Recent Updates
Recently added Catalysts

salmon calcitonin, salmon calcitonin

Phase 1

Osteoarthritis | Small Molecules | Musculoskeletal |Novartis AG|Trials Updated: Jun 14, 2007

salmon calcitonin, salmon calcitonin target and mechanism

Molecular targetCALCR
Target classAgonist
ModalitySmall Molecules

Also known as Oral salmon calcitonin, salmon calcitonin

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment142

FDA Designations

No designations recorded

salmon calcitonin, salmon calcitonin clinical trials

salmon calcitonin, salmon calcitonin · 4 trials · 2 indications

Phase 1 4
NCT00486317Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With OsteoarthritisOsteoarthritis
COMPLETED- Analytics
NCT00486369SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days StudyOsteoarthritis
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
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study
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
Changes in serum osteocalcin and serum CTX-I
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Oral salmon calcitonin, salmon calcitonin nasal sprayDRUG -
Oral salmon calcitoninDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Osteoarthritis 134 trials

Frequently asked questions about salmon calcitonin, salmon calcitonin

What is salmon calcitonin used for?

Salmon calcitonin is being studied for osteoarthritis and postmenopausal osteoporosis. The clinical program has focused on oral formulations of the hormone, with Phase 1 trials conducted in patients with osteoarthritis and in healthy postmenopausal women. It is a musculoskeletal therapeutic developed by Novartis AG.

What does salmon calcitonin target?

Salmon calcitonin targets CALCR, the calcitonin receptor, and acts as an agonist at that receptor. This receptor is involved in calcium regulation and bone metabolism, which is the basis for studying the drug in postmenopausal osteoporosis and osteoarthritis.

Who makes salmon calcitonin?

Novartis AG, which trades under the ticker NVS, is the developer of salmon calcitonin. The company has sponsored the clinical studies of the oral formulation 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. The completed Phase 1 trials evaluated pharmacokinetics, pharmacodynamics, absorption, efficacy and tolerance, with a total enrollment of 142 participants across the studies.

What clinical trials is salmon calcitonin in?

Four completed Phase 1 trials have studied salmon calcitonin: NCT00486369 and NCT00486317 in osteoarthritis, and NCT00411125 and NCT00395395 in healthy postmenopausal women. All were conducted in Denmark. Two were randomized and double blind, and enrollment in the two osteoporosis studies was 86 and 56 participants respectively.

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 for salmon calcitonin, referring to different formulations of the same hormone. The clinical trials listed here used the oral formulation in osteoarthritis and postmenopausal osteoporosis.