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Also known as SMC021 Oral Calcitonin
SMC021 Calcitonin · 2 trials · 2 indications
The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty).
The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter). The outcome is the number of new vertebral fractures from baseline to 36 months.
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | SMC021 Oral Calcitonin, 0.8 mg twice daily during 24 months |
| 2 | PLACEBO_COMPARATOR | SMC021 Placebo, orally twice daily during 24 months |
| SMC021- Placebo | PLACEBO_COMPARATOR | SMC021 - placebo |
| Name | Type | Description |
|---|---|---|
| SMC021 Oral Calcitonin | DRUG | 0.8mg SMC021 (Oral Calcitoinin) twice daily |
| SMC021 Placebo | DRUG | Placebo orally, twice daily |
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...
Top 5 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 2 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
SMC021 Calcitonin is an oral formulation of salmon calcitonin developed by Novartis AG as a small molecule calcitonin receptor (CALCR) agonist. It was studied in Phase 3 clinical trials for osteoporosis in postmenopausal women and for knee osteoarthritis. It is an investigational product and is not approved.
SMC021 Calcitonin was developed for two musculoskeletal indications: osteoporosis in postmenopausal women and knee osteoarthritis. The Phase 3 osteoporosis study enrolled postmenopausal women aged 55 and older who were also taking calcium and vitamin D, while the osteoarthritis study enrolled adults with knee osteoarthritis.
SMC021 Calcitonin is an agonist of CALCR, the calcitonin receptor. By activating this receptor, the drug mimics the action of endogenous calcitonin. It is delivered orally as a small molecule formulation, in contrast to conventional calcitonin products that are given by injection or nasal spray.
SMC021 Calcitonin is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical development program for the oral calcitonin candidate in osteoporosis and osteoarthritis.
SMC021 Calcitonin reached Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The program has not produced an approved product, so SMC021 Calcitonin remains an investigational agent rather than an FDA-approved therapy.
SMC021 Calcitonin has been evaluated in two completed Phase 3 trials. NCT00525798 tested oral salmon calcitonin in postmenopausal women with osteoporosis across 12 countries and enrolled 4,665 participants. NCT00486434 evaluated efficacy and safety in patients with knee osteoarthritis and enrolled 1,176 participants. Both were randomized, double-blind, and placebo-controlled.
Yes. SMC021 Calcitonin, SMC021 Oral Calcitonin, and SMC021 Oral calcitonin refer to the same investigational asset from Novartis. The alternative names simply emphasize the oral route of administration of this salmon calcitonin formulation.