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MonographTesamorelin

Tesamorelin: free base and acetate, trial evidence and status

A 44-residue GRF analogue acylated at Tyr1 and supplied as an acetate salt: the two identity records and what separates them, the Falutz and Stanley trials, and dated status in three jurisdictions.

Last reviewed
2026-09-22
Reviewer
editorial review pending
Revision
1
Sources
33

Summary

Tesamorelin is a synthetic 44-residue analogue of human growth hormone-releasing factor (GRF, also called GHRH) carrying a trans-3-hexenoyl group on the N-terminal tyrosine and a C-terminal leucinamide, prepared as an acetate salt and developed under the code TH9507 12. Unlike most compounds in this pillar it is a licensed medicine in one of the three jurisdictions covered here: FDA has authorised it since 10 November 2010 under application 022505, held by Theratechnologies, for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy, and that former new drug application was deemed to be a biologics licence application on 23 March 2020 31. In the European Union the centralised application was withdrawn on 21 June 2012 with a provisional negative opinion from the CHMP, and in the United Kingdom searches of the MHRA products database and the electronic medicines compendium returned no record 456. Tesamorelin is named in section S2.2.4 of the WADA Prohibited List and is prohibited at all times 7.

The evidence level is therefore licensed for one indication in one jurisdiction, resting on two 26-week phase 3 trials with 26-week extensions and a pooled analysis of them, supplemented by later investigator-initiated randomised trials in liver fat, type 2 diabetes and neurocognitive endpoints 891011.

Identity · Tesamorelinverified 2026-09-21
Synonyms
TH9507, TH-9507, (3E)-Hex-3-enoylsomatoliberin (human), N-((3E)-1-oxo-3-hexenyl)somatoliberin (human pancreatic islet), Egrifta, Egrifta SV, Egrifta WR, tesamorelina, tesamoreline, tesamorelinum
CAS
218949-48-5· PubChem, National Library of Medicine, FDA / NCATS Global Substance Registration System
UNII
MQG94M5EEO· FDA / NCATS Global Substance Registration System, PubChem, National Library of Medicine
PubChem CID
16137828
Formula
C221H366N72O67S· PubChem, National Library of Medicine, DailyMed, National Library of Medicine (label by Theratechnologies Inc.)
Mol. weight
5135.9 g/mol· DailyMed, National Library of Medicine (label by Theratechnologies Inc.), PubChem, National Library of Medicine
Class
Synthetic peptide; growth hormone-releasing factor (GRF/GHRH) analogue; ATC H01AC06
Targets
Growth hormone-releasing factor (GRF/GHRH) receptor on pituitary somatotrophs (agonist)
Modifications
Human GRF/GHRH(1-44) amide sequence with a trans-3-hexenoyl group (C6 chain, double bond at position 3) attached to the N-terminal tyrosine; C-terminal leucinamide. Prepared as an acetate salt.
Sequence (one-letter) · 44 residues
  1. Y
  2. A
  3. D
  4. A
  5. I
  6. F
  7. T
  8. N
  9. S
  10. Y
  11. R
  12. K
  13. V
  14. L
  15. G
  16. Q
  17. L
  18. S
  19. A
  20. R
  21. K
  22. L
  23. L
  24. Q
  25. D
  26. I
  27. M
  28. S
  29. R
  30. Q
  31. Q
  32. G
  33. E
  34. S
  35. N
  36. Q
  37. E
  38. R
  39. G
  40. A
  41. R
  42. A
  43. R
  44. L

Identity and structure

Free base and acetate are two records

The public databases hold tesamorelin twice, and a certificate of analysis has to say which substance it describes. The free base carries CAS 218949-48-5, UNII MQG94M5EEO and PubChem CID 16137828, with the molecular formula C221H366N72O67S agreed by PubChem and the FDA label 12131. The acetate salt carries its own CAS number 901758-09-6, UNII LGW5H38VE3 and PubChem CID 44147413 1415.

