The FDA-approved dose of tesamorelin depends entirely on which formulation you have, and most dosing guides online are quoting a discontinued one. Egrifta WR, the product currently marketed in the US, is 1.28 mg subcutaneously once daily. Egrifta SV is 1.4 mg once daily. The original Egrifta was 2 mg once daily — that is the dose used in every pivotal trial, and it is the number almost every peptide site still repeats, years after that presentation was replaced.
If you take one thing from this page: “tesamorelin is dosed at 2 mg” is no longer a correct statement about any product you can currently be prescribed in the United States. Below is what the label actually says for each formulation, what the trials measured, what happens when people stop, and which of the protocols circulating online trace back to a real study.
Approved dosing by formulation
| Product | Vial | Daily dose | Reconstitution and hold time | Status |
|---|---|---|---|---|
| Egrifta WR | 11.6 mg | 1.28 mg | 1.3 mL bacteriostatic water; 0.16 mL per dose; good for 7 days at room temperature | Current product |
| Egrifta SV | 2 mg | 1.4 mg | 0.5 mL sterile water; 0.35 mL per dose; inject immediately, discard the rest | Transitional supply |
| Egrifta (original) | 1 mg | 2 mg | Two vials per dose; sterile water; inject immediately | Discontinued |
Two practical notes that follow from that table and that a lot of published advice gets wrong. Egrifta WR and Egrifta SV are explicitly not substitutable — the label says so in those words, and the doses and diluents differ. And neither currently marketed presentation requires refrigeration. Only the discontinued original was stored at 2–8 °C. Egrifta WR is kept at room temperature before mixing and stays at room temperature for its seven days after mixing; it should not be refrigerated or frozen once reconstituted.
What tesamorelin is actually approved for
Tesamorelin is a growth hormone-releasing factor analog. The approved indication is narrow and specific: “reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.” That is the whole of it.
The label then carries a Limitations of Use section that most people searching for this drug have never read. Quoted exactly:
“EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect.”
The trial data backs that up rather than contradicting it. Across the two pivotal studies, weight changed by −0.4 kg on tesamorelin versus 0.0 kg on placebo in one, and +0.5 versus +0.3 kg in the other. Neither difference was statistically significant. What moved was the distribution of fat, not the number on the scale.
What the trials measured
The registration programme was two 26-week randomised placebo-controlled trials in people with HIV-associated lipodystrophy, both dosing 2 mg daily, later pooled into an 806-patient analysis. The endpoint was visceral adipose tissue measured by CT at the L4–L5 level.
| Measure | Study 1 | Study 2 |
|---|---|---|
| Visceral fat at 26 weeks | −18% vs +2% placebo | −14% vs −2% placebo |
| Trunk fat | −1.0 kg | −0.8 kg |
| Lean body mass | +1.3 kg | +1.2 kg |
| Waist circumference | −3 cm | −2 cm |
| IGF-1 | +107 ng/mL | +108 ng/mL |
What happens when you stop
This is the part that changes how you should think about the whole thing, and it is almost never covered.
At week 26 the trials re-randomised people who had been on tesamorelin: half continued, half switched to placebo for another 26 weeks. In those who switched, visceral fat rose by 22% in one study and 16% in the other — back towards where they started. In those who continued, it held. The original investigators described the effect as not lasting beyond the duration of treatment.
So tesamorelin is not a course you complete. It is a treatment that works while you take it, which is exactly why the label frames continuation as an ongoing risk-benefit judgment and states plainly that long-term cardiovascular safety has not been established. Anyone selling you a fixed “cycle” after which the result sticks is describing something the evidence does not show.
How it is given, and the timing question
Injection is subcutaneous, into the abdomen only. The label instructs rotating sites across different areas of the abdomen and avoiding scar tissue, bruises and the navel — not as a comfort measure but because injection site reactions occurred in 17% of treated patients versus 6% on placebo.
