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Sermorelin vs Tesamorelin: Two GHRH Analogues, Different Fates

Both peptides copy growth hormone-releasing hormone (GHRH), the brain signal that tells the pituitary to release growth hormone. Sermorelin was an approved medicine for children until it was discontinued in 2008. Tesamorelin is approved today for one specific use in adults with HIV.

Unapproved FDA Approved No head-to-head trial
Comparison banner for sermorelin, a discontinued GHRH fragment, and tesamorelin, an FDA-approved GHRH analogue sold as Egrifta.
A 29-amino-acid GHRH fragment and a modified 44-amino-acid GHRH analogue acting on the same pituitary receptor. Illustration © Inside Peptides.
Evidence-Based Short Answer

Evidence-Based Summary

Sermorelin is the first 29 amino acids of human GHRH. FDA approved it as Geref for a pituitary test (1990) and for growth failure in children with idiopathic growth hormone deficiency (1997); the maker discontinued both in 2008, and FDA later found this was not for safety or effectiveness reasons. No approved sermorelin product is sold in the U.S. now. Tesamorelin is the full 44-amino-acid GHRH sequence with a small chemical cap (a hexenoyl group) added at one end. It is FDA-approved (Egrifta, 2010) to reduce excess abdominal fat in adults with HIV and lipodystrophy, based on Phase 3 trials of 412 and 806 patients. Both raise growth hormone and IGF-1 by acting on the pituitary. No trial has compared them, and neither is proven to slow aging or build muscle in healthy adults. Both are banned in sport (WADA S2).

Educational content only. Tesamorelin is a prescription medicine with contraindications, including active cancer and pregnancy. Sermorelin is currently available only through compounding, which FDA has not approved. We do not give dosing information.
At a Glance

Quick Comparison: Sermorelin vs Tesamorelin

A high-level comparison of molecule class, molecular receptor targets, FDA regulatory approvals, and verified clinical programs.

Table 1: Verified regulatory, pharmacological, and clinical comparison between Sermorelin and Tesamorelin.
Feature Sermorelin Tesamorelin
Class GHRH(1-29) amide: the active fragment of natural GHRH Full GHRH(1-44) with an N-terminal hexenoyl group
Target receptor GHRH receptor on pituitary somatotroph cells GHRH receptor on pituitary somatotroph cells
How it is given Was given by daily subcutaneous injection (treatment) or intravenously (diagnostic test) Daily subcutaneous injection (Egrifta WR is mixed weekly and injected daily)
U.S. regulatory status Geref approvals withdrawn after 2008 discontinuation; no approved product; 503B category 1 (under evaluation) FDA-approved 2010 (Egrifta; Egrifta SV and WR labels current) for excess abdominal fat in adults with HIV and lipodystrophy
Strongest human evidence 1990s pediatric trials in GH deficiency (110-child open-label study; 43-child randomized comparison with GH) Phase 3 randomized trials in HIV lipodystrophy (412 patients; pooled 806)
Main safety concerns Few modern data; 1990s pediatric studies reported no excess bone-age advance Label warnings: neoplasm risk, raised IGF-1, fluid retention, glucose intolerance, hypersensitivity
WADA status (2026) Prohibited at all times (S2, named) Prohibited at all times (S2, named)
Receptor Biology

Same Receptor, Different Engineering

Both act on the GHRH receptor in the pituitary, so the body's own growth hormone is released and still regulated by feedback from somatostatin and IGF-1. Neither one is growth hormone itself.

Sermorelin

Sermorelin (GHRH 1-29 amide)

Primary Target: Pituitary GHRH receptor

Affinity Profile: Agonist; short-acting native fragment

The shortest fully active piece of GHRH. In children with GH deficiency it increased growth rate; in older men it raised GH and IGF-1 over two weeks. Because it acts through the pituitary, it cannot work if the pituitary cannot make GH.

