Ligandrol
updated
Ligandrol increased DXA lean mass during 21 days in healthy men without a significant strength result. A later hip-fracture registry also reports lean-mass changes, but only 79 of 108 starters contributed to the primary measurement and the record does not establish better mobility, independence, falls, or fracture recovery.
nonsteroidal selective androgen-receptor modulator
- Also called LGD-4033 and VK5211
- Small molecule, not a peptide
- Human pharmacokinetics are measured
- No FDA-approved finished product
What exactly is ligandrol?
Ligandrol, LGD-4033, and VK5211 identify the same nonsteroidal androgen-receptor SARM in the development record. A retail label using one of those names does not establish identity, strength, purity, or study-equivalent exposure.
FDA SRS · ligandrol identity
Official substance-identity record
US Food and Drug Administration Substance Registration System.
The record links VK-5211, LGD-4033, and ligandrol to UNII 1EJT54415A and the same chemical identity. Substance registration is not marketing approval or proof of a retail product’s contents.
Read the original sourceFDA 2025 · marketed LGD-4033 product
FDA warning letter
US Food and Drug Administration, 12 December 2025.
FDA identified one seller's LGD-4033 product, marketed with drug claims, as an unapproved new drug. The letter does not establish its ligandrol content.
Read the original sourceDoes ligandrol increase strength or improve recovery?
The 21-day healthy-men trial increased lean mass without a significant leg-press-strength or stair result. The hip-fracture registry measured DXA lean mass and did not establish mobility, independence, fewer falls, or fewer fractures.
| Evidence | Measured | Not established |
|---|---|---|
| Healthy-men trial | PK, lean mass, hormones, lipids | Strength or stair benefit |
| Hip-fracture registry | DXA lean mass | Mobility, independence, falls, or refracture |
21-day RCT · lean mass without strength benefit
Randomized placebo-controlled trial
Basaria S et al. Journals of Gerontology Series A, 2013.
Seventy-six healthy men were randomized and 68 completed. Daily LGD-4033 produced dose-related lean-mass gain, but leg-press-strength trend was not significant (P=.203) and stair-climbing outcomes were not significant. Total testosterone, sex hormone-binding globulin, HDL cholesterol, and triglycerides fell dose-dependently; free testosterone and FSH fell significantly at the highest group. Reported elimination half-life was 24 to 36 hours with about threefold accumulation by day 21.
- Participants / model
- 76 healthy men aged 21 to 50; 68 completed
- Treatment
- Placebo or oral LGD-4033 0.1, 0.3, or 1.0 mg daily
- Follow-up
- 21 days plus 5 weeks follow-up
- Study design
- Randomized placebo-controlled ascending-dose trial
- Funding
- Industry study drug and support were disclosed in the paper
Short exposure in healthy men cannot establish long-term safety or recovery benefit in older patients.
Read the original sourceNCT02578095 · 108 started, 79 primary measurements
Registry-posted phase 2 results
ClinicalTrials.gov NCT02578095, results posted 29 December 2025.
The sponsor reports 108 starters across placebo and three VK5211 groups, 75 completers, and primary DXA measurements from 79 participants: 20 placebo, 27 at 0.5 mg, 17 at 1.0 mg, and 15 at 2.0 mg. Placebo-adjusted total-body-less-head lean-mass changes were 4.75%, 7.15%, and 9.08% in the active groups. The primary endpoint was a DXA surrogate, not walking, independence, falls, or refracture, and the cited sources include no peer-reviewed outcomes paper.
- Participants / model
- 108 adults aged 65 or older after hip fracture
- Treatment
- Placebo or oral VK5211 at three dose levels
- Follow-up
- 12 weeks with follow-up through 24 weeks
- Study design
- Randomized quadruple-masked phase 2 trial with registry-posted results
The registry calls the analysis ITT but provides 79 primary measurements from 108 starters; missing measurements limit interpretation.
Read the original sourceWhy do 108 starters become 79 primary measurements?
The registry reports 108 starters, 75 completers, and 79 people with the primary DXA measurement. The lean-mass estimate therefore excludes primary measurements from 29 starters despite the registry's ITT label.
NCT02578095 · 108 started, 79 primary measurements
Registry-posted phase 2 results
ClinicalTrials.gov NCT02578095, results posted 29 December 2025.
The sponsor reports 108 starters across placebo and three VK5211 groups, 75 completers, and primary DXA measurements from 79 participants: 20 placebo, 27 at 0.5 mg, 17 at 1.0 mg, and 15 at 2.0 mg. Placebo-adjusted total-body-less-head lean-mass changes were 4.75%, 7.15%, and 9.08% in the active groups. The primary endpoint was a DXA surrogate, not walking, independence, falls, or refracture, and the cited sources include no peer-reviewed outcomes paper.
