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Identity And Regulatory Status — Quick Reference

By Editorial Desk · published 2026-07-01 · last reviewed 2026-08-01 · Wiki

Certificate of analysis is one of those subjects where the details matter more than the headlines. This page pulls together the background, the mechanisms, and the practical points readers ask about most.

Updated 2026-08-01. Numbers and descriptions here follow the published literature rather than marketing material.

Identity and Regulatory Status

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.

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.

Regulatory Status and Detection Context

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.

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.

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, Regulation, and Quality Context

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.

Related pages on this site

Detection, Stability, and Quality

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.

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.

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.

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.

Supporting material

anti-emetics IV antibiotics intravenous fluids with electrolytes injections of vitamin B plasma or whole blood transfusion Feeding should be continued as long as possible. A highly digestible diet is preferred, but the individual animal's preferences may dictate giving whatever it will eat. In anorexic, hypoproteinemic, vomiting and diarrheic cats parenteral nutrition is required. In a disease outbreak, unvaccinated kittens or adults can be given anti-FPV serum containing FPV antibodies injected subcutaneously or intraperitoneal. This may provide protection for 2–4 weeks. Therapeutic efficacy of anti-FPV serum has been demonstrated in dogs, and similar beneficial effects may be expected in cats. Several studies have shown recombinant feline interferon omega is effective in the treatment of parvoviral enteritis in dogs and also inhibits replication of FPV in cell culture. So far no data are available on its efficacy in FPV-infected cats.

== Family == Convulxin is part of the snake venom C-type lectin family, a group of hemorrhagic toxins that disrupt body homeostasis. The name describes their similarity in structure to C-type lectins from other animals, proteins that bind calcium to induce various signalling pathways. Proteins of about 130 amino acids in length, C-type lectins contain at least a carbohydrate recognition domain (CRD), which mediates sugar and calcium binding. They are involved in various biological activities, ranging from cell-cell adhesion, serum glycoprotein turnover, to immune responses and cell apoptosis.

El Niño conditions are established when the Walker circulation weakens or reverses and the Hadley circulation strengthens, leading to the development of a band of warm ocean water in the central and east-central equatorial Pacific (approximately between the International Date Line and 120°W), including the area off the west coast of South America, as upwelling of cold water occurs less or not at all offshore. This warming causes a shift in the atmospheric circulation, leading to higher air pressure in the western Pacific and lower in the eastern Pacific, with rainfall reducing over Indonesia, India and northern Australia, while rainfall and tropical cyclone formation increases over the tropical Pacific Ocean. The low-level surface trade winds, which normally blow from east to west along the equator, either weaken or start blowing from the other direction. El Niño phases are known to happen at irregular intervals of two to seven years, and lasts nine months to two years. The average period length is five years. When this warming occurs for seven to nine months, it is classified as El Niño "conditions"; when its duration is longer, it is classified as an El Niño "episode".

Sources: en.wikipedia.org

Notes from published material

Inactivated vaccines are composed of micro-organisms that have been killed with chemicals and/or heat and are no longer infectious. Examples are vaccines against flu, cholera, plague, and hepatitis A. Most vaccines of this type are likely to require booster shots. Live, attenuated vaccines are composed of micro-organisms that have been cultivated under conditions which disable their ability to induce disease. These responses are more durable, however, they may require booster shots. Examples include yellow fever, measles, rubella, and mumps. Toxoids are inactivated toxic compounds from micro-organisms in cases where these (rather than the micro-organism itself) cause illness, used prior to an encounter with the toxin of the micro-organism. Examples of toxoid-based vaccines include tetanus and diphtheria. Subunit, recombinant, polysaccharide, and conjugate vaccines are composed of small fragments or pieces from a pathogenic (disease-causing) organism. A characteristic example is the subunit vaccine against Hepatitis B virus. In addition, there are some newer types of vaccines in use:

RdRps can be used as drug targets for viral pathogens as their function is not necessary for eukaryotic survival. By inhibiting RdRp function, new RNAs cannot be replicated from an RNA template strand, however, DNA-dependent RNA polymerase remains functional. Some antiviral drugs against Hepatitis C and COVID-19 specifically target RdRp. These include Sofosbuvir and Ribavirin against Hepatitis C and remdesivir, an FDA approved drug against COVID-19 GS-441524 triphosphate is a substrate for RdRp, but not mammalian polymerases. It results in premature chain termination and inhibition of viral replication. GS-441524 triphosphate is the biologically active form of remdesivir. Remdesivir is classified as a nucleotide analog that inhibits RdRp function by covalently binding to and interrupting termination of the nascent RNA through early or delayed termination or preventing further elongation of the RNA polynucleotide. This early termination leads to nonfunctional RNA that gets degraded through normal cellular processes. Baloxavir marboxil is an approved drug for the treatment of influenza infection. In addition, suraxavir marboxil and tivoxavir marboxil are currently undergoing clinical trials for the same indication. The development of an other inhibitor pimodivir, has been halted.

36. Georgian Med News. 2006 Apr;(133):111-5. Anti-aging peptide bioregulators induce reactivation of chromatin. Lezhava T(1), Monaselidze J, Kadotani T, Dvalishvili N, Buadze T. Author information: (1)Tbilisi State University. The effect of synthetic peptide bioregulators (Epitalon, Livagen and Vilon) on structural and facultative heterochromatin of cultivated lymphocytes have been studied among old (75-88yr.) people. The data obtained indicate that epitalon, livagen and vilon: 1) activate synthetic processes, caused by reactivation of ribosomal genes as a result of deheterochromatinization (decondensation) of nucleolus organizer regions; 2) induce unrolling (deheterochromatinization) of total heterochromatin; 3) release genes repressed by heterochromatinization (condensation) of euchromatic regions forming facultative heterochromatin; 4) epitalon and livagen induce deheterochromatinization (decondensation) of pericentromeric structural heterochromatin of the chromosomes1 and 9. However, vilon does not induce deheterochromatinization of pericentromeric structural heterochromatin. These results indicate that peptide bioregulators Epitalon, Livagen and Vilon cause activation (deheterochromatinization) of chromatin in lymphocytes of old individuals.

For example, when treated with potassium fluoride and hydrofluoric acid, Th4+ forms the complex anion [ThF6]2− (hexafluorothorate(IV)), which precipitates as an insoluble salt, K2[ThF6] (potassium hexafluorothorate(IV)). Thorium borides, carbides, silicides, and nitrides are refractory materials, like those of uranium and plutonium, and have thus received attention as possible nuclear fuels. All four heavier pnictogens (phosphorus, arsenic, antimony, and bismuth) also form binary thorium compounds. Thorium germanides are also known. Thorium reacts with hydrogen to form the thorium hydrides ThH2 and Th4H15, the latter of which is superconducting below 7.5–8 K; at standard temperature and pressure, it conducts electricity like a metal. The hydrides are thermally unstable and readily decompose upon exposure to air or moisture.

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.

Is cardarine approved for any medical use?

No. Cardarine has not received approval for human therapeutic use in major jurisdictions. It remains an investigational compound.

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