Sold as Egrifta. The only FDA-approved peptide specifically for reducing belly fat, though only in one narrow medical condition. The off-label conversation is much bigger than the official label.
The 30-second read
Tesamorelin is a slightly modified version of growth hormone-releasing hormone (GHRH). It tells the pituitary gland to release growth hormone in a natural pulsing pattern. Two large Phase 3 trials in HIV-associated lipodystrophy showed it reduces visceral fat, the deep belly fat around your organs, by about 15 to 20% over six months. The FDA approved it in 2010 as Egrifta for that one specific indication. Since then, doctors have prescribed it off-label for visceral-fat issues outside the HIV context, and research-peptide circles discuss it for general body composition. It's an injectable, prescription-only, and has a defined safety profile from years of clinical use. Real efficacy in the approved use case; the off-label evidence is much thinner.
Why this peptide is on people's radar
Tesamorelin sits in an unusual spot. It's an FDA-approved drug, a real one, with Phase 3 trials, a published label, and 15 years of post-marketing safety data, but its approved indication is narrow: HIV-associated lipodystrophy, a condition where antiretroviral medications cause fat to accumulate around the abdominal organs. Outside that population, the drug has a quiet but persistent off-label conversation around visceral fat, body composition, and growth-hormone optimization in adults.
The 2010 FDA approval was based on two big Phase 3 trials showing roughly 15 to 18% reductions in visceral adipose tissue (the deep, internal belly fat that's most strongly linked to metabolic disease) over 26 weeks. That's a meaningful effect, and the same approach has been tested in non-HIV populations for things like NAFLD/MASH, with positive but smaller-scale results.
For research-peptide and longevity-clinic audiences, tesamorelin is interesting because it's a "real" GHRH analog with a known safety profile, unlike CJC-1295 / Ipamorelin which are research compounds without FDA review. The trade-off is that it's prescription-only, more expensive, and only labeled for one specific clinical situation.
What people are usually trying to do with it
People exploring tesamorelin tend to be working on one of these:
Reduce stubborn visceral fat, the deep belly fat that doesn't respond to typical weight-loss measures
Manage HIV-associated lipodystrophy (the FDA-approved use)
Get the metabolic-improvement effects of higher GH and IGF-1 with a more natural pulse pattern than direct GH
Improve liver fat (the basis for the off-label MASLD/MASH research)
Find an FDA-reviewed, prescribable alternative to research-only GHRH analogs
What the science actually shows
Tesamorelin has more rigorous evidence than most peptides in this space. Plain-English summary:
Visceral fat reduction (FDA-approved indication)
Two Phase 3 trials in HIV-associated lipodystrophy showed about 15 to 18% reduction in visceral adipose tissue over 26 weeks at 2 mg daily. The effect plateaus and partially reverses if treatment stops.12
IGF-1 and GH elevation
Tesamorelin reliably raises IGF-1 (the downstream marker of GH activity) into the upper-normal range in adults. Unlike direct GH, the elevation comes from a pulsatile pattern of GH release that more closely resembles the body's natural rhythm.3
Liver fat (MASLD/MASH research)
Smaller trials in non-HIV populations with metabolic-associated fatty liver disease have shown reductions in hepatic fat content. The effect is real but the studies are smaller and not yet sufficient for an FDA approval in that indication.4
Triglycerides and lipid profile
Phase 3 data showed reductions in triglycerides and improvements in HDL ratios, consistent with the visceral-fat reduction.5
What it has not been shown to do
Produce dramatic overall weight loss (the visceral-fat reduction does not always translate to large changes on the scale). Reverse aging or significantly extend healthspan in healthy adults. Substitute for direct GH replacement when that is medically indicated.
The honest read
What's solid:
For its approved indication, the evidence is strong and the safety database is mature. Two large Phase 3 trials, FDA approval, and 15 years of post-marketing surveillance, far more rigorous than most peptides in this category.
What's still being worked out:
The off-label use case in adults without HIV-associated lipodystrophy. The MASLD/MASH application is being studied but not yet approved. Long-term effects of pulsatile GH elevation in healthy adults are less well-characterized than in the HIV-lipodystrophy population.
What's hyped beyond the evidence:
Framing it as a general weight-loss drug, it isn't. The visceral-fat reduction is real, but overall body weight changes in trials were modest. Also: claims that it's clearly "better" than research-peptide GHRH analogs like CJC-1295, those don't have approved-drug data behind them, but tesamorelin's specific advantages (in safety profile and regulatory clarity) come at the cost of being prescription-only and more expensive.
Things to know if you're looking into it
How it's used: a once-daily subcutaneous injection (typically into belly fat). The standard FDA-approved dose is 2 mg per day for the lipodystrophy indication.
Brand name: Egrifta (original formulation) and Egrifta SV (a stable-vial reformulation requiring fewer storage steps). Manufactured by Theratechnologies.