The weights differ in what they describe. The FDA label states 5135.9 Da as free-base equivalent, and PubChem gives 5136 g/mol for the same formula 112. For the salt as supplied no source gives a weight at all: the label writes the acetate as C221H366N72O67S with x molecules of acetic acid where x is approximately seven, a non-stoichiometric description, while PubChem models a 1:1 monoacetate with formula C223H370N72O69S and 5196 g/mol 11615. The label's own potency equivalents show the practical size of the difference: 2 mg of tesamorelin corresponds to about 2.2 mg of the acetate, and 11.6 mg to about 11.9 mg 171.

A third set of figures appears in the FDA substance registry, which displays an estimated formula C221H365N71O69S and 5040 Da; its own validation notes state that the terminal modifications are not counted, and the same record cross-references a PubChem identifier, 91886675, whose formula C220H364N72O67S does not match the label 13. The free-base PubChem record additionally carries a depositor synonym 804475-66-9 that no second source explains 12. The anti-doping literature gives a monoisotopic mass of 5132.7 for the intact peptide, consistent with the labelled free base rather than with the registry estimate 18.

Sequence and modifications

The 44-residue one-letter sequence is YADAIFTNSYRKVLGQLSARKLLQDIMSRQQGESNQERGARARL, all residues of L-configuration 131819. The peptide is the sequence of human GRF(1-44) amide with a hexenoyl moiety, a six-carbon chain with a double bond at position 3, attached to the N-terminal tyrosine 1. The originating non-clinical paper describes the molecule as hGRF(1-44)NH2 minimally modified by a trans-3-hexenoyl group on Tyr1 2. The substance registry encodes exactly two structural modifications, (3E)-3-hexenoyl tyrosine at position 1 and leucinamide at position 44, with acetic acid as the salt-forming agent in the acetate record and no disulfide bridge or glycosylation site in either 1314. Other cross-references recorded are ATC code H01AC06 and ChEMBL CHEMBL1237026 1320. Brand names appear in the record only as regulatory history: the US products have been labelled Egrifta, Egrifta SV and Egrifta WR 171.

Mechanism and pharmacology

The label states that tesamorelin binds and stimulates human GRF receptors in vitro with potency similar to endogenous GRF, and that GRF acts on pituitary somatotrophs to stimulate the synthesis and pulsatile release of endogenous growth hormone, which is anabolic and lipolytic 1. The N-terminal acylation is what distinguishes the analogue pharmacokinetically: no degradation was observed on incubation with dipeptidyl peptidase-IV, and the in vitro half-life in human plasma was reported as roughly six- to fifteen-fold that of unmodified hGRF depending on conditions 192.

Human pharmacokinetics as summarised in the labels are those of a short-lived peptide: absolute subcutaneous bioavailability below 4% in healthy adults, median time to maximum concentration of 0.15 hours, volume of distribution 4.8 plus or minus 1.9 L/kg, and a mean elimination half-life given as 11 minutes in the current multiple-dose label and 8 minutes in the earlier single-dose label; no formal human metabolism studies are described 117. Pharmacodynamically, the trials measured insulin-like growth factor I rather than growth hormone as the durable marker: mean IGF-I rose by 81.0% in the first phase 3 trial and by about 108 ng/mL in the pooled analysis over 26 weeks 810. In non-clinical work, growth hormone and IGF-1 increased in pigs, rats and dogs at the doses studied, the apparent elimination half-life in dogs was 21 to 45 minutes, and adverse findings in dogs were attributed to sustained supraphysiological growth hormone and IGF-1 rather than to the peptide itself 2. Raised IGF-1 was the CHMP's principal safety concern at the EU withdrawal 4.

Clinical and preclinical evidence

The registered programme is two phase 3 trials with re-randomised extensions, later pooled; the subsequent literature is investigator-initiated. Dose arms appear only as the design of the cited studies. Label and publication report different percentages for the same trials because different statistical models were used, and both are recorded 18.

