MuscleLedger

Tesamorelin vs Sermorelin: Two Approvals for Two Different Jobs, and No Trial Comparing Them

Both copy the body's growth-hormone-releasing hormone. One was approved for short children and later dropped, not for safety; the other is approved for abdominal fat in HIV. Twelve papers name both, none compares them clinically.

Leon H · Edited by Caroline S · Published 2026-09-30

Illustration: Two distinct medical vials on a sterile concrete lab bench under blue and warm light.
Illustration

Tesamorelin and sermorelin are often sold side by side as two strengths of the same idea, and chemically that is close to true. Their regulatory histories do not overlap at all. Each was approved for a different patient, tested against a different endpoint, and each sits in a different corner of federal law today. Nobody has put the two in the same trial. This page sets out the record side by side; it reports research and regulation and gives no usage guidance, per our editorial standards. The individual entries, tesamorelin and sermorelin, carry the depth on each.

Same hormone, cut differently

Both copy growth-hormone-releasing hormone (GHRH), the hypothalamic signal that tells the pituitary to release growth hormone. The difference is how much of the hormone each keeps and whether it is protected:

Sermorelin Tesamorelin
Length 29 amino acids (GHRH 1-29) 44 amino acids (full GHRH)
Modification None Hexenoyl (C6) chain on the first amino acid
Molecular weight ~3.4 kDa 5,135.9 Da (label, free base)
Label half-life No current label 8 minutes (Egrifta SV label, healthy adults)
Bioavailability under the skin Not on a current label Under 4% (Egrifta label, 2 mg dose)

The hexenoyl chain was added to protect tesamorelin from the enzyme that breaks GHRH down. Even so, its own label reports an 8-minute elimination half-life and less than 4% absolute bioavailability from a subcutaneous injection. Both molecules act in short pulses, and neither stays in the body for long.

Two approval histories that never met

Sermorelin (Geref) Tesamorelin (Egrifta)
Sponsor EMD Serono Theratechnologies
Approved NDA 019863, 28 Dec 1990; NDA 020443, 26 Sep 1997 10 Nov 2010, new molecular entity
Approved for Diagnosing pituitary growth-hormone reserve; growth in GH-deficient children Reducing excess abdominal fat in HIV-infected adults with lipodystrophy
Status today Both discontinued, "not discontinued or withdrawn for safety or effectiveness reasons" (Federal Register determination) On the market (Egrifta SV, Egrifta WR)
Application type now Drug (NDA) Biologic (BLA 022505)

Sermorelin is the rare compound in this market that was approved, and approved twice. Tesamorelin is the only GHRH analogue approved today. Neither approval had anything to do with building muscle in adults.

Why one became a biologic: the 40-amino-acid line

FDA's database lists Egrifta under BLA 022505, the same number it was approved under in 2010 with a biologics prefix. The reason is size. Federal rules define a protein as "any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size" (21 CFR 600.3). The Biologics Price Competition and Innovation Act, enacted in March 2010, provided that an approved drug application for such a product "shall be deemed to be a license" under the Public Health Service Act ten years after enactment, which was March 2020 (42 U.S.C. 262, statutory note).

At 44 amino acids tesamorelin is a protein under that definition; at 29, sermorelin is a peptide and stays a drug. Nothing about either molecule changed. What moved was the legal box, and with it the rules for future generic or biosimilar copies.

What each trial actually measured

The two compounds were never tested on the same endpoint, so their results cannot be read against each other:

Sermorelin Tesamorelin
Pivotal population 110 previously untreated, prepubertal GH-deficient children (86 in the efficacy analysis) 412 (Study 1) and 404 (Study 2) HIV-infected adults with lipodystrophy and excess abdominal fat
Design Open-label, one year, no placebo Randomised, double-blind, placebo-controlled, 26 weeks + 26-week extension
Amount 30 µg/kg once daily at bedtime, under the skin 2 mg daily, under the skin
Primary measure Height velocity: 4.1 cm/yr at baseline → 8.0 at 6 months → 7.2 at 12 months Percent change in visceral fat by CT scan at L4–L5
Source Thorner 1996, PMID 8772599 Egrifta WR label, section 14 (openFDA, effective 2026-07-29)

Sermorelin's evidence is about making short children grow, and it showed that a once-a-day injection could roughly double height velocity in the first months in children whose pituitaries still responded. Tesamorelin's evidence is about moving fat out of the abdomen in a specific adult population. Its pooled lean-mass effect is covered on the tesamorelin entry, and its label calls it weight-neutral. The idea that one is "stronger" than the other in lifters rests on no trial at all.

The census: twelve papers, no comparison

PubMed, 2026-09-30. Tesamorelin returns 94 records; sermorelin (or GHRH 1-29) returns 198. Records naming both: 12. Read by type:

  • 3 reviews (2026), on performance-enhancing peptides and on peptides in orthopaedics and sports medicine.
  • 9 anti-doping method papers (2015–2026), developing urine and blood tests that detect GHRH analogues, both of these among them.
  • 0 clinical comparisons.

ClinicalTrials.gov, 2026-09-30: 24 registrations list tesamorelin as an intervention and 27 list sermorelin. None tests one against the other.

