Tesamorelin (Egrifta): Trials, FDA Label and Sleep Claims

Tesamorelin is a prescription drug approved in the United States to reduce excess abdominal fat in adults with HIV and lipodystrophy. Its trials measured visceral fat, IGF-1 and glucose. We found no completed trial that measured sleep as a result, which matters because a viral claim ties tesamorelin to short, restful sleep.

Key points

• Tesamorelin is an FDA-approved growth hormone-releasing hormone (GHRH) analogue, first approved on 2010-11-10, for excess abdominal fat in HIV-infected adults with lipodystrophy. It is not approved for sleep, weight loss or cognition [1][2][3].
• Two phase 3 trials (412 and 404 adults, 26 weeks each) reduced visceral fat compared with placebo. The label also records raised IGF-1 and more new cases of HbA1c of 6.5% or higher (5% against 1%) [1][4][5].
• In the extension phase, people switched to placebo regained visceral fat [1][6].
• The only two registered tesamorelin sleep trials were withdrawn with zero participants. A 2026 pilot compared sleep among many measures and reported no significant changes [17][18][10].
• The EU never authorised it: the application was withdrawn in 2012 [22]. We did not check the UK or Germany.

What tesamorelin is

Tesamorelin is a synthetic analogue of human growth hormone-releasing factor: the 44 amino acids of the human molecule plus a six-carbon hexenoyl group. It acts on the pituitary gland to prompt release of the body’s own growth hormone (GH), which raises IGF-1 [1].

Approval history and current indication

openFDA lists the original application (BLA 022505, Theratechnologies) as approved on 2010-11-10 as a new molecular entity, with prescription-only status [3]. Two formulations are now labelled: EGRIFTA SV (label dated 03/2024) and EGRIFTA WR (03/2025). The labels state they are not substitutable [1][2]. DailyMed published both records in mid-2026.

The indication is the same for both: “reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.” The label adds that long-term cardiovascular safety is not established, that the drug is not for weight loss, and that there are no data showing better adherence to HIV therapy [1].

The pivotal trials

The label rests on two multicentre, randomised, double-blind, placebo-controlled studies with a 26-week main phase and a 26-week extension. Adults were 18 to 65, with a large waist circumference, on stable HIV treatment. People with type 1 diabetes or on diabetes medication were excluded [1].

	Study 1 (NCT00123253)	Study 2 (NCT00435136)
Adults randomised	412 (273 tesamorelin, 137 placebo) [1]	404 (270 tesamorelin, 126 placebo) [1]
Visceral fat, published	-15.2% vs +5.0% [4]	-10.9% (-21 cm²) vs -0.6% (-1 cm²) [5]
Visceral fat, label table	-18% vs +2% [1]	-14% vs -2% [1]
IGF-1	+81.0% vs -5.0% [4]	rose, P < 0.001 [5]
Glucose, as published	no significant differences [4]	no change in glucose parameters [5]

The published and label percentages differ because the label’s table uses its own model (intent-to-treat, last observation carried forward) [1]. We give both. Mean baseline visceral fat was 176 cm² in study 1 and 189 cm² in study 2 [1].

Glucose needs a closer reading. The label’s pooled 26-week data show HbA1c of 6.5% or higher in 5% of tesamorelin and 1% of placebo recipients, a hazard ratio of 3.3 (95% CI 1.4 to 9.6) [1]. The label also reports anti-tesamorelin antibodies in 50% of patients at 26 weeks and 47% at 52 weeks [1].

Funding: ClinicalTrials.gov lists Theratechnologies, the maker, as sponsor of study 1 and the extension [7]. We could not open a registry record for study 2 and did not review the papers’ conflict statements.

What happens after stopping

In the extension, 207 (study 1) and 177 (study 2) tesamorelin completers were re-randomised to continue or switch to placebo. Visceral fat changed by 0% (study 1) and -5% (study 2) in those who continued. In those switched to placebo it rose by 22% and 16% [1]. In study 1, placebo-switched patients also gained 1.4 kg trunk fat and lost 1.8 kg lean mass, while IGF-1 fell further than in those who continued [1]. The extension paper concludes the effects “do not last beyond the duration of treatment” [6]. The trials did not randomise beyond 52 weeks. The label notes that fluid-retention reactions either pass or resolve on stopping [1].

Trials outside the approved use

Fatty liver in HIV. A 2014 MGH trial randomised 50 adults with HIV for 6 months: visceral fat fell 34 cm² on tesamorelin and rose 8 cm² on placebo, and liver fat (lipid-to-water percentage) changed by a median -2.0 against +0.9. Fasting glucose was higher at 2 weeks but not at 6 months [11]. A 2019 trial enrolled 61 people with HIV and liver fat of 5% or more, 12 months, NIH-funded: liver fat fell by an absolute 4.1% (37% relative) against placebo; 35% against 4% ended under 5%; glucose and HbA1c did not differ [12]. Without HIV, a 51-person trial (NCT03375788) finished in 2025. Its registry reports median liver-fat change of -5.3 against +3.6 (percent change, 18 and 16 analysed) [13]. We found no paper for it.

