Miacalcin, Fortical
Evidence Grade A — Regulatory approved. 44 published studies. 131 registered clinical trials.
Loading...
Calcitonin-salmon (sold as Miacalcin and generics) is a synthetic version of a bone-regulating hormone, available mainly as a nasal spray. It slows the breakdown of bone and has been used for osteoporosis, Paget's disease of bone, and to quickly bring down dangerously high blood calcium levels. It also has a notable pain-relieving effect on bone pain, particularly from spinal fractures.
44 published studies: 28 human, 6 animal, 1 in-vitro, 10 reviews
Calcitonin-salmon is marketed as Miacalcin and generic equivalents (injection approved 1986, nasal spray approved 1995). It is used for postmenopausal osteoporosis, Paget's disease of bone, and emergency treatment of high blood calcium.
The PROOF trial showed a 33% reduction in vertebral fractures with the nasal spray, though this finding has been debated due to high dropout rates. In 2013, the European Medicines Agency recommended withdrawing calcitonin nasal spray due to a small increased risk of cancer with long-term use, though the FDA kept it available with duration-of-use guidance. Calcitonin has largely been superseded by more effective osteoporosis treatments like bisphosphonates, denosumab, and bone-building agents, but retains a role in acute pain management for vertebral compression fractures and emergency calcium-lowering.
Calcitonin works by directly targeting osteoclasts — the cells responsible for breaking down bone. When calcitonin binds to receptors on these cells, it causes them to shrink, detach from bone surfaces, and stop resorbing bone. This slows bone loss. Calcitonin also has a pain-relieving effect on bone pain that appears to work through the central nervous system, which is why it has been used for painful vertebral fractures. The salmon form is used because it is 40–50 times more potent than human calcitonin.
The PROOF trial reported a 33% reduction in spinal fractures with the nasal spray, though that finding has been questioned due to high dropout rates during the study. A more significant concern emerged in 2013 when European regulators identified a small increased risk of cancer with long-term use, leading them to recommend withdrawal of the nasal spray. US regulators kept it available but added guidance to limit treatment duration. In practice, calcitonin has been largely replaced by more effective osteoporosis treatments — bisphosphonates, denosumab, and bone-building agents like teriparatide all offer stronger fracture protection. Calcitonin still has a recognised role in managing the acute pain of spinal compression fractures and in emergency calcium-lowering, but it is no longer a front-line osteoporosis treatment. Ongoing research is limited.
Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU
Chinese Real-world Study of Treatment of Vestibular Migraine
A Study to Compare Blood Levels of Different Dosage Formulations of the Study Medicine That Is a CGRP Receptor Antagonist in Healthy Adults
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels in Patients With Head and Neck Malignancies Undergoing Radiotherapy
Induction of Migraine Attacks With Aura Using Calcitonin Gene-Related Peptide
Health Canada Market Authorisation
FDA ORIG 1
FDA SUPPL 1
FDA SUPPL 2
FDA SUPPL 7
FDA SUPPL 6
FDA SUPPL 4
FDA SUPPL 9
FDA SUPPL 8
FDA SUPPL 3
FDA SUPPL 5
FDA SUPPL 10
FDA SUPPL 11
FDA SUPPL 12
FDA SUPPL 14
FDA SUPPL 13
FDA SUPPL 15
FDA SUPPL 16
FDA SUPPL 17
FDA SUPPL 18
FDA SUPPL 20
FDA SUPPL 22
FDA SUPPL 24
FDA ORIG 1
FDA ORIG 1
FDA SUPPL 30
FDA SUPPL 34
FDA SUPPL 8
FDA SUPPL 3
FDA SUPPL 10
FDA SUPPL 33
FDA SUPPL 35
FDA SUPPL 36
FDA SUPPL 5
FDA SUPPL 6
FDA SUPPL 13
FDA SUPPL 37
FDA SUPPL 14
FDA ORIG 1
FDA ORIG 1
FDA ORIG 1
FDA ORIG 1
FDA ORIG 1
FDA ORIG 1
FDA ORIG 1
Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.
Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.
Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.
