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Compound reference

RAD-140

Testolone

SARMs8 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

Human observational studyAbstract inspected

The RAD140 phase 1 study in 22 heavily pretreated metastatic breast cancer patients (21 confirmed androgen-receptor-positive; doses 50, 100 or 150 mg daily) reported treatment-emergent elevations in aspartate aminotransferase (59.1 percent of patients), alanine aminotransferase (45.5 percent) and total bilirubin (27.3 percent). Grade 3 or 4 treatment-emergent adverse events occurred in 72.7 percent of patients, most often AST/ALT elevations and hypophosphatemia. Its small size, high doses and heavily pretreated cancer population prevent a reliable risk estimate for unapproved use by healthy people.[2]

  • Treatment-emergent events are not all necessarily caused by the drug; the abstract alone cannot resolve individual causality.
  • Treatment-emergent events in a heavily pretreated cancer population reflect that population's own baseline risk as well as any drug effect.
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 treatment-emergent adverse-event percentages (AST, ALT, bilirubin, Grade 3/4 rate) and dose levels rather than the qualitative 'frequent elevations' description alone.

Case reportAbstract inspected

Independent published case reports describe cholestatic or hepatocellular drug-induced liver injury in men who used RAD140 alone as a supplement, including a 24-year-old man with a peak total bilirubin of 38.5 mg/dL and biopsy-confirmed cholestasis after five weeks of use, a 26-year-old man with acute liver injury that resolved after stopping RAD140, and a 29-year-old man with hepatic steatosis and a liver lesion after three months of use. Symptoms and liver-test abnormalities resolved after stopping the compound in each report.[3][4][5]

  • 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 three reports; full biopsy/causality-assessment narratives were 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 RAD-140 use, corroborating the phase 1 trial's own liver-enzyme findings with three independent reports.

Case reportAbstract inspected

A separate published case describes severe cholestatic liver injury, complicated by pancreatitis and acute kidney injury and requiring plasmapheresis and intensive care, in a man who used a single supplement product containing both RAD-140 and Andarine (S4) together. Because the product combined two SARMs, this report cannot attribute the injury to either compound alone; it is a product coexposure case, not pure-compound evidence for RAD-140 or Andarine individually.[6]

  • A combined-product coexposure case cannot isolate which compound, or their combination, caused the injury.
  • Only the indexed abstract was inspected; the article is not open access and the full case discussion was not reviewed.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· New finding added per this batch's instruction to keep product-labelled coexposure cases separate from pure-compound evidence; attached to both rad-140 and andarine because the product named in the report contained both compounds.

Case reportSupporting passage inspected

A man reporting use of an online RAD-140 product developed cholestatic liver injury; liver tests worsened after he stopped and later normalized. A validated causality tool (Naranjo score 8) rated the reaction a probable adverse drug reaction. The case supports a product-associated safety signal without proving its composition or estimating incidence.[7]

  • Self-reported exposure; no interaction was studied and no claim about YK-11 is supported.
  • This patient reported RAD-140 alone, not combined with LGD-4033; it is a separate case from the Alpha Bolic/Alpha Elite coexposure report.
Inspection history

Clinical review: not reviewed by a qualified clinician.

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

· Independently re-read the full publisher case report on 2026-09-09; added the Naranjo causality score (8, probable) and confirmed RAD-140-only exposure, distinguishing this case from the separate RAD-140/LGD-4033 coexposure report.

Pharmacokinetics

Human observational studyAbstract inspected

The reported RAD140 terminal half-life of 44.7 hours came from a phase 1 study in postmenopausal women with metastatic breast cancer receiving oral study treatment. It is not a measured value in healthy male performance users.[2]

  • Population, exposure and disease context limit application of this estimate.
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 abstract via Europe PMC REST and reconfirmed its own words verbatim: the half-life (t1/2) of 44.7 hours supported QD dosing, reported from a first-in-human phase 1 dose-escalation study in 22 (21 androgen-receptor-positive) heavily pretreated postmenopausal women with ER-positive/HER2-negative metastatic breast cancer receiving oral RAD140 at 50, 100 or 150 milligrams once daily. Confirmed no PMC copy or open-access full text exists for this record; the only full-text route is the subscription DOI. No indexed correction or retraction found. A PubMed search for RAD140 healthy men randomized returned no results, consistent with no measured half-life in a healthy or male population through the cutoff. Independent editorial review pending.

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.[8]

  • 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.[9][8]

  • 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.

Tied pharmacokinetics and liver-enzyme findings to the first-in-human metastatic-breast-cancer population.

  • Healthy-user pharmacokinetics, endocrine effects, long-term safety and recovery remain unverified.
  • 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. A First-in-Human Phase 1 Study of a Novel Selective Androgen Receptor Modulator (SARM), RAD140, in ER+/HER2- Metastatic Breast Cancer.

    2021-08-20. PMID:34565686 · DOI:10.1016/j.clbc.2021.08.003 Abstract only.

    Inspected location: Abstract: patient population, pharmacokinetics and treatment-emergent adverse events

    Study context and inspection record
  3. RAD-140 Drug-Induced Liver Injury.

    2022. PMID:36561105 · DOI:10.31486/toj.22.0005 · PMCID:PMC9753945 Abstract only.

    Inspected location: Abstract: case presentation and outcome (liver biopsy: intracytoplasmic and canalicular cholestasis with minimal portal inflammation; resolved after cessation)

    Study context and inspection record
  4. Idiosyncratic drug-induced liver injury related to use of novel selective androgen receptor modulator RAD140 (Testalone): a case report.

    2023-03-29. PMID:36978171 · DOI:10.1186/s13256-023-03847-8 · PMCID:PMC10054042 Abstract only.

    Inspected location: Abstract: case presentation and outcome (no other definite cause of liver injury was identified in the reported workup)

    Study context and inspection record
  5. Selective Androgen Receptor Modulators Leading to Liver Injury: A Case Report.

    2024-08-27. PMID:39328701 · DOI:10.7759/cureus.67958 · PMCID:PMC11426965 Abstract only.

    Inspected location: Abstract: case presentation and outcome (symptoms resolved after discontinuation)

    Study context and inspection record
  6. Unregulated gains: a case of RAD-140-induced liver injury.

    2026-07-08. PMID:42417499 · DOI:10.1080/08998280.2026.2691619 Abstract only.

    Inspected location: Abstract: case presentation and outcome (the product combined two SARMs; the abstract itself calls this the most severe RAD-140-associated case reported to date)

    Study context and inspection record
  7. Severe liver injury following use of RAD-140, a selective androgen receptor modulator, for body building

    2024-02-20. PMID:38444893 · DOI:10.18773/austprescr.2024.004 Full text inspected.

    Inspected location: Case (43-year-old man, RAD-140 alone, 2 months' use, stopped 1 week before presentation); Table 1 admission pathology; Naranjo score and biopsy findings; Figure 1 bilirubin recovery; Comment

    Study context and inspection record
  8. 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
  9. 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-34565686: Abstract: patient population, pharmacokinetics and treatment-emergent adverse events

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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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