Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lasofoxifene · 4 trials · 2 indications
Lumbar Spine Bome Mineral Density
Percent change from baseline in lumbar spine BMD at Month 12
| Arm | Type | Description |
|---|---|---|
| Lasofoxifene 0.25 mg | EXPERIMENTAL | lasofoxifene 0.25 mg/day |
| raloxifene | ACTIVE_COMPARATOR | raloxifene 60 mg/day |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| lasofoxifene 0.5 mg/day | EXPERIMENTAL | - |
| lasofoxifene 0.25 mg/day | EXPERIMENTAL | - |
| Lasofoxifene 0.25 mg/d | EXPERIMENTAL | - |
| Lasofoxifene Dose 1 | EXPERIMENTAL | 0.05 mg |
| Lasofoxifene Dose 2 | EXPERIMENTAL | 0.25 mg |
| Lasofoxifene Dose 3 | EXPERIMENTAL | 0.5 mg |
| Name | Type | Description |
|---|---|---|
| lasofoxifene | DRUG | lasofoxifene 0.25mg |
| raloxifene | DRUG | raloxifene 60 mg/day |
| Placebo | DRUG | 0 mg/day |
Inclusion Criteria: * Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings Exclusion Criteria: * Presence of metabolic bone disease, fractures, blood clots, or recent cancer. * Any use of selective estrogen receptor ...
Lasofoxifene is being studied for bone loss and osteoporosis, conditions of reduced bone mineral density. It is an investigational small molecule developed by Ligand Pharmaceuticals Incorporated, trading as LGND. The clinical program has focused on postmenopausal women, including trials in osteoporosis and bone loss across the United States, Europe, and Asia.
Lasofoxifene targets the estrogen receptors ESR2 and ESR1. It is classified as a modulator of these receptors, meaning it acts on estrogen receptor signaling rather than simply blocking or activating it uniformly. This receptor activity underlies its investigation in endocrine-related bone conditions such as osteoporosis and bone loss.
Lasofoxifene is developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company is the sponsor associated with the drug's clinical development program in bone loss and osteoporosis. Lasofoxifene is a small molecule in the endocrine therapeutic area.
Lasofoxifene is in Phase 2 development and is investigational. Its clinical program includes Phase 2 and Phase 3 studies, all of which are completed, with no active trials currently listed. It has been evaluated in randomized, double-blind, placebo-controlled trials in postmenopausal women with osteoporosis or bone loss.
Completed lasofoxifene trials include NCT00674453, a Phase 2 bone loss study in the United Kingdom; NCT00163137, a Phase 3 comparison with raloxifene and placebo; NCT00143273, a Phase 2 dose-response study in Japanese and Asian postmenopausal women; and NCT00141323, the Phase 3 PEARL osteoporosis study. Total enrollment across these trials was 9,593 participants.
Across the four listed lasofoxifene trials, total enrollment was 9,593 participants. The largest was the Phase 3 PEARL study, NCT00141323, with 8,556 postmenopausal women with osteoporosis. The other trials enrolled 51, 540, and 497 participants, and all four studies are completed.