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Compound reference

Ostarine

MK-2866 · Enobosarm · GTx-024

SARMs3 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.

Endocrine & recovery

Human randomized studySupporting passage inspected

The enobosarm trial reported significant reductions in total testosterone in men at the 1-mg (-6.4 nmol/L) and 3-mg (-7.4 nmol/L) doses (both P<0.001) and a significant reduction in SHBG at 3 mg in men (-15.8 nmol/L, P=0.048), without a significant reduction in free testosterone at any dose. HDL decreased by 17 percent at 1 mg and 27 percent at 3 mg. One participant was discontinued after an alanine aminotransferase elevation to 4.2 times the upper limit of normal that returned to normal after stopping the drug; transient alanine aminotransferase elevations above the upper limit of normal occurred in 8 of 120 participants overall, resolving in 7 of those 8 while still on treatment. In postmenopausal women, hormone levels did not differ significantly from placebo at any dose except for a reduction in SHBG. A simple universal suppression-severity label loses these distinctions.[2]

  • The trial does not establish the incidence of liver injury or endocrine outcomes after longer or higher exposure.
  • Reported P values are unadjusted two-sided tests per the authors' stated methods, with no correction for multiple secondary comparisons.
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 the full-text results tables and adverse-event narrative and added the exact testosterone/SHBG/HDL changes by sex and dose, and the specific 4.2x ULN ALT figure for the discontinued participant plus the overall transient-ALT count (8 of 120).

Clinical & experimental findings

Human randomized studySupporting passage inspected

In a 12-week trial in 120 selected older men and postmenopausal women (115 completed; 24 per dose arm), enobosarm increased total lean body mass dose-dependently, reaching +1.3 kg versus placebo at the highest (3 mg) dose (P<0.001), and significantly improved stair-climb power at that same dose (P=0.013); total fat mass decreased by about 322 g at 3 mg (P=0.049). Improvements were significant only at the highest studied dose. These endpoints do not establish long-term health benefits or results in younger performance users.[2]

  • Small dose groups and the selected population limit generalization.
  • Lower doses did not reach statistical significance for the primary lean-mass endpoint; only the 3-mg group did.
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 the full-text results tables and added the exact lean-mass, fat-mass and stair-climb-power effect sizes, completion count, and the fact that significance was reached only at the highest dose.

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.

Inspected the full primary trial and retained total-versus-free testosterone distinctions, HDL change and ALT discontinuation.

  • Long-term cardiovascular, reproductive and higher-exposure risks remain unresolved.
  • 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.

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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 selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women: results of a double-blind, placebo-controlled phase II trial.

    2011-08-02. PMID:22031847 · DOI:10.1007/s13539-011-0034-6 Full text inspected.

    Inspected location: Methods (recruitment, randomization, dosing schedule); Results: Table 1 (demographics), Table 2 (lean/fat mass and stair-climb power), Table 3 (adverse events), Table 4 (lipids), Table 5 (serum hormones by sex); Discussion

    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-22031847: Methods; Results: lean body mass, physical function, endocrine function and safety; Discussion

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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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