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Identity And Regulatory Status — 2026 Update

By Editorial Desk · published 2026-06-02 · last reviewed 2026-07-05 · Faq

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

This page was last updated on 2026-07-05 and is reviewed periodically as new material appears.

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.

Detection, Stability, and Quality

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.

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.

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

Regulatory Status and Detection Context

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.

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Preclinical Findings and Safety Signals

Human trials of GW501516 were small and short in duration. They examined lipid levels, glucose handling, and other metabolic markers, but the programs were halted after the animal cancer findings. No approved therapeutic product exists, and published human data are insufficient for establishing long-term safety. Reports of use for athletic performance come mainly from non-clinical settings and cannot be verified through controlled trials. Independent testing of products sold as cardarine has found inconsistent purity and labeling.

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.

Detection, Regulation, and Quality Context

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.

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.

Reference notes

In June 2025, two months after India suspended the Indus Water Treaty over Pakistan's alleged "cross border linkages" to the Pahalgam Attack, Bhutto Zardari threatened war with India stating that "either India shares water fairly or we will secure it from ‘all 6 rivers.’" In August, at a function organized by the Culture Department of the Sindh government, Bhutto Zardari once again raised the prospect of war with India, citing escalating tensions over the Treaty. He warned that if India continued actions perceived as "violations of the treaty", Pakistan would be compelled to consider all options, including military action. He stated that the people of Pakistan were "strong enough" to wage war in order to "reclaim all six rivers".

To address these challenges, the Pittsburgh Model of Function deconstructs 'function' into five meanings to describe the different properties that are acquired by a locus undergoing de novo gene birth: Expression, Capacities, Interactions, Physiological Implications, and Evolutionary Implications. It is generally accepted that a genuine de novo gene is expressed in at least some context, allowing selection to operate, and many studies use evidence of expression as an inclusion criterion in defining de novo genes. The expression of sequences at the mRNA level may be confirmed individually through techniques such as quantitative PCR, or globally through RNA sequencing (RNA-seq). Similarly, expression at the protein level can be determined with high confidence for individual proteins using techniques such as mass spectrometry or western blotting, while ribosome profiling (Ribo-seq) provides a global survey of translation in a given sample. Ideally, to confirm a gene arose de novo, a lack of expression of the syntenic region of outgroup species would also be demonstrated. Genetic approaches to detect a specific phenotype or change in fitness upon disruption of a particular sequence, are useful to infer function. Other experimental approaches, including screens for protein-protein and/or genetic interactions, may also be employed to confirm a biological effect for a particular de novo ORF. Evolutionary approaches may be employed to infer the existence of a molecular function from computationally derived signatures of selection.

Submuscular pocket: The plastic surgeon emplaces the prosthetic breast beneath the pectoralis major muscle without cutting the inferior origin of that muscle. The total coverage of the prosthetic breast can be achieved by releasing the lateral muscles of the chest wall (either the serratus muscle or the pectoralis minor muscle) and then attach those lateral muscles to the pectoralis major muscle to augment the breast.

A blood smear is a thin layer of blood smeared on a glass microscope slide and then stained in such a way as to allow the various blood cells to be examined microscopically. This technique can be used to detect sickled cells visually; however, it does not detect sickle cell carriers. A solubility test relies on the fact that HbS is less soluble than normal haemoglobin (HbA); it is highly reliable but does not distinguish between full sickle cell disease and carrier status. Tests which can be used for sickle cell disease as well as for other hemoglobinopathies:

Pempel (1966), professor of political science and former director of the Institute of Asian Studies at the University of California, Berkeley Roger Sanjek (1966), professor of anthropology at Queens College, City University of New York David Weissbrodt (1966), legal scholar at the University of Minnesota Law School known for drafting the Minnesota Protocol Jay Winter (1966), World War I specialist at Yale University Paul Gewirtz (1967), constitutional law scholar Karl Klare (1967), critical legal studies theorist Norman Friedman (1967), author and naval analyst Mott T. Greene (1967), historian of science, professor at University of Puget Sound Reza Sheikholeslami (1967), Soudavar Professor of Persian Studies at Wadham College, Oxford Jeremy Siegel (1967), professor of the Wharton School of the University of Pennsylvania Terrell Carver (1968), political theorist; professor at the University of Bristol Samuel R. Gross (1968), professor at the University of Michigan Law School; editor of the National Registry of Exonerations project Charles Lindholm (1968), University Professor of Anthropology at Boston University Alfred W. McCoy (1968), historian of Southeast Asia; professor at the University of Wisconsin–Madison Lawrence Susskind (1968), urban planner and mediator; professor at the Massachusetts Institute of Technology Jerry Avorn (1969), professor at the Harvard Medical School William Boone Bonvillian (1969), scholar of innovation technology policy, former director of MIT's Washington, D.C.

Sources: en.wikipedia.org

Notes from published material

An alginate dressing is a natural wound dressing derived from carbohydrate sources released by clinical bacterial species, in the same manner as biofilm formation. These types of dressings are best used on wounds that have a large amount of exudate. They may be used on full-thickness burns, surgical wounds, split-thickness graft donor sites, Mohs surgery defects, refractory decubiti, and chronic ulcers. They can also be applied onto dry wounds after normal saline is first applied to the site of application. Alginate dressings are produced from the calcium and sodium salts of alginic acid, a polysaccharide comprising mannuronic and guluronic acid units. Alginate is initially extracted from the cell wall of brown seaweeds. Alginate dressings can be in the form of freeze-dried, porous (foam) sheets or flexible fibres. Flexible fibres are used to treat cavity wounds. The alginate will form a gel in contact with the exudates of the wound and give it a strong absorbent power.

=== Aviation === In 2023, Transworld Group expanded into the aviation sector with its luxury private jet charter service, Airavat, operating in the Middle East, Europe, and Asia. In 2024, Transworld Group entered into a joint venture with former SpiceJet COO Arun Kashyap's Sirius India Airlines to begin operations in India.

the industrialized countries of Europe and North America) to suppress the demand for drugs." However, it is unclear whether this provision actually does mandate prohibition of drug possession for personal use, due to the caveat that such possession need only be prohibited if it is "contrary to the provisions of the 1961 Convention, the 1961 Convention as amended or the 1971 Convention." The American National Commission on Marijuana and Drug Abuse found that the provisions of the 1961 Single Convention on Narcotic Drugs against possession apply only to possession related to illicit trafficking, while the Canadian Le Dain Commission of Inquiry into the Non-Medical Use of Drugs found otherwise.

== Education and career == Flegg received her PhD in Applied Mathematics from Queensland University of Technology in 2009. Her dissertation, "Mathematical Modelling of Chronic Wound Healing", was supervised by Dr. Sean McElwain. From 2010 to 2013, she was a researcher at the University of Oxford developing mathematical models for the spread of resistance to antimalarial drugs. From 2014 to early 2017, she was a mathematical lecturer in the School of Mathematical Sciences at Monash University. In May 2017, she joined the School of Mathematics and Statistics at the University of Melbourne as a senior lecturer in Applied Mathematics and was promoted to associate professor in 2020 and again to Professor in 2022. Flegg is an expert in the field of mathematical biology, with special focus in infectious disease epidemiology, wound healing and tumor growth. As of 2020, Flegg also serves as an editorial board member for PLOS Computational Biology, eLife and the Bulletin of Mathematical Biology.

=== Tertiary structure === GALE structure has been resolved for a number of species, including E. coli and humans. GALE exists as a homodimer in various species. While subunit size varies from 68 amino acids (Enterococcus faecalis) to 564 amino acids (Rhodococcus jostii), a majority of GALE subunits cluster near 330 amino acids in length. Each subunit contains two distinct domains. An N-terminal domain contains a 7-stranded parallel β-pleated sheet flanked by α-helices. Paired Rossmann folds within this domain allow GALE to tightly bind one NAD+ cofactor per subunit. A 6-stranded β-sheet and 5 α-helices comprise GALE's C-terminal domain. C-terminal residues bind UDP, such that the subunit is responsible for correctly positioning UDP-glucose or UDP-galactose for catalysis.

