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Identity And Regulatory Status — Research Overview

By Editorial Desk · published 2026-05-15 · last reviewed 2026-06-19 · News

A practical reference on clinical development: what it is, how it behaves, what the literature reports, and where the honest uncertainties sit.

Reviewed 2026-06-19. Anything still debated is marked as such rather than presented as settled.

Identity and Regulatory Status

Regulatory treatment varies, but cardarine is not approved as a medicine. Sports authorities list GW501516 as a prohibited substance, and it is banned at all times under the World Anti-Doping Agency code. Many countries restrict sales for human consumption, while online vendors market it as a research chemical. Such products may lack purity data, and their actual contents can differ from the label. Purchasing or possessing cardarine may carry legal consequences depending on jurisdiction. The compound is not a dietary supplement ingredient in regulated markets.

Clinical development stopped after rodent studies showed tumors at multiple sites. Whether those findings predict human cancer risk remains an open question, but they led sponsors to discontinue programs. Human safety data are limited to small, short-term studies that were not designed to assess cancer risk. Reported effects in those studies included changes in blood lipids, but the evidence is insufficient for medical use. Long-term consequences of nonmedical use are not well characterized. Questions about dose, duration, and individual susceptibility remain unresolved.

Cardarine is a common name for GW501516, an investigational compound developed in the 1990s for metabolic conditions. It acts as an agonist at peroxisome proliferator-activated receptor delta, a nuclear receptor involved in lipid and energy metabolism. The compound is frequently mislabeled as a selective androgen receptor modulator, or SARM, but its molecular target is different. GW501516 reached early clinical testing before development was discontinued. It has no approved therapeutic use in any country. The name cardarine is not a formal international nonproprietary name.

Preclinical Findings and Safety Signals

Laboratory studies indicate that GW501516 activates PPARδ, a nuclear receptor involved in fatty acid oxidation and energy metabolism. In rodent experiments, treated animals often showed increased endurance and reduced fat mass. These effects were observed under controlled conditions and do not establish safe or effective use in humans. The exact dose-response relationship in humans remains poorly characterized. Species differences in metabolism can affect how results translate across animals and people.

Safety concerns emerged from long-term animal studies. In rodents given the compound for extended periods, researchers found an increased incidence of certain cancers, including liver and bladder tumors. These findings contributed to the discontinuation of clinical development. Whether similar risks apply to short-term or low-level exposure in humans is not established, and controlled human safety data are limited. The relevance of high-dose rodent carcinogenicity findings to human use remains a subject of debate.

Cardarine at a glance

PropertyValueNotes
Common synonymsGW501516; GW-1516; endurobolGW501516 is the research code
Drug classPPARδ agonistNot a selective androgen receptor modulator
Molecular formulaC21H18F3NO3S2Established chemical formula
Molar mass453.5 g/molCalculated from the formula
Regulatory statusProhibited in sport; not approved as medicineStatus varies by country

Detection, Stability, and Quality

Stability of GW501516 depends on form, temperature, light exposure, and moisture. Solid reference material is typically stored frozen or refrigerated in a desiccator and protected from light. Solutions in organic solvents such as dimethyl sulfoxide are often kept frozen in aliquots to reduce freeze-thaw cycling. Aqueous solubility is low, so aqueous stock solutions can be difficult to prepare without cosolvents. Degradation may appear as changes in chromatographic purity or mass spectral signal. Stability studies are needed to establish shelf life for any specific preparation.

Quality assessment for cardarine samples usually combines identity, purity, and impurity testing. Nuclear magnetic resonance spectroscopy and mass spectrometry can confirm molecular structure, while high-performance liquid chromatography estimates purity. Certificates of analysis from testing laboratories may list these results, but they do not establish safety or legality. In the absence of approved manufacturing, products sold online may contain the wrong compound, variable amounts, or unlisted contaminants. Independent verification is therefore central to analytical work and to interpreting any reported biological activity.

Laboratory detection of GW501516 commonly uses liquid chromatography coupled with tandem mass spectrometry. The method can identify the parent compound or its metabolites in urine and blood after sample cleanup. Protein precipitation, solid-phase extraction, or enzymatic hydrolysis may precede analysis, depending on the matrix. Reference standards are required for accurate quantification and confirmation. Because the compound is not approved, testing often occurs in anti-doping, forensic, or research settings rather than routine clinical care. Results are reported with limits of detection and quantification.

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Detection, Regulation, and Quality Context

Cardarine can be detected in biological samples and product materials using liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS). The method separates compounds by chromatography and identifies them by mass-to-charge transitions, allowing low-level detection in urine or blood. Sample preparation often involves enzymatic hydrolysis, solid-phase extraction, or protein precipitation. Certified reference materials and isotope-labeled internal standards improve quantification. Detection windows depend on metabolism, matrix, and assay sensitivity, so no single universal window applies.

