Helen Frankenthaler Foundation

Calcitonin for osteoporosis research

Salmon calcitonin

Description

A medication used to treat diseases of the bone such as osteoporosis and Paget's disease.

DrugBank ID

DB00017

Modality

Protein Based Therapies:

  • Hormones

Clinical Trials

Phase 0: 0

Phase 1: 4

Phase 2: 8

Phase 3: 10

Phase 4: 8

Therapeutic Categories

  • Bone Density Conservation Agents
  • Calcitonin Preparations
  • Parathyroid Hormones and Analogues

Mechanism of Action

  • Calcitonin receptor Agonist

Summary

Salmon calcitonin is a synthetic peptide form of calcitonin used to inhibit bone resorption in the treatment of hypercalcemia, osteoporosis, and Paget's disease.

Brand Names

Calcimar, Fortical, Miacalcin

Generic Name

Salmon calcitonin

DrugBank Accession Number

DB00017

Background

Synthetic peptide, 32 residues long formulated as a nasal spray.

Modality

Protein Based Therapies

Hormones

Groups Approved, Investigational

Protein Structure

Protein Chemical Formula C 145 H 240 N 44 O 48 S 2

Protein Average Weight 3431.853 Da

Synonyms

  • Calcitonin (Salmon Synthetic)
  • Calcitonin salmon
  • Calcitonin salmon recombinant
  • Calcitonin-salmon
  • Calcitonin, salmon
  • Calcitonina salmón sintética
  • Recombinant salmon calcitonin
  • Salmon calcitonin

External IDs

  • SMC-021
  • SMC021

Associated Conditions

Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofHypercalcemia•••••••••••• Create Account•••••••••• ••••••••
Prevention ofOsteoporosis•••••••••••• Create Account•••••••••••• •••••••••• •••••••••••••••••••••••
Management ofOsteoporosis•••••••••••• Create Account••••••••••••••••••••
Management ofPaget’s disease•••••••••••• Create Account•••••••••• ••••••••••• ••••••••• ••••••••••••••••
Management ofSymptomatic paget's disease•••••••••••• Create Account•••••••••• ••••••••

Pharmacodynamics

Calcitonin inhibits bone resorption by osteoclasts (bone remodeling cells) and promotes bone formation by osteoblasts. This leads to a net increase in bone mass and a reduction in plasma calcium levels. It also promotes the renal excretion of ions such as calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption. In consequence, there is an increase in the jejunal secretion of water, sodium, potassium, and chloride.

Mechanism of action

Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway.

TargetActionsOrganism
Calcitonin receptoragonistHumans

Absorption

Salmon calcitonin is rapidly absorbed with bioavailability of 71% following subcutaneous injection and 66% following intramuscular injection in humans. Via the nasal route, the bioavailability varies between 3 to 5% relative to IM.

Volume of distribution

0.15 to 0.3 L/kg

Protein binding

Protein binding is about 30 to 40%.

Metabolism

Salmon calcitonin primarily undergoes degradation in the kidneys to form pharmacologically inactive metabolites. It is also metabolized in the blood and the peripheral tissue.

Route of elimination

Urine. Studies with injectable calcitonin show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption in the kidney.

Half-life

Half-life elimination (terminal): I.M. 58 minutes; SubQ 59 to 64 minutes; Nasal: ~18 to 23 minutes

Clearance

Not Available

Toxicity

Salmon calcitonin was shown to inhibit lactation in animals and is not recommend in nursing mothers. While research in animals have shown a decrease in fetal weight, no studies have yet shown similar results in humans. It is recommended however to proceed carefully when administering salmon calcitonin to pregnant women and consider if the benefits outweigh the risks. Because of its protein nature, salmon calcitonin may provoke an allergy reaction (bronchospams and swelling of the tongue/throat) that can turn into a full-blown anaphylactic response. The manufacturer also reports an increase in the risk of malignancies from oral route (0.7%) to intranasal route (2.4%) compared to placebo. The same may apply to IV, IM and SC routes since the systemic exposure is higher in those cases. Nausea is noticeable in some patients but tends to decrease with continued administration. Rhinitis, headaches and back pain have also been reported among others.

