Tesamorelin is often discussed as a "legal" way to increase your own growth hormone, since it is a registered drug. However, registration in medicine and permission in sports are completely different things. The editors explain how tesamorelin is classified by the World Anti-Doping Agency, what the consequences of its detection are, and what the legal status of the drug looks like in different jurisdictions.

Tesamorelin on the WADA Prohibited List

The WADA Prohibited List is updated every year and takes effect on January 1. Tesamorelin belongs to section S2 "Peptide hormones, growth factors, related substances and mimetics", namely to the group of growth hormone releasing factors. In this group, the list directly names GHRH and its analogues, among which tesamorelin, sermorelin and CJC-1295 are mentioned.

Substances of section S2 are prohibited at all times - both in competition and out of competition. This is a fundamental difference from, for example, stimulants, which are prohibited only during competitions. Therefore, the athlete subject to testing cannot use tesamorelin in the off-season.

It is worth paying attention to the wording "including, but not limited to". The list of names in the list are examples and not an exhaustive list. Any substance with a similar chemical structure or similar biological effect is also considered prohibited, even if its name is not in the document.

The logic of the ban is clear: tesamorelin stimulates the pituitary gland to release its own growth hormone, and growth hormone and insulin-like growth factor-1 (IGF-1) are considered potentially performance-enhancing substances, masking the use of other agents and carrying health risks. Accordingly, not only the growth hormone itself is prohibited, but also all ways of its artificial increase.

Sanctions and non-Specified Substances

The World Anti-Doping Code divides prohibited substances into specified and non-specified. Non-specified substances include substances whose use for a legitimate purpose is unlikely or which have a significant doping potential. Substances of section S2 belong precisely to unspecified ones.

For a violation involving an non-Specified Substance, the base period of disqualification under the Code is four years. It is possible to reduce it to two years only if the athlete proves that the violation was not intentional. A further reduction is possible in exceptional cases where it is established that there was no significant fault or negligence.

AspectWhat the WADA Code provides for S2 substances
Prohibition periodPermanently (in competitive and non-competitive periods)
StatusNon-Specified Substance
Basic sanction for the first violationUp to 4 years of disqualification
If inadvertence is provenUp to 2 years, with a possible further reduction under the circumstances of the case
Other violationsPossession, attempted use, distribution are also violations

It is important that not only the presence of a substance in the sample is considered a violation. The Code separately defines as a violation the attempted use, possession of a prohibited substance and its distribution. So even an unused bottle in an athlete's bag can become a subject of consideration.

The principle of strict liability also applies: the athlete is responsible for any substance found in his body, regardless of how it got there. The reference to a "contaminated additive" does not automatically exempt from liability, although it may affect the duration of the sanction.

Editorial illustration for Tesamorelin: WADA classification and legal status
Photo: National Institute of Allergy and Infectious Diseases / Unsplash

How tesamorelin is detected in doping control

Growth hormone has long been considered a difficult target for doping control due to its short half-life and the identity of the exogenous hormone to its own. However, the situation with releasing peptides is different: tesamorelin is a synthetic molecule with a modification that is not found in natural human proteins, so it can be detected directly.

WADA-accredited laboratories use methods of liquid chromatography with tandem mass spectrometry for peptide releasing factors. These methods make it possible to identify the molecule itself or its specific metabolites in urine or blood. Research groups, including the Cologne laboratory, regularly publish reviews of analytical approaches to the detection of such substances.

  • Direct detection is the search for the peptide itself or its fragments in a biological sample.
  • Indirect Markers — Growth Hormone Biomarker Test that assesses IGF-1 and N-terminal propeptide of type III collagen.
  • Biological passport — long-term monitoring of an athlete's indicators, which allows you to notice atypical changes.
  • Sample storage — samples can be stored for up to ten years and reanalyzed with new methods.

The last point is especially important. Even if a certain substance is difficult to detect today, re-analysis after a few years can invalidate the results. The history of doping scandals with repeated analysis of the Olympic trials illustrates this well.

So, the idea that peptides are "not visible" in doping tests is outdated. For an athlete subject to control, tesamorelin is not a hidden tool, but a direct risk of disqualification.

