Teriparatide
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed glucocorticoid-induced osteoporosis 2 milestones | |||||
| Filed | EU (EMA) | — | glucocorticoid-induced osteoporosis | 2019-05-30 | “today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) submitted for PF708 (Teriparatide).” alvogen.com ↗ “Lilly filed applications with the FDA and EMEA, respectively, for a supplemental indication for teriparatide” lilly.com ↗ |
| Filed | US (FDA) | — | glucocorticoid-induced osteoporosis | — | “Lilly filed applications with the FDA and EMEA, respectively, for a supplemental indication for teriparatide” lilly.com ↗ |
| Filed osteoporosis 1 milestone | |||||
| Filed | Other | — | osteoporosis | 2019-10-21 | “Alvogen has also submitted the marketing authorization application for Teriparatide (PF708) to the Kingdom of Saudi Arabia's Saudi Food and Drug Authority” alvogen.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | BONSITY | — | 2023-11-16 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | FORTEO | — | 2009-07-22 – 2020-11-16 | fda.gov ↗ |
| Approved | EU (EMA) | Forsteo | — | 2003-06-10 | europa.eu ↗ |
| Approved | US (FDA) | FORTEO | — | 2002-11-26 | fda.gov ↗ |
Trials 96 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials · 1 met primary | ||||||
| Phase 1 | NCT07497503 | Apr → Sep 2026 overdue | — | Syneos Health | Recruiting | No outcome recorded |
| Phase 1 | NCT05965167 | May 2023 → Feb 2026 | disease of bone structure, hypoparathyroidism, osteoporosis | Entera Bio Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02656810 | Dec 2015 → Jul 2016 | osteoporosis | Pfenex, Inc | Completed | No outcome recorded |
| Phase 1 | NCT02571140 | Oct 2013 → Aug 2017 | — | Entera Bio Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01935479 | Aug 2013 → Feb 2014 | osteoporosis | Asahi Kasei Therapeutics Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01551602 | Mar → Sep 2012 | osteoporosis | Asahi Kasei Therapeutics Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01250145 | Nov 2010 → May 2011 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00676312 | May → Aug 2008 | postmenopausal osteoporosis | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT00277706 | Aug 2004 → Jul 2009 | bone resorption disease, periodontitis | University of Michigan | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06303284 | Mar 2027 → Dec 2030 expected | — | University of Calgary | Not yet recruiting | No outcome recorded |
| Phase 221 trials · 1 met primary · 5 missed | ||||||
| Phase 2 | NCT07579936 | Apr → Jul 2026 overdue | postmenopausal osteoporosis | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT04473989 | Jun 2021 → Dec 2023 | — | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02824718 | Jun 2017 → May 2020 | autosomal dominant hypocalcemia | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT02972424 | May 2017 → Mar 2021 | osteoporosis | Hospital for Special Surgery, New York | Completed | Missed primary |
| Phase 2 | NCT02152228 | Jul 2014 → Jun 2015 | hypoparathyroidism | Entera Bio Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02025179 | Jan 2013 → Aug 2015 | disease of bone structure, osteoporosis, spinal cord injury | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT01679080 | Nov 2012 → Jul 2020 | osteogenesis imperfecta | University of Aarhus | Terminated | No outcome recorded |
| Phase 2 | NCT01279187 | Feb 2011 → Mar 2015 | — | University of Michigan | Terminated | No outcome recorded |
| Phase 2 | NCT01171690 | Nov 2010 → Dec 2013 | secondary hypoparathyroidism due to impaired parathormon secretion | Mayo Clinic | Terminated | Met primary Stop: Business |
| Phase 2 | NCT01225055 | Oct 2010 → Aug 2015 | disease of bone structure, osteoporosis, spinal cord injury | Thomas J. Schnitzer | Completed | Missed primary |
| Phase 2 | NCT00926380 | Jun 2009 → Dec 2016 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | Missed primary |
| Phase 2 | NCT00623974 | May 2008 → Jun 2010 | — | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00535860 | Apr 2008 → Mar 2009 | osteoporosis | TransPharma Medical | Completed | No outcome recorded |
| Phase 2 | NCT00593177 | Oct 2007 → Jun 2008 | psoriasis | Manhattan Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00393380 | Sep 2006 → Nov 2009 | Hodgkins lymphoma, acute myeloid leukemia, aplastic anemia, chronic lymphocytic leukemia/small lymphocytic lymphoma +2 | The Emmes Company, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT00668941 | Sep 2005 → Feb 2016 | osteoporosis | Helen Hayes Hospital | Unknown | Missed primary |
| Phase 2 | NCT00191867 | Feb 2005 → Mar 2006 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00190944 | Dec 2004 → Jun 2007 | — | Eli Lilly and Company | Completed | Missed primary |
| Phase 2 | NCT00086619 | May 2004 → Dec 2009 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00018447 | Nov 1998 → Oct 2003 | postmenopausal osteoporosis | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 2 | NCT00001304 | Oct 1991 → Mar 2014 | hypoparathyroidism | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00697463 | Aug 2008 → Jan 2012 | premenopausal osteoporosis | Columbia University | Completed | No outcome recorded |
