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SMC021

Phase 2

Health Postmenopausal Women | Small molecule | Endocrine |Novartis AG|Trials Updated: Jun 22, 2007

SMC021 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2007

SMC021 target and mechanism

Molecular targetCALCR
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

SMC021 clinical trials

SMC021 · 1 trial · 1 indication

Phase 2 1
NCT00421590Drug Interaction of SMC021 With Concomitant Antacid (Calcium Carbonate/Magnesium Hydroxide).Health Postmenopausal Women
COMPLETED38 Analytics
PHASE2COMPLETED
Drug Interaction of SMC021 With Concomitant Antacid (Calcium Carbonate/Magnesium Hydroxide).
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Study Endpoints

Primary Endpoints

To assess the effect of concomitant antacid (calcium carbonate / magnesium hydroxide) on the pharmacokinetics and pharmacodynamics (decrease in serum CTX-I) of SMC021 (0.8 mg salmon calcitonin/200 mg 5-CNAC)

Secondary Endpoints

To assess the tolerability of concomitantly-administered antacid and SMC021
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
SMC021DRUG -
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Eligibility Criteria

Age Range40 Years to 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy postmenopausal female subjects, 40 to 70 years of age, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. * At Screening, and Baseline, vital signs (systolic and diastolic b...

Countries:Denmark
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Frequently asked questions about SMC021

What is SMC021?

SMC021 is an investigational small molecule developed by Novartis AG for use in healthy postmenopausal women. It is a calcitonin receptor (CALCR) agonist studied in the endocrine therapeutic area. SMC021 has been evaluated in a Phase 2 clinical trial and is not described as approved; it remains an investigational agent in clinical development.

What does SMC021 target?

SMC021 targets CALCR, the calcitonin receptor. It acts as an agonist at this receptor. The calcitonin receptor is a G protein-coupled receptor involved in calcium regulation, and SMC021 was studied as a small molecule agonist of it in healthy postmenopausal women.

Who makes SMC021?

SMC021 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical development of this calcitonin receptor agonist small molecule.

What phase is SMC021 in?

SMC021 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been described as approved by the FDA.

What clinical trials is SMC021 in?

SMC021 has been studied in one completed Phase 2 trial, NCT00421590, titled "Drug Interaction of SMC021 With Concomitant Antacid (Calcium Carbonate/Magnesium Hydroxide)." The trial enrolled 38 participants, was randomized and double blind, and was conducted in Denmark in healthy postmenopausal women aged 40 years and older.

What is SMC021 used for?

SMC021 has been studied in healthy postmenopausal women within the endocrine therapeutic area. Its only listed clinical trial evaluated a drug interaction with a concomitant antacid, calcium carbonate and magnesium hydroxide. The drug remains investigational, and no approved indication has been described for it.