Studies as reported · design and results from the cited publication or registry record
StudyDesignnInterventionComparatorDurationPrimary endpointResult
Falutz et al. 2007 (phase 3 study 1, main phase)NCT00123253Multicentre, randomised 2:1, double-blind, placebo-controlled; HIV-infected adults on antiretroviral therapy with abdominal fat accumulation (86% men)412Tesamorelin 2 mg subcutaneously once daily (n = 273 per the FDA label)placebo (n = 137 per the FDA label)26 weeksPercentage change from baseline in visceral adipose tissue by computed tomographyPublication: visceral adipose tissue -15.2% versus +5.0% (P<0.001); triglycerides -50 versus +9 mg/dL; IGF-I +81.0% versus -5.0%. FDA label (intention to treat, last observation carried forward, least-squares means): -18% versus +2%, treatment difference -20% (95% CI -24, -15); absolute change -27 versus +4 cm2. [falutz-2007-n-engl-j-med]
Falutz et al. 2008 (study 1, 26-week extension)NCT00123253Re-randomised, blinded extension: tesamorelin participants re-randomised to tesamorelin (154) or placebo (50); placebo participants switched to tesamorelin (111)315Tesamorelin 2 mg subcutaneously once dailyplacebo in the withdrawal group26 weeks, 52 weeks in totalLong-term safety, including adverse events and glucose parametersVisceral adipose tissue change sustained at -18% over 52 weeks in the continued-treatment group (P<0.001 versus baseline); triglycerides -51 mg/dL; glucose changes not clinically significant; visceral adipose tissue re-accumulated after discontinuation. [falutz-2008-aids]
Falutz et al. 2010, JAIDS (phase 3 study 2, main phase with extension)NCT00435136 as cited by the FDA label, which ClinicalTrials.gov resolves as an alias of NCT00123253; extension NCT00608023Multicentre, randomised 2:1, double-blind, placebo-controlled 6-month phase followed by a 6-month re-randomised extension404Tesamorelin 2 mg subcutaneously once daily (n = 270 per the FDA label)placebo (n = 126 per the FDA label)26 weeks plus a 26-week extensionVisceral adipose tissuePublication: -10.9% (-21 cm2) versus -0.6% (-1 cm2), P<0.0001; about -18% in those continuing for 12 months; the change was lost on switching to placebo. FDA label: -14% versus -2%, treatment difference -12% (95% CI -16, -7). [falutz-2010-j-acquir-immune-defic-syndr]
Falutz et al. 2010, JCEM (pooled analysis of both phase 3 trials)nonePooled analysis of two multicentre, double-blind, placebo-controlled trials with 26-week safety extensions806Tesamorelin 2 mg subcutaneously once daily (543 participants)placebo (263 participants)26 weeks plus a 26-week extensionPercentage change in visceral adipose tissue by computed tomography at week 26Visceral adipose tissue -24 plus or minus 41 versus +2 plus or minus 35 cm2 (P<0.001; treatment effect -15.4%); abdominal subcutaneous adipose tissue unchanged; triglyceride treatment effect -12.3%; IGF-I +108 versus -7 ng/mL; at week 52 visceral adipose tissue -17.5% in the continued-treatment group; no clinically meaningful glucose differences. [falutz-2010-j-clin-endocrinol-metab]
Stanley et al. 2014 (visceral and liver fat)NCT01263717Single-centre, randomised, double-blind, placebo-controlled; antiretroviral-treated adults with HIV and abdominal fat accumulation50Tesamorelin 2 mg subcutaneously once daily (28 participants)placebo (22 participants)6 monthsChange in visceral adipose tissue and in liver fatVisceral adipose tissue treatment effect -42 cm2 (95% CI -71 to -14; P=.005); liver fat median change -2.0% versus +0.9% (P=.003), net effect -2.9%; fasting glucose higher at 2 weeks (effect 7 mg/dL, P=.03) but not at 6 months. Registry enrolment 54. [stanley-2014-jama]
Stanley et al. 2019 (non-alcoholic fatty liver disease in HIV)NCT02196831Two-centre, randomised 1:1, double-blind, placebo-controlled, followed by a 6-month open-label phase; people with HIV and hepatic fat fraction of 5% or more61Tesamorelin 2 mg once daily (30 treated)identical placebo (30 treated)12 monthsChange in hepatic fat fraction from baseline to 12 monthsAbsolute effect size -4.1% (95% CI -7.6 to -0.7; p=0.018), relative -37%; hepatic fat fraction below 5% at 12 months in 35% versus 4% (p=0.0069); fasting glucose and HbA1c not different at 12 months. [stanley-2019-lancet-hiv]
Clemmons et al. 2017 (type 2 diabetes safety study)NCT01264497Randomised, placebo-controlled, three-arm study in adults with type 2 diabetes53Tesamorelin 1 mg or 2 mg dailyplacebo12 weeksRelative insulin response after oral glucoseNo significant between-group differences in relative insulin response, fasting glucose or HbA1c at week 12. [clemmons-2017-plos-one]
Ellis et al. 2025 (neurocognitive impairment with abdominal obesity in HIV)not stated in the abstractRandomised 3:2, open-label, tesamorelin versus standard of care; virally suppressed people with HIV, abdominal obesity and neurocognitive impairment73Tesamorelin 2 mg subcutaneously dailystandard of care, no placebo6 monthsChange in neurocognitive functioning at 6 monthsBetween-group difference not significant (P=.673); waist circumference reduced more with tesamorelin, median difference -2.7 cm (P=.015). [ellis-2025-j-infect-dis]