Prescription only: tesamorelin is a prescription drug. Off-label prescribing is legal in the U.S. but requires a clinician willing to prescribe it for that purpose.
Common side effects: injection-site reactions, joint pain, swelling, paresthesia (tingling). Most are mild and resolve over time. A small percentage of patients discontinue due to side effects.
Cost and access: as a brand-name drug for a relatively small population, tesamorelin is expensive. Insurance coverage for off-label use is generally limited.
Healthcare provider involvement: not optional. Tesamorelin requires monitoring of IGF-1 levels, glucose, and other parameters; a clinician's involvement is essential.
Specific dosing schedule, mechanism, half-life, and trial detail: all in the "Want to go deeper?" section below.
Reconstitution & dose calculator
FDA-approved prescription drug — narrow indication. Tesamorelin (Egrifta®) is approved for HIV-associated lipodystrophy at 2 mg/day. The dose math below covers that indication and the off-label use that exists outside it. IGF-1 monitoring is non-negotiable, and a clinician's involvement is essential. This is an educational reference, not dosing guidance.
Suggested start
1 mg/day
Conservative starting point; FDA label is 2 mg/day flat
Common range
1–2 mg/day
2 mg is the FDA label dose
Max dose
2 mg/day
FDA-approved ceiling; no benefit shown above
Cycle
Continuous
Effect partially reverses if stopped
mL
Defaults to a 5 mg/mL dilution — gives clean syringe-unit numbers at the standard 1 and 2 mg doses (20 and 40 units respectively). Adjust to taste.
mg
Once-daily subcutaneous injection, typically in the evening. Often into belly fat.
Above the FDA-approved max. The approval ceiling is 2 mg/day. Doses above this haven't shown additional benefit and increase IGF-1 and side-effect risk.
Concentration
5.0 mg/mL
Per dose
0.20 mL
20 units on insulin syringe
Doses per vial
~10
~10 days (~1.4 weeks) of daily dosing
When to stay put vs. step up
Stay put at 1 mg/day when you're tolerating it well, when IGF-1 levels are within target range on follow-up labs (4–6 week intervals are standard), or when the response is what you're after. There's no benefit to escalating just because you can.
Consider stepping to the 2 mg/day FDA dose only after at least four weeks at 1 mg/day with good tolerability and IGF-1 levels still within range. The full 2 mg dose was studied for 26 weeks in HIV-lipodystrophy patients; outside that population the long-term picture is less characterized.
Step back to 1 mg/day or pause if IGF-1 climbs above the upper-normal range, if joint pain or hand/foot swelling become noticeable, if blood glucose trends up (especially if you have insulin resistance), or if injection-site reactions become limiting. These are dose-dependent and usually resolve when the dose drops.
Don't go above 2 mg/day. The label and trial data top out at 2 mg. There's no published evidence of additional benefit at higher doses, and the IGF-1 elevation and side-effect profile both worsen.
About the 5-on-2-off pattern. Some off-label users dose Monday–Friday and skip the weekend. The thinking is that brief weekly breaks may help moderate IGF-1 accumulation and joint side effects, and it's easier to stay consistent with a weekday pattern. There are no head-to-head studies comparing it to the FDA's continuous daily schedule, so it's community practice rather than evidence-based. If you go this route, the IGF-1 monitoring intervals don't change.
For educational and research purposes only. This is not medical advice. Tesamorelin is FDA-approved for HIV-associated lipodystrophy only; use outside that indication is off-label. Required monitoring includes IGF-1, fasting glucose, and assessment for fluid retention and joint symptoms. Consult a licensed healthcare provider before any health decision.
What people often ask
Is tesamorelin a weight-loss drug?
Not exactly. It's specifically reduces visceral fat, the deep belly fat around organs, rather than overall body weight. The scale doesn't always move much; the waist measurement and body composition do.
How is it different from CJC-1295?
Tesamorelin is an FDA-approved drug with Phase 3 trials, a known safety profile, and prescription regulation. CJC-1295 is a research peptide with similar but not identical mechanism, no FDA approval, and far less safety data. Same general category (GHRH analog), very different regulatory and evidence picture.
Will it help me with general weight loss?
Modestly, at best. The trials in HIV-lipodystrophy patients showed visceral fat reduction without major changes in total body weight. People with obesity who don't have HIV-lipodystrophy aren't the population the drug was studied in.
Is it FDA-approved?
Yes, but only for one specific indication: HIV-associated lipodystrophy. Approved in 2010 as Egrifta and later as Egrifta SV. Off-label prescribing for other purposes is legal but not endorsed by the FDA approval.
Who shouldn't take it?
People with active or recent cancer (theoretical concerns about GH/IGF-1 effects on tumor biology), uncontrolled diabetes, severe sleep apnea, or known hypersensitivity. Pregnancy is a contraindication.
What about side effects?