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

  • Approved
  • Vet approved
  • Nutraceutical
  • Illicit
  • Withdrawn
  • Investigational
  • Experimental
  • All Drugs
DrugInteraction
Integrate drug-drug interactions in your software
AbacavirSalmon calcitonin may decrease the excretion rate of Abacavir which could result in a higher serum level.
AcalabrutinibThe therapeutic efficacy of Salmon calcitonin can be decreased when used in combination with Acalabrutinib.
AcebutololThe risk or severity of adverse effects can be increased when Acebutolol is combined with Salmon calcitonin.
AceclofenacAceclofenac may decrease the excretion rate of Salmon calcitonin which could result in a higher serum level.
AcemetacinAcemetacin may decrease the excretion rate of Salmon calcitonin which could result in a higher serum level.

Food Interactions

  • Administer calcium supplement. Individuals who are taking salmon calcitonin for the treatment of postmenopausal osteoporosis should ingest at least 1000mg of elemental calcium daily (by food or through supplementation).
  • Administer vitamin supplements. Individuals who are taking salmon calcitonin for the treatment of postmenopausal osteoporosis should take at least 400 international units of vitamin D daily.

International/Other Brands

Calcimar

Brand Name Prescription Products

NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
ForticalSpray, metered2200 [iU]/1mLNasalPhysicians Total Care, Inc.2005-12-30Not applicable
MiacalcinSpray, metered200 [iU]/1NasalPhysicians Total Care, Inc.1995-08-012010-06-30
MiacalcinInjection, solution200.0 [iU]/1.0mLIntramuscular; SubcutaneousNovartis1986-07-032017-02-28
MiacalcinInjection, solution200 [iU]/1mLIntramuscularSebela Pharmaceuticals Inc.1986-07-032018-03-31
MiacalcinSpray, metered200 [iU]/1NasalNovartis1995-08-012017-02-20

Generic Prescription Products

NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalPhysicians Total Care, Inc.2011-12-09Not applicable
Calcitonin SalmonSpray, metered200 [iU]/1NasalSandoz S.P.A.1995-08-01Not applicable
Calcitonin SalmonSpray, metered200 [iU]/1NasalApotex Corporation2008-12-09Not applicable
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalENDO USA, Inc.2009-06-08Not applicable
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalbryant ranch prepack2009-06-08Not applicable

Drug Categories

  • Amino Acids, Peptides, and Proteins
  • Bone Density Conservation Agents
  • Bone Density, drug effects
  • Calcitonin Preparations
  • Calcium Homeostasis
  • Calcium-Regulating Hormones and Agents
  • Drugs that are Mainly Renally Excreted
  • Hormones
  • Hormones, Hormone Substitutes, and Hormone Antagonists
  • Nerve Tissue Proteins
  • Neuropeptides
  • Parathyroid and Antiparathyroid Agents
  • Parathyroid Hormones and Analogues
  • Peptide Hormones
  • Peptides
  • Proteins
  • Systemic Hormonal Preparations, Excl. Sex Hormones and Insulins
  • Thyroid Products

Chemical Taxonomy Provided by Classyfire

Description Not Available

Kingdom

Organic Compounds

Super Class

Organic Acids

Class

Carboxylic Acids and Derivatives

Sub Class

Amino Acids, Peptides, and Analogues

Direct Parent

Peptides

Alternative Parents

Not Available

Substituents

Not Available

Molecular Framework

Not Available

External Descriptors

Not Available

Affected organisms

  • Humans and other mammals

UNII

7SFC6U2VI5

CAS number

47931-85-1

Synthesis Reference

Marcos C. Poblet, Berta P. Obiols, Gemma J. Farres, "Procedure for preparing salmon calcitonin." U.S. Patent US5527881, issued October, 1991.

General References

Not Available

Clinical Trials

Clinical Trial & Rare Diseases Add-on Data Package Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more.

PhaseStatusPurposeConditionsCountStart DateWhy Stopped100+ additional columns
Unlock 175K+ rows when you subscribe. View sample data
Not AvailableActive Not RecruitingNot AvailableOsteoporosis,Neurological Disorders1somestatus Unlock 75,000+ rows when you subscribe Explore data packages curated & structured to speed up your pharmaceutical research View Sample Datastop reasonjust information to hide
Not AvailableActive Not RecruitingPreventionCalcitonin/Paravertebral/Thoracotomy1