| Phase 323 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT04921124 | May → Jul 2021 | — | Norfolk and Norwich University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT04750460 | Mar 2021 → Feb 2022 | hypoparathyroidism, renal osteodystrophy | Saint Petersburg State University, Russia | Completed | No outcome recorded |
| Phase 3 | NCT04196855 | Dec 2019 → Jun 2022 | — | University of East Anglia | Unknown | No outcome recorded |
| Phase 3 | NCT03133195 | May 2017 → Jun 2022 | — | King Chulalongkorn Memorial Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03002428 | Dec 2016 → May 2018 | osteoporosis | Pfenex, Inc | Completed | No outcome recorded |
| Phase 3 | NCT01801397 | Mar 2014 → Jun 2016 | osteoporosis | University of Zurich | Unknown | No outcome recorded |
| Phase 3 | NCT01473589 | Feb 2012 → Dec 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01473602 | Jan 2012 → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00503399 | Jul 2007 → Oct 2010 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00433160 | Jan 2007 → Sep 2008 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00414973 | Dec 2006 → Jul 2008 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00395538 | Oct 2006 → Sep 2017 | DiGeorge syndrome, hypoparathyroidism | National Institute of Dental and Craniofacial Research (NIDCR) | Terminated | No outcome recorded |
| Phase 3 | NCT00343252 | Jun 2006 → Jun 2009 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00500409 | Dec 2005 → Dec 2006 | osteoporosis | Virchow Group | Completed | No outcome recorded |
| Phase 3 | NCT00191321 | Jul 2004 → Dec 2005 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00065637 | Dec 2003 → Sep 2005 | osteoporosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT00532207 | Nov 2003 → Dec 2004 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00191893 | Sep 2003 → Nov 2006 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00191802 | Sep 2003 → Oct 2005 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00543023 | Jun 2003 → Aug 2004 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00051558 | Nov 2002 → Jul 2006 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00670501 | Aug 1996 → Apr 1999 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00046137 | — | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 432 trials · 5 met primary · 2 missed | ||||||
| Phase 4 | NCT06264609 | Feb 2024 → Dec 2029 expected | osteoporosis | Paul F Netzel | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06061354 | Aug 2023 → Aug 2024 | — | Universidad de Valparaiso | Unknown | No outcome recorded |
| Phase 4 | NCT04522622 | Dec 2021 → Sep 2026 overdue | chronic kidney disease, heart disorder, renal osteodystrophy | Ditte Hansen | Recruiting | No outcome recorded |
| Phase 4 | NCT03994172 | Jul 2019 → Jun 2025 | osteoporosis | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT02955056 | Oct 2016 → Oct 2017 | — | Nottingham University Hospitals NHS Trust | Unknown | No outcome recorded |
| Phase 4 | NCT02156960 | May 2014 → May 2015 | osteoporosis | Shinshu University | Unknown | No outcome recorded |
| Phase 4 | NCT04241211 | Jan 2014 → Dec 2018 | — | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02130973 | Aug 2013 → Aug 2018 | osteoporosis | Health Research, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT01945788 | Jun 2013 → Oct 2014 | postmenopausal osteoporosis | Bio Sidus SA | Unknown | No outcome recorded |
| Phase 4 | NCT01753856 | Jan 2013 → Jun 2014 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT01705587 | Dec 2012 → Sep 2016 | osteoporosis | Susan L. Greenspan | Completed | No outcome recorded |
| Phase 4 | NCT01709110 | Oct 2012 → Jul 2016 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT02090244 | Aug 2012 → May 2018 | spinal stenosis | University Hospital, Linkoeping | Completed | No outcome recorded |
| Phase 4 | NCT01292252 | Aug 2011 → Dec 2015 | spondylolisthesis, spondylosis | Shane Burch | Completed | No outcome recorded |
| Phase 4 | NCT01430104 | Aug → Dec 2011 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT01400516 | Aug 2011 → Jul 2015 | rheumatoid arthritis | Brigham and Women's Hospital | Completed | Missed primary |
| Phase 4 | NCT01360424 | May 2011 → Nov 2013 | osteoporosis | Helsinki University Central Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01293292 | Jan 2011 → Aug 2015 | osteoporosis | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT01173081 | Jul 2010 → Apr 2014 | — | Ohio Orthopedic Center of Excellence | Unknown | No outcome recorded |
| Phase 4 | NCT01105832 | Apr 2010 → Feb 2014 | — | University Hospital, Linkoeping | Completed | Missed primary |