On timing, an honest answer: the FDA label says nothing about what time of day to inject. Not bedtime, not with or without food, not “the same time each day.” Guides that present bedtime dosing as a label instruction are inventing it. There is a reasonable physiological argument for evening dosing — it aligns with the body’s own nocturnal growth hormone pulses — but that is clinical reasoning, not labelling, and we will tell you which is which. In practice it matters less than it sounds: tesamorelin reaches peak concentration in about nine minutes and has an elimination half-life of roughly eleven minutes.
Monitoring: the two things that are actually required
The label mandates exactly two, and no specific interval for either.
- IGF-1. Tesamorelin works by raising growth hormone, so IGF-1 rises with it. Among patients treated for 26 weeks, 47% had IGF-1 above 2 standard deviation scores and 36% above 3. The label says to monitor levels and to consider discontinuing at persistent elevations above 3 SDS, particularly where the response has not been strong.
- Glucose. Evaluate before starting, then monitor periodically. In the trials, 5% of treated patients crossed an HbA1c of 6.5% versus 1% on placebo — an odds ratio of 3.3. If you have diabetes, the label also asks for regular retinopathy checks, because IGF-1 elevation is the relevant mechanism.
That monitoring requirement is the single strongest argument for having this prescribed and followed by a clinician rather than self-managed. A number you cannot measure is a number you cannot dose against.
Side effects and who should not take it
The reactions reported more often than placebo in the 26-week trials were injection site reactions (17% vs 6%), arthralgia (13% vs 11%), pain in an extremity and myalgia (6% each), peripheral oedema (6%) and paraesthesia (5%). Hypersensitivity reactions — itching, redness, flushing, urticaria, rash — occurred in 4%. Fluid retention is a recognised class effect of raising growth hormone and can show up as oedema, joint pain or carpal tunnel symptoms; it is usually transient or resolves on stopping.
The contraindications are absolute, and three of them matter well beyond the HIV population the drug was approved in:
| Contraindication | Why |
|---|---|
| Active malignancy | Tesamorelin releases endogenous growth hormone, a known growth factor. Any pre-existing malignancy must be inactive and its treatment complete first. |
| Disruption of the hypothalamic-pituitary axis | Hypophysectomy, hypopituitarism, pituitary tumour or surgery, head irradiation or head trauma. The drug acts on that axis. |
| Pregnancy | Modifying visceral fat offers no benefit in pregnancy and could cause fetal harm. Discontinue if pregnancy occurs. |
| Known hypersensitivity | To tesamorelin or the excipients. |
There is also a class warning about increased mortality in acute critical illness, and a drug-interaction note: growth hormone can alter the clearance of drugs metabolised by CYP450, and patients on glucocorticoid replacement may need their maintenance dose revisited.
The protocols circulating online: which ones are real
| Protocol you will see | Traceable to a published human trial? |
|---|---|
| 2 mg daily | Yes — it is the dose used in every phase 3 trial. But it is the dose of a formulation that is no longer marketed. |
| 1 mg daily | No. Not a studied or approved dose. The familiar “1–2 mg” range brackets a real figure with an invented one. |
| Five days on, two days off | No. Every trial dosed continuously, seven days a week. No randomised study has compared intermittent with continuous dosing. |
| Twelve-week cycles | No. The pivotal trials ran 26 weeks plus a 26-week extension. The label sets no course length and describes no cycling. |
One regulatory fact worth knowing before you buy anything
Tesamorelin has been a licensed biologic since March 2020, when a group of protein products were reclassified from drug applications to biologics licences. That sounds like paperwork, and for most drugs it would be. Here it has a concrete consequence: the compounding pathway that applies to many peptides — the 503A bulk drug substances framework we describe in our GHK-Cu dosage guide — does not extend to licensed biologics at all. Tesamorelin appears in no category on those lists, and FDA guidance states that products licensed under a biologics licence will not be considered for the 503A bulks list.