Tesamorelin

Tesamorelin (Egrifta)

Primary Targets: Pituitary GHRH receptor

Affinity Profile: Agonist; full-length GHRH with an N-terminal hexenoyl cap

The label describes the 44-amino-acid human GRF sequence with a hexenoyl group attached to the first amino acid. In Phase 3 trials, IGF-1 rose and visceral fat fell. The label contraindicates it when the hypothalamic-pituitary axis is disrupted.

Regulatory Status

A Discontinued Medicine vs a Current One

Checked 11 October 2026 against Drugs@FDA, DailyMed, the Federal Register and FDA's 503B category list.

Unapproved

Sermorelin Status & Formulations

Geref was approved in 1990 (NDA 019863, diagnostic) and 1997 (NDA 020443, pediatric growth failure). EMD Serono discontinued both in 2008 and FDA withdrew the approvals; in 2013 FDA determined they were not withdrawn for safety or effectiveness reasons. Sermorelin acetate is in FDA's 503B category 1 (under evaluation). Compounded sermorelin is not an FDA-approved product.

FDA Approved

Tesamorelin Status & Formulations

Egrifta (now Egrifta SV and Egrifta WR)

Approval History: 2010 (Application 022505, now listed as BLA 022505)

Approved Indications: Reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Not indicated for weight loss; long-term cardiovascular safety not established.

View Regulatory Package

Critical Regulatory Distinction

Tesamorelin's approval covers one indication in one population. 'Anti-aging' or muscle-building use of either peptide is off-label or unapproved. Compounded products are not FDA-approved equivalents.

Human Evidence

Pediatric Growth Trials vs HIV Fat-Reduction Trials

No trial has compared sermorelin with tesamorelin. The two were studied in different people for different outcomes, so their results cannot be ranked.

Sermorelin: Sermorelin (1990s)

In a multicenter open-label study of 110 prepubertal children with GH deficiency (1996), growth velocity roughly doubled in the first six months and stayed raised at a year, without a control group. In a 43-child randomized comparison (1993), sermorelin increased growth but only growth hormone improved height relative to bone age. Studies in older men were tiny: 10 men for 14 days showed GH and IGF-1 increases; an uncontrolled 11-man study showed no body-composition change.

Tesamorelin: Tesamorelin (Phase 3)

In a 26-week trial of 412 patients with HIV and abdominal fat (2007), visceral fat fell 15.2% with tesamorelin and rose 5.0% with placebo, with improved triglycerides and an 81% IGF-1 rise. A pooled analysis of two Phase 3 trials (806 patients, 2010) confirmed a treatment effect of about -15% on visceral fat with no meaningful change in fat under the skin. An NIH-funded 61-person trial (2019) reduced liver fat in HIV-associated fatty liver disease; this is not an approved use. Phase 3 trials were sponsored by the manufacturer.

Safety & Tolerability

Label Warnings vs Limited Modern Data

Raising growth hormone and IGF-1 carries class-wide questions about glucose, fluid retention and cell growth. Tesamorelin's risks are set out in a current label; sermorelin's data are mostly from 1990s pediatric studies.

Table 4: Evidence-supported safety considerations and adverse-reaction frequency for Sermorelin and Tesamorelin.
Safety Consideration Sermorelin Tesamorelin
Contraindications No current U.S. label Disrupted hypothalamic-pituitary axis, active malignancy, hypersensitivity, pregnancy
IGF-1 and cancer Long-term data lacking Label: monitor IGF-1; pre-existing cancer must be inactive and treated
Glucose No change over two weeks in older men (small study) Label: glucose intolerance or diabetes may develop
Fluid retention Not well characterized Label: edema, joint pain, carpal tunnel syndrome
Product quality Compounded products only; not FDA-approved FDA-approved manufactured product
Pharmacological Commonalities

What Sermorelin and Tesamorelin Have in Common

Where the two compounds overlap in biology, evidence or regulatory context.

Same receptor

Both are GHRH receptor agonists that make the pituitary release the body's own growth hormone.

Need a working pituitary

Neither works when the pituitary cannot make growth hormone.

Banned in sport

WADA's 2026 list names both in class S2, prohibited at all times.