| Phase 4 | NCT00927186 | Jul 2009 → Oct 2010 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00826228 | Jun 2009 → Mar 2012 | disease of bone structure, osteoporosis, spinal cord injury | Thomas J. Schnitzer | Completed | No outcome recorded |
| Phase 4 | NCT00887354 | Apr 2009 → Aug 2015 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00557310 | Nov 2007 → Oct 2010 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00446589 | Jul 2006 → ? | osteoporosis | Papageorgiou General Hospital | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT00259298 | Nov 2005 → Jul 2009 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 4 | NCT00239629 | Sep 2005 → Jan 2007 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00079924 | Nov 2004 → May 2007 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00532545 | Apr 2003 → Apr 2004 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00191425 | Aug 2002 → Nov 2005 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00035256 | Oct 2001 → Jul 2005 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT02416271 | Apr 2001 → May 2003 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase not applicable9 trials · 1 missed | ||||||
| — | NCT07242612 | Oct 2025 → Mar 2026 overdue | postmenopausal osteoporosis | Khyber Medical University Peshawar | Recruiting | No outcome recorded |
| — | NCT05866029 | May 2023 → Sep 2026 overdue | osteoporosis | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| — | NCT03770338 | Mar 2019 → Mar 2026 overdue | osteoporosis | The University of Hong Kong | Active not recruiting | No outcome recorded |
| — | NCT02563353 | Nov 2015 → Nov 2018 | osteoporosis | Odense University Hospital | Completed | Mixed |
| — | NCT02440581 | Jul 2015 → Jun 2021 | chronic renal failure syndrome | Hartmut Malluche, MD | Completed | Missed primary |
| — | NCT01760798 | Jan 2012 → Jun 2014 | osteoporosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| — | NCT00754442 | Feb 2007 → Aug 2008 | non-renal secondary hyperparathyroidism | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT00365924 | Dec 2006 → Apr 2008 | osteoporosis | Pfizer | Completed | No outcome recorded |
| — | NCT00347737 | Jun 2006 → May 2008 | osteoporosis | Leland Graves III, MD | Withdrawn | No outcome recorded |
| Comparator or background therapy50 trials | ||||||
| Phase 1 | NCT05164614 Comparator | Feb → Oct 2022 | — | RANI Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01913834 Comparator | Sep 2013 → Aug 2014 | osteoporosis | Nottingham University Hospitals NHS Trust | Unknown | No outcome recorded |
| Phase 1 | NCT02202603 Comparator | Jul 2011 → Aug 2013 | — | Entera Bio Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01224717 Comparator | Sep 2010 → Apr 2011 | postmenopausal osteoporosis | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT02223416 Comparator | ? → Jan 2015 | — | Gedeon Richter Plc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03720886 Comparator | Oct 2018 → May 2020 | postmenopausal osteoporosis | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05018637 Background | Sep 2020 → Dec 2022 | osteoporosis, vertebral disorder | Inbo Han | Unknown | No outcome recorded |
| Phase 2 | NCT03702140 Comparator | Oct 2018 → Oct 2023 | osteoporosis | Shinshu University | Unknown | No outcome recorded |
| Phase 2 | NCT03072147 Comparator | May 2017 → Sep 2022 | osteoarthritis, knee | Christopher Ritchlin | Completed | No outcome recorded |
| Phase 2 | NCT02023411 Comparator | Jan 2014 → Dec 2018 | neurogenic arthropathy | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 2 | NCT01440803 Comparator | Aug 2012 → Jan 2018 | premenopausal osteoporosis | Elizabeth Shane | Completed | No outcome recorded |
| Phase 2 | NCT01604057 Comparator | Nov 2011 → Jul 2012 | osteoporosis | Azelon Pharmaceuticals | Unknown | No outcome recorded |
| Phase 2 | NCT01321723 Comparator | Feb → Oct 2011 | postmenopausal osteoporosis | Unigene Laboratories Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01063504 Comparator | Feb 2010 → Jun 2013 | osteoarthritis, knee | University Hospital, Linkoeping | Completed | No outcome recorded |
| Phase 2 | NCT01011556 Comparator | Nov 2009 → Sep 2011 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00896532 Comparator | Jun 2009 → Feb 2011 | postmenopausal osteoporosis | Amgen | Completed | Met primary |
| Phase 2 | NCT00759772 Comparator | Sep 2008 → Feb 2016 | anorexia nervosa, osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00743782 Comparator | Aug 2008 → Apr 2014 | autoimmune polyendocrine syndrome type 1, autosomal dominant hypocalcemia 1 | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 2 | NCT00624481 Comparator | Mar 2008 → Apr 2009 | osteoporosis | Nastech Pharmaceutical Company, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT00489918 Comparator | Jun 2007 → Apr 2008 | osteoporosis | Zosano Pharma Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00471237 Comparator | May 2007 → Dec 2008 | osteoporosis | GlaxoSmithKline | Terminated | Met primary |
| Phase 2 | NCT00542425 Comparator | Apr 2007 → Jun 2009 | osteoporosis | Radius Health, Inc. | Completed | Met primary |
