Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Calcitonin-Salmon (Miacalcin / Fortical): what the evidence says

Name: Calcitonin-Salmon (Miacalcin / Fortical)
Published: 2026-10-27

At a glance

What it is: a 32-amino-acid synthetic copy of salmon calcitonin. FDA approved the injection (NDA 017808) and nasal sprays (Miacalcin NDA 020313, Fortical NDA 021406). ^{R1, R2, R3} Drugs@FDA lists both nasal-spray brands as discontinued; one injection product remains. ^{R2, R3, R1}

What the evidence says: in PROOF (1,255 women), the middle nasal-spray dose cut new spine fractures by 33%, but only 511 finished 5 years and the other doses did not show the same effect. ^R4

Biggest risks: a small rise in cancers in pooled trials led regulators to limit its use. ^R5 UNVERIFIED the size of the signal and the FDA/EMA review details.

Rating


Human Human evidence	Moderate: PROOF RCT, n = 1,255 ^R4
Animal Animal / lab evidence	Not reviewed
Regulatory	FDA-approved; nasal sprays discontinued ^{R2, R3, R1} · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R6, R7, R8} · not named by WADA ^R9
Established human dose	Yes, label dose

Evidence verdict: Spine fracture prevention: Moderate (one RCT, high dropout) · Paget's disease / hypercalcemia: approved uses · Cancer signal: Concern (small, from pooled trials)

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: PROOF lost many participants and only one dose worked, so its result is weaker than it looks. Newer drugs have stronger data.

What is it?

Related pages: Teriparatide, Abaloparatide, Cagrilintide.

Does it work?

Human Osteoporosis (PROOF): 51 of 287 vs 70 of 270 new spine fractures at the middle dose (RR 0.67). ^R4
Human Paget's disease: a 9-patient nasal-spray series found it mildly effective. ^R10

Is it safe?

Caution Cancer signal in pooled trials. ^R5 UNVERIFIED specifics.

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved; nasal sprays listed discontinued. ^{R2, R3, R1}
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R6, R7, R8}
Sport: not named on WADA's 2026 Prohibited List. ^R9

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
PROOF 2000	1,255 postmenopausal women	Nasal daily	100, 200 or 400 IU	5 years	200 IU: RR 0.67	PMID 10996576
Paget's 1988	9 patients	Nasal	Per study	Per study	Small series	PMID 3365896

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Drugs@FDA, Miacalcin injection, application NDA 017808 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA 017808
^R2 Drugs@FDA, Miacalcin nasal spray, application NDA 020313 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA 020313
^R3 Drugs@FDA, Fortical nasal spray, application NDA 021406 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA 021406
^R4 Chesnut CH 3rd, et al. Am J Med. 2000. PMID 10996576
^R5 Lempicki KA, et al. J Am Geriatr Soc. 2014. PMID 25516047
^R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R9 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R10 D'Agostino HR, et al. Clin Orthop Relat Res. 1988. PMID 3365896

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Calcitonin-Salmon (Miacalcin / Fortical). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).