The registry records for the first phase 3 trial, its extension and the two Stanley trials are the corresponding primary sources for design and enrolment 21222324.

Evidence level

Licensed in the United States for one indication on the strength of two randomised phase 3 trials (n = 412 and n = 404) with re-randomised extensions and a pooled analysis (n = 806); later randomised evidence is investigator-initiated and smaller 891025.

Analytical characterisation

No pharmacopoeial monograph for tesamorelin was retrieved for the dossier from the sources on the allow-list 19. The fullest public account of the substance's quality is the EMA withdrawal assessment report, which records manufacture by solid-phase peptide synthesis under an active substance master file and a drug-substance specification covering appearance, solubility, amino acid analysis, specific rotation, mass spectral analysis, identity, peptide purity, peptide impurities, peptide content, acetate content, trifluoroacetate content, water content, residual solvents, mass balance, bioburden and endotoxins 19. Impurities above 0.2% of peak area were characterised; two named impurities were qualified and tested negative for genotoxicity in vitro, and tightened limits for one of them and for total related substances were proposed during the assessment 19.

Published method work comes from doping control. An LC-HRMS/MS procedure identifies tesamorelin in human plasma after immunoaffinity purification on protein A/G tips with a polyclonal GHRH antibody, using nano-ultra-high-pressure liquid chromatography and positive electrospray ionisation; the peptide was observed as the seven-times-protonated ion at m/z 734, with a monoisotopic mass of 5132.7 and a retention time of 19.7 minutes, and the lower limit of detection was below 50 pg/mL 18. No abundant degradation products were seen after incubation in human plasma, and the intact peptide was identified in rat plasma up to 8 hours after intravenous administration 18.

Analytical data

Certificates of analysis, identity data and lot verification for the research material characterised on this page.

View analytical data · Tesamorelin →

Stability and handling

The figures below are laboratory handling data drawn from regulatory assessment and from licensed finished products. They describe specific formulations with their own excipients, not unformulated peptide, and no solubility statement was found in the FDA labels, the EMA report, PubChem or the substance registry, so that field is null 19112.

  • Drug substance: stability data on nine batches up to 72 months supported a re-test period of two years at -20 °C 19.
  • Drug product proposed in the EU (2 mg per vial, mannitol formulation): a 36-month shelf-life at 5 °C was proposed, and a photostability study showed the product to be light-sensitive but stable in its opaque carton 19.
  • The original 1 mg US vials were labelled for storage at 2 to 8 °C, protected from light and not frozen 16.
  • The 2 mg histidine, mannitol, polysorbate 20 and sucrose formulation is labelled for 20 to 25 °C with excursions of 15 to 30 °C in the original box, with a solution pH of 4.5 to 7.4 and the solution after mixing neither frozen nor refrigerated 17.
  • The 11.6 mg hydroxypropyl betadex and mannitol formulation is labelled for 20 to 25 °C in the original box, with the vial kept at 20 to 25 °C after mixing and discarded after seven days, and not frozen 1.