| Phase 2 | NCT00005006 Comparator | Sep 1987 → Feb 2003 | osteoporosis | Helen Hayes Hospital | Completed | No outcome recorded |
| Phase 3 | NCT06898060 Comparator | Jun 2025 → May 2027 expected | postmenopausal osteoporosis | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02091492 Comparator | Jun 2014 → Sep 2015 | osteoporosis | Medical University of Vienna | Withdrawn | No outcome recorded |
| Phase 3 | NCT01896011 Comparator | Jul 2013 → Dec 2021 | — | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 3 | NCT01796301 Comparator | Jan 2013 → May 2015 | postmenopausal osteoporosis | Amgen | Completed | Met primary |
| Phase 3 | NCT01343004 Comparator | Apr 2011 → Oct 2014 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | Met primary |
| Phase 3 | NCT00577863 Background | Jan → May 2008 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00439244 Comparator | Dec 2006 → Feb 2009 | osteoporosis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT01611571 Comparator | Dec 2003 → Nov 2011 | osteoporosis | Columbia University | Completed | No outcome recorded |
| Phase 3 | NCT00542984 Comparator | Aug 2003 → Nov 2004 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00543218 Comparator | Dec 2002 → Jun 2004 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT06558188 Comparator | Feb 2025 → Nov 2027 expected | postmenopausal osteoporosis | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04589819 Comparator | Dec 2022 → Dec 2026 expected | — | University of South Carolina | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05151484 Comparator | Mar 2022 → Jan 2027 expected | osteoporosis | Madhumathi Rao | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04026256 Comparator | Sep 2019 → Apr 2022 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03472846 Comparator | Mar 2017 → Sep 2022 | postmenopausal osteoporosis, type 2 diabetes mellitus | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT03735537 Comparator | Nov 2016 → Feb 2025 | osteogenesis imperfecta | University of Edinburgh | Completed | No outcome recorded |
| Phase 4 | NCT02176382 Comparator | Aug 2014 → Feb 2020 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01750086 Comparator | Jan 2013 → Apr 2014 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01734824 Comparator | May 2012 → Sep 2015 | bone marrow disorder, bone remodeling disease | Medical University of Vienna | Suspended | No outcome recorded |
| Phase 4 | NCT01166958 Comparator | Sep 2010 → Nov 2012 | osteoporosis | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT01153425 Comparator | Jul 2008 → Dec 2012 | osteoporosis | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT01535027 Comparator | Mar 2006 → Dec 2012 | osteoporosis | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT00131469 Comparator | Jun 2005 → Jan 2011 | osteogenesis imperfecta | Oregon Health and Science University | Completed | No outcome recorded |
| — | NCT04669782 Background | Nov 2020 → Jul 2024 | osteoporosis | University of Milano Bicocca | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01656629 Comparator | Aug 2012 → Jun 2014 | osteoporosis | Johns Hopkins University | Terminated | No outcome recorded Stop: Business |
| — | NCT01309399 Comparator | Aug 2010 → Nov 2014 | osteoporosis | Health Research, Inc. | Completed | No outcome recorded |
| — | NCT00594906 Comparator | Jan 2008 → Jul 2012 | — | University of Rochester | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 47
| Date | Issuer | Release |
|---|---|---|
| 2026-06-22 | Entera Bio Ltd. | Regulatory Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis enterabio.com ↗
The FDA feedback is in response to a Clinical Amendment submitted by Entera to its Investigational New Drug (IND) application, as announced in March 2026. |
| 2026-06-15 | Entera Bio Ltd. | Results ENDO 2026 Oral Presentation Highlights Comparative Clinical Data for Entera’s Breakthrough Single Tablet EB613 (First-in-Class Oral PTH(1-34) Anabolic for Osteoporosis) enterabio.com ↗
Single tablet EB613 achieved a comparable PK/PD profile to Forteo® and multi-tablet EB613, which was evaluated in Entera’s Phase 2 study in postmenopausal women with osteoporosis and low bone mass |
| 2026-03-04 | Entera Bio Ltd. | Regulatory Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis enterabio.com ↗
Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today announced the submission to the U.S. Food and Drug Administration (FDA) of a clinical amendment providing a streamlined Phase 3 protocol, statistical analysis plan (SAP), and open-label extension synopsis to the Company’s Investigational New Drug (IND) 505(b)(2) submission, to evaluate EB613 (Oral PTH(1-34), teriparatide). |
| 2025-12-15 | Amphastar Pharmaceuticals, Inc. | Regulatory Amphastar Announces FDA Approval for Teriparatide Injection amphastar.com ↗
Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen. |