The papers that put these two names together most often are the ones written to catch athletes using them. That is the same pattern found when ipamorelin was compared with each of them: every paper naming ipamorelin and sermorelin, or tesamorelin and ipamorelin, is a review.

Status in sport

WADA's 2026 Prohibited List names both compounds by name in section S2.2.4, "growth hormone releasing factors": "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)", prohibited at all times. The detection papers above are the practical side of that listing. The compound-by-compound map is on WADA status by compound, and the wider class is on growth-hormone secretagogues.

Where the dose question is covered

This page leaves dose tables out on purpose. Peptifact's tesamorelin and sermorelin dosage page and Medibact Guides' tesamorelin vs sermorelin dosing comparison set out the label and trial figures and the arithmetic.

The honest summary

  • Same hormone, different lengths: sermorelin 29 amino acids, unmodified; tesamorelin 44 plus a hexenoyl chain.
  • Sermorelin: approved 1990 and 1997 for children's growth and diagnosis; both discontinued, not for safety or effectiveness.
  • Tesamorelin: approved 2010 for abdominal fat in HIV lipodystrophy; a biologic since 2020 because it is longer than 40 amino acids.
  • Different endpoints: height velocity in children vs CT-measured visceral fat in adults.
  • No comparison exists: 12 co-mentions on PubMed, all reviews or doping tests; 0 head-to-head registrations.

Limits of this page

The sermorelin molecular weight is the approximate figure for GHRH 1-29 amide and is not taken from a current label, because no current label exists. The Geref paediatric study was open-label with no control group, so its height-velocity gain is a before-and-after figure. The Federal Register determination records why FDA believes Geref was not withdrawn; it does not state the sponsor's commercial reason. PubMed and registry counts depend on query wording and were taken on one date.

Sources and dates

  • openFDA drugs@FDA, queried 2026-09-30: NDA 019863 and NDA 020443 (Geref, EMD Serono, both discontinued with the Federal Register determination); BLA 022505 (Egrifta, Theratechnologies, original approval 2010-11-10, type 1 new molecular entity).
  • EGRIFTA SV and EGRIFTA WR prescribing information, openFDA label records effective 2026-07-29: sections 1, 2, 11, 12.3 and 14.
  • 21 CFR 600.3(h)(6), definition of protein — eCFR, read 2026-09-30.
  • Biologics Price Competition and Innovation Act of 2009, section 7002(e)(4), as reproduced in the statutory note to 42 U.S.C. 262, read 2026-09-30.
  • Thorner M, et al.; Geref International Study Group. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. J Clin Endocrinol Metab 1996;81:1189–96 — PMID 8772599
  • PubMed, searched 2026-09-30: tesamorelin[tiab] → 94; sermorelin[tiab] OR "GHRH(1-29)"[tiab] → 198; both → 12, all read by title and publication type.
  • ClinicalTrials.gov API v2, searched 2026-09-30: intervention tesamorelin → 24; sermorelin → 27.
  • World Anti-Doping Agency, 2026 Prohibited List, section S2.2.4, read 2026-09-30.

Frequently asked questions

What is the difference between tesamorelin and sermorelin?

Both are copies of the body's growth-hormone-releasing hormone and act on the same receptor. Sermorelin is a shortened version, the first 29 of the hormone's 44 amino acids, with no protective modification. Tesamorelin is the full 44-amino-acid chain with a hexenoyl group added at one end to slow its breakdown. They were approved for unrelated uses: sermorelin to diagnose and treat growth-hormone deficiency in children, tesamorelin to reduce abdominal fat in adults with HIV lipodystrophy.

Which is better for muscle, tesamorelin or sermorelin?

No study has compared them, for muscle or anything else. Twelve PubMed records name both, and all are reviews or anti-doping detection papers. Tesamorelin has randomised trials reporting a small lean-mass increase in adults with HIV; sermorelin's clinical record is growth in children and diagnostic testing. Neither has a trial in healthy lifters.

Is sermorelin still FDA approved?

No approved sermorelin product is on the market. Both Geref applications are listed as discontinued in FDA's database, each with a Federal Register determination that it was not withdrawn for safety or effectiveness reasons. That wording rules out the two most common explanations, a ban or a failed drug.

Why is tesamorelin a biologic when sermorelin is not?

Size. Federal rules define a protein as a chain of more than 40 amino acids, and a 2010 law moved approved drug applications for proteins into the biologics system ten years later, in March 2020. Tesamorelin has 44 amino acids, so its application is now filed as BLA 022505; sermorelin has 29 and stayed a drug application.

What doses were used in the trials?

Reported as journalism, not guidance. The Geref paediatric study gave 30 micrograms per kilogram once daily at bedtime by injection under the skin. Egrifta's trials used 2 mg daily under the skin; the later Egrifta WR formulation's label dose is 1.28 mg, shown to give comparable exposure. Dose-focused comparisons are on the pages linked from this one.

Are tesamorelin and sermorelin banned in sport?

Yes. WADA's 2026 Prohibited List names both sermorelin and tesamorelin in section S2.2.4, growth-hormone-releasing factors, prohibited at all times, and anti-doping laboratories have published detection methods naming both. The section-by-section map is on this site's WADA status page.