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Home/Compounds/Calcitonin (Salmon)
OtherFDA approvedRx required

Calcitonin (Salmon)

Also known as: Miacalcin · Fortical
Brands: Miacalcin · Fortical

Synthetic salmon-sequence calcitonin used for osteoporosis, Paget disease, and hypercalcemia.

A
Grade A
Multiple human RCTs
Human studies23
PubMed citations29
Routeintranasal, subcutaneous
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

32-amino-acid peptide from salmon; binds calcitonin receptor. Inhibits osteoclast activity and lowers serum calcium.

Evidence summary

23
Human studies
29
PubMed citations
25
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
intranasalsubcutaneous

Side effects & safety

From the FDA label
Source
abdominal painarthralgiadiarrheadizzinessfatigueheadachenauseapruritusurticariavomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for postmenopausal osteoporosis (nasal), Paget disease, and hypercalcemia (Miacalcin, Fortical). FDA noted a possible association with malignancy in 2014.

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT04445857Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled TrialCompleted · Phase 4 · Analgesia · n=90NCT03935984Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan with Calcitonin Pre-treatment for Primary HyperparathyroidismRecruiting · Phase 4 · Primary Hyperparathyroidism · n=37NCT03812991The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring InjuriesCompleted · Phase 4 · Pelvic Ring Fractures · n=21NCT03342001Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With LevothyroxineCompleted · Phase 4 · Hypothyroidism · n=11NCT00486434A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee OsteoarthritisCompleted · Phase 3 · Osteoarthritis · n=1176NCT00704847A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee OsteoarthritisTerminated · Phase 3 · Osteoarthritis · n=1030NCT00478335Pharmacologic Treatment of Congenital Nephrogenic Diabetes InsipidusCompleted · N/A · Nephrogenic Diabetes Insipidus · n=4NCT01652573Calcitonin for Treating X-linked HypophosphatemiaCompleted · N/A · Hypophosphatemic Rickets, X Linked Dominant · n=21NCT00754884Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of FibromyalgiaWithdrawn · Phase 4 · FibromyalgiaNCT01292187A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of Oral Recombinant Salmon Calcitonin (rsCT) in the Prevention of Postmenopausal Osteoporosis in Women at Increased Risk of FractureCompleted · Phase 2 · Osteopenia · n=129NCT00803686A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal WomenCompleted · Phase 2 · Phase 1 Pharmacodynamic Study · n=12NCT00959764A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel Group, 48-Week, Study of Oral Recombinant Salmon Calcitonin (rsCT) Compared to Salmon Calcitonin (sCT) Nasal Spray in Postmenopausal Osteoporotic WomenCompleted · Phase 3 · Osteoporosis, Postmenopausal · n=565

Showing 12 of 25 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 39596206Hsu SH, Chen LR et al. · Primary Osteoporosis Induced by Androgen and Estrogen Deficiency: The Molecular and Cellular Perspective on Pathophysiological Mechanisms and Treatments.International journal of molecular sciences (2024)HumanPMID 36670271Chen K, Smith CJ · Best Practices for Submission of NMR Data to Support Higher Order Structure Assessment of Generic Peptide Drugs.The AAPS journal (2023)HumanPMID 34745472Kaneb A, Berardino K et al. · Calcitonin (FORTICAL, MIACALCIN) for the treatment of vertebral compression fractures.Orthopedic reviews (2022)HumanPMID 32247161Wu P, Li M et al. · Impurities identification and quantification for calcitonin salmon by liquid chromatography-high resolution mass spectrometry.Journal of pharmaceutical and biomedical analysis (2021)PMID 29661063Allison SL, Davis KW · Calcitonin Stewardship Strategies.Journal of pharmacy practice (2020)HumanPMID 30946329Hu J, He S et al. · Management of brown tumor of spine with primary hyperparathyroidism: A case report and literature review.Medicine (2019)HumanPMID 29763252Marmolejo VS, Arnold JF et al. · Charcot Foot: Clinical Clues, Diagnostic Strategies, and Treatment Principles.American family physician (2019)HumanPMID 26993105Tabrizi R, Fardisi S et al. · Can calcitonin nasal spray reduce the risk of recurrence of central giant cell granuloma of the jaws? A double-blind clinical trial.International journal of oral and maxillofacial surgery (2018)HumanPMID 25822610Kesselheim AS, Polinski JM et al. · Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.Drugs (2016)HumanPMID 25716148Zeng K, Geerlof-Vidavisky I et al. · Liquid Chromatography-High Resolution Mass Spectrometry for Peptide Drug Quality Control.The AAPS journal (2015)PMID 25726417Zarowitz BJ, Cheng LI et al. · Osteoporosis prevalence and characteristics of treated and untreated nursing home residents with osteoporosis.Journal of the American Medical Directors Association (2015)HumanPMID 19226627Costantino HR, Culley H et al. · Development of Calcitonin Salmon Nasal Spray: similarity of peptide formulated in chlorobutanol compared to benzalkonium chloride as preservative.Journal of pharmaceutical sciences (2010)PMID 20332498Vondracek SF · Managing osteoporosis in postmenopausal women.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists (2010)HumanPMID 20332495Michaud LB · Managing cancer treatment-induced bone loss and osteoporosis in patients with breast or prostate cancer.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists (2010)HumanPMID 17269853O'Connell MB · Prescription drug therapies for prevention and treatment of postmenopausal osteoporosis.Journal of managed care pharmacy : JMCP (2007)HumanPMID 16274829Matsuyama T, Morita T et al. · Enhancement of nasal absorption of large molecular weight compounds by combination of mucolytic agent and nonionic surfactant.Journal of controlled release : official journal of the Controlled Release Society (2006)PMID 15969922Hinchcliffe M, Jabbal-Gill I et al. · Effect of chitosan on the intranasal absorption of salmon calcitonin in sheep.The Journal of pharmacy and pharmacology (2005)PMID 15167766Kessel B · Hip fracture prevention in postmenopausal women.Obstetrical & gynecological survey (2004)HumanPMID 14983569Kessenich C · An approach to postmenopausal osteoporosis treatment: a case study review.Journal of the American Academy of Nurse Practitioners (2004)HumanPMID 11502478Cornish J, Callon KE et al. · Effects of calcitonin, amylin, and calcitonin gene-related peptide on osteoclast development.Bone (2001)Human

Showing 20 of 29 papers. View all on PubMed →