Is calcitonin-salmon FDA-approved, and what does the research show?

What is calcitonin-salmon?

Calcitonin is a hormone that lowers the level of calcium in the blood and increases the amount held in bone ³. In mammals it is secreted by the parafollicular cells of the thyroid gland, cells lying beside the thyroid's follicles, and in birds and fish by a separate gland ¹. Calcitonin-salmon is a synthetic polypeptide, a chain of amino acids, 32 long, built in the same linear sequence as the hormone of the salmon ¹.

The salmon form acts essentially like the calcitonins of mammals, but it is more potent per milligram and lasts longer ¹. It is sold in the United States as Miacalcin injection and as generic injections and nasal sprays, all on prescription ⁴. Its approved uses are all disorders of bone and calcium ¹, ².

Is calcitonin-salmon FDA-approved?

Yes. Calcitonin-salmon is approved by FDA as the prescription medicine Miacalcin, with "Initial U.S. Approval: 1975" on the label's header ¹. FDA's Drugs@FDA record lists NDA 017808, Miacalcin injection, approved July 3, 1986, held by Mylan Ireland, with marketing status "Prescription" for the strength now sold ⁴. The 1975 approval predates this application, and Drugs@FDA lists two earlier Calcimar applications, now discontinued; NDA 017769 was approved April 17, 1978 ¹, ⁴, ⁵.

FDA withdrew approval of Calcimar (NDA 017497) effective September 22, 1999, after its holder told the agency the product was "no longer marketed" ⁶. FDA withdrew approval of Calcimar (NDA 017769) effective December 7, 2007, after its holder told the agency the product was "no longer marketed" ⁷.

The brand nasal spray, NDA 020313, was approved August 17, 1995 and now carries the status "Discontinued" ⁴. The record carries a "Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons," the Federal Register being the U.S. government's daily journal of rules and notices ⁴. Eleven generic products, nine injections and two nasal sprays, hold the status "Prescription" as of November 6, 2026, the date of the data ⁴.

The injection label approves three uses, each in its own words. The first is "the treatment of symptomatic Paget's disease of bone in patients with moderate to severe disease," and only "in patients who do not respond to alternative treatments or for whom such treatments are not suitable" ¹. The second is "the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required" ¹. The label frames this use as a bridge "until more specific treatment of the underlying disease can be accomplished" ¹.

The third is "the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause," again "reserved for patients for whom alternative treatments are not suitable" ¹. For this use the label states that "Fracture reduction efficacy has not been demonstrated" ¹. The nasal spray label carries the osteoporosis use alone, with the same limits ². Both labels add a limitation of use: "Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis" ¹, ².

FDA's own drug-safety page describes the products as "used for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable" ⁸. Drugs@FDA lists labeling supplements approved March 11, 2014 for both Miacalcin products, with that safety page attached to each record ⁴. FDA's March 11, 2014 approval of supplement S-035 revised the injection label's "Indications and Usage, Warnings and Precautions, and Adverse Reactions sections" on "information that suggests an increased risk of overall malignancies in calcitonin-salmon-treated patients" ⁹.

Europe went further. On July 19, 2012 the European Medicines Agency completed a review of calcitonin-containing medicines, "concluding that there was evidence of a small increased risk of cancer with long-term use of these medicines" ³. Its committee recommended that they "should only be authorised for short-term use in Paget's disease, acute bone loss due to sudden immobilisation and hypercalcaemia caused by cancer," and that for osteoporosis "they should no longer be used for this condition" ³. The committee confirmed that recommendation on November 15, 2012, and the European Commission issued its decision on February 13, 2013 ³.

In the United States the osteoporosis use remains on the labels, reserved for women for whom alternative treatments are not suitable ¹, ². The route to any of its uses is a licensed clinician's prescription ⁴.

See the FDA status of every peptide, updated weekly.

How does calcitonin-salmon work?

