Peptide reference
Calcitonin
Calcitonin-salmon ·Salmon calcitonin ·Miacalcin ·Fortical ·Calcimar
What cited sources report about Calcitonin
Calcitonin (specifically calcitonin-salmon) is a 32-amino-acid synthetic polypeptide based on the salmon-sequence calcitonin, which is approximately 40-50 times more potent at the human calcitonin receptor than native human calcitonin. The peptide is FDA-approved as Miacalcin and Fortical for limited osteoporosis, Paget’s disease, and hypercalcemia indications. Regulatory positioning has narrowed substantially since the 2012 EMA referral identified a small increase in cancer incidence with long-term use. The summaries below report what individual cited sources state; this page does not assert claims beyond what those sources report.
FDA DailyMed — Miacalcin nasal spray prescribing information
The Miacalcin nasal spray label indicates treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause when alternative treatments are not suitable. The recommended dose is 200 IU intranasally once daily, alternating nostrils. The Warnings section addresses the small but consistent increase in malignancy reported across long-term controlled trials.
MIACALCIN Nasal Spray is a calcitonin indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause when alternative treatments are not suitable.
DailyMed — Miacalcin Nasal Spray ↗
FDA DailyMed — Miacalcin injection prescribing information
The Miacalcin injection label lists indications for symptomatic Paget’s disease of bone (in patients who do not respond to alternatives or for whom alternatives are not suitable), hypercalcemia (as adjunctive therapy), and postmenopausal osteoporosis. Recommended doses include 100 IU daily SC or IM for Paget’s disease, with provisions for dose reduction once response is achieved.
DailyMed — Miacalcin injection ↗
Chesnut et al. (2000) — American Journal of Medicine (PROOF)
The PROOF (Prevent Recurrence Of Osteoporotic Fractures) study was a 5-year randomized double-blind placebo-controlled trial in 1,255 postmenopausal women with established osteoporosis randomized to intranasal salmon calcitonin 100, 200, or 400 IU/day, or placebo, all with calcium and vitamin D. The 200 IU/day arm reported a 33% relative reduction in new vertebral fractures (RR 0.67; 95% CI 0.47-0.97), while the 100 IU and 400 IU arms did not reach statistical significance.
200 IU of nasal spray salmon calcitonin significantly reduces the risk of new vertebral fractures in postmenopausal women with osteoporosis.
PubChem CID 16129616 — National Center for Biotechnology Information
The PubChem record for synthetic salmon calcitonin lists the 32-amino-acid polypeptide structure with the characteristic 1-7 disulfide bridge, molecular formula C145H240N44O48S2, molecular weight 3431.9 g/mol, and aggregated synonyms (Miacalcin, Calcimar, Fortical).
Coverage notes
Calcitonin-salmon retains a narrow but defined regulatory niche in the US for postmenopausal osteoporosis (intranasal) and Paget’s disease and hypercalcemia (injection), with labeling restricted to patients for whom alternative therapies are not suitable. The 2012 EMA referral represents the most influential post-marketing reassessment and led to harmonized restrictions across Europe. This page reflects FDA labeling and EMA referral findings current as of the cited sources.