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Bone & calcium

Calcitonin (salmon)

A salmon-derived hormone peptide once common in bone disease, now used more narrowly after regulators weighed modest benefit against a debated malignancy signal.

L4Strong humanApproved medicineApprovedModerate confidenceLast reviewed 2026-08-23
NasalSC injectionIM

Also known as: salmon calcitonin, Miacalcin, Fortical

Evidence passport

Last reviewed 2026-08-23

Evidence level
L4Strong human
Confidence
Moderate confidence
Human efficacy
65/100
Human safety
60/100
Regulatory status
Approved medicine
Development
Approved
Routes
NasalSC injectionIM
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Source curation pending
Clinical maturity
Established medicine with a narrowed modern role

Overview

Human evidence65/100
Preclinical evidence65/100
Human safety evidence60/100

Clinical maturity: Established medicine with a narrowed modern role

Routes & formulations

Studied / approved routes

NasalSC injectionIM

Injectable and nasal products carry different approved indications; evidence for one does not generalise to the other.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A synthetic version of salmon calcitonin, a hormone peptide that slows bone breakdown by acting on osteoclasts; more potent milligram-for-milligram than human calcitonin.

What people claim

  • Slows bone loss in postmenopausal osteoporosis
  • Treats Paget's disease and high blood calcium

What the evidence actually says

Older controlled trials support its labelled bone indications, but its fracture-prevention effect is weaker than newer osteoporosis medicines, and regulators in Europe and the US have weighed a small numerical imbalance in malignancy rates seen across long-term trials. Its modern role is deliberately narrow.

Human evidence

  • Randomised trials in postmenopausal osteoporosis and Paget's disease.
  • Regulatory safety reviews (EU 2012; US advisory discussion in 2013) of a malignancy imbalance.

Preclinical evidence

  • Osteoclast pharmacology and bone-turnover models.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Calcitonin-receptor activation inhibits osteoclast-mediated bone resorption.

Safety and unknowns

  • Regulators reviewed a small numerical imbalance in malignancy rates across long-term trials; causality was not established, but EU indications were narrowed.
  • Hypocalcaemia and hypersensitivity reactions are labelled.

Cancer relevance

Monitored in trials; not demonstrated in humans

A documented regulatory review found a small numerical imbalance in malignancy rates in long-term trials of calcitonin-salmon products; causality was not established. This is observed-trial-data discussion, not a purely mechanistic concern.

Regulatory status

Approved formulations have included injectable products (e.g. for Paget's disease and hypercalcaemia) and nasal spray products (for postmenopausal osteoporosis in women at least five years past menopause when alternatives are unsuitable). Availability and indications vary by product and market; European regulators restricted uses after a 2012 safety review.

Evidence grade

L4Strong humanModerate confidence

Solid controlled human trials, though not yet definitive or fully replicated.

What would change our rating?

  • Definitive resolution of the long-standing malignancy-imbalance question.

References and sources

Source curation pending
  • To be curatedSources to be curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.