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FDA-approved medicine

Tesamorelin Egrifta SV · Egrifta WR

Tesamorelin is a prescription copy of the hormone that prompts growth hormone release, sold as Egrifta.

What matters first

Why people look it up
It is approved for one thing: reducing excess belly fat in adults with HIV-related lipodystrophy. It is bought off-label for visceral fat and for general anti-aging.
What the evidence shows
Its label is unusually blunt about the second use. It says the drug is not approved for weight loss, and describes the effect on body weight as neutral.
Dose status
Tesamorelin is a prescription medicine, sold as Egrifta SV and Egrifta WR, given as an injection under the skin. The label dose is 1.4 mg. It is taken once daily into the abdomen (Egrifta SV, the 2 mg-per-vial formulation).

Evidence snapshot

FDA-approved label

The fastest way to see what kind of evidence this page is built on.

Regulation
FDA approvedEgrifta SV · Egrifta WR
Dose source
Human study1 reported dose row
Safety evidence
20 listed safety findingsCommon and serious effects shown apart
Sources
2 cited sourcesMedical review complete · 2026-08-12
Tesamorelin at a glance: FDA-approved label, dosing basis, regulatory status, safety coverage, and cited-source count. These details summarize the available sources; they are not treatment recommendations.

Further down: research and dosing details · how good the evidence is · questions

Medically reviewed by Jennifer Montecillo, MD · non-practicing medical reviewerReviewed 2026-08-12open the primary sources

What is known about Tesamorelin

Tesamorelin is an FDA-approved medicine sold as Egrifta SV and Egrifta WR. It is approved to reduce excess belly fat in adults with HIV-related lipodystrophy. The powder is mixed before a once-daily injection under the skin of the abdomen. Its label states that it is not a weight-loss drug. It describes the effect on body weight as neutral.

Tesamorelin research and regulatory details: evidence quality, approval status, doses, handling, and presentation.
TopicValue
Strongest sourceFDA label
FDA approvalApproved (Egrifta SV, Egrifta WR)
Maintenance dosing1.4 mg once daily into the abdomen (Egrifta SV, the 2 mg-per-vial formulation) from the FDA-approved label
Typical vials2 mg

Every row links back to a source listed below. These facts are for reference, not a personal recommendation.

Tesamorelin dosage chart: two labels, two doses

Tesamorelin has two current FDA product labels. They specify different vial strengths, doses, diluents, draw volumes, and storage rules.

Egrifta SV and Egrifta WR are not substitutable. A number from one label does not describe the other product.

Tesamorelin dosage chart: two labels, two doses. Egrifta SV and Egrifta WR are not substitutable. A number from one label does not describe the other product.
ProductVialLabel doseMix and drawAfter mixing
Egrifta SV2 mg single-dose vial1.4 mg once dailyAdd 0.5 mL Sterile Water; inject 0.35 mLUse immediately; discard the remainder
Egrifta WR11.6 mg single-patient-use vial1.28 mg once dailyAdd 1.3 mL Bacteriostatic Water; inject 0.16 mLSeven daily doses; discard 7 days after mixing

Every row is transcribed from the current Egrifta SV or Egrifta WR prescribing information. Read the sources.

What the evidence for Tesamorelin is

The dosing numbers come from an FDA-approved prescribing label. FDA reviewed the manufacturer’s studies before approving the product, and the label can change when new dosing or safety information appears.

FDA label
What it establishes
The schedule was tested for the approved use, FDA reviewed the results, and the approved product must meet manufacturing standards.
What it does not establish
It does not show that every dose step is right for every person. A clinician still has to consider health history, side effects and other medicines.

Use these numbers for the named product and approved use. A different brand, product form or use may have a different schedule.

Where Tesamorelin is in clinical trials

18 registered studies; the program has reached phase 4, and 2 are still enrolling.

The soonest a running study expects to finish measuring people is December 2027. That is when the sponsor expects to finish collecting the main measurement. It is not a results date, and not a date anything goes on sale.

  • Phase 4Stopped early

    Body Composition and Adipose Tissue in HIV

    Columbia University · HIV Lipodystrophy Syndrome, Growth Hormone Deficiency · 6 participants · started February 2018

    Main measurement due April 2025

    NCT03226821 on ClinicalTrials.gov

  • Phase 4Stopped early

    Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®

    Theratechnologies · Diabetic Retinopathy, HIV · 129 participants · started June 2012

    Main measurement due May 2018

    NCT01591902 on ClinicalTrials.gov

  • Phase 3Completed

    TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

    Theratechnologies · Lipodystrophy, HIV Infections · 263 participants · started August 2007

    Main measurement due October 2008

    NCT00608023 on ClinicalTrials.gov

We left one registration out of the count above. Registering a study does not prove it is running, and these did not hold up.

  • NCT07481734 self-declared example: title declares itself an example (“Mock Stud”)

Check them yourself and disagree with us if you think we got it wrong.

A registered study means a sponsor filed a plan and started enrolling. It is not evidence the drug works, and most drugs tested in people never reach a pharmacy. Sponsors write and update these sources themselves; the National Library of Medicine publishes them without checking them.

ClinicalTrials.gov · retrieved 2026-08-23

Every compound we track, and what stage each one has reached →

Regulatory status

Tesamorelin won FDA approval in 2010.

It sells in two forms, and their own labels state they are not substitutable. Egrifta SV holds 2 mg per vial and gives 1.4 mg once daily. Its label directs Sterile Water, and use right away.

Egrifta WR holds 11.6 mg per vial and gives 1.28 mg once daily. Its label directs Bacteriostatic Water, then discard 7 days after mixing. Dose, diluent, vial count and storage all differ.

A number read off one form does not describe the other.

Full regulatory tracker →

How Tesamorelin compares

Each page says which kind of comparison it is: one trial that tested both, or two separate trials read side by side — which is much weaker, however close the numbers look.

Where to go next on Tesamorelin

The schedule, the side effects and the mixing math each have their own page.

Safety notes

  • Approved only for excess abdominal fat in adults with HIV and lipodystrophy — the label says it is not approved for weight loss
  • Egrifta SV and Egrifta WR are not substitutable: different vial strength, dose, diluent, vial count and storage
  • Egrifta SV is reconstituted with Sterile Water, injected immediately, and the remainder thrown away — its label states not to refrigerate or freeze the mixed solution
  • Reaction percentages come from the 26-week EGRIFTA trials at the 2 mg dose, which both current labels bridge their safety to
  • The label says not to use it with active cancer, a disrupted hypothalamic-pituitary axis or pregnancy

Questions about Tesamorelin

Is Tesamorelin FDA-approved?

Yes — it is sold as Egrifta SV and Egrifta WR. That is why the schedule on this site is quoted from a label rather than summarized from a study.

How is Tesamorelin taken?

By injection under the skin, once a day into the abdomen.

How does Tesamorelin differ from the other compounds in this class?

Tesamorelin is an approved medicine, but it is not a GLP-1 or amylin drug. It works through a different system, so its dose and results cannot be compared directly with weight-loss injections.

What is not known about Tesamorelin?

It does not show that every dose step is right for every person. A clinician still has to consider health history, side effects and other medicines.

2primary sources, each with the day we read it — open the documents used on this page