Obesity and diabetes. In 60 abdominally obese adults with low GH secretion, 12 months, tesamorelin reduced visceral fat by 35 cm² against placebo with no glucose change [14]. In 53 adults with type 2 diabetes, 12 weeks, it did not alter glycaemic control [15].

Cognition. A University of Washington trial (152 adults, 66 with mild cognitive impairment, ages 55 to 87, 20 weeks, NIH grants) reported a favourable effect on a cognition composite in intent-to-treat analysis (P = 0.03), with a positive effect on executive function (P = 0.005). Verbal memory showed only a trend (P = 0.08). IGF-1 rose 117%, and adverse events were reported by 68% on tesamorelin and 36% on placebo [8]. A 6-month open-label trial of 73 virally suppressed adults with HIV and abdominal obesity found no significant cognitive difference from standard care (P = 0.673) [9]. A 2026 double-blind pilot (22 adults, 10 weeks) reported no significant changes in its study measures [10].

Other. A COPD trial registered by the maker was terminated with 3 participants [16].

Did any trial measure sleep?

On 2026-11-08 we searched ClinicalTrials.gov for “tesamorelin sleep”, “Egrifta sleep” and “TH9507 sleep”; each returned the same two records, both withdrawn [17][18]. A PubMed search for tesamorelin and sleep returned 4 records [19].

• NCT02931474 (NIH, National Institute of Nursing Research): a crossover phase 2 trial of tesamorelin against placebo for insomnia after traumatic brain injury in service members, with change in non-REM sleep time as the primary outcome. Withdrawn, 0 enrolled; no reason is recorded [17].
• NCT01788462 (Johns Hopkins): tesamorelin and sleep-disordered breathing in HIV, registered as observational. Withdrawn, 0 enrolled, “Lack of funding” [18].
• The 2026 pilot (NCT02553603, 22 adults) lists sleep among measures compared. Its registered outcomes are cognition, brain perfusion, MRI, body composition and walking, not sleep. The abstract reports no significant changes and does not say what sleep measure was used [10].
• A 2006 review described phase II sleep-disorder trials as “underway” [20]. We found no results.
• Separately, a University of Washington trial of GHRH (not named as tesamorelin) for age-related sleep disturbance was completed in 2007. The registry shows no results. It links a cognition paper from the trial, and we did not identify a sleep-outcome paper [21].

There is physiology behind the idea. In a 2006 laboratory study of 48 adults aged 19 to 67 after 40 hours awake, repeated GHRH injections increased non-REM sleep on the recovery night compared with placebo. The authors note earlier findings that GHRH promoted sleep in men but impaired it in women [27]. That study did not use tesamorelin or test repeated nights at home.

The Huberman-linked claim

On 2025-04-01, Andrew Huberman replied to a post on sleep with a conditional sentence naming tesamorelin or pinealon, saying that someone who had tried either would be “sleeping 6hrs waking like a kid on Xmas morning” [23]. The wording is a personal remark, not a study. Verdict: not supported by any trial we found. No completed trial tests tesamorelin on sleep in healthy people. For the quote’s other substance and the viral posts, see our pinealon and Huberman claim check.

Regulatory status

• United States (checked 2026-11-08): prescription biologic approved for the indication above [1][3]. Tesamorelin is not named on FDA’s compounding pages for substances with safety risks (content current 2026-04-22) or the 503A bulks page (2026-05-14); that is not a statement about legality [24][25].
• EU: Egrifta is not authorised. Ferrer Internacional notified withdrawal of its application on 21 June 2012. EMA says the CHMP considered that benefits did not outweigh risks. Concerns included separating HIV-related from obesity-related fat, unclear clinical benefit, rising IGF-1 and a lack of long-term safety data [22].
• UK and Germany: not checked.
• Off-label use: FDA says clinicians may generally prescribe approved drugs for other uses, and that it has not determined the drug is safe and effective for such use [26].
• Research product: “research use only” vials are not the approved drug. No regulator has reviewed their identity, purity or sterility, and the label itself says the two approved formulations are not interchangeable [1]. Trial results belong to the approved products.

Risks and unknowns

Documented in the label: contraindicated in pregnancy (rat offspring developed hydrocephalus), active malignancy, hypothalamic-pituitary disruption and hypersensitivity. Warnings cover new malignancy risk, raised IGF-1 (47% above 2 standard deviation scores at 26 weeks; 36% above 3), fluid retention, glucose intolerance, hypersensitivity (4%), injection-site reactions (25% against 14% on placebo) and excess mortality in critical illness [1]. Common reactions (over 5%) were joint pain, injection-site redness and itch, limb pain, swelling and muscle pain [1]. Interactions are possible with CYP450-metabolised drugs and glucocorticoid replacement [1]. The label has no information for people over 65, and safety in children is not established [1].

Not studied: sleep outcomes with a completed placebo-controlled trial, healthy volunteers over long periods, and effects of non-approved products.

Frequently asked questions

Is tesamorelin approved for sleep? No. The FDA indication is reducing excess abdominal fat in HIV-infected adults with lipodystrophy [1].

