Bones & muscles Calcitonin receptor agonist
Calcitonin-salmon
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
-
- Miacalcin (injection)
- nasal spray sold as a generic
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Calcitonin-salmon is an FDA-approved synthetic version of a natural hormone that slows bone breakdown, used mainly for postmenopausal osteoporosis, Paget's disease of bone, and high blood calcium (hypercalcemia). It comes as an injection, sold as Miacalcin, and as a nasal spray sold as a generic. A modest effect on fractures and a small possible cancer risk with long-term use make it a second-line option today.
At a glance
- Drug class
- Calcitonin receptor agonist
- Brand names
- Miacalcin (injection); nasal spray sold as a generic
- Routes
- Nasal spray; injection (under the skin or into a muscle)
- Main uses
- Postmenopausal osteoporosis, Paget's disease, hypercalcemia
- Regulatory status
- FDA-approved
- Evidence strength
- FDA approved
Summary
Calcitonin-salmon is an FDA-approved hormone copy used for osteoporosis, Paget's disease, and high blood calcium. Learn how it works and where it fits.
What is calcitonin-salmon?
Calcitonin-salmon is a lab-made copy of calcitonin, a hormone that helps regulate how much calcium is in the blood and how bone is maintained. The version used in medicine is modeled on the calcitonin found in salmon rather than the human form because the salmon hormone is more potent and longer-lasting in the body. It is approved by the FDA and has been used in clinical practice for decades under the brand names Miacalcin and Fortical.
How does it work?
It works by putting a brake on the cells that break down bone. Bone is constantly being remodeled: cells called osteoclasts dissolve old bone while others build new bone. Calcitonin-salmon binds to calcitonin receptors on osteoclasts and quiets their activity, which slows the release of calcium from bone into the blood. It also nudges the kidneys to pass more calcium in the urine. Together these effects lower blood calcium and can modestly protect bone.
What is it used for?
Calcitonin-salmon is approved for three main situations:
- In postmenopausal osteoporosis, it is used to help reduce the risk of spinal fractures in women who are more than five years past menopause and who cannot use other treatments.
- In Paget's disease of bone, a disorder in which bone is remodeled too quickly and becomes weak or misshapen, it helps bring that overactive turnover back toward normal.
- In hypercalcemia, a dangerous rise in blood calcium, the injection can be used for its rapid calcium-lowering effect.
How is calcitonin-salmon taken?
There are two main ways to use calcitonin-salmon, and the right one depends on the condition.
The nasal spray is the more convenient, needle-free option and is used for postmenopausal osteoporosis. It is delivered as a single spray into one nostril each day, alternating nostrils from day to day. Because it avoids injections, many people find it easier to stay on long term.
The injection is given either under the skin (subcutaneously) or into a muscle (intramuscularly). This form is used for Paget's disease and for hypercalcemia, and it can also be used for osteoporosis when the spray is not suitable. For hypercalcemia in particular, the injection is preferred because it lowers blood calcium quickly. People who need the injection long term are sometimes taught to give it to themselves at home, similar to how insulin is self-administered.
What does the research say?
Editor’s note
Evidence strength: FDA approved
It is approved by the FDA for postmenopausal osteoporosis, Paget's disease of bone, and hypercalcemia, with the nasal spray's osteoporosis benefit supported by the five-year, placebo-controlled PROOF trial, though the effect on fractures was modest and later reviews narrowed its long-term use.
The strongest evidence comes from a large trial of the nasal spray in osteoporosis. According to PubMed, the five-year PROOF study of 1,255 postmenopausal women found that the 200 IU daily nasal dose reduced the risk of new spinal fractures by about 33% compared with placebo. The result was statistically significant, but the effect was modest and, notably, the higher and lower doses tested did not show the same clear benefit, which left some uncertainty about how robust the finding was.
Safety and the cancer-risk review
The most important safety development came years after approval. In 2013, a reassessment by European regulators, echoed by an FDA advisory committee, pooled data across trials and found a small but consistent increase in cancer rates among people treated with calcitonin over long periods. Regulators concluded that the modest benefit no longer clearly outweighed this risk for routine, long-term osteoporosis use.
As a result, the nasal spray's role in osteoporosis was narrowed, and calcitonin-salmon is now generally reserved for people who cannot take other, better-established bone treatments. More common, milder side effects include nasal irritation with the spray and nausea or flushing with the injection. The injection's label also warns of serious allergic reactions and low blood calcium.
Sources: Drugs.com calcitonin-salmon monograph; DrugBank (calcitonin salmon); the PROOF Study (Chesnut et al., The American Journal of Medicine, 2000, DOI: 10.1016/s0002-9343(00)00490-3), indexed on PubMed; and the European Medicines Agency calcitonin referral and cancer-risk review. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
- [5]
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