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Identity And Regulatory Status — Explained

By Editorial Desk · published 2026-07-11 · last reviewed 2026-08-01 · News

Certificate of analysis raises a handful of sensible questions. This page answers them in order, starting with the fundamentals and moving to applications.

Reviewed 2026-08-01. Anything still debated is marked as such rather than presented as settled.

Identity and Regulatory Status

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.

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.

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.

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

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.

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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.

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.

Notes from published material

Construction was interrupted by Cuba's involvement in World War I, but it was completed on February 9, 1920. On opening day, hundreds of visitors from around Havana and the surrounding areas came to tour the facility, including the Provincial Governor of Havana, Colonel Alberto Barreras, who was also a Freemason. Governor Barrearas oversaw a twelve gun salute and a performance of La Bayamesa by the General Staff Band. Three flags were raised; the flag of Cuba, the flag of the Supreme Council of Cuba, and the flag of the Grand Lodge of Cuba. Priority was given to Freemasons, but anyone could apply for housing here. There were only four rules needed to become a resident here: Residents had to be someone who needed public charity to live, "...even if they got there through vices." Residents had to be homeless. If the resident wasn't a Freemason, they needed to have letters of recommendation. All residents needed to pay up to 100 dollars to secure housing. As the years went by, the name "Asilo," or Asylum, became increasingly problematic. The original business model of the Mercy Asylum under its previous owners from 1886 had been to take beggars off of the street and put them into the shelter. As Cuba's new sphere of academia and the social welfare science studies advanced, earlier common practices in charity and relief work were radically transformed. Around the world, people began associating the term asylum with places like Bellevue Hospital and Bethlem Royal Hospital, and the Freemasons wanted to avoid that association.

Establishing SIUT, Sukkur, was an innovative response to the need of the people of Sindh was planned in the year 2009. Rizvi anticipates the needs of his patients and responds accordingly. To make dialysis accessible, he conceptualized a network of satellite centers in various parts of Pakistan to save patients the trouble of commuting from far-flung areas of Sindh, southern parts of Punjab and Baluchistan to go for this procedure twice a week as far as Karachi. On 2 February 2012 Adibul Hasan Rizvi, Director Sindh Institute of Urology and Transplantation, along with a team of doctors and paramedical staff inaugurated SIUT-Chablani Medical Center Sukkur. Initially as a day care Dialysis Center with 16 Haemodialysis machines and OPD, which shall facilitate a large number of underprivileged patients of Upper Sindh, Lower Punjab & Baluchistan.

Dextrorphan (DXO) is a psychoactive drug of the morphinan class which acts as an antitussive or cough suppressant and in high doses a dissociative hallucinogen. It is the dextrorotatory enantiomer of racemorphan; the levorotatory enantiomer is levorphanol. Dextrorphan is produced by O-demethylation of dextromethorphan by CYP2D6. Dextrorphan is an NMDA antagonist and contributes to the psychoactive effects of dextromethorphan.

no free IP would have improved anything related to this pandemic." His foundation has instead helped other countries reach licensing deals as in the case of the Oxford/AstraZeneca vaccine being produced by India's Serum Institute. Another concern, raised by Pfizer CEO Albert Bourla, is that allowing unauthorized third-party vaccine production would severely disrupt vaccine developers' efforts to ramp up vaccine production when original developers and third-party producers all end up competing for the same scarce raw materials. This is why some conclude that voluntary technology transfers are the superior option for producing more doses—since the transferor's active assistance can help the transferee bypass time-consuming clinical trials by taking advantage of existing approvals for the transferor's vaccine—and others describe patent waiver proposals as "more symbolic than practical". Derek Lowe has characterized the U.S. government's May 2021 announcement of support for patent waiver proposals as "almost as much of a PR move as anything else". By November 2021, the prospects for approval of such proposals (which by WTO tradition must be unanimous) looked increasingly remote; participants criticized the United States for not working to bridge the gap between supporters and opponents. Meanwhile, Tedros Adhanom Ghebreyesus has rejected the dichotomy between waiving patents and initiating technology transfers by including both measures as part of a list of four steps towards increasing vaccine production.

== Film and television == When it comes to portrayals in entertainment, depictions typically represent mentally ill characters as being recognizably different, often exaggerating their mannerisms and appearance to further distinguish them from normal characters. Throughout the last century of filmmaking, they have most commonly been portrayed as villains, often either the victims or perpetrators of violence, and generally dangerous.

Sources: en.wikipedia.org

Further detail

== Bibliography == R N Kaul (1963): Need for afforestation in the arid zones of India, LA-YAARAN, Vol 13 R C Ghosh (1977): Hand book on afforestation techniques, Dehradun. R K Gupta & Ishwar Prakasah (1975): Environmental analysis of the Thar Desert, Dehradun.