Regulatory status

The dated per-jurisdiction rows below are rendered from the database and cover the United States, where tesamorelin acetate is the active ingredient of a licensed prescription product; the European Union, where the centralised application was withdrawn in 2012; the United Kingdom, where no record was found in either register searched; and section S2.2.4 of the WADA Prohibited List, which names tesamorelin as an example of a GHRH analogue prohibited at all times 3457.

Regulatory status · TesamorelinActive substance of a licensed medicine

This material is a research-grade chemical. It is not a medicinal product, has not been manufactured under GMP for medicinal use, and is not the licensed medicine whose active substance shares its name. It is supplied for laboratory research only.

The regulatory rows below describe the authorisation status of medicines containing this substance in each jurisdiction. They say nothing about this material, which is not authorised for any use in or on humans or animals.

United Kingdom
No record found: searches for 'tesamorelin' and 'egrifta' in the MHRA Products database, and for 'tesamorelin' on eMC, returned no results on 2026-09-21.Checked 2026-09-21 · Medicines and Healthcare products Regulatory Agency
European Union
Not authorised: the centralised marketing authorisation application for Egrifta (EMEA/H/C/002427, applicant Ferrer Internacional S.A.) was withdrawn on 21 June 2012.Checked 2026-09-21 · European Medicines Agency
United States
Approved prescription biological product (BLA 022505, Theratechnologies; original approval 10 November 2010) for reduction of excess abdominal fat in HIV-infected adults with lipodystrophy.Checked 2026-09-21 · US Food and Drug Administration
WADA Prohibited List
Prohibited at all times: tesamorelin is named as an example of a GHRH analogue under S2.2.4 (growth hormone releasing factors) of the WADA Prohibited List.Checked 2026-09-21 · World Anti-Doping Agency

Open questions

  1. The acetate stoichiometry is unresolved between the label's approximately seven acetic acid molecules and PubChem's 1:1 model, and no source states a molecular weight for the salt as supplied 115.
  2. The substance registry's computed formula and 5040 Da exclude the terminal modifications, and its cross-referenced PubChem identifier does not match the labelled formula 1312.
  3. The acetate CAS number rests on the substance registry alone, and the additional depositor synonym on the free-base record is unexplained 1412.
  4. The registry identifier of the second phase 3 trial is ambiguous: the FDA label cites NCT00435136, which ClinicalTrials.gov resolves as an alias of the first trial's record, and only the extension has a record of its own 12122.
  5. Label and publication effect sizes differ for both phase 3 trials because different statistical models were used; both are recorded above 19.
  6. The elimination half-life is 11 minutes in the current label and 8 minutes in the earlier one 117.
  7. The Drugs@FDA product table did not show the 11.6 mg strength on the date checked, although the supplement approving that presentation is listed 326.
  8. Whether a product regulated as a biologic falls outside the sections 503A and 503B pathways was not verified in a retrieved FDA document; only absence from FDA's safety-risk bulk substance page was confirmed 27.
  9. No UK legal-classification statement specific to tesamorelin was retrieved; the finding is limited to absence from the two registers searched 56.
  10. The 2026 Prohibited List PDF could not be fetched and the class wording was read from WADA's rendered page 7.
  11. Solubility, and the stability of unformulated tesamorelin in solution, remain unsourced 19.
  12. Ellis et al. 2025 gives no registry number in its abstract, so no record is linked here 28.
  13. The naming history of the US presentations rests on the supplement approval letters and the labels themselves 293031.