| 2025-09-08 | Entera Bio Ltd. | Results Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025 enterabio.com ↗
EB613 Demonstrates Significant Effects on Both Trabecular and Cortical Bone Compartments After Just 6 Months of Treatment in Phase 2 Study; Cortical Improvements Comparable to Injectable Teriparatide and Abaloparatide |
| 2025-07-28 | Entera Bio Ltd. | Regulatory Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis enterabio.com ↗
the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal |
| 2024-06-03 | Entera Bio Ltd. | Results Entera Bio Reports Phase 1 Clinical Data of First-in-Class, Oral PTH(1-34) Peptide Candidate (EB612) for Patients with Hypoparathyroidism at ENDO 2024 enterabio.com ↗
Significant systemic exposure was reported following both administrations of EB612 tablets. |
| 2023-11-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of a Generic Version of Forteo® (teriparatide injection), in the U.S. tevapharm.com ↗
Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States. |
| 2023-10-16 | Entera Bio Ltd. | Results Entera Bio Reports Rapid Pharmacodynamic (PD) Response and Consistent Pharmacokinetic (PK) Data for its First-in-Class Oral PTH(1-34) Mini Tablets at the ASBMR 2023 Annual Meeting enterabio.com ↗ |
| 2023-02-15 | Entera Bio Ltd. | Regulatory Entera Bio Announces FDA’s Acceptance of a Type D Meeting Review to Affirm Design of the Pivotal, Phase 3 Protocol for EB613 PTH Mini Tablets, as the First Oral Osteoanabolic Treatment of Post-Menopausal Osteoporosis enterabio.com ↗ |
| 2022-12-06 | RANI Therapeutics | Results Rani Therapeutics Announces Repeat-Dose Topline Results from RT-102 Phase 1 Study ranitherapeutics.com ↗
The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill™ GO. |
| 2022-11-14 | Halcygen Pharmaceuticals Limited | Regulatory Stelis receives a positive recommendation from European Medicines Agency (EMA) granting market authorization for KaulivTM, a recombinant human teriparatide biosimilar to treat osteoporosis strides.com ↗
Stelis receives a positive recommendation from European Medicines Agency (EMA) granting market authorization for KaulivTM, a recombinant human teriparatide biosimilar to treat osteoporosis. |
| 2022-11-10 | Entera Bio Ltd. | Results Entera Bio Provides Corporate Updates and Financial Results for the Third Quarter of 2022 enterabio.com ↗
These findings are consistent with the positive correlation between the change in lumbar spine BMD and EB613 dose after six months of treatment. |
| 2022-10-06 | Entera Bio Ltd. | Regulatory Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis enterabio.com ↗
The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613 in post-menopausal osteoporosis patients. |
| 2022-09-12 | Entera Bio Ltd. | Results Entera Bio Presents Dose Proportional Absorption and Correlation to BMD Clinical Response Data from its Phase 2 Study of EB613 in Post-Menopausal Osteoporosis Patients at the ASBMR 2022 Annual Meeting enterabio.com ↗
These new analyses of blood hPTH concentration shortly after a dose of oral EB613 tablets confirm a strong, statistically significant correlation between mean blood level and the dose of EB613 taken. |
| 2022-08-10 | RANI Therapeutics | Results Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of RT-102 in Osteoporosis ranitherapeutics.com ↗
specifically RT-102 delivered PTH with between 300-400% greater bioavailability than subcutaneous Forteo® (teriparatide) in the study. |
| 2022-07-18 | Entera Bio Ltd. | Regulatory Entera Bio Announces Execution of Key Regulatory Milestones for EB613, the First Oral Anabolic Drug Proposed for the Treatment of Osteoporosis; Miranda Toledano Assumes CEO Position enterabio.com ↗
FDA re-confirmed that with a well-designed BMD study, EB613 approval would not require a fracture study |
| 2022-02-20 | MinaPharm Pharmaceuticals | Results Minapharm Pharmaceuticals Announces the Successful Completion of its Phase 1 Clinical Trial in Europe for its Recombinant Teriparatide, Bonosome. minapharm.com ↗
The primary endpoints of demonstrating pharmacokinetic equivalence between Bonosome rDNA and the reference product FORSTEO® were reached and were within the biosimilarity ranges of 80% to 125%. |
| 2021-10-28 | Entera Bio Ltd. | Results Entera Bio Publishes Key Study Describing its Oral Delivery Technology Platform for Biologic Drugs enterabio.com ↗
The researchers concluded that an appropriate combination of these different technological approaches considerably contributes to the efficient oral delivery of a number of biological macromolecules. |
| 2021-08-16 | Entera Bio Ltd. | Results Entera Bio Reports Second Quarter 2021 Financial Results and Provides Clinical Updates enterabio.com ↗
The most important BMD endpoint — change in lumbar spine BMD after 6 months — was met in the double-blind, dose-ranging, placebo-controlled study in 161 postmenopausal female subjects with osteoporosis or with low BMD. |
| 2021-08-02 | Entera Bio Ltd. | Results Entera Bio to Present Phase 2 EB613 Oral PTH Osteoporosis Treatment 3-Month Findings at the American Society for Bone and Mineral Research Annual Meeting enterabio.com ↗