Status of medicinal products in different countries

In the US, tesamorelin was approved by the Food and Drug Administration (FDA) in 2010 under the name Egrifta. The indication is narrow — reduction of excess abdominal fat in adult patients with HIV and lipodystrophy. The drug is available only by prescription, and its use for weight loss or improving sports results is not a registered indication.

Medicine (USA)Prescription drugNarrow indication:lipodystrophy in HIV Sports (WADA)Section S2Prohibited at all timesNon-Specified Substance EU and UkraineNo validregistration asmedicinal product
Fig. 1. Three planes of the status of tesamorelin: medical, sports and regulatory (schematically; the state at the time of preparation of the material, check the current registers).

In the European Union, the situation is different. The application for marketing authorization for tesamorelin was reviewed by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). According to information available in the agency's public documents, in 2013 the committee recommended denying registration, believing that the drug's benefits did not outweigh its risks for the claimed indication.

In Ukraine, as far as the editors know, tesamorelin is not included in the State Register of Medicinal Products. This means that it cannot be legally sold in pharmacies as a medicine. The advertising and sale of "research peptides" that are actually intended for human injections are in a legal "gray zone" and have no guarantees of quality.

The legal status may change, so before making any conclusions, you should check the current state registers and official documents of the regulators. The editors provide a general picture, not legal advice.

Therapeutic use and TUE

If an athlete has a medical indication for a Prohibited Substance, they may apply for a Therapeutic Use Exemption (TUE). WADA's international standard for TUEs requires that without the drug the athlete's health would be significantly impaired, that the drug would not provide an advantage over a return to normal health, and that there would be no reasonable permitted alternative.

These criteria are difficult to fulfill for tesamorelin. The registered indication concerns a very specific group of patients, and for most conditions associated with excess weight or adipose tissue, there are other treatment methods that are not prohibited in sports.

The request for TUE is submitted in advance, before the start of application, except for urgent situations. Retroactive obtaining of permission is possible only in cases defined by the standard. Therefore, an athlete to whom a doctor prescribes any peptide drug should immediately contact his national anti-doping organization.

Doctors who work with athletes should remember: prescribing a prohibited substance without a TUE can have consequences for both the athlete himself and the medical staff, because the Code provides for the responsibility of support staff for facilitating violations.

Important. The article is for informational purposes only and does not constitute legal or medical advice. Tesamorelin is a prescription drug; the issue of its use should be resolved with a doctor, and for athletes, also with the national anti-doping organization.

Editorial conclusion

Tesamorelin is permanently banned by WADA as a growth hormone-releasing factor from section S2. It is an non-Specified Substance and a violation carries a disqualification of up to four years.

Modern laboratory methods allow detection of synthetic releasing peptides directly, and samples are stored for years for repeated analysis. The notion of "invisibility" of peptides is not true.

As a medicinal product, tesamorelin is registered in the USA with a narrow indication, while it has not received registration in the EU, and is not included in the state register in Ukraine. Products sold under this name outside the pharmacy network do not have quality guarantees.

We recommend that you also read our materials on how to distinguish high-quality tesamorelin from a fake, on the status of hexarelin on the WADA list, and on the mechanism of action of hexarelin.

References

  1. World Anti-Doping Agency. The World Anti-Doping Code International Standard: Prohibited List. Montreal: WADA; updated every year.
  2. World Anti-Doping Agency. World Anti-Doping Code 2021. Montreal: WADA; 2021.
  3. World Anti-Doping Agency. International Standard for Therapeutic Use Exemptions (ISTUE). Montreal: WADA.
  4. EGRIFTA SV (tesamorelin for injection). Prescribing information. Theratechnologies Inc.
  5. European Medicines Agency. Egrifta (tesamorelin): refusal of the marketing authorisation. EMA/CHMP; 2013.
  6. Holt RIG, Ho KKY. The use and abuse of growth hormone in sports. Endocr Rev. 2019;40(4):1163–1185.
  7. Thevis M, Kuuranne T, Geyer H. Annual banned-substance review: analytical approaches in human sports drug testing. Drug Test Anal.