Drugs / salmon calcitonin
salmon calcitonin
also known as
SMC021 · sCT · Calcitonin Salmon · Oral Calcitonin · oSCT · Recombinant Salmon Calcitonin (rsCT) · ssCT · synthetic salmon calcitonin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CALCIMAR | — | 1978-04-17 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT00486369 | Jan 2007 → ? | osteoarthritis | Nordic Bioscience A/S | Completed | No outcome recorded |
| Phase 1 | NCT00395395 | Oct 2006 → ? | postmenopausal osteoporosis | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT00411125 | Aug → Nov 2006 | postmenopausal osteoporosis | Novartis | Completed | No outcome recorded |
| Phase 1 | NCT00486317 | Oct 2005 → ? | osteoarthritis | Nordic Bioscience A/S | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00421590 | Oct 2006 → ? | — | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00376311 | Sep 2002 → May 2004 | osteoarthritis | Catholic University of Louvain | Terminated | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT00959764 | Jun 2009 → Feb 2011 | postmenopausal osteoporosis | Tarsa Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT00372099 | Jan 2007 → Oct 2011 | — | Rene Rizzoli | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03812991 | Jul 2019 → Sep 2022 | — | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 4 | NCT00754884 | Oct 2008 → Feb 2009 | fibromyalgia | Unidad de Investigacion en Enfermedades Cronico-Degenerativas | Withdrawn | No outcome recorded |
| Phase 4 | NCT00239889 | Mar 2002 → ? | — | Novartis | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01652573 | Mar 2011 → Sep 2015 | X-linked dominant hypophosphatemic rickets | Yale University | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 2 | NCT00620854 Comparator | Feb → Apr 2008 | osteoporosis | Tarsa Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00704847 Comparator | Jun 2008 → May 2011 | osteoarthritis | Nordic Bioscience A/S | Terminated | No outcome recorded |
| Phase 3 | NCT00486434 Comparator | May 2007 → Sep 2010 | osteoarthritis | Nordic Bioscience A/S | Completed | No outcome recorded |
| Phase 3 | NCT00525798 Comparator | Mar 2007 → Aug 2011 | osteoporosis | Nordic Bioscience A/S | Completed | No outcome recorded |
| Phase 3 | NCT00414973 Comparator | Dec 2006 → Jul 2008 | osteoporosis | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT00542984 Comparator | Aug 2003 → Nov 2004 | postmenopausal osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00543023 Comparator | Jun 2003 → Aug 2004 | postmenopausal osteoporosis | Eli Lilly and Company | 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 ↗
Tarsa Therapeutics, Inc. today announced that it presented a new meta-analysis showing that salmon calcitonin does not appear to be associated with an increased risk of cancer in postmenopausal women. |
| 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 12 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | salmon calcitonin | “A total of 565 women age 46 to 86 (mean 66.5) years were randomized (4:3:2) to receive oral recombinant salmon calcitonin (rsCT) tablets (0.2 mg/d) plus placebo nasal spray,...” PMID 22437792 ↗ Aug 201214“Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials.” PMID 25582279 ↗ Jan 2015 |
| Known as | Calcitonin Salmon | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03812991 ↗ |
| Known as | Oral Calcitonin | “SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months” NCT00486434 ↗ |
| Known as | oSCT | “The aim of this study was to investigate the pharmacokinetic and pharmacodynamic parameters of oral salmon calcitonin (oSCT) administered over 14 days to men and women...” PMID 19747581 ↗ Sep 2009 |
| Known as | Recombinant Salmon Calcitonin (rsCT) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00620854 ↗ |
| Known as | sCT | “PURPOSE: To evaluate the structure-modifying and symptom efficacy, as well as safety and tolerability of oral salmon calcitonin (sCT) formulated with a 5-CNAC carrier (a...” PMID 25582279 ↗ Jan 20153“Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the...” NCT00376311 ↗ “The aim of the study was to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of 0.8 mg of oral salmon calcitonin (sCT) and the effect of timing of drug intake.” PMID 19055791 ↗ Dec 2008 “oral salmon calcitonin (sCT) treatment” PMID 20565725 ↗ Jun 2010 |
| Known as | SMC021 | “This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women” NCT00411125 ↗5“SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months” NCT00486434 ↗ “oral salmon calcitonin (SMC021)” NCT00395395 ↗ “SMC021 Oral Calcitonin” NCT00704847 ↗ |
| Known as | ssCT | “A total of 565 women age 46 to 86 (mean 66.5) years were randomized (4:3:2) to receive oral recombinant salmon calcitonin (rsCT) tablets (0.2 mg/d) plus placebo nasal spray,...” PMID 22437792 ↗ Aug 2012 |
| Known as | synthetic salmon calcitonin | “A total of 565 women age 46 to 86 (mean 66.5) years were randomized (4:3:2) to receive oral recombinant salmon calcitonin (rsCT) tablets (0.2 mg/d) plus placebo nasal spray,...” PMID 22437792 ↗ Aug 2012 |
| Action | Inhibit | “an inhibitor of osteoclast activity” PMID 18405390 ↗ Apr 2008 |
| Modality | Peptide | “Calcitonin is a polypeptide containing 32 amino acids” NCT03812991 ↗ |
| Route | Intranasal | “Salmon Calcitonin Nasal Spray” NCT00239889 ↗ |