The Phase 2 clinical trial of EB613, an oral formulation of human parathyroid hormone (PTH) (1-34), for the treatment of osteoporosis met its primary and key secondary endpoints, positioning it to be the first oral bone building (anabolic) product to treat osteoporosis patients. |
| 2021-05-20 | Entera Bio Ltd. | Results Entera Bio Reports First Quarter 2021 Financial Results and Provides Clinical Updates enterabio.com ↗
The study met its primary 3-month endpoint. |
| 2021-03-18 | Entera Bio Ltd. | Results Entera Bio Ltd Announces Operating and Financial Results for the Fourth Quarter and Year Ended December 31, 2020 enterabio.com ↗
Achieved Primary Endpoint in EB613 Phase 2 Clinical Trial |
| 2021-03-15 | MinaPharm Pharmaceuticals | Regulatory Minapharm Announces the First of its Kind Approval from the German Regulatory Authority BfArM to Conduct a Phase 1 Clinical Trial of a Biosimilar Developed in Egypt and the Region minapharm.com ↗
Minapharm Pharmaceuticals S.A.E has announced today that the German regulatory authority BfArM (Federal Institute for Drugs and Medical Devices) approved a phase 1 clinical trial for its biosimilar teriparatide in Germany. |
| 2021-03-11 | Entera Bio Ltd. | Results Entera Bio Ltd Announces Positive Topline EB613 Phase 2 Biomarker Data enterabio.com ↗
The trial’s primary endpoint was met - the complete 3-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P <0.04) as compared to placebo. |
| 2021-02-25 | Entera Bio Ltd. | Results Entera Bio Announces Publication of Phase 2 Hypoparathyroidism Study in the Journal of Bone and Mineral Research enterabio.com ↗
The Phase 2a study demonstrated the safety and tolerability of EB612 administered four times daily for 16 weeks to patients with HypoPT. |
| 2020-08-20 | Entera Bio Ltd. | Results Entera Bio Ltd Announces Interim Data From Phase 2 Clinical Trial of EB613 in Osteoporosis and Second Quarter 2020 Financial Results enterabio.com ↗
Based on the 6-month data, EB613 generated a mean placebo adjusted increase in lumbar spine BMD of 2.15% (p = 0.08) for the 14 patients in the 1.5 mg treatment arm, as compared to 16 patients in the placebo arm. |
| 2020-05-21 | Entera Bio Ltd. | Results Entera Bio Ltd Announces Interim Biomarker Data From Phase 2 Clinical Trial of EB613 and First Quarter 2020 Financial Results enterabio.com ↗
The study demonstrated statistically significant effects on the P1NP biomarker after one month of treatment (p<0.001) as compared to placebo, and meaningful increases at months two and three as compared to placebo with the highest EB613 dose (1.5 mg). |
| 2019-05-30 | Alvogen Korea | Regulatory Alvogen and Pfenex Announce Acceptance of MAA for PF708 alvogen.com ↗
Alvogen and Pfenex Inc. (NYSE American: PFNX) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) submitted for PF708 (Teriparatide). |
| 2017-11-09 | Eli Lilly and Company | Results New Data on FORTEO® (teriparatide [rDNA origin] injection) Showed Reduced Risk for New Vertebral and Clinical Fractures in Postmenopausal Women with Severe Osteoporosis lilly.com ↗
Results from the study's primary endpoint showed that at 24 months, fewer patients taking FORTEO® had new vertebral fractures as compared to patients taking risedronate (5.4% vs. 12.0%, p <0.0001). |
| 2016-04-01 | Amgen | Results Amgen And UCB Present Positive Data At ENDO 2016 Comparing Romosozumab With Teriparatide amgen.com ↗
At the hip, patients transitioning to teriparatide showed either no gains or significant decreases in these parameters. |
| 2015-10-12 | Amgen | Results New Exploratory Analysis Showed Romosozumab Increased Estimated Bone Strength More Than Teriparatide amgen.com ↗
The small exploratory sub-study data showed that, at month 12, the investigational bone-forming agent romosozumab increased estimated bone strength (percent change from baseline) at the spine and hip more than open-label teriparatide in postmenopausal women with low bone mass. |
| 2015-09-01 | Amgen | Results Amgen And UCB Announce Positive Top-Line Results From Open-Label Phase 3 Study Of Romosozumab Compared With Teriparatide amgen.com ↗
The study (NCT01796301) met the primary endpoint, demonstrating a statistically significant difference in favor of romosozumab in the percent change of total hip bone mineral density (measured by DXA) through month 12. |
| 2013-05-29 | Eli Lilly and Company | Results New Data on FORTEO® (teriparatide [rDNA origin] injection) Show Increased Bone Mineral Density in Men with Glucocorticoid-Induced Osteoporosis lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced new data showing that FORTEO significantly increased lumbar spine volumetric bone mineral density (vBMD) compared to risedronate in men with glucocorticoid-induced osteoporosis. |