Most common: injection-site reactions, joint pain, swelling in hands or feet (fluid retention from elevated GH/IGF-1), and paresthesias. Generally mild and dose-dependent. Hyperglycemia can occur in people with insulin resistance or diabetes.
Is it covered by insurance?
For the approved indication (HIV-associated lipodystrophy), often yes. For off-label use, usually no. Cost without coverage is significant.
FDA and regulatory status
Status as of May 5, 2026: FDA-approved as Egrifta (November 2010) and later as Egrifta SV (a reformulated stable vial), for reduction of excess abdominal fat in HIV patients with lipodystrophy. Manufactured by Theratechnologies. Approved in Canada and the EU for the same indication. Status updates land here when they happen.
Want to go deeper?
Mechanism, dosing, the lipodystrophy and MASLD trial detail, side-effect profile, and references. Click to expand.
Background and development
Tesamorelin is a 44-amino-acid synthetic analog of growth hormone-releasing hormone (GHRH), with a single trans-3-hexenoic acid modification at the N-terminus that resists degradation by dipeptidyl peptidase-IV (DPP-IV) and extends biological activity vs. native GHRH. Developed by Theratechnologies. FDA-approved November 2010 as Egrifta for HIV-associated lipodystrophy.
Mechanism of action
Tesamorelin binds the GHRH receptor on pituitary somatotrophs, stimulating pulsatile growth hormone (GH) release. The downstream effect, elevated IGF-1 produced by the liver in response to GH, drives the metabolic changes observed in trials, including selective reduction of visceral adipose tissue.
Half-life and dosing
Plasma half-life is 26 to 38 minutes, short enough that GH release remains pulsatile rather than sustained. Daily subcutaneous administration is required to maintain the GH and IGF-1 effects.
FDA-approved dosing schedule
This is a prescription medication. Dosing is established by your prescriber.
FDA-approved dose: 2 mg subcutaneous injection once daily. Reconstituted from a lyophilized powder using sterile water. Egrifta SV has a stable-vial design that simplifies reconstitution and storage compared to the original Egrifta formulation.
Treatment is continuous; visceral fat reduction observed in trials gradually reverses if treatment is discontinued.
The Phase 3 trials
LIPO-010 and LIPO-011
The pivotal Phase 3 trials in adults with HIV-associated lipodystrophy. Both showed approximately 15 to 18% reductions in visceral adipose tissue (measured by CT scan) at 26 weeks at 2 mg daily, with corresponding improvements in triglycerides, HDL/total-cholesterol ratios, and waist circumference. Published in NEJM (2007) and AIDS (2010).
Off-label / non-HIV studies
Smaller trials have studied tesamorelin in non-HIV populations with metabolic-associated steatotic liver disease (MASLD) and cardiometabolic disease. Reductions in hepatic fat content and visceral adiposity have been reported. These studies have not led to expanded FDA approvals.
Side effects and safety profile
The most commonly reported adverse events in trials and post-marketing surveillance:
Injection-site reactions, common, generally mild
Arthralgia (joint pain), common
Peripheral edema (fluid retention), common, related to GH/IGF-1 effects
Paresthesia (tingling, especially in hands), moderate frequency
Hyperglycemia, can occur, particularly in people with insulin resistance or diabetes
Hypersensitivity reactions, uncommon
Contraindications include disruption of the hypothalamic-pituitary axis (e.g., pituitary tumor), pregnancy, and active malignancy. Caution with diabetes, sleep apnea, and a history of glucose intolerance.
References
Falutz J, Allas S, Blot K, et al. (2007). "Metabolic effects of a growth hormone-releasing factor in patients with HIV." N Engl J Med, 357(23), 2359–2370. PubMed
Falutz J, Mamputu JC, Potvin D, et al. (2010). "Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials." J Clin Endocrinol Metab, 95(9), 4291–4304. PubMed
Stanley TL, Falutz J, Mamputu JC, et al. (2011). "Effects of tesamorelin on inflammatory markers in HIV patients with excess abdominal fat." J Clin Endocrinol Metab, 96(11), 3467–3475. PubMed
Stanley TL, Fourman LT, Feldpausch MN, et al. (2019). "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV." Lancet HIV, 6(12), e821–e830. PubMed
Adrian S, Scherzinger A, Sanyal A, et al. (2018). "The growth hormone releasing hormone analogue, tesamorelin, decreases muscle fat and increases muscle area in adults with HIV." J Frailty Aging, 7(4), 245–250. PubMed
U.S. Food and Drug Administration. "Egrifta Prescribing Information." FDA.gov
For educational and research purposes only. This is not medical advice. Tesamorelin (Egrifta) is a prescription medication FDA-approved for one specific indication. Off-label use is at the discretion of a licensed prescriber. PeptideLibraryHub is independent and does not sell peptides or accept money from anyone who does. Information current as of May 2026.