The practical takeaway for a patient is simple and worth acting on: ask any provider exactly what preparation you are being offered, who made it, and under what authority. “Research use only” tesamorelin bought online is neither an approved product nor a compounded medication in any regulated sense, and nothing about its contents, concentration or sterility has been verified by anyone.
If you are weighing tesamorelin against other growth hormone secretagogues, our comparison of tesamorelin and CJC-1295 covers how they differ mechanically, and sermorelin vs ipamorelin vs CJC-1295 covers the rest of the family. For what tesamorelin is being used for and in whom, see our overview of tesamorelin and body composition, and our peptide therapy page for what we currently offer.
Frequently asked questions
What is the correct tesamorelin dose?
It depends on the formulation. Egrifta WR is 1.28 mg subcutaneously once daily, Egrifta SV is 1.4 mg once daily, and the discontinued original Egrifta was 2 mg once daily. The 2 mg figure quoted almost everywhere online belongs to a product that is no longer marketed.
Is tesamorelin FDA approved?
Yes, but narrowly: for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. It is not approved for weight loss, for general fat loss, or for anti-aging, and the label states it is not indicated for weight loss management because its effect on weight is neutral.
Should tesamorelin be injected at night?
The label gives no timing instruction at all. Evening dosing is a clinical convention based on the body’s natural overnight growth hormone pulses, not a labelled requirement. Given that tesamorelin peaks within about nine minutes and clears with a half-life of roughly eleven, timing is a smaller variable than most guides imply.
Does tesamorelin need to be refrigerated?
Not either of the currently marketed products. Egrifta WR is stored at room temperature before mixing and stays at room temperature for seven days after; it should not be refrigerated once reconstituted. Egrifta SV is stored at room temperature and injected immediately after mixing. Only the discontinued original required refrigeration.
How long do you stay on tesamorelin?
There is no defined course. Visceral fat rose by 16 to 22% within 26 weeks in trial participants who stopped, so the effect does not persist after treatment ends. The label frames continued use as an ongoing risk-benefit decision and notes that long-term cardiovascular safety has not been established.
Will tesamorelin make me lose weight?
Not on the scale. In the trials weight changed by under half a kilogram in either direction, with no significant difference from placebo. What changed was visceral fat, trunk fat and lean mass — a redistribution, not a reduction in body weight.
Important medical disclaimer
These statements have not been evaluated by the Food and Drug Administration. Tesamorelin is FDA-approved only for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy; any other use is off-label. This article is educational, reflects labelling at the time of writing, and is not medical advice or a substitute for evaluation by a qualified clinician. Tesamorelin raises IGF-1 and can affect glucose tolerance, and it is contraindicated in active malignancy, pregnancy, disruption of the hypothalamic-pituitary axis and known hypersensitivity. Do not obtain or self-administer research-grade peptides purchased online.
Sources referenced
FDA prescribing information for EGRIFTA WR, revised March 2025. · FDA prescribing information for EGRIFTA SV, revised February 2024. · FDA prescribing information for EGRIFTA, revised November 2010. · Falutz J, Allas S, Blot K, et al. “Metabolic effects of a growth hormone-releasing factor in patients with HIV.” New England Journal of Medicine, 2007;357(23):2359–2370. · Falutz J, Mamputu J-C, Potvin D, et al. “Effects of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials.” Journal of Clinical Endocrinology & Metabolism, 2010;95(9):4291–4304. · Falutz J, Potvin D, Mamputu J-C, et al. Journal of Acquired Immune Deficiency Syndromes, 2010;53(3):311–322. · Falutz J, Allas S, Mamputu J-C, et al. AIDS, 2008;22(14):1719–1728. · US Food and Drug Administration, “List of Approved NDAs for Biological Products That Were Deemed to be BLAs on March 23, 2020.” · US Food and Drug Administration, “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A,” January 2025.
Medically reviewed by Biana Borchenko, FNP-BC (A4M) — Robertson Wellness & Aesthetics, Beverly Hills.