Calcitonin-salmon is a calcitonin receptor agonist, a molecule that binds and switches on the receptor for calcitonin ¹. It "acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized" ¹. In bone, a single injection causes "a marked transient inhibition of the ongoing bone resorptive process," and prolonged use "a persistent, smaller decrease in the rate of bone resorption" ¹. Bone resorption is the breakdown of bone by cells called osteoclasts; under treatment their number falls and their activity appears to decrease ¹.

The label states the limits of this account: "The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated," though calcitonin receptors have been found on osteoclasts and on bone-forming osteoblasts ¹. In the kidney the drug increases the excretion of filtered phosphate, calcium and sodium ¹. In healthy adults blood calcium falls but stays within the normal range; in people whose bone resorption is faster, the fall is more pronounced ¹. This is the label's account of the mechanism for an approved drug ¹.

What does the research show?

The evidence sits at the top of the scale, an FDA approval ¹. The trials the injection label describes are open-label, a design in which everyone knows who is treated ¹.

Approved for Paget's disease: the trials ran several months to two years and were judged against historical controls, records of earlier patients rather than a concurrent comparison group ¹. The label does not give the number of patients in the Paget's trials ¹. Biochemical abnormalities improved by more than 30 percent in about two thirds of patients, and bone pain improved in a similar fraction ¹. Hearing loss improved infrequently, in 4 of 29 patients studied by audiometry ¹. The label adds that "There is no evidence that the prophylactic use of calcitonin-salmon is beneficial in asymptomatic patients" ¹.

Approved for hypercalcemia: four open-label trials enrolled 53 patients with elevated blood calcium from cancer, from multiple myeloma, a bone-marrow cancer, or from primary hyperparathyroidism, overactive parathyroid glands ¹. They were treated only after other methods of lowering calcium had failed or were unsuitable ¹. Against each patient's own pre-treatment level, serum calcium fell within 1 to 2 hours and the effect peaked at 24 to 48 hours ¹. The average reduction 8 hours after an injection was about 9 percent, and patients with higher calcium tended to fall further ¹. The response in primary hyperparathyroidism was smaller ¹.

Approved for postmenopausal osteoporosis by injection: two randomized, open-label, two-year studies enrolled women aged 50 to 74 with low total body calcium and vertebral bone loss or a compression fracture ¹. Total body calcium rose at one year, then trended down at two years while staying above baseline ¹. Across the two studies, 34 women on calcitonin-salmon had 6 new vertebral fractures in the first year and 7 in the second; 35 controls had 5 and 7 ¹. The label states that "No evidence currently exists to indicate whether Miacalcin injection decreases the risk of osteoporotic fracture," and that a controlled study, stopped early, "failed to demonstrate any benefit of calcitonin-salmon on fracture rate" ¹.

The nasal spray's approval rests on two randomized, two-year trials in 266 women more than 5 years past menopause, controlled by a placebo, an inactive spray given for comparison ². All had low bone mineral density, the measure of bone mass taken by scan, at the spine, forearm or hip ². In the study with calcium supplements, 100 women were analyzed, and lumbar spine density rose 1.36 percentage points more than on placebo over two years ². In the study without supplements, 39 women were analyzed and the difference was 2.87 points ². No effect on the dense outer cortical bone of the forearm or hip was shown, and the label states the spray "has not been shown to increase spinal bone mineral density in early postmenopausal women" ².

Studied in people for fractures: PROOF, a five-year randomized, placebo-controlled trial published in September 2000, enrolled 1,255 postmenopausal women with established osteoporosis ¹⁰. It was double-blind, so neither the women nor the investigators knew who received the drug ¹⁰. They received one of three strengths of nasal spray or placebo, all with calcium and vitamin D ¹⁰. Of them, 1,108 had at least one follow-up spine X-ray, 783 completed three years and 511 completed five ¹⁰. Lumbar spine density rose 1 to 1.5 percent from baseline in all active arms ¹⁰.

