Safety findings

Regulatory recordSupporting passage inspected

WADA’s 2013 alert states that GW501516 development was terminated after serious preclinical toxicities. The alert supports a significant development-stage safety concern, but not a numerical human cancer risk.[2]

  • Original animal toxicology tables were not inspected; no species-specific tumor incidence or causal human cancer claim is made.
  • The alert's own one-page text does not use the words cancer, tumor or carcinogenicity and cites no specific study, species or dose; it is an anti-doping notice reporting a pharmaceutical company's development decision, not a published toxicology report.
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 original one-page WADA/FIA alert PDF directly (HTTP 200) and read it in full in both languages; reconfirmed the claim's quoted language verbatim (development terminated when serious toxicities were discovered in pre-clinical studies) and confirmed the alert itself never uses the words cancer, tumor or carcinogenicity and names no specific study, species, dose or organ. A further PubMed search for the underlying rodent carcinogenicity bioassay (queries: GW501516 carcinogenicity rat, GW501516 tumorigenicity, GW501516 rodent bioassay, endurobol toxicology) found no dedicated peer-reviewed publication of that bioassay; results returned only general PPAR-delta cancer-biology mechanistic papers unrelated to this specific compound's preclinical program. This remains an explicit, unresolved evidence gap, not a finding either way about carcinogenic risk. Independent editorial review pending.

Clinical & experimental findings

Human randomized studyAbstract inspected

GW501516 (cardarine) is a PPAR-delta agonist, not a SARM. In an 18-person, two-week randomized trial (6 per arm) comparing GW501516, a comparator PPAR-alpha agonist and placebo in moderately overweight adults, GW501516 reduced fasting triglycerides by 30 percent, LDL cholesterol by 23 percent and apolipoprotein B by 26 percent, and reduced liver fat by 20 percent, without a significant change in HDL cholesterol. These surrogate lipid and liver-fat changes over two weeks do not demonstrate improved endurance, prevention of cardiovascular disease or long-term safety.[1]

  • This is a non-SARM mechanism and a surrogate-endpoint study.
  • A 2-week study in 6 participants per arm cannot establish clinical cardiovascular outcomes or long-term safety.
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 abstract and added the exact percentage changes in triglycerides, LDL, apolipoprotein B and liver fat, and the per-arm sample size (6 of 18 total).

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 a small human surrogate study from the original WADA preclinical toxicity alert.

  • Original toxicology tables, long-term human outcomes and a numerical human cancer risk were not verified.
  • 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. Activation of peroxisome proliferator-activated receptor (PPAR)delta promotes reversal of multiple metabolic abnormalities, reduces oxidative stress, and increases fatty acid oxidation in moderately obese men.

    2007-11-16. PMID:18024853 · DOI:10.2337/db07-1318 Abstract only.

    Inspected location: Abstract: methods and results

    Study context and inspection record
  2. WADA alert: GW501516

    WADA athlete alert. The dateline reads Montreal, March 21, 2013, matching the recorded publication date; confirmed on direct fresh retrieval of the original PDF on 2026-09-09. 2013-03-21. Regulatory document.

    Inspected location: Single-page bilingual (English/French) alert: development termination and preclinical toxicities

    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-pmid-18024853: Abstract: methods and results
  • peptide-wada-gw501516-2013: Single-page alert: development termination and preclinical toxicities

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Related records in this class

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

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