Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALX1-11 · 4 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | All patients entering the study will receive 100mcg daily for up to 6 months, making their total exposure 24 months |
| placebo | PLACEBO_COMPARATOR | Daily subcutaneous injection into thigh or abdomen with 700 mg Calcium and 400 IU Vitamin D daily |
| PTH(1-84) 100 mcg | EXPERIMENTAL | Subcutaneous injection of PTH(1-84) with 700 mg Calcium and 400 IU Vitamin D daily |
| 2 | EXPERIMENTAL | 50 mcg PTH(1-84) |
| 3 | EXPERIMENTAL | 75mcg PTH(1-84) |
| 4 | EXPERIMENTAL | 100 mcg PTH(1-84) |
| Name | Type | Description |
|---|---|---|
| ALX1-11 | DRUG | - |
| ALX1-11 (drug) | DRUG | 100 mcg PTH(1-84) injected subcutaneously daily in either the thrigh and abdomen. |
| placebo | DRUG | Daily subcutaneous injection with placebo |
| ALX1-11 50 mcg | DRUG | PTH(1-84) 50 mcg for subcutaneous injection into thigh or abdomen |
| ALX1-11 75mcg | DRUG | PTH(1-84)75 mcg for subcutaneous injection |
Inclusion Criteria: * Received placebo in TOP * Completed 18 months of daily treatment with ALX1-11 in OLES * Received their last dose of ALX1-11 in OLES within 3 months (90 days) of dosing in this study * Have the ability to continue to self-administer, or have a designee administer, a daily injec...
| 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 |
ALX1-11 is an investigational small molecule being developed for the treatment of osteoporosis. It has been studied in postmenopausal women with osteoporosis, including trials evaluating its effect on fracture incidence and bone density. The drug is currently in Phase 3 clinical development.
ALX1-11 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company has conducted multiple clinical trials of the drug in patients with osteoporosis.
ALX1-11 is in Phase 3 clinical development. It has completed four clinical trials, including Phase 2 and Phase 3 studies, with a total enrollment of 4,523 participants. The drug is investigational and not yet approved.
ALX1-11 has been studied in four completed clinical trials. The largest, NCT00172081, was a Phase 3 study of 2,532 postmenopausal women with osteoporosis. Other trials include NCT00172107, a Phase 2 dose-ranging study, and two open-label extension studies, NCT00172120 and NCT00172133.
Yes, ALX1-11 is also known as PREOS. One of its Phase 3 trials, NCT00172133, is titled "Open Label Extension Study of PREOS," confirming that PREOS is an alternative name for the same drug being developed for osteoporosis.