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Also known as ALX1-11 (drug), PREOS
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...
ALX1-11 is being developed for the treatment of osteoporosis. Its clinical program focused on postmenopausal osteoporosis, including a Phase 3 study evaluating fracture incidence in women with the condition. The trials enrolled women aged 45 and older.
ALX1-11 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor behind the drug's clinical development program in osteoporosis.
ALX1-11 has reached Phase 3 clinical development for osteoporosis. Four trials have been completed, including Phase 3 studies, and no trials are currently active. The drug remains investigational and is not approved.
ALX1-11 has been studied in four completed trials. These include the Phase 3 TOP study (NCT00172081) on fracture incidence, two Phase 3 open label extension studies (NCT00172133 and NCT00172120), and a Phase 2 dose-ranging study (NCT00172107).
Across its four completed trials, ALX1-11 enrolled a total of 4,523 participants. The largest was the Phase 3 TOP study with 2,532 women, followed by an open label extension with 1,683 participants. All trials were randomized, double-blind, and placebo-controlled.