- Participants / model
- 108 adults aged 65 or older after hip fracture
- Treatment
- Placebo or oral VK5211 at three dose levels
- Follow-up
- 12 weeks with follow-up through 24 weeks
- Study design
- Randomized quadruple-masked phase 2 trial with registry-posted results
The registry calls the analysis ITT but provides 79 primary measurements from 108 starters; missing measurements limit interpretation.
Read the original sourceDoes androgen-receptor selectivity remove androgen risk?
Androgen-receptor selectivity did not confine ligandrol's effects to muscle. Human exposure changed sex-hormone and lipid markers within 21 days.
21-day RCT · lean mass without strength benefit
Randomized placebo-controlled trial
Basaria S et al. Journals of Gerontology Series A, 2013.
Seventy-six healthy men were randomized and 68 completed. Daily LGD-4033 produced dose-related lean-mass gain, but leg-press-strength trend was not significant (P=.203) and stair-climbing outcomes were not significant. Total testosterone, sex hormone-binding globulin, HDL cholesterol, and triglycerides fell dose-dependently; free testosterone and FSH fell significantly at the highest group. Reported elimination half-life was 24 to 36 hours with about threefold accumulation by day 21.
- Participants / model
- 76 healthy men aged 21 to 50; 68 completed
- Treatment
- Placebo or oral LGD-4033 0.1, 0.3, or 1.0 mg daily
- Follow-up
- 21 days plus 5 weeks follow-up
- Study design
- Randomized placebo-controlled ascending-dose trial
- Funding
- Industry study drug and support were disclosed in the paper
Short exposure in healthy men cannot establish long-term safety or recovery benefit in older patients.
Read the original sourceFDA · unapproved products and class risks
FDA safety and enforcement communication
US Food and Drug Administration, updated December 2025.
FDA states that SARM products marketed for bodybuilding are unapproved drugs and are not lawful dietary-supplement ingredients. The agency attributes class concerns including heart attack or stroke, liver injury, infertility, sexual dysfunction, and testicular shrinkage.
- Study design
- Agency class-risk communication
The class communication does not provide ligandrol-specific incidence.
Read the original sourceWhat safety limits matter?
The short healthy-men study found hormone and lipid suppression and was too small and brief for chronic cardiovascular, hepatic, reproductive, psychiatric, or cancer outcomes. The older hip-fracture population and retail-product quality create additional uncertainty.
21-day RCT · lean mass without strength benefit
Randomized placebo-controlled trial
Basaria S et al. Journals of Gerontology Series A, 2013.
Seventy-six healthy men were randomized and 68 completed. Daily LGD-4033 produced dose-related lean-mass gain, but leg-press-strength trend was not significant (P=.203) and stair-climbing outcomes were not significant. Total testosterone, sex hormone-binding globulin, HDL cholesterol, and triglycerides fell dose-dependently; free testosterone and FSH fell significantly at the highest group. Reported elimination half-life was 24 to 36 hours with about threefold accumulation by day 21.
- Participants / model
- 76 healthy men aged 21 to 50; 68 completed
- Treatment
- Placebo or oral LGD-4033 0.1, 0.3, or 1.0 mg daily
- Follow-up
- 21 days plus 5 weeks follow-up
- Study design
- Randomized placebo-controlled ascending-dose trial
- Funding
- Industry study drug and support were disclosed in the paper
Short exposure in healthy men cannot establish long-term safety or recovery benefit in older patients.
Read the original sourceNCT02578095 · 108 started, 79 primary measurements
Registry-posted phase 2 results
ClinicalTrials.gov NCT02578095, results posted 29 December 2025.
The sponsor reports 108 starters across placebo and three VK5211 groups, 75 completers, and primary DXA measurements from 79 participants: 20 placebo, 27 at 0.5 mg, 17 at 1.0 mg, and 15 at 2.0 mg. Placebo-adjusted total-body-less-head lean-mass changes were 4.75%, 7.15%, and 9.08% in the active groups. The primary endpoint was a DXA surrogate, not walking, independence, falls, or refracture, and the cited sources include no peer-reviewed outcomes paper.
- Participants / model
- 108 adults aged 65 or older after hip fracture
- Treatment
- Placebo or oral VK5211 at three dose levels
- Follow-up
- 12 weeks with follow-up through 24 weeks
- Study design
- Randomized quadruple-masked phase 2 trial with registry-posted results
The registry calls the analysis ITT but provides 79 primary measurements from 108 starters; missing measurements limit interpretation.
Read the original sourceFDA · unapproved products and class risks
FDA safety and enforcement communication
US Food and Drug Administration, updated December 2025.
FDA states that SARM products marketed for bodybuilding are unapproved drugs and are not lawful dietary-supplement ingredients. The agency attributes class concerns including heart attack or stroke, liver injury, infertility, sexual dysfunction, and testicular shrinkage.
- Study design
- Agency class-risk communication
The class communication does not provide ligandrol-specific incidence.
