calcitonin salmon

Trade name: Calcimar

Animal productapproved

Approved

Jun 1, 1973

Calcitonin-salmon is a polypeptide hormone secreted by the parafollicular cells of the ultimobranchial gland of salmon fish. Calcitonin-salmon Nasal Spray is a polypeptide of 32 amino acids manufactured by recombinant DNA technology and is identical to calcitonin produced by salmon fish or chemical synthesis. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts. Single injections of calcitonin cause a marked transient inhibition of the ongoing bone resorptive process. With prolonged use, there is a persistent, smaller decrease in the rate of bone resorption. Histologically, this is associated with a decreased number of osteoclasts and an apparent decrease in their resorptive activity. In vitro studies have shown that calcitonin-salmon causes inhibition of osteoclast function with loss of the ruffled osteoclast border responsible for resorption of bone. Calcitonin-salmon Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females. — NCATS

Clinical trial activity

26 trials · 22 clinical orgs · 17 marketing orgs

Phase 1
4
Phase 2
13
Phase 3
7
Phase 4
4

Earliest trial started Nov 1, 1992 (NCT00004358)

Timeline

1970s

  1. Jun 1, 1973

    Earliest FDA Approval

  2. Jun 1, 1975

    Rhone Poulenc — First NDA Organization

  3. Jun 1, 1975

    Rhone Poulenc — NDA Organization

  4. Apr 17, 1978

    Sanofi-Aventis — NDA Secondary Org

1980s

  1. Jul 3, 1986

    Mylan — NDA Secondary Org

1990s

  1. Jan 1, 1992

    Earliest Phase 2 Sponsor(trial)

  2. Aug 17, 1995

    PHARMOBEDIENT — Marketing Organization

2000s

  1. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  3. Aug 12, 2005

    Upsher-Smith Laboratories — NDA Secondary Org

  4. Nov 17, 2008

    Apotex — Marketing Organization

  5. Jun 8, 2009

    Par Pharmaceuticals — Marketing Organization

  6. Jun 8, 2009

    PH HEALTH — Marketing Organization

2020s

  1. May 14, 2021

    Custopharm Inc — Marketing Organization

  2. Nov 10, 2021

    Bristol-Myers Squibb — Marketing Organization

  3. Apr 11, 2024

    Dr. Reddy's Laboratories — Marketing Organization

  4. Sep 20, 2024

    Cipla — Marketing Organization

  5. Dec 5, 2024

    Fresenius — Marketing Organization

  6. Jul 9, 2025

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  7. Sep 26, 2025

    Amneal Pharmaceuticals — Marketing Organization

  8. Mar 4, 2026

    Zydus Discovery DMCC — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedJun 1, 1973

