Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bazedoxifene · 3 trials · 2 indications
New vertebral fracture: decrease in anterior, mid, or posterior vertebral (vt) height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
New vertebral fracture: decrease in anterior, mid, or posterior vt height of approximately 20% and 4 millimeter (mm) or more from baseline (base) to end of study confirmed by measurement of involved vt body, a semi-quantitative grade change of 1 from base for any vertebra from fourth thoracic to fourth lumbar vertebra (T4 to L4), provided vertebra was not fractured at base. Participant was counted only once irrespective of how many new vt fractures were diagnosed. Stratification factor was base fracture status, categorized as no prevalent fracture and at least 1 prevalent fracture.
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | - |
| B | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Bazedoxifene Acetate | DRUG | BZA 20mg, daily, oral |
| Placebo | OTHER | Placebo, daily, oral |
| Bazedoxifene Acetate (TSE-424) | DRUG | - |
| Bazedoxifene | DRUG | - |
Inclusion Criteria: * Must be at least 2 years postmenopausal * Osteoporotic subjects without vertebral fracture who meet BMD criteria, or Osteoporotic subjects with vertebral fracture Exclusion Criteria: * Diseases that may affect bone metabolism * Vasomotor symptoms requiring treatment * Known ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
Bazedoxifene is an investigational small molecule being studied for conditions related to menopause, including postmenopausal osteoporosis, vaginal atrophy, endometrial hyperplasia, and vasomotor symptoms associated with menopause. It is being developed by Pfizer, Inc. (PFE) and is currently in Phase 3 clinical development.
Bazedoxifene is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The drug is an investigational small molecule in Phase 3 clinical development for multiple menopause-related conditions, including osteoporosis and vasomotor symptoms.
Bazedoxifene is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Pfizer, Inc. (PFE) is the developer, and the drug is being studied for postmenopausal osteoporosis, vaginal atrophy, and vasomotor symptoms associated with menopause.
Bazedoxifene has completed three clinical trials. One Phase 3 trial (NCT00238732) evaluated Bazedoxifene with conjugated estrogens for vasomotor symptoms and vaginal atrophy in 650 women. A Phase 2 trial (NCT00238745) studied dose-response in 375 Japanese patients with postmenopausal osteoporosis. Two Phase 1 trials (NCT00479778, NCT00706225) assessed pharmacokinetics and drug interactions in healthy postmenopausal women.
Bazedoxifene has been studied in combination with conjugated estrogens. Clinical trials such as NCT00238732 evaluated Bazedoxifene with conjugated estrogen combinations for vasomotor symptoms and vaginal atrophy, and NCT00479778 examined the pharmacokinetic profile of Bazedoxifene in two Bazedoxifene and conjugated estrogen forms.
Bazedoxifene is a small molecule being developed for menopause-related conditions. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects on postmenopausal osteoporosis, vaginal atrophy, and vasomotor symptoms.