Read the original sourceIs ligandrol approved or permitted in sport?
The cited FDA records list no approved ligandrol product. FDA treats marketed SARM bodybuilding products as unapproved drugs, and WADA prohibits ligandrol for covered athletes.
FDA · unapproved products and class risks
FDA safety and enforcement communication
US Food and Drug Administration, updated December 2025.
FDA states that SARM products marketed for bodybuilding are unapproved drugs and are not lawful dietary-supplement ingredients. The agency attributes class concerns including heart attack or stroke, liver injury, infertility, sexual dysfunction, and testicular shrinkage.
- Study design
- Agency class-risk communication
The class communication does not provide ligandrol-specific incidence.
Read the original sourceFDA 2025 · marketed LGD-4033 product
FDA warning letter
US Food and Drug Administration, 12 December 2025.
FDA identified one seller's LGD-4033 product, marketed with drug claims, as an unapproved new drug. The letter does not establish its ligandrol content.
Read the original sourceWADA 2026 · SARM prohibited
Sports rule
World Anti-Doping Agency, effective 1 January 2026.
SARMs including ligandrol are prohibited under the anabolic-agents category for athletes governed by the World Anti-Doping Code.
- Study design
- Binding sport rule for covered athletes
Studies and sources
FDA SRS · ligandrol identity
Official substance-identity record
US Food and Drug Administration Substance Registration System.
The record links VK-5211, LGD-4033, and ligandrol to UNII 1EJT54415A and the same chemical identity. Substance registration is not marketing approval or proof of a retail product’s contents.
Read the original source21-day RCT · lean mass without strength benefit
Randomized placebo-controlled trial
Basaria S et al. Journals of Gerontology Series A, 2013.
Seventy-six healthy men were randomized and 68 completed. Daily LGD-4033 produced dose-related lean-mass gain, but leg-press-strength trend was not significant (P=.203) and stair-climbing outcomes were not significant. Total testosterone, sex hormone-binding globulin, HDL cholesterol, and triglycerides fell dose-dependently; free testosterone and FSH fell significantly at the highest group. Reported elimination half-life was 24 to 36 hours with about threefold accumulation by day 21.
- Participants / model
- 76 healthy men aged 21 to 50; 68 completed
- Treatment
- Placebo or oral LGD-4033 0.1, 0.3, or 1.0 mg daily
- Follow-up
- 21 days plus 5 weeks follow-up
- Study design
- Randomized placebo-controlled ascending-dose trial
- Funding
- Industry study drug and support were disclosed in the paper
Short exposure in healthy men cannot establish long-term safety or recovery benefit in older patients.
Read the original sourceNCT02578095 · 108 started, 79 primary measurements
Registry-posted phase 2 results
ClinicalTrials.gov NCT02578095, results posted 29 December 2025.
The sponsor reports 108 starters across placebo and three VK5211 groups, 75 completers, and primary DXA measurements from 79 participants: 20 placebo, 27 at 0.5 mg, 17 at 1.0 mg, and 15 at 2.0 mg. Placebo-adjusted total-body-less-head lean-mass changes were 4.75%, 7.15%, and 9.08% in the active groups. The primary endpoint was a DXA surrogate, not walking, independence, falls, or refracture, and the cited sources include no peer-reviewed outcomes paper.
- Participants / model
- 108 adults aged 65 or older after hip fracture
- Treatment
- Placebo or oral VK5211 at three dose levels
- Follow-up
- 12 weeks with follow-up through 24 weeks
- Study design
- Randomized quadruple-masked phase 2 trial with registry-posted results
The registry calls the analysis ITT but provides 79 primary measurements from 108 starters; missing measurements limit interpretation.
Read the original sourceFDA · unapproved products and class risks
FDA safety and enforcement communication
US Food and Drug Administration, updated December 2025.
FDA states that SARM products marketed for bodybuilding are unapproved drugs and are not lawful dietary-supplement ingredients. The agency attributes class concerns including heart attack or stroke, liver injury, infertility, sexual dysfunction, and testicular shrinkage.
- Study design
- Agency class-risk communication
The class communication does not provide ligandrol-specific incidence.
Read the original sourceFDA 2025 · marketed LGD-4033 product
FDA warning letter
US Food and Drug Administration, 12 December 2025.
FDA identified one seller's LGD-4033 product, marketed with drug claims, as an unapproved new drug. The letter does not establish its ligandrol content.
Read the original sourceWADA 2026 · SARM prohibited
Sports rule
World Anti-Doping Agency, effective 1 January 2026.
SARMs including ligandrol are prohibited under the anabolic-agents category for athletes governed by the World Anti-Doping Code.
- Study design
- Binding sport rule for covered athletes
Why is Ligandrol in C tier?
C tier comes from measured human pharmacology and DXA lean-mass changes without a significant strength result. Chronic safety and hip-fracture function remain unresolved, and retail products are not authenticated by the clinical studies.