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salmon calcitonin, salmon calcitonin

Phase 1

Osteoarthritis | Small molecule | Musculoskeletal |Novartis AG|Last Updated: Jun 14, 2007

Target and mechanism

Molecular targetCALCR
Target classAgonist
ModalitySmall molecule

Also known as Oral salmon calcitonin, salmon calcitonin nasal spray, Oral salmon calcitonin, salmon calcitonin

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

salmon calcitonin, salmon calcitonin · 3 trials · 2 indications

Phase 1 3
NCT00486317Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With OsteoarthritisOsteoarthritis
COMPLETED- Analytics
NCT00395395Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal WomenPostmenopausal Osteoporosis
COMPLETED56 Analytics
NCT00411125Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal WomenPostmenopausal Osteoporosis
COMPLETED86 Analytics
PHASE1COMPLETED
Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis
OsteoarthritisUnlock trial analytics
PHASE1COMPLETED
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Postmenopausal OsteoporosisUnlock trial analytics
PHASE1COMPLETED
Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Postmenopausal OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events
Pharmacokinetic (PK) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
Pharmacokinetic profile of the new variant compared to the current variant on Day 1
Effect on bone resorption biomarker on Day 1

Secondary Endpoints

Changes in Urine CTX-I and CTX-II
Changes in serum osteocalcin
Pharmacodynamic (PD) profile of oral salmon calcitonin taken in the morning with 50 ml or 200 ml water and at 10, 30 or 60 minutes before a meal
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Oral salmon calcitonin, salmon calcitonin nasal sprayDRUG -
Oral salmon calcitoninDRUG -
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Eligibility Criteria

Age Range52 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Medical history and symptoms of knee osteoarthritis Exclusion Criteria: * Any other disease or medication affecting the bone or cartilage. * Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering t...

Countries:Denmark
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Frequently asked questions about salmon calcitonin, salmon calcitonin

What is salmon calcitonin used for?

Salmon calcitonin is being studied for osteoarthritis and postmenopausal osteoporosis. It is an investigational therapy in Phase 1 clinical development, and the completed trials evaluated its pharmacokinetics and pharmacodynamics in patients with osteoarthritis and in healthy postmenopausal women.

How does salmon calcitonin work?

Salmon calcitonin is an agonist of CALCR, the calcitonin receptor. By binding to and activating this receptor, it mimics the action of endogenous calcitonin, which regulates calcium homeostasis and bone metabolism. This mechanism underlies its investigation in musculoskeletal conditions such as osteoarthritis and postmenopausal osteoporosis.

Who is developing salmon calcitonin?

Salmon calcitonin is being developed by Novartis AG, which trades under the ticker NVS. The company is responsible for the clinical program evaluating the drug in osteoarthritis and postmenopausal osteoporosis.

What phase is salmon calcitonin in?

Salmon calcitonin is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The program includes completed Phase 1 trials, and no active trials are currently listed.

What clinical trials is salmon calcitonin in?

Salmon calcitonin has been evaluated in completed Phase 1 trials, including NCT00486317 in patients with osteoarthritis, and NCT00411125 and NCT00395395 in healthy postmenopausal women. These studies assessed pharmacokinetics and pharmacodynamics, with the latter two also examining effects of water and food intake.

Is salmon calcitonin the same as oral salmon calcitonin or salmon calcitonin nasal spray?

Yes, oral salmon calcitonin and salmon calcitonin nasal spray are alternative names or formulations of salmon calcitonin. The drug is also known by these terms, which refer to different routes of administration of the same active substance.