Two Phase 3 trials, extension data, current FDA labels, and additional condition-specific human studies.
Why this matters
Research depth describes how large and mature the overall record is. It does not tell you whether the results were positive.
Compound library
Growth hormone–releasing hormone (GHRH) analog
Tesamorelin
FDA approved for a defined indication
Tesamorelin is a GHRH analog with an FDA-approved role in reducing excess abdominal fat in adults with HIV and lipodystrophy. It has controlled human evidence for that specific outcome, but it is weight neutral and is not approved as a general weight-loss drug.
Controlled human studyOther human evidenceMechanistic rationale
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Publicly anonymous by default. Your account keeps reports editable and helps reduce duplicate submissions.Educational research record—not medical advice. Evidence reviewed through July 25, 2026. Peer-reviewed findings, regulatory labeling, sponsor-reported topline results, and unreported registered trials are labeled separately.
Research at a glance
Tesamorelin in 60 seconds
Depth and confidence summarize the research record—not effectiveness, safety, or a recommendation.
Visceral-fat reduction is well supported in adults with HIV-associated lipodystrophy; evidence outside that population is much narrower.
Why this matters
Confidence describes how reliable and consistent the conclusions are. It can be high for one outcome and low for another.
Why this matters
The strongest evidence type shows what the best-supported conclusions are actually based on.
Why this matters
Human findings are more directly relevant than animal or laboratory results, but they still apply only to the populations and outcomes studied.
Route-specific record
What changes by administration method
Route studiedSubcutaneous injection in controlled trials and approved products
Schedules studiedOnce daily in the pivotal, extension, liver-fat, cognition, and approved-product records
Amounts studiedHistorical efficacy trials principally used 2 mg daily; current EGRIFTA SV is labeled at 1.4 mg daily and EGRIFTA WR at 1.28 mg daily
Why this matters
These are exposures used in cited research for a specific route and population—not a suggested amount.
Half-lifeAbout 8 minutes for EGRIFTA SV and 11 minutes for EGRIFTA WR after a single SubQ dose
Why this matters
Half-life describes how long it takes the measured amount in the body to fall by half. It is not a dosing recommendation.
Route evidenceLarge controlled human program plus formulation-specific FDA labeling
Why this matters
Evidence can change by administration method. Findings from one route should not automatically be applied to another.
Evidence boundary: The historical 2 mg formulation, EGRIFTA SV, and EGRIFTA WR have different strengths and preparation requirements and are not interchangeable. The short plasma half-life does not describe the duration of downstream GH/IGF-1 effects. Amounts shown describe cited research exposure—not a dosage recommendation.
Practical starting point
Why people research it
Common goals and questions—not recommendations or promises of benefit.
- Reducing excess abdominal fat in HIV lipodystrophyApproved use
- Reducing visceral abdominal fatSupported by human studies
- Fatty-liver research in people with HIVEarly human evidence
- General weight lossNot demonstrated
The overview, studies, and source ledger below explain what supports each label—and where the evidence stops.
The short version
What is Tesamorelin?
Tesamorelin is a GHRH analog with an FDA-approved role in reducing excess abdominal fat in adults with HIV and lipodystrophy. It has controlled human evidence for that specific outcome, but it is weight neutral and is not approved as a general weight-loss drug.
Approved + ongoing researchCurrent development stage
5Peer-reviewed sources
0Topline source releases
How it is designed to work
- Pituitary GHRH receptor agonism
Studied research areas
Evidence checked through July 25, 2026
Includes the March 2025 EGRIFTA WR label, February 2024 EGRIFTA SV label, Phase 3 HIV-lipodystrophy evidence, a 2019 liver-fat trial, a 2024 modern-antiretroviral subgroup analysis, and the 2025 cognition trial.
What the evidence says
What we know—and what we’re still learning
What we know
Two randomized Phase 3 trials enrolling 816 adults with HIV-associated abdominal fat accumulation found meaningful reductions in CT-measured visceral fat over 26 weeks, with effects maintained during continued treatment in extension data.
Why this matters
This is the strongest supported conclusion in the current human evidence—not a summary of every claim made about the compound.
What we’re still learning
Long-term cardiovascular safety, multi-year durability after discontinuation, and whether meaningful benefits extend beyond the narrow HIV-associated populations actually studied.