Regulatory treatment of cardarine differs by context and jurisdiction. In competitive sport, the World Anti-Doping Agency lists PPARδ agonists, including GW501516, as prohibited at all times. Outside sport, it lacks approval as a prescription medicine in major drug markets, and products sold for human consumption may be treated as unapproved drugs. Some countries also restrict importation or sale through general consumer protection and medicines laws. These classifications affect availability, testing, and legal risk without establishing therapeutic value.

Because cardarine is not an approved medicine, no pharmacopeial monograph defines its identity, purity, or storage requirements. Laboratories typically rely on in-house methods and reference standards when testing materials labeled as GW501516. Certificates of analysis may report purity and identity for a specific batch, but their scope varies and they do not guarantee safety or legal status. Independent verification can include high-performance liquid chromatography, mass spectrometry, nuclear magnetic resonance, and elemental analysis. The distinction between research chemical labeling and human use is significant because quality standards and oversight differ.

Regulatory Status and Detection Context

Analytical laboratories typically identify cardarine and its metabolites using liquid chromatography-tandem mass spectrometry. Urine is a common matrix in anti-doping testing, while blood and tissue may be used in research settings. Detection windows depend on the assay, the sample matrix, and the compound's metabolism. Because cardarine is extensively metabolized, laboratories often target specific metabolites to improve sensitivity and confirmation. Reference standards are required for reliable quantification. Method validation includes checks for selectivity, linearity, and carryover.

A persistent misconception is that cardarine is a fat-burning drug or a safe alternative to anabolic steroids. No approved therapeutic product exists, and human safety data are limited. The tumor findings in rodents remain a central concern in scientific reviews. Products sold online may contain inaccurate labels, impurities, or different compounds entirely, which complicates any assessment of effects. Independent testing of such products has reported frequent mislabeling. For these reasons, discussions in the literature emphasize risks and unknowns rather than benefits.

Cardarine is not approved for human therapeutic use in any major jurisdiction. It appears on the World Anti-Doping Agency Prohibited List as a PPARδ agonist within the hormone and metabolic modulators category. Sports organizations test for it because it has been detected in athlete samples and seized products. Regulatory actions against marketed research chemical versions have occurred in several countries, though enforcement varies. Availability through unregulated channels complicates oversight.

Notes from published material

==== Psilocybin ==== Psilocybin has been shown in several studies to improve symptoms in people with treatment-resistant depression. In 2018 and 2019, the FDA designated psilocybin as a "breakthrough therapy" for drug-resistant depression and major depressive disorder.

=== DNA repair === Lymphoblastoid cell lines established from blood samples of centenarians have significantly higher activity of the DNA repair protein PARP (Poly ADP ribose polymerase) than cell lines from younger (20 to 70 years old) individuals. The lymphocytic cells of centenarians have characteristics typical of cells from young people, both in their capability of priming the mechanism of repair after H2O2 sublethal oxidative DNA damage and in their PARP capacity. PARP activity measured in the permeabilized mononuclear leukocyte blood cells of thirteen mammalian species correlated with maximum lifespan of the species. These findings suggest that PARP mediated DNA repair activity contributes to the longevity of centenarians, consistent with the DNA damage theory of aging.

=== Approval ratings === In a survey conducted by Ipespe/Febraban and released in February 2023, Lula's third government was rated as good or excellent by 40% of Brazilians, regular by 27%, and bad or terrible by 28%, while 5% did not respond. In the following month, between the 2nd and 6th, Ipec conducted an analysis that was released on the 19th; in it, 41% of Brazilians rated the government as "good or excellent", 30% considered the administration "regular", and 24% thought it was "bad or terrible"; 5% did not know or preferred not to respond. In this way, Lula began his third term with higher approval than his predecessor, Jair Bolsonaro, who in March 2019 was considered "good or excellent" by 34%. Regarding confidence in Lula, 53% of the population said they trusted him, while 43% stated that they did not trust him and 4% preferred not to express an opinion. Finally, the survey found that the president's way of governing had the approval of 57% of Brazilians. On 29 and 30 March, Datafolha interviewed 2,028 people in 126 municipalities, and the Lula government was rated as excellent or good by 38%, regular by 30%, and bad or terrible by 29% of respondents. On 23 May, according to a new survey, 54% of respondents approved of the government, while 39% of respondents disapproved of the government. In June 2023, according to a new Ipec survey, the Lula government had the approval of 37% of the population, while 32% considered it regular, 28% disapproved of it, and 3% did not know how to answer.

Sources: en.wikipedia.org

Background from the literature

Intranasal midazolam is found to be highly effective in acute episodes of seizures in children. Recently, the upper part of the nasal cavity, as high as the cribriform plate, has been proposed for drug delivery to the brain. This "transcribrial route", published first in 2014, was suggested by the author for drugs to be given for Primary Meningoencephalitis.

==== Road ==== The post road built by Thomas Telford from London strengthened Holyhead's position as the port from which the Royal Mail was dispatched to and from Dublin on the Mail coach. The A5 terminates at Admiralty Arch (1822–24), which was designed by Thomas Harrison to commemorate a visit by King George IV in 1821 en route to Ireland and marked the zenith of Irish Mail coach operations. Holy Island and Anglesey are separated by the Cymyran Strait which used to be crossed on the Four Mile Bridge; so called, because the bridge was 4 miles (6 kilometres) from Holyhead on the old turnpike.

