Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TVB-009 · 1 trial · 1 indication
Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52
| Arm | Type | Description |
|---|---|---|
| TVB-009 main treatment period | EXPERIMENTAL | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 |
| PROLIA main treatment period | ACTIVE_COMPARATOR | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 |
| TVB-009 main / TVB-009 transition period | EXPERIMENTAL | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period |
| PROLIA main / PROLIA transition period | ACTIVE_COMPARATOR | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period |
| PROLIA main / TVB-009 transition period | EXPERIMENTAL | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period |
| Name | Type | Description |
|---|---|---|
| TVB-009 | COMBINATION_PRODUCT | TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| Prolia® | COMBINATION_PRODUCT | Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
Inclusion Criteria: * Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis * Body weight ≥50 kg and ≤90 kg * Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening * At ...
TVB-009 is an investigational small molecule being studied for the treatment of postmenopausal osteoporosis. It is being developed by Teva Pharmaceutical Industries Limited (TEVA) and is currently in Phase 3 clinical development.
The specific molecular target of TVB-009 has not been disclosed. It is a small molecule being evaluated for its efficacy in relieving postmenopausal osteoporosis, but its mechanism of action is not publicly detailed.
TVB-009 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 3 clinical trials for postmenopausal osteoporosis.
TVB-009 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to evaluate its effectiveness in postmenopausal osteoporosis.
TVB-009 has one completed Phase 3 clinical trial, identified as NCT04729621. This randomized, double-blind, active-controlled study enrolled 332 female participants aged 60 years and older with postmenopausal osteoporosis, across multiple countries including the United States and several European nations.
TVB-009 is also known as TVB-009P. The clinical trial NCT04729621, which tested the drug's effectiveness in relieving postmenopausal osteoporosis, used the name TVB-009P in its title, indicating that TVB-009 and TVB-009P refer to the same investigational drug.