Questions this page answers

What is the difference between tesamorelin free base and tesamorelin acetate?
They are separate substance records. The free base carries CAS 218949-48-5, UNII MQG94M5EEO and the formula C221H366N72O67S; the acetate carries CAS 901758-09-6, UNII LGW5H38VE3 and is written by the FDA label as C221H366N72O67S with approximately seven acetic acid molecules. The licensed products contain the acetate, while the label states strength as free-base equivalent.
Does tesamorelin have a stated molecular weight?
For the free base, yes: the FDA label gives 5135.9 Da as free-base equivalent and PubChem gives 5136 g/mol for the same formula. For the acetate as supplied, no source gives a weight. PubChem models a 1:1 monoacetate at 5196 g/mol, which does not match the label's non-stoichiometric acetate content.
Is tesamorelin authorised in the UK or the EU?
No. The MHRA products database and the electronic medicines compendium returned no result for tesamorelin when checked for the dossier, and the EU centralised application for Egrifta was withdrawn on 21 June 2012 after the CHMP formed a provisional opinion that it could not have been approved. Tesamorelin has been approved in the United States since 10 November 2010.
Is tesamorelin on the WADA Prohibited List?
Yes. Tesamorelin is named in section S2.2.4, growth hormone releasing factors, as an example of a growth hormone-releasing hormone analogue, alongside CJC-1293, CJC-1295 and sermorelin. Class S2 is prohibited at all times, in and out of competition.
What solubility and stability data exist for tesamorelin?
No solubility statement was found in the FDA labels, the EMA withdrawal assessment report, PubChem or GSRS, so the field is recorded as null. All storage data describe licensed finished products with their own excipients, or the drug substance as assessed by the EMA, for which a re-test period of two years at -20 °C was accepted. No study of unformulated peptide in plain aqueous solution was retrieved.

