Recent Updates
Recently added Catalysts

SMC021

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

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).
Health Postmenopausal WomenUnlock trial analytics

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
SMC021DRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about SMC021

What is SMC021 used for?

SMC021 is an investigational small molecule being studied in healthy postmenopausal women. It is in Phase 2 clinical development for an endocrine-related condition, though the specific indication has not been disclosed. The drug is being developed by Novartis AG.

Who makes SMC021?

SMC021 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for use in healthy postmenopausal women.

What phase is SMC021 in?

SMC021 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a drug interaction study. The drug is investigational and has not been approved by regulatory authorities. It is being studied in healthy postmenopausal women.

What clinical trials is SMC021 in?

SMC021 has one completed clinical trial, NCT00421590, titled 'Drug Interaction of SMC021 With Concomitant Antacid (Calcium Carbonate/Magnesium Hydroxide).' This Phase 2 study enrolled 38 healthy postmenopausal women in Denmark and was a randomized, double-blind, uncontrolled trial.

Is SMC021 FDA approved?

SMC021 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The drug has completed one Phase 2 trial, but it remains under investigation and has not been approved for any use by regulatory authorities.