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Calcitonin salmon (Miacalcin, Fortical)

Also known as Miacalcin and Fortical.

In 2013 an FDA advisory panel voted against its continued marketing for osteoporosis, over a possible cancer signal. The FDA did not fully withdraw it.

CysSerAsnLeuSerThrCysValLeuGlyLysLeuSerGlnGluLeuHisLysLeuGlnThrTyrProArgThrAsnThrGlySerGlyThrPro
32 amino acids, in order. End caps, bridges and anything attached to the chain are not drawn. Source: PubChem.
Human evidence
Grade A

Large trials

Completed randomized trials
3+

The plus sign marks a floor: the record counts more trials than it lists.

Approved?
US and EU

Approved in the US. Approved in the EU historically

Sport (WADA)
Not named

Not named on WADA's list. That is not clearance.

Checked on .

How we count a trial
Short answer

As of September 2026, salmon calcitonin is an approved medicine in the US for osteoporosis and Paget's disease. In the EU the record calls it "approved historically". In 2013 an FDA advisory panel voted against its continued marketing for osteoporosis, over a possible cancer signal. The FDA did not fully withdraw it. If a vial reached you outside a pharmacy, you cannot tell from the outside what it holds.

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What is salmon calcitonin?

Calcitonin is a natural hormone that helps regulate calcium and slows bone breakdown. The medicine is made in a lab to match salmon calcitonin, which the record says is far more potent in people than the human form. It has been used since the 1970s or 1980s for postmenopausal osteoporosis, Paget's disease of bone and high blood calcium.

Does salmon calcitonin work?

The FDA reviewed the trials and approved it for osteoporosis and Paget's disease. The PROOF trial showed fewer new spine fractures than placebo at the approved strength, and the record calls the effect modest next to newer bone drugs.

What we found. 3+ completed randomized trials counted on the record. The study list names one trial, PROOF. Its second row is a panel review of pooled trials, and its third was a regulatory notice, now in the legal section. The number shows with a plus sign until every counted trial is listed.

Studies on the salmon calcitonin record: each study, what it was tested in, its status and what it shows.
PROOF trial, of one form of the medicinePeoplePublished 2000Fewer spine fractures than placebo at the approved strength
Pooled calcitonin trials, reviewed by an FDA advisory committeePeopleReviewed by the panel in 2013A possible small rise in cancer cases. The panel voted against continued marketing for osteoporosis
How we count a trial

Is salmon calcitonin safe?

In 2013 an FDA advisory committee reviewed pooled trial data that suggested a small rise in cancer cases with long-term use. Those trials were not each designed to assess cancer risk. No dedicated long-term safety study has directly confirmed or refuted the signal. The panel voted that the benefits for osteoporosis no longer outweighed the risk. That history belongs to the approved medicine. A vial from another source is a different matter, and the next section covers it.

What is in a vial sold as salmon calcitonin?

Miacalcin and Fortical are the brand names on this record. The record shows no sign of salmon calcitonin sold outside pharmacies. If a vial reached you another way, no study on this page looked at it, and the checklist lists what to ask the seller.

What don't we know?

  • Whether the 2013 cancer signal is real. The pooled trials were not each designed to assess cancer risk.
  • What a dedicated long-term safety study would show. None has confirmed or refuted the signal.
  • What its approval status in the EU is today. The record says "approved historically" and gives no date.
  • What is in any vial that did not come from a pharmacy.

The other side

Salmon calcitonin comes with a prescription and a doctor's care, and people have used it for decades. The 2013 vote was about the osteoporosis use, and the FDA did not fully withdraw the medicine. The record says it is used today mainly as an older or second-line option.

What would change this record?

  • A long-term safety or registry study built to measure cancer cases with salmon calcitonin. The record says it would do most to settle the open safety question.

Change log

  • Record checked. No change logged yet.
Every change on the Table

Three questions to ask next

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More questions about salmon calcitonin

Is salmon calcitonin still approved?

In the US, yes, for osteoporosis and Paget's disease. A 2013 advisory panel recommended against continued marketing for osteoporosis, and the FDA did not fully withdraw the medicine.

Does salmon calcitonin cause cancer?

That is not settled. Pooled trial data suggested a small rise in cancer cases with long-term use. Those trials were not each designed to assess cancer risk, and no dedicated study has confirmed or refuted the signal.

Is Miacalcin the same as salmon calcitonin?

Miacalcin and Fortical are the brand names on this record for salmon calcitonin.

Why is it called salmon calcitonin?

The medicine is made in a lab to match the salmon form of the hormone. The record says that form is far more potent in people than human calcitonin.

What is salmon calcitonin used for?

The record lists postmenopausal osteoporosis, Paget's disease of bone and high blood calcium. It says use today is mainly as an older or second-line option.
Sources

Record checked on . Each source shows the date it was checked.

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