| 2012-10-15 | Eli Lilly and Company | Results Lilly Announces New Data Further Exploring Mechanistic Differences Between FORTEO® (teriparatide [rDNA origin] injection) and Zoledronic Acid lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today presented data comparing the effects of FORTEO and zoledronic acid on transiliac crest bone biopsies at six months in postmenopausal women with osteoporosis, based on additional analysis of data from the SHOTZ trial. |
| 2012-08-07 | Eli Lilly and Company | Results Lilly Announces Study Results Regarding Postmenopausal Women with Back Pain Caused by Vertebral Fractures lilly.com ↗
At six months, more than half of patients in both treatment groups reported a 30 percent or greater reduction in worst back pain (FORTEO — 59.2 percent, risedronate — 57.4 percent; p=0.64). |
| 2011-09-19 | Eli Lilly and Company | Results Research Suggests FORTEO® Significantly Increases Bone Strength lilly.com ↗
Researchers concluded that FORTEO increased vertebral and femoral strength in the spine and hip bones compared to baseline. |
| 2011-09-19 | Eli Lilly and Company | Results New Data Explore Mechanistic Differences Between FORTEO® and Zoledronic Acid lilly.com ↗
Dynamic indices of bone formation, including mineralizing surface/bone surface (MS/BS) and bone formation rate (BFR), were significantly higher in women treated with FORTEO than in women treated with zoledronic acid at six months. |
| 2009-07-23 | Eli Lilly and Company | Regulatory /C O R R E C T I O N -- Eli Lilly and Company/ lilly.com ↗
the U.S. Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug FORTEO(R) [teriparatide (rDNA origin) injection] |
| 2008-02-22 | Eli Lilly and Company | Regulatory FORSTEO(R) Receives Positive Opinion from the European Committee for Medicinal Products for Human Use for the Treatment of Glucocorticoid-Induced Osteoporosis lilly.com ↗
Eli Lilly and Company (NYSE: LLY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of FORSTEO(R) (teriparatide [rDNA origin] injection) for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture. |
| 2007-11-14 | Eli Lilly and Company | Results FORTEO(R) Increased Spine Bone Mineral Density in Patients with Glucocorticoid-Induced Osteoporosis lilly.com ↗
In this head-to-head comparator study, the increase in lumbar spine BMD was significantly greater in patients receiving teriparatide compared with alendronate at 6, 12, and 18 months of treatment (p 0.001 at all time points). |
| 2005-09-27 | Eli Lilly and Company | Results Teriparatide Relies on More than Bone Mineral Density to Reduce Vertebral Fracture Risk in Postmenopausal Women with Osteoporosis lilly.com ↗
A new data analysis of the Fracture Prevention Trial showed that increases in bone mineral density (BMD) account for 30 to 40 percent of the vertebral fracture risk reduction seen with teriparatide. |
| 2005-08-08 | Eli Lilly and Company | Results New Study Provides In-Depth Look at How Osteoporosis Treatments Function Within Bone lilly.com ↗
The study, which provides more in-depth information than previously available about these two treatments, found that both therapies increase bone mineral density (BMD), but to different degrees and through different means. |
| 2004-10-04 | Eli Lilly and Company | Results Analysis Showed Teriparatide Reduced Fracture Risk Independent of Bone Turnover lilly.com ↗
Data presented today at the 26th annual meeting of the American Society for Bone and Mineral Research (ASBMR) show that the ability of teriparatide to prevent fractures remained consistent regardless of pretreatment bone turnover status. |
| 2004-10-03 | Eli Lilly and Company | Results Number, Severity of Fractures Predicts Future Risk lilly.com ↗
These trends were not observed in women treated with FORTEO. |
| 2004-06-16 | Eli Lilly and Company | Results New Analysis Showed Early Patient Response to Forteo in Postmenopausal Women with Osteoporosis lilly.com ↗ |
| 2001-07-27 | Eli Lilly and Company | Regulatory FDA Advisory Committee Recommends Approval of Lilly's FortéoTM for the Treatment of Osteoporosis in Postmenopausal Women lilly.com ↗ |
All press releases naming this drug 54 releases
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 154 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Teriparatide | “This study is a Phase 1, multi-center, 2-part, subject- and investigator-blind, randomized, placebo-controlled, multiple dose study of transdermal teriparatide (80-µg dose) in...” NCT01250145 ↗131“Teriparatide (TP), a recombinant human parathyroid hormone (PTH 1-34), is a bone forming agent mainly used to treat osteoporotic patients with high risk of osteoporotic fracture.” NCT04241211 ↗ “Teriparatide (recombinant human parathyroid hormone [1-34]) increases bone formation and improves bone microarchitecture, thereby reducing the risk of fractures.” PMID 18822620 ↗ Jun 2008 “This longitudinal clinical trial assessed outcomes of periodontal surgery and teriparatide administration in vitamin-D-sufficient and -insufficient individuals.” PMID 21555774 ↗ May 2011 “Teriparatide is a drug currently prescribed for some osteoporosis patients by their doctor to be taken by injection.” NCT01913834 ↗ “Teriparatide Injection daily formulation administered for 2 weeks, followed by SAL056 for 6 weeks.” NCT07579936 ↗ “The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab” NCT02130973 ↗ “the sub-cutaneous form of teriparatide, the active ingredient in PTH134” NCT01224717 ↗ “Teriparatide (Forsteo®), 20µg s.c. daily for 24 months.” NCT01801397 ↗ “transdermal administration of teriparatide acetate” NCT01551602 ↗ “Forsteo (Teriparatide)” NCT01321723 ↗ |