Sources: en.wikipedia.org

Background from the literature

===== Corynebacterium ===== Non-pathogenic species of the gram-positive Corynebacterium are used for the commercial production of various amino acids. The C. glutamicum species is widely used for producing glutamate and lysine, components of human food, animal feed and pharmaceutical products. Expression of functionally active human epidermal growth factor has been done in C. glutamicum, thus demonstrating a potential for industrial-scale production of human proteins. Expressed proteins can be targeted for secretion through either the general, secretory pathway (Sec) or the twin-arginine translocation pathway (Tat). Unlike gram-negative bacteria, the gram-positive Corynebacterium lack lipopolysaccharides that function as antigenic endotoxins in humans.

=== Selected articles === Ganzler, K., Salgó, A., & Valkó, K. (1986). Microwave extraction: A novel sample preparation method for chromatography. Journal of Chromatography A, 371, 299–306. Valkó, K., Snyder, L. R., & Glajch, J. L. (1993). Retention in reversed-phase liquid chromatography as a function of mobile-phase composition. Journal of Chromatography A, 656(1–2), 501–520. Valkó, K., Bevan, C., & Reynolds, D. (1997). Chromatographic hydrophobicity index by fast-gradient RP-HPLC: a high-throughput alternative to log P/log D. Analytical Chemistry, 69(11), 2022–2029. Valko, K., Nunhuck, S., Bevan, C., Abraham, M. H., & Reynolds, D. P. (2003). Fast gradient HPLC method to determine compounds binding to human serum albumin. Relationships with octanol/water and immobilized artificial membrane lipophilicity. Journal of Pharmaceutical Sciences, 92(11), 2236–2248. Valkó, K. (2004). Application of high-performance liquid chromatography based measurements of lipophilicity to model biological distribution. Journal of Chromatography A, 1037(1–2), 299–310. Valko, K. (2016) Lipophilicity and biomimetic properties measured by HPLC to support drug discovery. Journal of Pharmaceutical and Biomedical Analysis, (130), 35–54. Valko, K.Ivanova-Berndt, G. Beswick, P. Kindey, M. Ko, D. (2018) Application of biomimetic HPLC to estimate lipophilicity, protein and phospholipid binding of potential peptide therapeutics. ADMET & DMPK 6(2) 162–175.

A 2024 systematic review of human and animal observational studies concluded that MNPs are "suspected" to be harmful to human reproductive, respiratory, and digestive health. The World Health Organization has acknowledged growing concerns, but note that standardized measurement methods and risks have not been established, calling for further research and improved management of plastic throughout its life-cycle.

The majority of early research suggested that the translocation of polycationic CPPs across biological membranes occurred via an energy-independent cellular process. It was believed that translocation could progress at 4 °C and most likely involved a direct electrostatic interaction with negatively charged phospholipids. Researchers proposed several models in attempts to elucidate the biophysical mechanism of this energy-independent process. Although CPPs promote direct effects on the biophysical properties of pure membrane systems, the identification of fixation artifacts when using fluorescent labeled probe CPPs caused a reevaluation of CPP-import mechanisms. These studies promoted endocytosis as the translocation pathway. An example of direct penetration has been proposed for TAT. The first step in this proposed model is an interaction with the unfolded fusion protein (TAT) and the membrane through electrostatic interactions, which disrupt the membrane enough to allow the fusion protein to cross the membrane. After internalization, the fusion protein refolds due to the chaperone system. This mechanism was not agreed upon, and other mechanisms involving clathrin-dependent endocytosis have been suggested. Many more detailed methods of CPP uptake have been proposed including transient pore formation.

=== Type 2 diabetes === There are contradictory reviews. From one, vitamin C supplementation cannot be recommended for management of type 2 diabetes. However, another reported that supplementation with high doses of vitamin C can decrease blood glucose, insulin and hemoglobin A1c.

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.

How is cardarine measured in biological samples?

LC-MS/MS is common, often after sample cleanup. The assay targets GW501516 or its metabolites.

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