Chemistry & pharmacology

Loading structure…

SMILES

CNC(Cc1ccccc1)C(=O)C(C)C2CC(=O)NCCCC(CC(=C)C(Cc3c[nH]cn3)C(C)C(=O)C(Cc4ccccc4)CC(=O)C(CCCCN)C(C)C2=C)C(=O)C
Mol. weight
834.16 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • calcihexal
  • calcimar
  • calcimar
  • calcimar
  • calcimar
  • calcimar
  • calcitare
  • calcitonin
  • calcitonin
  • calcitonin
  • calcitonin
  • calcitonin salmon
  • calcitonin salmon
  • calcitonin salmon
  • calcitonin salmon
  • calcitonin salmon
  • calcitonin salmon
  • calcitonin (salmon)
  • calcitonin (salmon)
  • calcitonin (salmon)
  • calcitonin (salmon)
  • calcitonin (salmon)
  • calcitonin-salmon
  • calcitonin-salmon
  • calcitonin-salmon
  • calcitonin, salmon
  • calcitonin, salmon
  • calcitonin, salmon
  • calcitonin salmon recombinant
  • calcitonin salmon recombinant
  • calcitonin salmon recombinant
  • calcitonin salmon recombinant
  • calcitonin salmon recombinant
  • calcitonin (salmon synthetic)
  • calcitonin (salmon synthetic)
  • calcitonin (salmon synthetic)
  • calcitonin (salmon synthetic)
  • calcitonin (salmon synthetic)
  • calsynar
  • calsynar
  • forcaltonin
  • forcaltonin
  • forcaltonin
  • fortical
  • fortical
  • fortical
  • leppin
  • miacalcic
  • miacalcic
  • miacalcic
  • miacalcin
  • miacalcin
  • miacalcin
  • miacalcin
  • polycal
  • recombinant salmon calcitonin
  • recombinant salmon calcitonin
  • recombinant salmon calcitonin
  • salcatonin
  • salmon calcitonin
  • salmon calcitonin
  • salmon calcitonin
  • salmon calcitonin
  • salmon calcitonin
  • salmon calcitonin
  • salmon calcitonin (1-32)
  • synthetic salmon calcitonin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03812991Phase 4Feb 28, 2019University of Missouri
NCT02115360N/AApr 1, 2014Tanta University
NCT01652573N/AMar 1, 2011National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Yale University
NCT01292187Phase 2Jan 1, 2011Tarsa Therapeutics, Inc.
NCT00959764Phase 3Jun 1, 2009Tarsa Therapeutics, Inc.
NCT00803686Phase 2Dec 1, 2008Bio-Kinetic Clinical Applications, Tarsa Therapeutics, Inc.
NCT00754884Phase 4Oct 1, 2008Unidad de Investigacion en Enfermedades Cronico-Degenerativas
NCT00704847Phase 3Jun 1, 2008Nordic Bioscience, Novartis
NCT00688077N/AMay 1, 2008Rijnstate Hospital
NCT00620854Phase 2Feb 1, 2008Bio-Kinetic Clinical Applications, Tarsa Therapeutics, Inc.
NCT02358304Phase 2Sep 1, 2007University of Tehran
NCT00478335N/AMay 1, 2007Aarhus University, University of Colorado, Denver
NCT00444808Phase 4Feb 1, 2007University of Montreal
NCT00486369Phase 1Jan 1, 2007Nordic Bioscience, Novartis
NCT00372099Phase 3Jan 1, 2007University of Geneva
NCT00414973Phase 3Dec 1, 2006Eli Lilly
NCT00395395Phase 1Oct 1, 2006Novartis
NCT00411125Phase 1Aug 1, 2006Novartis
NCT00486317Phase 1Oct 1, 2005Nordic Bioscience, Novartis
NCT00114803N/AJan 1, 2004Crohn's and Colitis Foundation, Harvard University, National Institutes of Health (NIH)
Showing 20 of 26 trials
Page 1 / 2

Organizations

Research & Development (22)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit7342002
Eli LillyFor profit4412002
Tarsa Therapeutics, Inc.For profit4422008
Nordic BioscienceFor profit3322005
Bio-Kinetic Clinical ApplicationsFor profit2012008
Aarhus UniversityAcademic/Hospital1012007
Crohn's and Colitis FoundationAcademic/Hospital1012004
Harvard UniversityAcademic/Hospital1112004
National Center for Research Resources (NCRR)Government1111992
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government1012011
National Institutes of Health (NIH)Government1012004
Northwestern UniversityAcademic/Hospital1011992
Rijnstate HospitalAcademic/Hospital1112008
Tanta UniversityAcademic/Hospital1112014
Unidad de Investigacion en Enfermedades Cronico-DegenerativasAcademic/Hospital1112008
Université catholique de LouvainAcademic/Hospital1112002
University of Colorado, DenverAcademic/Hospital1112007
University of GenevaAcademic/Hospital1112007
University of MissouriAcademic/Hospital1112019
University of MontrealAcademic/Hospital1112007
22 organizations
Page 1 / 2

Marketing (18)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGSep 26, 2025
ApotexFor profitMKTGNov 17, 2008
Bristol-Myers SquibbFor profitMKTGNov 10, 2021
CiplaFor profitMKTGSep 20, 2024
Custopharm IncFor profitMKTGMay 14, 2021
Dr. Reddy's LaboratoriesFor profitMKTGApr 11, 2024
FreseniusFor profitMKTGDec 5, 2024
MylanFor profitNDA2Jul 3, 1986
PH HEALTHFor profitMKTGJun 8, 2009
PHARMOBEDIENTFor profitMKTGAug 17, 1995
Par PharmaceuticalsFor profitMKTGJun 8, 2009
Par PharmaceuticalsFor profitSYNNov 10, 2021
Rhone PoulencFor profitNDAJun 1, 1975
Sagent Pharmaceuticals, Inc.For profitMKTGJul 9, 2025
Sanofi-AventisFor profitNDA2Apr 17, 1978
Teligent PharmaceuticalsFor profitMKTG
Upsher-Smith LaboratoriesFor profitNDA2Aug 12, 2005
Zydus Discovery DMCCFor profitMKTGMar 4, 2026