| Known as | AK159 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01935479 ↗ |
| Known as | Forsteo | “Patients were administered 20mcg of TP (Forsteo) subcutaneously once a day from the day between before 3months to after 3months about surgery.” NCT04241211 ↗6“in comparison to Forsteo®, the sub-cutaneous form of teriparatide” NCT01224717 ↗ “Teriparatide (Forsteo) 20 micrograms daily during four weeks” NCT01105832 ↗ “Teriparatide (Forsteo®), 20µg s.c. daily for 24 months.” NCT01801397 ↗ |
| Known as | Forteo | “Each side will be grafted with Bio-Oss® or Bio-Oss® combined with 1 dose (20 µg) of teriparatide (Forteo®).” NCT06061354 ↗13“The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab” NCT02130973 ↗ “teriparatide (Forteo) has been shown to improve bone mass and microarchitecture” NCT01440803 ↗ “has been approved for the treatment of osteoporosis as FORTEO by Eli Lilly” NCT00277706 ↗ “daily injections with 20 µg teriparatide (PTH 1-34 (Forteo)) for 4 weeks” PMID 26179771 ↗ Jul 2015 “30 participants will receive teriparatide (Forteo) injection pens.” NCT00594906 ↗ “Teriparatide (Forteo) 20 ug daily Sub-Q over 12 months” NCT02025179 ↗ “two teriparatide products (PF708 and Forteo)” NCT02656810 ↗ “"Teriparatide", "Forteo® or Teribon"” NCT03702140 ↗ “Drug: Teriparatide (Forteo)” NCT03002428 ↗ “Teriparatide Forteo” NCT01945788 ↗ |
| Known as | hPTH 1-34 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00086619 ↗ |
| Known as | Osteofortil | “Teriparatide Osteofortil” NCT01945788 ↗ |
| Known as | Parathyroid Hormone (1-34) | “Oral administration of EnteraBio's Oral Parathyroid Hormone (1-34)” NCT02152228 ↗ |
| Known as | PF708 | “Drug: Teriparatide (PF708)” NCT03002428 ↗ |
| Known as | PTH | “received Synthetic Human Parathyroid Hormone 1-34 (PTH) delivered through an insulin pump” NCT00743782 ↗ |
| Known as | PTH 1-34 | “Teriparatide or PTH 1-34 is a 34 amino acid peptide derived by recombinant DNA technology from the authentic sequence of human parathyroid hormone.” NCT03994172 ↗8“Teriparatide (PTH 1-34) treatment increases peripheral hematopoietic stem cells in postmenopausal women” PMID 24420643 ↗ Jun 2014 “an oral PTH (1-34) preparation produced by Entera Bio” NCT02152228 ↗ “Teriparatide (PTH 1-34)” NCT00697463 ↗ |
| Known as | rhPTH 1-34 | “Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone.” NCT04196855 ↗1“standard treatment + Forsteo (rhPTH 1-34) during 4 weeks” NCT01105832 ↗ |
| Known as | Synthetic Human Parathyroid Hormone 1-34 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00743782 ↗ |
| Known as | Teribon | “"Teriparatide", "Forteo® or Teribon"” NCT03702140 ↗ |
| Known as | Teribone | “56.5μg teriparatide acetate(Teribone™) administered by subcutaneous injection once a week for 24 weeks.” NCT03720886 ↗ |
| Known as | teriparatide acetate | “56.5μg teriparatide acetate(Teribone™) administered by subcutaneous injection once a week for 24 weeks.” NCT03720886 ↗ |
| Known as | TPTD | “In order to maximize the early anabolic effect with teriparatide (TPTD), and to avoid the development of tachyphylaxis to the continued daily administration of TPTD beyond 6...” NCT02130973 ↗7“PURPOSE: To evaluate the effects of cyclic vs daily teriparatide treatment (TPTD) on volumetric bone mineral density (vBMD) and bone strength at the hip and spine in women who...” PMID 36410666 ↗ Nov 2022 “Treatment of osteoporosis with an anabolic agent, teriparatide [human PTH 1-34 (TPTD)], is effective in reducing incident fractures, but patient resistance to daily sc...” PMID 19858319 ↗ Oct 2009 “Teriparatide (TPTD) increases skeletal mass, bone turnover markers, and bone strength, but in vivo effects at individual skeletal sites have not been characterized.” PMID 19929434 ↗ May 2010 “INTRODUCTION: To determine if teriparatide (20 μg/day; TPTD) results in improved radiologic healing, reduced pain, and improved functional outcome vs placebo” PMID 34383100 ↗ Aug 2021 “Teriparatide (TPTD) or PTH 1-34 which will be obtained from commercial sources and given at 20 mcg daily, by SC injection.” NCT03994172 ↗ “human recombinant parathyroid hormone (hPTH) 1-34 (or teriparatide (TPTD))” NCT01440803 ↗ “Teriparatide (TPTD) 20mcg daily using Teriparatide Pen Injector” NCT03735537 ↗ |
| Action | Restore | “therapeutic PTH replacement” NCT00001304 ↗ |
| Modality | Protein / enzyme biologic | “79 adults with OI were randomized to receive 20 μg recombinant human parathyroid hormone (teriparatide) or placebo for 18 months” PMID 24463451 ↗ Jan 2014 |
| Route | Subcutaneous | “twice daily subcutaneous injections” NCT00001304 ↗ |