 2025 |
| Apotex | For profit | MKTG | Nov 16, 2023 |
| Eli Lilly | For profit | NDA | Nov 26, 2002 |
| Pfenex, Inc | For profit | MKTG | Oct 4, 2019 |
| Sanofi-Aventis | For profit | NDA2 | — |
| Teva | For profit | MKTG | Nov 16, 2023 |