References

  1. 1.EGRIFTA WR (tesamorelin) kit - prescribing information (revised 03/2025). DailyMed, National Library of Medicine (label by Theratechnologies Inc.) (2025). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75 · accessed 2026-09-21
  2. 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). doi:10.1111/j.1742-7843.2007.00008.x PMID 17214611 · accessed 2026-09-21
  3. 3.Drugs@FDA: BLA 022505 EGRIFTA (tesamorelin acetate), Theratechnologies. US Food and Drug Administration (2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505 · accessed 2026-09-21
  4. 4.Egrifta: withdrawn application (EMEA/H/C/002427). European Medicines Agency (2012). https://www.ema.europa.eu/en/medicines/human/EPAR/egrifta · accessed 2026-09-21
  5. 5.MHRA Products: search results for 'tesamorelin'. Medicines and Healthcare products Regulatory Agency (2026). https://products.mhra.gov.uk/search/?search=tesamorelin&page=1 · accessed 2026-09-21
  6. 6.electronic medicines compendium (eMC): search results for 'tesamorelin'. Datapharm (eMC) (2026). https://www.medicines.org.uk/emc/search?q=tesamorelin · accessed 2026-09-21
  7. 7.The Prohibited List (2026): S2 Peptide hormones, growth factors, related substances and mimetics. World Anti-Doping Agency (2026). https://www.wada-ama.org/en/prohibited-list?q=tesamorelin · accessed 2026-09-21
  8. 8.Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med (2007). doi:10.1056/NEJMoa072375 PMID 18057338 · accessed 2026-09-21
  9. 9.Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr (2010). doi:10.1097/QAI.0b013e3181cbdaff PMID 20101189 · accessed 2026-09-21
  10. 10.Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab (2010). doi:10.1210/jc.2010-0490 PMID 20554713 · accessed 2026-09-21
  11. 11.Stanley TL, Fourman LT, Feldpausch MN, Purdy J, Zheng I, Pan CS, Aepfelbacher J, Buckless C, Tsao A, Kellogg A, Branch K, Lee H, Liu CY, Corey KE, Chung RT, Torriani M, Kleiner DE, Hadigan CM, Grinspoon SK. Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. Lancet HIV (2019). doi:10.1016/S2352-3018(19)30338-8 PMID 31611038 · accessed 2026-09-21
  12. 12.Tesamorelin (CID 16137828). PubChem, National Library of Medicine (2026). https://pubchem.ncbi.nlm.nih.gov/compound/16137828 · accessed 2026-09-21
  13. 13.TESAMORELIN (UNII MQG94M5EEO) substance record. FDA / NCATS Global Substance Registration System (2026). https://gsrs.ncats.nih.gov/api/v1/substances/4d617865-aeea-4d37-bbbf-dfe0031b2c1b?view=full · accessed 2026-09-21
  14. 14.TESAMORELIN ACETATE (UNII LGW5H38VE3) substance record. FDA / NCATS Global Substance Registration System (2026). https://gsrs.ncats.nih.gov/api/v1/substances/0815de8e-8238-401d-a2f6-f88577ae1947?view=full · accessed 2026-09-21
  15. 15.Tesamorelin acetate [USAN] (CID 44147413). PubChem, National Library of Medicine (2026). https://pubchem.ncbi.nlm.nih.gov/compound/44147413 · accessed 2026-09-21
  16. 16.EGRIFTA (tesamorelin for injection) original prescribing information, NDA 022505. US Food and Drug Administration (2010). https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf · accessed 2026-09-21
  17. 17.EGRIFTA SV (tesamorelin) kit - prescribing information (revised 03/2024). DailyMed, National Library of Medicine (label by Theratechnologies Inc.) (2024). https://dailymed.nlm.nih.gov/dailymed/services/v2/spls/3d783378-b02d-4f19-99dd-0fc91a042224.xml · accessed 2026-09-21
  18. 18.Knoop A, Thomas A, Fichant E, Delahaut P, Schanzer W, Thevis M. Qualitative identification of growth hormone-releasing hormones in human plasma by means of immunoaffinity purification and LC-HRMS/MS. Anal Bioanal Chem (2016). doi:10.1007/s00216-016-9377-3 PMID 26879649 · accessed 2026-09-21
  19. 19.Withdrawal assessment report for Egrifta (EMA/588044/2012). European Medicines Agency, CHMP (2012). https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-egrifta_en.pdf · accessed 2026-09-21
  20. 20.TESAMORELIN (CHEMBL1237026). ChEMBL, EMBL-EBI (2026). https://www.ebi.ac.uk/chembl/api/data/molecule/CHEMBL1237026.json · accessed 2026-09-21
  21. 21.TH9507 in Patients With HIV-Associated Lipodystrophy (NCT00123253; alias NCT00435136). ClinicalTrials.gov (2026). https://clinicaltrials.gov/study/NCT00123253 · accessed 2026-09-21
  22. 22.TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy (NCT00608023). ClinicalTrials.gov (2026). https://clinicaltrials.gov/study/NCT00608023 · accessed 2026-09-21
  23. 23.Effects of Growth Hormone Releasing Hormone in HIV (NCT01263717). ClinicalTrials.gov (2026). https://clinicaltrials.gov/study/NCT01263717 · accessed 2026-09-21
  24. 24.Tesamorelin Effects on Liver Fat and Histology in HIV (NCT02196831). ClinicalTrials.gov (2026). https://clinicaltrials.gov/study/NCT02196831 · accessed 2026-09-21
  25. 25.Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK. Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA (2014). doi:10.1001/jama.2014.8334 PMID 25038357 · accessed 2026-09-21
  26. 26.BLA 022505/S-020 supplement approval letter, Egrifta WR (tesamorelin) for injection. US Food and Drug Administration (2025). https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022505Orig1s020ltr.pdf · accessed 2026-09-21
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For laboratory research use only. This article summarises published literature and regulatory records; it does not describe or recommend any use of a material in or on humans or animals.
Cite this page
Harvard
HelixEVO Labs (2026) Tesamorelin: free base and acetate, trial evidence and status. Available at: https://helixevo.net/knowledge-base/compounds/tesamorelin (Accessed: 2026-09-25).
APA
HelixEVO Labs. (2026). Tesamorelin: free base and acetate, trial evidence and status. https://helixevo.net/knowledge-base/compounds/tesamorelin
BibTeX
@misc{helixevo-2026-tesamorelin-free-base-and-acetate-trial-,
  title = {Tesamorelin: free base and acetate, trial evidence and status},
  author = {{HelixEVO Labs}},
  year = {2026},
  howpublished = {\url{https://helixevo.net/knowledge-base/compounds/tesamorelin}},
  note = {Reviewed 2026-09-22; accessed 2026-09-25}
}
Revision history
  1. r1 · 2026-09-25 · Initial import