Identification

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Name
Salmon Calcitonin
Accession Number
DB00017  (BTD00025, BIOD00025)
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Hormones
Description

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

Protein structure
Db00017
Protein chemical formula
C145H240N44O48S2
Protein average weight
3431.853 Da
Sequences
>DB00017 sequence
CSNLSTCVLGKLSQELHKLQTYPRTNTGSGTP
Download FASTA Format
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
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Calcimar Solution Inj 200unit/mlSolutionIntramuscular; SubcutaneousSanofi Aventis1983-12-31Not applicableCanada
Calcitonin (salmon) Injection, BPSolutionIntramuscular; SubcutaneousMylan PharmaceuticalsNot applicableNot applicableCanada
Caltine Inj 100 Unit/ml (1ml Amp)LiquidIntramuscular; SubcutaneousFerring Pharmaceuticals1993-12-312014-07-25Canada
Caltine Inj 100unit/ml (0.5ml Amp)LiquidIntramuscular; SubcutaneousFerring Pharmaceuticals1993-12-312002-01-30Canada
ForcaltoninInjection, solution100 IUIntramuscular; Intravenous; SubcutaneousUnigene Laboratories Inc.1999-01-112008-11-17Eu
ForticalSpray, metered2200 [iU]/1mLNasalPhysicians Total Care, Inc.2005-12-30Not applicableUs
ForticalSpray, metered2200 [iU]/1mLNasalUpsher Smith Laboratories2005-08-12Not applicableUs
MiacalcinSpray, metered200 [iU]/1NasalNovartis1995-08-012017-02-20Us
MiacalcinInjection, solution200 [iU]/1mLIntramuscularSebela Pharmaceuticals Inc.1986-07-032018-03-31Us
MiacalcinInjection, solution200.0 [iU]/1.0mLIntramuscular; SubcutaneousNovartis1986-07-032017-02-28Us
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Generic Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Apo-calcitonin InjectableLiquidIntramuscular; SubcutaneousApotex Corporation2003-05-012013-08-02Canada
Apo-calcitonin Nasal SpraySolutionNasalApotex Corporation2003-09-122013-10-01Canada
Calcitonin SalmonSpray, metered200 [iU]/1NasalSandoz1995-08-01Not applicableUs
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalPhysicians Total Care, Inc.2011-12-09Not applicableUs
Calcitonin SalmonSpray, metered200 [iU]/0.09mLNasalPar Pharmaceutical, Inc.2009-06-08Not applicableUs
Calcitonin SalmonSpray, metered200 [iU]/1NasalApotex Corporation2008-12-09Not applicableUs
Pro-calcitonin - 200SolutionNasalPro Doc Limitee2008-07-042011-07-27Canada
Sandoz-calcitonin NSLiquidNasalSandoz Canada Incorporated2004-12-012013-10-01Canada
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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International/Other Brands
Calcimar
Categories
UNII
7SFC6U2VI5
CAS number
47931-85-1

Pharmacology

Indication

Used in the treatment of symptomatic Paget's disease for patients unresponsive to alternate treatments or intolerant to such treatments. In addition, it is used in emergency situations when serum calcium levels must be decreased quickly until the underlying condition is identified. It can also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. Calcitonin can be used in patients with azotemia and cases where intravenous fluids would be contraindicated due to limited cardiac reserves. Also for the treatment of post-menopausal osteoporosis in women more than 5 years post-menopause.

Associated Conditions
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
UCalcitonin receptor
agonist
Humans
Additional Data Available
Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

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.
DrugInteraction
2,5-Dimethoxy-4-ethylamphetamineThe risk or severity of adverse effects can be increased when 2,5-Dimethoxy-4-ethylamphetamine is combined with Salmon Calcitonin.
2,5-Dimethoxy-4-ethylthioamphetamineThe risk or severity of adverse effects can be increased when 2,5-Dimethoxy-4-ethylthioamphetamine is combined with Salmon Calcitonin.
4-Bromo-2,5-dimethoxyamphetamineThe risk or severity of adverse effects can be increased when 4-Bromo-2,5-dimethoxyamphetamine is combined with Salmon Calcitonin.
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.
AcarboseSalmon Calcitonin may decrease the excretion rate of Acarbose which could result in a higher serum level.
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.
AcetaminophenSalmon Calcitonin may decrease the excretion rate of Acetaminophen which could result in a higher serum level.
Additional Data Available
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  • Severity
    Severity

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Food Interactions
Not Available

References

Synthesis Reference

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

US5527881
General References
Not Available
External Links
UniProt
P01263
Genbank
Y00765
KEGG Drug
D00249
KEGG Compound
C06865
PubChem Substance
46506061
Therapeutic Targets Database
DAP001302
PharmGKB
PA448715
RxList
RxList Drug Page
Wikipedia
Calcitonin
ATC Codes
H05BA01 — Calcitonin (salmon synthetic)
AHFS Codes
  • 68:24.00 — Parathyroid and Antiparathyroid Agents