Chloroplast – Cell Centered Database Clegg MT, Gaut BS, Learn GH, Morton BR (July 1994). "Rates and patterns of chloroplast DNA evolution". Proceedings of the National Academy of Sciences of the United States of America. 91 (15): 6795–801. Bibcode:1994PNAS...91.6795C. doi:10.1073/pnas.91.15.6795. PMC 44285. PMID 8041699. Co-Extra research on chloroplast transformation NCBI full chloroplast genome

== Interactions == The substance is metabolised by the liver enzyme CYP3A4. In a study, the strong CYP3A4 inhibitor ketoconazole increased the maximal blood plasma concentrations of lercanidipine by a factor of eight, and the area under the curve by a factor of 15. In another study, ciclosporin increased lercanidipine plasma levels threefold when given at the same time. Other inhibitors of this enzyme, such as itraconazole, erythromycin, and grapefruit juice, are also expected to increase plasma concentrations and thus amplify the antihypertensive effect. Conversely, CYP3A4 inductors such as carbamazepine, rifampicin, and St John's wort probably lower plasma levels and effectiveness of lercanidipine. By comparison, amlodipine has a lower potential for CYP3A4 mediated interactions. Lercanidipine increases plasma levels of ciclosporin and digoxin.

Barbara Seliger Larsen is a mass spectrometrist, with a career in instrumentations and applications of mass spectrometry in industry, and served on the board of the American Society for Mass Spectrometry for several terms.

Center for the Advancement of Science in Space—operates the US National Laboratory on the ISS Dielectric wall accelerator Lawrence Berkeley National Laboratory List of US DOE National Laboratories Top 100 US Federal Contractors

Sources: en.wikipedia.org

Background from the literature

Patients with Type II diabetes will have elevated glucagon levels during a fast and after eating. These elevated glucagon levels over stimulate the liver to undergo gluconeogenesis, leading to elevated blood glucose levels. Consistently high blood glucose levels can lead to organ damage, neuropathy, blindness, cardiovascular issues and bone and joint problems. It is not entirely clear why glucagon levels are so high in patients with Type II diabetes. One theory is that the alpha cells have become resistant to the inhibitory effects of glucose and insulin and do not respond properly to them. Another theory is that nutrient stimulation of the gastrointestinal tract, thus the secretion of gastric inhibitory polypeptide and Glucagon-like peptide-1, is a very important factor in the elevated secretion of glucagon.

Tellurium-128 and -130 are essentially stable. They only decay by double beta decay, with half-lives >1020 years. They constitute the major fraction of natural occurring tellurium at 32 and 34% respectively. Tellurium-132 and its daughter 132I are important in the first few days after a criticality. It was responsible for a large fraction of the dose inflicted on workers at Chernobyl in the first week. The isobar forming 132Te/132I is: Tin-132 (half-life 40 s) decaying to antimony-132 (half-life 2.8 minutes) decaying to tellurium-132 (half-life 3.2 days) decaying to iodine-132 (half-life 2.3 hours) which decays to stable xenon-132. The creation of tellurium-126 is delayed by the long half-life (230 k years) of tin-126.

On 21 September 1922, in Casignana, a small town in Aspromonte, carabinieri and fascists opened fire on laborers from the “Garibaldi” agricultural cooperative, who had organized an occupation of land owned by the prince of Roccella. They killed socialist alderman Pasquale Micchia and two peasants, Rosario Conturno and Girolamo Panetta, while mayor Francesco Ceravolo was seriously wounded; this massacre ended the occupation. On 4 October 1922, at the inauguration of the Casignana Fascio, shots were fired, wounding a fascist who was part of his entourage. In retaliation, the fascists ravaged the house of the president of the “Garibaldi” cooperative, while the Carabinieri arrested a dozen antifascists. These events inspired writer Mario La Cava for his novel, The Facts of Casignana. The penetration of fascism into Calabrian society reflected the rest of the country: in city areas, merchants and industrialists were promoters of the fascists, who gained the support of the forces of law and order; in rural areas, by contrast, the backbone of fascism was represented by large landowners and village notables, who joined the new party.

==== Human biofluid metabolomes ==== Scientists at the University of Alberta have been systematically characterizing specific biofluid metabolomes including the serum metabolome, the urine metabolome, the cerebrospinal fluid (CSF) metabolome and the saliva metabolome. These efforts have involved both experimental metabolomic analysis (involving NMR, GC-MS, ICP-MS, LC-MS and HPLC assays) as well as extensive literature mining. According to their data, the human serum metabolome contains at least 4,200 different compounds (including many lipids), the human urine metabolome contains at least 3,000 different compounds (including hundreds of volatiles and gut microbial metabolites), the human CSF metabolome contains nearly 500 different compounds while the human saliva metabolome contains approximately 400 different metabolites, including many bacterial products.

For a soleus receptor, Houk and Simon obtain average values of K=57 pulses/sec/kg, A=0.31, a=0.22 sec−1, B=0.4, b=2.17 sec−1, C=2.5, c=36 sec−1 . When modeling a cat stretch reflex, Lin and Crago improved upon this model by adding a logarithmic nonlinearity before the Houk and Simon model and a threshold nonlinearity after.

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 detected in anti-doping tests?

Anti-doping laboratories typically use LC-MS/MS to detect GW501516 and its metabolites in urine. The method is sensitive and can identify the compound at low concentrations. Detection depends on sample timing, metabolism, and the specific assay.

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