Why this matters
Keeping the main uncertainty visible prevents an early or promising finding from looking more settled than it is.
The evidence story
How the research changed over time
Importance shows how much an item changes the evidence story. Quality shows how much confidence the design deserves. A strong negative study can score highly on both.
Why this matters
Importance and quality answer different questions. A rigorous study can be highly important even when it challenges a popular claim.
Effects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity
The trial did not find a statistically significant between-group improvement in the primary neurocognitive outcome. Waist circumference decreased more in the tesamorelin group.
n = 736 months
Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors
Among the 31 subgroup participants who completed 12 months, median VAT changed by −25 cm² with tesamorelin versus +14 cm² with placebo, and liver fat changed by −4.2 versus −0.5 percentage points.
n = 3812 months
Effects of tesamorelin on non-alcoholic fatty liver disease in HIV
Tesamorelin reduced hepatic fat fraction versus placebo, with an absolute treatment effect of −4.1 percentage points. Thirty-five percent of tesamorelin participants versus 4% of placebo participants reached liver fat below 5%.
n = 6112 months
Effects of tesamorelin (TH9507) in HIV-infected patients with excess abdominal fat: pooled Phase 3 analysis
Across the two trials, tesamorelin reduced visceral abdominal fat while body weight changed little. The FDA label reports mean VAT changes of −18% versus +2% in Study 1 and −14% versus −2% in Study 2 at 26 weeks.
n = 81626-week randomized phase with 26-week extensions
Long-term safety and effects of tesamorelin in HIV patients with abdominal fat accumulation
The visceral-fat reduction was sustained at about 18% among participants who continued treatment for 52 weeks. The effect was lost after participants switched from tesamorelin to placebo.
n = 41052 weeks total
Administration and handling
What official research does—and does not—provide
FDA-labeled, formulation-specific administration
Current U.S. labels describe once-daily subcutaneous abdominal administration, but EGRIFTA WR and EGRIFTA SV have different strengths, labeled doses, volumes, diluents, and mixing procedures. EGRIFTA WR is labeled at 1.28 mg (0.16 mL) daily after weekly reconstitution; EGRIFTA SV is labeled at 1.4 mg (0.35 mL) immediately after single-vial reconstitution. These are official product descriptions—not personalized directions.
EGRIFTA SV and EGRIFTA WR are not interchangeable
The March 2025 WR label says to mix one 11.6 mg vial with 1.3 mL of its supplied bacteriostatic water, swirl rather than shake, keep the mixed vial at 20–25°C, and discard it after seven days. The February 2024 SV label says to mix one 2 mg vial with 0.5 mL of its supplied sterile water, roll gently rather than shake, use it immediately, and discard unused solution and diluent. These instructions apply only to the named FDA-approved presentations—not generic or vendor-supplied vials.
Primary-source ledger
Trace every major statement
FDA prescribing information
FDA prescribing informationEGRIFTA WR (tesamorelin) U.S. Prescribing Information
2025-03-01
Peer reviewed
Peer reviewedEffects of Tesamorelin on Neurocognitive Impairment in Persons With HIV and Abdominal Obesity
2025-01-15 · PMID 39813152 · NCT02572323 · DOI 10.1093/infdis/jiaf012
Peer reviewed
Peer reviewedEfficacy and safety of tesamorelin in people with HIV on integrase inhibitors
2024-10-01 · PMID 38905488 · NCT02196831 · DOI 10.1097/QAD.0000000000003965
FDA prescribing information
FDA prescribing informationEGRIFTA SV (tesamorelin) U.S. Prescribing Information
2024-02-01
Peer reviewed
Peer reviewedEffects of tesamorelin on non-alcoholic fatty liver disease in HIV
2019-10-11 · PMID 31611038 · NCT02196831 · DOI 10.1016/S2352-3018(19)30338-8
Peer reviewed
Peer reviewedEffects of tesamorelin (TH9507) in HIV-infected patients with excess abdominal fat: pooled Phase 3 analysis
2010-09-01 · PMID 20554713 · NCT00123253; NCT00435136 · DOI 10.1210/jc.2010-0490
Peer reviewed
Peer reviewedLong-term safety and effects of tesamorelin in HIV patients with abdominal fat accumulation
2008-09-12 · PMID 18690162 · NCT00123253 · DOI 10.1097/QAD.0b013e32830a5058