Approval Probability
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Adjusted LOA
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VK5211 · 1 trial · 1 indication
Efficacy of VK5211 after 12 weeks of treatment by mean placebo-corrected percentage change in total body less head (TBLH) lean body mass assessed by whole body dual-energy x-ray absorptiometry scan (DXA) scan.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo QD |
| VK5211- 0.5mg | EXPERIMENTAL | 0.5mgQD |
| VK5211- 1.0mg | EXPERIMENTAL | 1.0mg QD |
| VK5211- 2.0mg | EXPERIMENTAL | 2.0mg QD |
| Name | Type | Description |
|---|---|---|
| VK5211 | DRUG | Capsule |
| Placebo | DRUG | Capsule |
Inclusion Criteria: * Males or females ≥65 years old who are recovering from a hip fracture (occurring 3-7 weeks prior) with no residual surgical issues will be eligible for participation. Exclusion Criteria: * Pathological fracture (e.g. fracture due to Paget's disease of bone, malignancy, etc.)...
VK5211 is an investigational small molecule being developed for hip fractures. It is intended for patients 65 years of age or older who have suffered an acute hip fracture. Viking Therapeutics is studying it in this musculoskeletal indication, and it has not been approved for any use.
VK5211 targets the androgen receptor (AR) and acts as a modulator of that receptor. By interacting with AR, the small molecule is designed to influence androgen signaling. This mechanism is the basis for its investigation in hip fracture recovery, where androgen pathway activity may affect musculoskeletal outcomes.
VK5211 is being developed by Viking Therapeutics, Inc., which trades on the Nasdaq under the ticker VKTX. The company is responsible for the clinical program evaluating the drug in patients with acute hip fractures.
VK5211 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The completed Phase 2 trial evaluated the drug in patients with acute hip fractures.
VK5211 has been studied in one completed Phase 2 trial, NCT02578095, titled Acute Hip Fracture Study in Patients 65 Years or Greater. The randomized, double-blind, placebo-controlled trial enrolled 108 patients across the United States, Hungary, Romania, and Serbia. No active trials are currently listed.