Distinguishing Features

Key Scientific & Clinical Differences

Meaningful distinctions in mechanism, strength of evidence, safety and regulatory status.

Structure

Sermorelin is a 29-amino-acid fragment; tesamorelin is the full 44-amino-acid sequence with a hexenoyl cap.

Approval today

Tesamorelin is currently FDA-approved; sermorelin's approvals ended after it was discontinued in 2008.

Population studied

Sermorelin's main trials were in children with GH deficiency; tesamorelin's in adults with HIV-associated abdominal fat.

Inside Peptides Editorial Policy

Scientific Comparison vs Clinical Recommendations

Inside Peptides compares scientific evidence, receptor pharmacology, and official regulatory documents to advance public and professional understanding. We do not determine which compound is appropriate for an individual patient, rank medications with arbitrary scores, or recommend initiating or switching treatments.

Decisions about any medicine require a licensed healthcare professional who can weigh personal medical history, contraindications, interactions and monitoring needs. Unapproved peptides have no established safe use, and products sold as “research chemicals” are not the preparations studied in clinical research.

Evidence Verification

Approved Uses vs Online Claims

A critical scientific distinction between verified, FDA-approved clinical uses and unverified claims circulating on social media and vendor platforms.

Sermorelin or tesamorelin reverses aging

Not supported
Regulatory Context:

No GHRH analogue is FDA-approved for aging.

Scientific Reality:

Studies in older adults were tiny and short and measured hormone levels, not aging outcomes. Tesamorelin's evidence is for visceral fat in HIV lipodystrophy.

Tesamorelin is a fat-loss drug for anyone

Supported for approved use only
Regulatory Context:

Egrifta label: indication and limitations of use.

Scientific Reality:

Trials showed reduced visceral fat in adults with HIV and lipodystrophy. The label says it is not indicated for weight loss.

Sermorelin is FDA-approved

Not supported
Regulatory Context:

Drugs@FDA lists both Geref applications as discontinued.

Scientific Reality:

It was approved as Geref, but those approvals were withdrawn after the 2008 discontinuation. Compounded sermorelin is not an approved product.

Claim-Level Certainty

Evidence Strength Across Clinical Domains

Inside Peptides evaluates scientific certainty at the claim level. Because clinical evidence varies significantly depending on the therapeutic endpoint evaluated, each domain is assessed independently.

Visceral fat in HIV lipodystrophy

Phase 3 randomized trials support tesamorelin; sermorelin was not tested for this.

Sermorelin: Insufficient Evidence
Tesamorelin: Strong Evidence

Pediatric GH deficiency

1990s trials support increased growth with sermorelin, less than with growth hormone; tesamorelin was not studied here.

Sermorelin: Moderate Evidence
Tesamorelin: Insufficient Evidence

Healthy aging, muscle or body composition

Only small, short studies of hormone levels; no proven clinical benefit.

Sermorelin: Insufficient Evidence
Tesamorelin: Insufficient Evidence
Unresolved Questions

What Research Still Doesn’t Tell Us

Identifying open scientific questions, pending active-comparator trials, and areas where long-term clinical data remain incomplete.

No direct comparison

No study has compared these two GHRH analogues.

Long-term IGF-1 effects

The effects of years of raised IGF-1 are unknown, as the tesamorelin label notes.

Compounded sermorelin quality

Compounded products are not FDA-reviewed for identity, purity or consistency.

Industry funding

The tesamorelin Phase 3 trials were manufacturer-sponsored; the sermorelin pediatric studies were run by the Geref study group.

Related Compound Profiles

Individual profiles provide full molecular datasheets, CAS numbers, preclinical histories, and compound monographs.

Bibliography & Sources

Scientific & Regulatory References

Every pharmacological mechanism, clinical trial result, and regulatory approval cited on this page is traceable to official FDA prescribing documentation, ClinicalTrials.gov registries, or peer-reviewed medical publications.