Has any trial tested tesamorelin for sleep? Two registered sleep trials were withdrawn before enrolling anyone [17][18]. A 2026 pilot compared sleep among many measures and found no significant changes [10].

What happens when tesamorelin is stopped? In the phase 3 extension, visceral fat returned in people switched to placebo [1][6].

Is it available in Europe? Not as an authorised medicine. The EU application was withdrawn in 2012 [22]. UK and German status was not checked.

Sources

1. FDA via DailyMed, “EGRIFTA WR (tesamorelin) for injection, prescribing information” (label revised 03/2025; record published 2026-08-03). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=839334d3-8c1d-4c26-9036-2ab524a6ea75
2. FDA via DailyMed, “EGRIFTA SV (tesamorelin) for injection, prescribing information” (label dated 03/2024; record published 2026-07-31). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224
3. FDA via openFDA, Drugs@FDA record for BLA022505, EGRIFTA (data updated 2026-11-06). https://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:egrifta
4. Falutz J, et al., “Metabolic effects of a growth hormone-releasing factor in patients with HIV,” New England Journal of Medicine (2007-12-06). https://pubmed.ncbi.nlm.nih.gov/18057338/
5. Falutz J, et al., “Effects of tesamorelin … in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension,” J Acquir Immune Defic Syndr (2010). https://pubmed.ncbi.nlm.nih.gov/20101189/
6. Falutz J, et al., “Long-term safety and effects of tesamorelin … in HIV patients with abdominal fat accumulation,” AIDS (2008). https://pubmed.ncbi.nlm.nih.gov/18690162/
7. ClinicalTrials.gov, NCT00123253 and NCT00608023 (sponsor Theratechnologies). https://clinicaltrials.gov/study/NCT00123253 ; https://clinicaltrials.gov/study/NCT00608023
8. Baker LD, et al., “Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults,” Archives of Neurology (2012). https://pubmed.ncbi.nlm.nih.gov/22869065/
9. “Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity,” Journal of Infectious Diseases (2025). https://pubmed.ncbi.nlm.nih.gov/39813152/
10. “The effect of growth hormone-releasing hormone on cognition and brain connectivity …,” eNeurologicalSci (2026); registry NCT02553603. https://pubmed.ncbi.nlm.nih.gov/42382101/ ; https://clinicaltrials.gov/study/NCT02553603
11. Stanley TL, et al., “Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial,” JAMA (2014). https://pubmed.ncbi.nlm.nih.gov/25038357/
12. “Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial,” Lancet HIV (2019). https://pubmed.ncbi.nlm.nih.gov/31611038/
13. ClinicalTrials.gov, NCT03375788, posted results (2025-11-20). https://clinicaltrials.gov/study/NCT03375788
14. “Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial,” J Clin Endocrinol Metab (2012). https://pubmed.ncbi.nlm.nih.gov/23015655/
15. “Safety and metabolic effects of tesamorelin … in patients with type 2 diabetes,” PLoS One (2017). https://pubmed.ncbi.nlm.nih.gov/28617838/
16. ClinicalTrials.gov, NCT01388920 (tesamorelin in COPD, terminated). https://clinicaltrials.gov/study/NCT01388920
17. ClinicalTrials.gov, NCT02931474 (withdrawn; status verified 2017-03-08). https://clinicaltrials.gov/study/NCT02931474
18. ClinicalTrials.gov, NCT01788462 (withdrawn; verified 2017-03). https://clinicaltrials.gov/study/NCT01788462
19. NCBI PubMed, search “tesamorelin AND sleep” (4 records; run 2026-11-08). https://pubmed.ncbi.nlm.nih.gov/?term=tesamorelin+AND+sleep
20. “Drug evaluation: tesamorelin, a synthetic human growth hormone releasing factor,” Curr Opin Investig Drugs (2006). https://pubmed.ncbi.nlm.nih.gov/17086939/
21. ClinicalTrials.gov, NCT00000380, GHRH for age-related sleep disturbances. https://clinicaltrials.gov/study/NCT00000380
22. EMA, “Egrifta” European public assessment report page (withdrawn application; accessed 2026-11-08). https://www.ema.europa.eu/en/medicines/human/EPAR/egrifta
23. Andrew Huberman (@hubermanlab), reply to @waitbutwhy (2025-04-01), read via fxtwitter mirror because X blocks automated access. https://x.com/hubermanlab/status/1906873861502857318
24. FDA, “Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks” (current 2026-04-22). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
25. FDA, “Bulk Drug Substances Used in Compounding Under Section 503A of the FDCA” (current 2026-05-14). https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
26. FDA, “Understanding Unapproved Use of Approved Drugs ‘Off Label’” (current 2018-02-05). https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
27. Schüssler P, et al., “Growth hormone-releasing hormone and corticotropin-releasing hormone enhance non-rapid-eye-movement sleep after sleep deprivation,” Am J Physiol Endocrinol Metab (2006). https://pubmed.ncbi.nlm.nih.gov/16912060/

This article is information, not medical advice.