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.

Identity & applicability

Human observational studyAbstract inspected

Human S-23 microdose metabolism research exists, so an absolute "no human exposure" statement is incorrect. A doping-control study administered single and multidose oral microdoses of 1, 10 and 50 micrograms and identified 18 metabolites in human urine; a single 1-microgram dose remained detectable for an average of up to 253 hours and a single 50-microgram dose for an average of up to 544 hours. This analytical detection work did not establish therapeutic efficacy or safety.[3]

  • Metabolism research does not establish clinical benefit, endocrine suppression severity or recovery.
  • These are microgram-level research microdoses for analytical detection, not a therapeutic or performance exposure of any kind.
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 and added the exact microdose amounts, metabolite count and average detection windows reported for the doping-control assay.

Endocrine & recovery

Animal / laboratorySupporting passage inspected

In intact male rats treated with S-23 plus estradiol benzoate for up to 10 weeks, the combination suppressed reproductive function: at the 0.1-milligram-per-day S-23 dose, 4 of 6 animals had no sperm detected in the testis, and the same treatment group had 0 of 12 pregnancies in mating trials during treatment. After treatment stopped, this infertility fully reversed, reaching a 100 percent pregnancy rate at 100 days of recovery in that animal experiment. This is not evidence for a human recovery timetable.[2]

  • The combination treatment and species prevent extrapolation to human fertility recovery after unapproved use.
  • This is a single preclinical rat study from one laboratory group with a small per-group sample size (6 animals per dose); independent replication was not found in this review.
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 verified every number now stated in the claim against the source verbatim: in the estradiol-benzoate plus S-23 (0.1 mg/d) group, four of six animals showed no sperm in the testis and zero of six pregnancies in mating trials; infertility was fully reversible, with a 100 percent pregnancy rate observed after 100 days of recovery; combined dosing is described as up to 10 weeks. Replaced the prior unquantified description with these exact figures. This record carries a PMCID (PMC2630904); full-text access was attempted through four routes (the NCBI PMC article page, the Europe PMC fullTextXML and BioC endpoints, and the Europe PMC PDF-render API) and each failed (anti-bot interstitial, 404, 404 and no PDF file found respectively); the Europe PMC HTML article page itself requires client-side JavaScript a scripted fetch cannot execute. Inspection stays abstract-level per the brief's instruction not to upgrade on a guess. No indexed correction or retraction found. Independent editorial review pending.

· Independent editorial review reopened PMC2630904 directly (HTTP 200 on a plain browser-header GET request, no CAPTCHA or bot-check encountered, contrary to the batch's reported access failure on this exact route) and read Results Tables 3 and 6. The abstract's 'zero pregnancies (none of six)' phrase does not match Table 3's own reported fraction of 0 of 12 pregnancies for the same 0.1 mg/d EB plus S-23 group; corrected the claim's mating-trial figure to 0 of 12 and upgraded verification to passage-checked. The 4 of 6 azoospermia figure and the 100 percent pregnancy rate at 100 days of recovery were both reconfirmed unchanged against the full text. Deliberately did not add the full text's intermediate 83 percent (10 of 12) pregnancy rate at 70 days after treatment ended, to avoid turning a single animal-only recovery figure into a multi-point recovery timeline. 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.

Identified human microdose metabolism research and separated it from S-23-plus-estradiol rat contraception.

  • Human therapeutic-dose endocrine and reproductive recovery outcomes 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.

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. Preclinical characterization of a (S)-N-(4-cyano-3-trifluoromethyl-phenyl)-3-(3-fluoro, 4-chlorophenoxy)-2-hydroxy-2-methyl-propanamide: a selective androgen receptor modulator for hormonal male contraception.

    2008-09-04. PMID:18772237 · DOI:10.1210/en.2008-0674 Full text inspected.

    Inspected location: Full text (PMC2630904, Endocrinology 150(1):385, electronic publication 2008-09-04): Results Table 3 (hormones and fertility during treatment) and Table 6 (reversibility of hormones, sperm counts and pregnancies after treatment); Discussion

    Study context and inspection record
  3. Investigations Into the Urinary Metabolite Elimination Profile of the Selective Androgen Receptor Modulator S-23 in Studies Mimicking Contaminated Product Ingestion for Doping Control Purposes.

    2025-06. PMID:40277337 · DOI:10.1002/bmc.70090 Abstract only.

    Inspected location: Abstract: administered human microdoses and metabolite identification

    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-18772237: Abstract: methods and results
  • peptide-pmid-40277337: Abstract: administered human microdoses and metabolite identification
  • Additional human metabolism abstract PMID 35182830 (2022) inspected; a volunteer exposure study does not establish therapeutic safety.

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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