  1. Multicenter open-label trial
    Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group.
    Thorner M et al. (1996) · J Clin Endocrinol Metab.
    110 prepubertal children enrolled; no control group.
    Direct Source DOI: 10.1210/jcem.81.3.8772599 PubMed: 8772599
  2. Randomized comparative trial
    Growth response to growth hormone-releasing hormone(1-29)-NH2 compared with growth hormone.
    Neyzi O et al. (1993) · Acta Paediatr Suppl.
    43 children; growth hormone itself performed better on height relative to bone age.
    Direct Source DOI: 10.1111/j.1651-2227.1993.tb12828.x PubMed: 8329826
  3. Randomized crossover study
    Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men.
    Corpas E et al. (1992) · J Clin Endocrinol Metab.
    Hormone levels only, over 14 days.
    Direct Source DOI: 10.1210/jcem.75.2.1379256 PubMed: 1379256
  4. Uncontrolled pilot study
    Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men.
    Vittone J et al. (1997) · Metabolism.
    11 men, no placebo group.
    Direct Source DOI: 10.1016/s0026-0495(97)90174-8 PubMed: 9005976
  5. Drug review
    Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency.
    Prakash A et al. (1999) · BioDrugs.
    Direct Source DOI: 10.2165/00063030-199912020-00007 PubMed: 18031173
  6. FDA Drugs@FDA record
    Drugs@FDA: GEREF (sermorelin acetate) injection, NDA 019863 (diagnostic product, discontinued)
    U.S. Food and Drug Administration (1990).
    Direct Source
  7. FDA Drugs@FDA record
    Drugs@FDA: GEREF (sermorelin acetate) injection, NDA 020443 (treatment product, discontinued)
    U.S. Food and Drug Administration (1997).
    Direct Source
  8. Federal Register notice
    Determination that GEREF (sermorelin acetate) injection products were not withdrawn from sale for reasons of safety or effectiveness
    U.S. Food and Drug Administration (2013).
    Direct Source
  9. FDA compounding list
    Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the FD&C Act (categories, updated March 21, 2025)
    U.S. Food and Drug Administration (2025).
    Sermorelin acetate appears in category 1 (bulk drug substances under evaluation).
    Direct Source
  10. Phase 3 randomized trial
    Metabolic effects of a growth hormone-releasing factor in patients with HIV.
    Falutz J et al. (2007) · N Engl J Med.
    412 patients with HIV and abdominal fat accumulation; 26 weeks.
    Direct Source DOI: 10.1056/NEJMoa072375 PubMed: 18057338
  11. Pooled analysis of two Phase 3 trials
    Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data.
    Falutz J et al. (2010) · J Clin Endocrinol Metab.
    806 patients randomized 2:1.
    Direct Source PubMed: 20554713
  12. Randomized placebo-controlled trial
    Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.
    Stanley TL et al. (2019) · Lancet HIV.
    61 participants; NIH-funded; not an approved indication.
    Direct Source DOI: 10.1016/S2352-3018(19)30338-8 PubMed: 31611038
  13. Registry Record
    TH9507 in Patients With HIV-Associated Lipodystrophy
    ClinicalTrials.gov (2007).
    Phase 3, completed, 412 enrolled; sponsor Theratechnologies.
    Direct Source
  14. FDA Drugs@FDA record
    Drugs@FDA: EGRIFTA (tesamorelin), application 022505
    U.S. Food and Drug Administration (2010).
    Original approval 10 November 2010; FDA's database now lists the application as BLA 022505.
    Direct Source
  15. Official U.S. prescribing information
    EGRIFTA WR (tesamorelin) for injection, current label
    DailyMed / National Library of Medicine (2026).
    Label published August 2026; checked 11 October 2026.
    Direct Source
  16. Official U.S. prescribing information
    EGRIFTA SV (tesamorelin) for injection, current label
    DailyMed / National Library of Medicine (2026).
    Direct Source
  17. Anti-doping rule
    World Anti-Doping Code International Standard: Prohibited List 2026
    World Anti-Doping Agency (2026).
    Section S2 lists GHRH and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin); S0 covers pharmacological substances with no current governmental approval for human therapeutic use.
    Direct Source