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentOsteoarthritis (OA)2
1CompletedTreatmentPostmenopausal Osteoporosis (PMO)2
2CompletedBasic ScienceOsteoporosis1
2CompletedTreatmentHealth Postmenopausal Women1
2CompletedTreatmentPhase 1 Pharmacodynamic Study1
2TerminatedTreatmentOsteoarthritis (OA)1
3CompletedTreatmentOsteoarthritis (OA)1
3CompletedTreatmentOsteoporosis2
3CompletedTreatmentPostmenopausal Osteoporosis (PMO)3
3CompletedTreatmentOne to five years postmenopausal1
3TerminatedTreatmentOsteoarthritis (OA)1
4CompletedTreatmentForearm Fractures1
4CompletedTreatmentHypothyroidism1
4Not Yet RecruitingTreatmentPelvic Ring Fractures1
4RecruitingDiagnosticHypercalcemia / Primary Hyperparathyroidism1
4WithdrawnTreatmentFibromyalgia1
Not AvailableCompletedTreatmentHypophosphatemic Rickets, X Linked Dominant1

Pharmacoeconomics

Manufacturers
  • Sanofi aventis us llc
  • Astrazeneca lp
  • Novartis pharmaceuticals corp
  • Apotex inc
  • Par pharmaceutical inc
  • Upsher smith laboratories inc
Packagers
  • Apotex Inc.
  • Novartis AG
  • Par Pharmaceuticals
  • Sandoz
  • Upsher Smith Laboratories
Dosage forms
FormRouteStrength
SolutionNasal
SolutionIntramuscular; Subcutaneous
Spray, meteredNasal200 [iU]/0.09mL
LiquidIntramuscular; Subcutaneous
Injection, solutionIntramuscular; Intravenous; Subcutaneous100 IU
Spray, meteredNasal2200 [iU]/1mL
Injection, solutionIntramuscular200 [iU]/1mL
Injection, solutionIntramuscular; Subcutaneous200 [USP'U]/1mL
Injection, solutionIntramuscular; Subcutaneous200.0 [iU]/1.0mL
Spray, meteredNasal200 [iU]/1
LiquidIntramuscular; Intravenous; Subcutaneous
SprayNasal
LiquidNasal
Prices
Unit descriptionCostUnit
Miacalcin 200 unit/act Solution 3.7ml Bottle139.39USD bottle
Calcitonin (Salmon) 200 unit/act Solution 3.7ml Bottle123.28USD bottle
Miacalcin For Inj, 2 unit = 1 Box 2ml Vial63.59USD vial
Miacalcin 200 unit nasal spray44.68USD ml
Calcitonin-salmon 200 unit sp39.51USD ml
Fortical 200 unit nasal spray34.3USD ml
Miacalcin 200 unit/ml vial30.73USD ml
Calcimar 200 iu/ml29.94USD ml
Caltine 100 (100 Iu/Ml) 100 iu/ml8.81USD ml
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US5733569No1998-03-312015-03-31Us
US6440392No2002-08-272021-02-02Us
USRE43580No2012-08-142021-02-02Us
USRE40812No2009-06-302021-02-02Us
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

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Properties

State
Liquid
Experimental Properties
PropertyValueSource
hydrophobicity-0.537Not Available
isoelectric point8.86Not Available

Taxonomy

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

Targets

Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Agonist
General Function
Receptor activity
Specific Function
This is a receptor for calcitonin. The activity of this receptor is mediated by G proteins which activate adenylyl cyclase. The calcitonin receptor is thought to couple to the heterotrimeric guanos...
Gene Name
CALCR
Uniprot ID
P30988
Uniprot Name
Calcitonin receptor
Molecular Weight
59351.865 Da
References
  1. Bouizar Z, Fouchereau-Peron M, Taboulet J, Moukhtar MS, Milhaud G: Purification and characterization of calcitonin receptors in rat kidney membranes by covalent cross-linking techniques. Eur J Biochem. 1986 Feb 17;155(1):141-7. [PubMed:3004987]
  2. Stroop SD, Moore EE: Intracellular calcium increases mediated by a recombinant human calcitonin receptor. J Bone Miner Res. 1995 Apr;10(4):524-32. [PubMed:7610922]
  3. Sarkar A, Dickerson IM: Cloning, characterization, and expression of a calcitonin receptor from guinea pig brain. J Neurochem. 1997 Aug;69(2):455-64. [PubMed:9231703]
  4. Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [PubMed:11752352]

Drug created on June 13, 2005 07:24 / Updated on September 21, 2019 03:42