In the middle-strength arm, 51 of 287 women had a new vertebral fracture, against 70 of 270 on placebo ¹⁰. That is a relative risk of 0.67, about a third fewer fractures, with a 95 percent confidence interval, the range the true effect likely lies in, of 0.47 to 0.97 ¹⁰. The lower and higher strengths did not differ significantly from placebo, with relative risks of 0.85 and 0.84 ¹⁰. The labels, both revised in 2017, still state that fracture reduction "has not been demonstrated" ¹, ².

None of the sources cited here studies calcitonin-salmon for weight, body composition, muscle, performance or aging, as of November 10, 2026 ¹, ², ¹⁰, ³.

What are the side effects?

The injection's safety was assessed "in open-label trials several months to two years in duration" ¹. Nausea with or without vomiting was noted in about 10 percent of patients, most evident at the start of treatment and tending to fade with continued use ¹. Local inflammation at the injection site occurred in about 10 percent, and flushing of the face or hands in 2 to 5 percent ¹. Skin rashes, itching of the ear lobes, night-time urination, a feverish sensation, eye pain, poor appetite, abdominal pain, swollen feet and a salty taste have also been reported ¹.

The nasal spray's safety comes from 5 randomized, double-blind, placebo-controlled trials of one to two years in postmenopausal women aged 45 to 75 ². Among 341 women on the spray and 131 on placebo, rhinitis, an inflamed, runny or stuffy nose, was reported by 12 percent against 7 ². Back pain was reported by 5 percent against 2, and nosebleed by 4 against 5 ².

The label warns that "severe ulceration" of the nasal lining can occur and recommends periodic nasal examinations ². Antibodies to the drug were found in 69 percent of women in a two-year nasal spray study, against 3 percent on placebo ². About one half of injection-treated Paget's patients tested had them, and the labels say they "may cause loss of response to treatment" ¹, ².

The malignancy warning rests on a meta-analysis, a pooled analysis of 21 randomized controlled trials of the nasal spray or investigational oral forms ¹. The trials lasted 6 months to 5 years and enrolled 10,883 patients, 6,151 on calcitonin-salmon and 4,732 on placebo ¹. Malignancies were reported in 254 treated patients, 4.1 percent, and 137 on placebo, 2.9 percent ¹. In the 18 nasal-spray trials alone the figures were 4.5 percent against 2.3 ¹, ². The result "was heavily influenced by a single large 5-year trial," imbalances remained when basal cell carcinoma, a skin cancer, was excluded, and "A mechanism for these observations has not been identified" ¹.

The labels conclude that a "definitive causal relationship between calcitonin-salmon use and malignancies cannot be established from this meta-analysis," and that the injected routes were not studied, so "It is not possible to exclude an increased risk" for them ¹, ². In rats, two years of injections increased pituitary adenomas, tumors of the pituitary gland that the label says did not spread ¹. The label calls the significance to humans unknown, and no such finding appeared in mice ¹.

FDA's label contraindicates the drug for "Hypersensitivity to calcitonin-salmon or any of the excipients," noting that "Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat" ¹. Its warnings cover hypocalcemia, too little calcium in the blood, "associated with tetany (i.e., muscle cramps, twitching) and seizure activity," which the label says "must be corrected before initiating therapy," and abnormal urine sediment seen in volunteers at bed rest ¹. Calcitonin-salmon with lithium "may lead to a reduction in plasma lithium concentrations" ¹.

"Safety and effectiveness in pediatric patients have not been established," and there are no studies in pregnant women ¹. In rabbits, injections during organogenesis, the period when the fetus's organs form, at 4 to 18 times the human dose lowered fetal birth weights ¹.

In sport

Calcitonin-salmon is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency ¹¹. The list's section S2 covers peptide hormones, growth factors and related substances, and calcitonin is not among them ¹¹.

What JumpstartMD offers

JumpstartMD does not prescribe calcitonin-salmon. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.