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 source
FDA 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 source

Does 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.

Measured outcomes and missing functional outcomes
EvidenceMeasuredNot established
Healthy-men trialPK, lean mass, hormones, lipidsStrength or stair benefit
Hip-fracture registryDXA lean massMobility, 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 source
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 source

Why 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 source

Does 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 source
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 source

What 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 source
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 source
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 source

Is 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 source
FDA 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 source
WADA 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
Read the original source

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 source
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 source
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 source
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 source
FDA 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 source
WADA 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
Read the original source

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.