== Education and career == Born in Montclair, New Jersey, Hamer obtained his BA at Trinity College in Connecticut, and his PhD from Harvard Medical School. He was an independent researcher at the National Institutes of Health for 35 years, where he was the Chief of Gene Structure and Regulation Section at the U.S. National Cancer Institute; upon retirement in 2011 he was designated Scientist Emeritus. Hamer has won numerous awards including the Trinity College Thompson History Prize, Maryland Distinguished Young Scientist Award, Ariens Kappers Award for Neurobiology, New York Times book-of-the year author, and an Emmy Award.

As of 2021, the largest producers of milk powder are New Zealand, China, Argentina and Brazil. European production of milk powder in fiscal year 2019–2020 was estimated at around 3.0 million tonnes of which the main volume was exported in bulk packing or consumer packs. Australia also has a significant milk powder export industry, exporting over 13,000 tonnes of skim and whole milk powder in fiscal year 2020–2021, to a value of approximately AUD $83 000 000. Brands on the market include Nido, from the company Nestlé, Incolac from the company Milcobel, Dutch Lady from FrieslandCampina and Puck from Arla Foods. Some of the largest businesses in the industry are Nestlé, Danone, Lactalis, Fonterra, FrieslandCampina, Dean Foods, Arla Foods, Dairy Farmers of America, Kraft Foods, Saputo, and Parmalat.

Sources: en.wikipedia.org

Further detail

==== MeSH E05.820.800 – reproductive techniques, assisted ==== MeSH E05.820.800.500 – embryo transfer MeSH E05.820.800.750 – fertilization in vitro MeSH E05.820.800.750.700 – sperm injections, intracytoplasmic MeSH E05.820.800.800 – posthumous conception MeSH E05.820.800.875 – gamete intrafallopian transfer MeSH E05.820.800.937 – insemination, artificial MeSH E05.820.800.937.515 – insemination, artificial, heterologous MeSH E05.820.800.937.525 – insemination, artificial, homologous MeSH E05.820.800.968 – oocyte donation MeSH E05.820.800.984 – ovulation induction MeSH E05.820.800.984.500 – superovulation MeSH E05.820.800.992 – zygote intrafallopian transfer

The study of catalysis and catalytic reactions is very important to the field of physical organic chemistry. A catalyst participates in the chemical reaction but is not consumed in the process. A catalyst lowers the activation energy barrier (ΔG‡), increasing the rate of a reaction by either stabilizing the transition state structure or destabilizing a key reaction intermediate, and as only a small amount of catalyst is required it can provide economic access to otherwise expensive or difficult to synthesize organic molecules. Catalysts may also influence a reaction rate by changing the mechanism of the reaction.

Facelift was certified gold by the Recording Industry Association of America (RIAA) for selling 500,000 copies on September 11, 1991, becoming the first album from Seattle's grunge movement to be certified gold. The band continued to hone its audience, opening for such artists as Iggy Pop, Van Halen, Poison, and Extreme. Facelift has since been certified triple-platinum by the RIAA, for shipments of 3,000,000 copies in the US. The concert at the Moore Theatre in Seattle on December 22, 1990, was recorded and released on VHS in mid-1991, as Live Facelift. It features five live songs and three music videos. The home video has been certified gold by the RIAA for sales exceeding 50,000 copies. In early 1991, Alice in Chains landed the opening slot for the Clash of the Titans tour with Anthrax, Megadeth, and Slayer, exposing the band to a wide metal audience but receiving mainly poor reception. Alice in Chains was nominated for a Best Hard Rock Performance Grammy Award in 1992 for "Man in the Box". Following the tour, Alice in Chains entered the studio to record demos for its next album, but ended up recording five acoustic songs instead. While in the studio, drummer Sean Kinney had a dream about "making an EP called Sap". The band decided "not to mess with fate", and on February 4, 1992, Alice in Chains released their second EP, Sap. The EP was released while Nirvana's Nevermind was at the top of the Billboard 200 charts, resulting in a rising popularity of Seattle-based bands, and of the term "grunge music". Sap was certified gold within two weeks.

Sources: en.wikipedia.org

Frequently asked questions

Is cardarine a SARM?

No. Cardarine is GW501516, a PPARδ agonist, while SARMs act on androgen receptors. The two classes are often grouped in informal discussions despite different mechanisms.

Is cardarine approved for human use?

No. It has no approved medical indication in any country. Regulatory agencies have not cleared it for treatment or prevention of any condition.

Why was its development discontinued?

Early clinical work stopped after rodent carcinogenicity findings. Those animal results raised concerns about long-term human risk, although direct human evidence is lacking. The human relevance of the tumors remains an open scientific question.

What did animal studies show?

Rodent studies reported increased endurance and fat oxidation after GW501516 exposure. Long-term studies also found higher rates of some tumors, which led to halted development.

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