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Compound reference

Ligandrol

LGD-4033 · VK5211

SARMs7 cited findingsClinical review: not reviewed

Regulatory record

Regulatory recordSupporting passage inspected

FDA states that SARMs are not FDA approved. Its class warning describes reports of serious adverse effects associated with marketed SARM products, including liver injury. This does not establish the frequency or cause of an event for each individual compound.[1]

Jurisdiction
United States
Product
Products marketed as selective androgen receptor modulators
Indication
No FDA-approved SARM therapeutic indication in the cited agency communication
Record date
2026-09-08
  • Class-level regulatory advice must not be mistaken for a study of every individual SARM or combination.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Independently reopened the FDA page directly; the live URL returned an automated bot-detection response on this attempt, so the Internet Archive Wayback Machine snapshot dated 2026-05-18 was read as a lawful alternative. Confirmed the full page text verbatim, that it names no individual SARM, and its footer statement Content current as of 04/26/2023. This claim's own regulatory.asOf field still carried the evidence-cutoff placeholder (2026-09-08) rather than the source's actual date even though the source record itself was already corrected to 2023-04-26 by an earlier batch; corrected regulatory.asOf to 2023-04-26 here. The claim text required no change. Independent editorial review pending.

· Independent editorial review: the 2026-09-09 change of regulatory.asOf from 2026-09-08 to 2023-04-26 is rejected and reverted. Every other regulatory claim in the published model (17 of 18, by direct count) and two prior coordinator corrections in this same pass (aas-coordinator-edits.json, ancillary-coordinator-edits.json) establish that regulatory.asOf records the date through which this pass confirms the described status is still current, capped at the evidence cutoff -- not the cited document's own date, which is already fully recorded on the source record's own publicationDate and availableBy fields. regulatory.asOf is restored to 2026-09-08. No other change to this claim's text, sources or limitations was required; independently reconfirmed the FDA page's class-only, no-molecule-named framing, its exact adverse-event list including liver injury and acute liver failure, and its footer date. No qualified clinical review has occurred.

Safety findings

Case reportAbstract inspected

Independent published case reports describe drug-induced liver injury in men who used Ligandrol (LGD-4033) alone as a supplement: biopsy-confirmed cholestatic hepatitis with portal, periportal and perisinusoidal fibrosis in a 32-year-old man, and jaundice with elevated liver enzymes in a 52-year-old man after three months of high-dose use. Both are single-patient reports describing individual events, not an incidence rate or established causal mechanism.[3][4]

  • Case reports describe individual reported events; they cannot establish incidence, absolute risk or causal certainty for the general user population.
  • Only the indexed abstracts were inspected for these two reports; the full causality-assessment methodology was not reviewed.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· New finding added after a deliberate search for published human hepatotoxicity case reports specific to pure LGD-4033 use, per this batch's instruction to check for liver-injury literature separately from the phase 1 trial's own safety labs.

Endocrine & recovery

Human randomized studySupporting passage inspected

In a 21-day trial in 76 healthy men randomized to placebo or 0.1, 0.3 or 1.0 mg LGD-4033 daily (68 of 76 completed), LGD-4033 reduced total testosterone, SHBG, HDL cholesterol and triglycerides in a dose-related manner; free testosterone and FSH suppression reached significance only in the 1.0-mg group. Hormones and lipids returned to baseline during the study's five-week post-treatment follow-up, and no participant discontinued because of an adverse event.[2]

  • The observed follow-up does not guarantee recovery after longer, higher-dose or multi-drug exposure.
  • The trial was not powered around a prespecified effect size, and 21 days is too short to characterize suppression or recovery after longer or higher exposure.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Reopened full text (PMC4111291) via a lawful alternate retrieval after the earlier pass could not access it; upgraded verification from abstract-checked to passage-checked and added the exact completion count (68/76) and the outcomes covered.

Pharmacokinetics

Human randomized studySupporting passage inspected

The same phase 1 trial reported a prolonged elimination half-life of 24 to 36 hours for LGD-4033, with roughly threefold higher serum concentrations on day 21 than day 1 of daily dosing, consistent with accumulation on repeated dosing. This is a measured value in healthy young men over 21 days at low-to-moderate doses, not a lifetime, high-dose or combined-use estimate.[2]

  • A short single-trial estimate in healthy young men at low-to-moderate doses; elimination kinetics after higher, longer or combined unapproved use are not established.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· New finding added after reopening the full text of the LGD-4033 phase 1 trial (PMC4111291), which the earlier fresh-pass abstract-only inspection could not access; distinguishes this measured human pharmacokinetic value from animal-derived or vendor estimates.

