Drugs / Calcitonin
Calcitonin
also known as
Calcitare · Calcitonin, unspecified · Calcitonina · Calcitonine · Calsynar · Miacalcic · salmon calcitonin · Throcalcitonin
Protein / enzyme biologic targets CALCR via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | TBRIA | postmenopausal osteoporosis | — | “its New Drug Application (NDA) for TBRIA TM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015” tarsatherapeutics.com ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01292187 | Jan 2011 → May 2012 | osteoporosis | Tarsa Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT00004358 | Nov 1992 → ? | calcinosis | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07655804 | Jul 2026 → Apr 2027 expected | herpes zoster | Tanta University | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03342001 | Jun 2018 → Jun 2019 | hypothyroidism | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT00444808 | Feb 2007 → Jan 2008 | — | University of Montreal | Terminated | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06330168 | Mar 2024 → May 2025 | — | Tanta University | Completed | No outcome recorded |
| — | NCT05805683 | May 2023 → May 2027 expected | neuropathy, painful, spinal cord injury, thyrocalcitonin secretion disease | Tanta University | Recruiting | No outcome recorded |
| — | NCT00688077 | May 2008 → Dec 2012 | hypophosphatemia | Rijnstate Hospital | Completed | No outcome recorded |
| — | NCT00478335 | May 2007 → Oct 2012 | nephrogenic diabetes insipidus | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00114803 | Jan 2004 → Oct 2006 | Crohn disease, ulcerative colitis | Boston Children's Hospital | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2 | NCT02358304 Comparator | Sep 2007 → Feb 2015 | giant cell reparative granuloma | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00543218 Comparator | Dec 2002 → Jun 2004 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT04445857 Comparator | Sep 2020 → Jan 2021 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT03935984 Background | May 2019 → Jun 2026 overdue | hypercalcemia disease, primary hyperparathyroidism | Joseph Sferra | Recruiting | No outcome recorded |
| — | NCT02115360 Comparator | Apr 2014 → Aug 2016 | congenital amputation | Tanta University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2015-10-19 | Tarsa Therapeutics, Inc. | Regulatory Tarsa Therapeutics’ NDA for TBRIA(TM), the First Oral Calcitonin for the Treatment of Postmenopausal Osteoporosis, Accepted for Filing tarsatherapeutics.com ↗
its New Drug Application (NDA) for TBRIA TM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review |
| 2013-10-07 | Tarsa Therapeutics, Inc. | Results Tarsa Therapeutics Presents Meta-analysis at ASBMR 2013 Showing Calcitonin Does Not Appear to be Associated with Increased Risk of Cancer tarsatherapeutics.com ↗
The meta-analysis yielded an odds ratio close to unity with a narrow bound on the error of estimation, suggesting that calcitonin does not appear to be associated with an increased risk of cancer. |
| 2012-10-16 | Tarsa Therapeutics, Inc. | Results Tarsa Therapeutics Reports Positive Results from Phase II Trial of Its Oral Calcitonin in Prevention of Post-Menopausal Osteoporosis tarsatherapeutics.com ↗
Tarsa’s oral calcitonin was superior to placebo in increasing BMD at the lumbar spine in this population, and its safety profile did not differ substantially from placebo. |
| 2012-10-12 | Tarsa Therapeutics, Inc. | Regulatory Tarsa Therapeutics to Assist Therapicon in Its Challenge to CHMP’s Recommendation to Limit Use of Calcitonin tarsatherapeutics.com ↗
Therapicon’s request for a reexamination of the recommendation has been acknowledged by the CHMP, and a timetable for the reexamination process has been set. |
| 2011-09-18 | Tarsa Therapeutics, Inc. | Results Tarsa Therapeutics Presents Positive Efficacy and Safety Data Comparing Its Oral Calcitonin to Nasal Calcitonin and Placebo in Phase III Osteoporosis Treatment Trial tarsatherapeutics.com ↗
The data reported today show that OSTORA achieved all of the efficacy endpoints in the trial and indicate that the safety profile of OSTORA did not substantially differ from nasal calcitonin or placebo. |
| 2011-03-24 | Tarsa Therapeutics, Inc. | Results Tarsa Therapeutics Reports Positive Top-Line Results from Pivotal Phase III Oracal Trial of Its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis tarsatherapeutics.com ↗
Tarsa Therapeutics today announced that the Phase III ORACAL trial of its oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, positive top-line results. |
| 2010-09-24 | Tarsa Therapeutics, Inc. | Results Tarsa Therapeutics and Unigene Present Preclinical Data Suggesting Calcitonin May Have Utility in Combination Therapy for the Treatment Of Osteoarthritis tarsatherapeutics.com ↗
In the data presented, calcitonin did exhibit synergistic effects in reducing collagen degradation when combined with low doses of each of two other experimental anti-arthritis agents, while none of the agents reduced collagen release on its own at the concentrations used. |
All press releases naming this drug 16 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | calcitonin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06330168 ↗ |
| Known as | Calcitare | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594242 ↗ |
| Known as | Calcitonin, unspecified | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594242 ↗ |
| Known as | Calcitonina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594242 ↗ |
| Known as | Calcitonine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594242 ↗ |
| Known as | Calsynar | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594242 ↗ |
| Known as | Miacalcic | “Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally” NCT04445857 ↗ |
| Known as | salmon calcitonin | “patients will receive subcutaneous salmon calcitonin 100 IU (ampoule = 1 ml) daily for three weeks.” NCT07655804 ↗ |
| Known as | Throcalcitonin | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594242 ↗ |
| Action | Activate | “Calcitonin receptor agonist” CHEMBL4594242 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL4594242 ↗ |
| Route | Subcutaneous | “subcutaneous injections of salmon calcitonin” NCT00004358 ↗ |
| Target | CALCR | “Calcitonin receptor agonist” CHEMBL4594242 ↗ |