FDA
1 application listed (Prescription)Drugs@FDA lists 1 application naming this active ingredient: BLA022505. Marketing status as listed: Prescription. Checked 2026-10-05.
Drugs@FDA via openFDATesamorelin: chemistry, literature and regulatory status
Research-use information. This page summarises published literature and regulator records. It is not guidance for use, not medical advice, and not a statement that any material is suitable for use in people or animals.
What is Tesamorelin?
Tesamorelin is human growth hormone-releasing factor (1-44) amide carrying a trans-3-hexenoyl group on Tyr1, a modification that slows degradation by dipeptidyl peptidase IV. Published work covers non-clinical pharmacology and analytical detection. It is supplied here as a research material for laboratory use only.
What are the chemical facts for Tesamorelin?
- Name
- Tesamorelin
- Also written
- TH9507
- Sequence
- Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-Gln-Gln-Gly-Glu-Ser-Asn-Gln-Glu-Arg-Gly-Ala-Arg-Ala-Arg-Leu-NH2 (source: PMID 6812220 (hGRF 1 to 44 amide) with the trans-3-hexenoyl group on Tyr1 described in PMID 17214611)
- Length
- 44 residues
- Molecular formula
C221H366N72O67S(matches the formula computed from the sequence)- Average molecular weight
- 5136 g/mol
- CAS number
218949-48-5(confirmed in PubChem)- PubChem
- CID 16137828
Chemistry checked against PubChem on 2026-10-05. Where the formula can be computed from the listed sequence, it was, and the two routes agree.
How does the literature describe the mechanism of Tesamorelin?
- The non-clinical paper reports that the hexenoyl modification slowed in vitro degradation in rat, dog and human plasma and prolonged plasma elimination in vivo.[2]
- Tesamorelin acts on the growth hormone-releasing hormone receptor, whose signal transduction and physiology are reviewed.[3]
Receptor and pathway background: Growth hormone-releasing hormone receptor.
What has published research on Tesamorelin looked at?
3 studies are cited for Tesamorelin. Each is labelled by design below, and each entry says what the paper measured.
- 1 analytical chemistry
- 1 animal study
- 1 review
PubMed returns 104 records for the search terms published on the method page (33 of them with a review publication type, 25 with a clinical-trial publication type), checked 5 October 2026. ClinicalTrials.gov lists 24 registered studies whose intervention matches the name (21 interventional), checked 5 October 2026.
- A validated UHPLC-MS/MS method detects growth hormone-releasing hormone analogues in urine for anti-doping analysis.[1]
Studies are listed by what they measured. Papers whose titles state an amount or schedule, or describe a clinical outcome of an approved medicine, are not listed. This is a wording rule, not a quality filter; see the method page.
What is the regulatory status of Tesamorelin?
EMA
Application withdrawnEMA medicines database (checked 5 October 2026): application withdrawn for EMEA/H/C/002427 on 2012-06-21. Centrally authorised procedures only.
EMA medicines dataMHRA
No product document foundNo SmPC, PIL or PAR document in MHRA Products matches the exact name "tesamorelin". Checked 2026-10-05; the control lookup (semaglutide) returned 271 documents.
MHRA ProductsWADA
Named, S2.2.4The WADA 2026 Prohibited List, in force 1 January 2026 names tesamorelin under S2.2.4 (growth hormone releasing factors,). A WADA entry is a sporting rule, not a statement about legality outside sport.
WADA Prohibited List 2026A regulator record is information about a database entry. It is not advice and not a statement that any use is lawful or unlawful in any country. How regulators approach research peptides.
Data dates: regulatory records 2026-10-05; WADA list 2026-10-05.
Which studies are cited for Tesamorelin?
[1] Cristea CD, Radu M, Toboc A, Stan C, David V. Cationic exchange SPE combined with triple quadrupole UHPLC-MS/MS for detection of GHRHs in urine samples. Anal Biochem. 2023;682:115336.
UHPLC-MS/MS method for detecting GHRH analogues in urine for anti-doping analysis.
[2] Ferdinandi ES, Brazeau P, High K, Procter B, Fennell S, Dubreuil P. Non-clinical pharmacology and safety evaluation of TH9507, a human growth hormone-releasing factor analogue. Basic Clin Pharmacol Toxicol. 2007;100:49-58.
Non-clinical pharmacology and safety evaluation of TH9507 (tesamorelin), a growth hormone-releasing factor analogue carrying a trans-3-hexenoyl group, including plasma stability.
[3] Mayo KE, Miller TL, DeAlmeida V, Zheng J, Godfrey PA. The growth-hormone-releasing hormone receptor: signal transduction, gene expression, and physiological function in growth regulation. Ann N Y Acad Sci. 1996;805:184-203.
Review of GHRH receptor signal transduction, gene expression and physiological function.
Data dates: citations read from PubMed 2026-10-05.
Where else in the research library is Tesamorelin covered?
Who wrote this page and how is it checked?
Peptency editorial team, last reviewed 5 October 2026. Citations are read back from PubMed, chemistry is checked against PubChem, and regulator records are read from each regulator's own database on the dates shown. The method page lists every source, search term and rule. Corrections are welcome through the contact details on the About page.