Clinical & experimental findings

Human randomized studySupporting passage inspected

In the same 21-day, 76-participant trial, LGD-4033 increased lean body mass dose-dependently without a significant change in fat mass. The study did not establish a meaningful strength or functional benefit, and its own authors state the short duration was not designed to demonstrate maximal effects on skeletal muscle.[2]

  • Lean mass is not equivalent to performance, health benefit or long-term safety.
  • The authors state the sample size was not based on effect-size considerations and the 21-day duration was not designed to show maximal muscle effects.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Reopened full text (PMC4111291); upgraded verification from abstract-checked to passage-checked and added the authors' own duration/power limitation statement.

Interaction evidence

Case reportAbstract inspected

Liver injury was reported in a man taking products labeled as RAD-140 and RAD-140/LGD-4033. This is a coexposure case report, not proof that an interaction between the named ingredients caused the injury.[5]

  • Ingredient content was not independently established in the inspected abstract; other explanations and product contaminants cannot be excluded.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

Mechanistic inferenceAbstract inspected

Liver injury reports involving oral methasteron and products labeled RAD-140/LGD-4033 motivate a possible overlapping liver concern. The additional risk when these agents are combined is unknown; this evidence does not identify YK-11 toxicity.[6][5]

  • This evidence does not establish the magnitude or frequency of harm from the selected combination.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Supporting passages inspected, scope corrected and legacy assertions reassessed; no clinician review performed.

· Independently reopened every cited source afresh on 2026-09-09 (interaction batch, fresh deep-research pass); disposition and wording reconfirmed against the live sources, not carried over from the prior pass. No qualified clinical review.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Separated the short trial findings from unresolved longer-exposure and recovery questions.

  • Full paper access was blocked; long-term/high-dose recovery, clinical risk incidence and exact kinetics require further review.
  • Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

Explore the interaction evidence for this compound →

References

  1. FDA warns of selective androgen receptor modulators marketed to teens and young adults

    FDA web page. The footer states "Content current as of: 04/26/2023" (26 April 2023); confirmed unchanged against a Wayback Machine snapshot dated 2026-05-18, inspected 2026-09-09. 2023-04-26. Regulatory document.

    Inspected location: Full consumer-update text: SARM approval status, listed adverse-event categories (including liver injury and acute liver failure), dietary-supplement/drug status and MedWatch reporting guidance

    Study context and inspection record
  2. The safety, pharmacokinetics, and effects of LGD-4033, a novel nonsteroidal oral, selective androgen receptor modulator, in healthy young men.

    2012-03-28. PMID:22459616 · DOI:10.1093/gerona/gls078 · PMCID:PMC4111291 Full text inspected.

    Inspected location: Full text (PMC4111291): Methods (screening 389, eligible 131, randomized 76, completed 68); Results (serum hormones, lipids, safety labs); Pharmacokinetics (elimination half-life 24-36 hours, approximately threefold accumulation by day 21 versus day 1); Discussion/limitations

    Study context and inspection record
  3. Ligandrol (LGD-4033)-Induced Liver Injury.

    2020-06-11. PMID:32637435 · DOI:10.14309/crj.0000000000000370 · PMCID:PMC7304490 Abstract only.

    Inspected location: Abstract: case presentation and outcome (liver biopsy: cholestatic hepatitis with mild portal, periportal and perisinusoidal fibrosis)

    Study context and inspection record
  4. LGD-4033 and a Case of Drug-Induced Liver Injury: Exploring the Clinical Implications of Off-Label Selective Androgen Receptor Modulator Use in Healthy Adults.

    2024-09-17. PMID:39421081 · DOI:10.7759/cureus.69601 · PMCID:PMC11485217 Abstract only.

    Inspected location: Abstract: case presentation and outcome (other causes of liver injury were ruled out in the reported workup)

    Study context and inspection record
  5. Drug-Induced Liver Injury Associated With Alpha Bolic (RAD-140) and Alpha Elite (RAD-140 and LGD-4033)

    2020-06. PMID:33062783 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record
  6. Methasteron-associated cholestatic liver injury: clinicopathologic findings in 5 cases

    2008-02. PMID:18187367 Abstract only.

    Inspected location: PubMed abstract; publication types and CommentsCorrections in NLM EFetch XML

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • peptide-fda-sarms: Sections explaining lack of FDA approval and reported adverse effects
  • peptide-pmid-22459616: Abstract: methods and results

View this compound in the research library →

Related records in this class

Grouped under SARMs for navigation only. Shared class membership does not make findings, formulations or evidence interchangeable between records.

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This reference discusses steroids, SARMs and other compounds. It is educational, not medical advice, and does not recommend using or combining them.

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