Tesamorelin: Evidenz, Dosierung, Sicherheit & Wechselwirkungen
GHRH(1-44) analog (trans-3-hexenoic acid-modified)
As the approved drug Egrifta, this genuinely works to reduce a specific type of belly fat in people with HIV — that's backed by strong evidence. Using it for general weight loss or anti-aging in people without HIV hasn't been tested nearly as well.
- What it is
- An FDA-approved GHRH analog (Egrifta) that reduces visceral abdominal fat specifically in people with HIV-associated lipodystrophy.
- Evidence
- Strong for the approved indication: two replicated Phase 3 RCTs (over 800 patients combined) plus a systematic review of 10 placebo-controlled trials. Essentially no dedicated RCT evidence exists for general anti-aging or fat-loss use outside HIV.
- Studied dose
- 2 mg subcutaneous once daily — the exact FDA-approved dose used in every pivotal trial. No other dose or schedule has been through a comparable trial.
- Safety
- Generally well tolerated over 52 weeks of trial data, with injection-site reactions and GH-related joint or fluid symptoms the main issues. Visceral fat loss reverses within months of stopping — this is a maintenance therapy, not a cure.
Was Studien am Menschen tatsächlich zeigen
Ausschließlich randomisierte, placebokontrollierte Studien am Menschen. Tierdaten erscheinen hier nie — sie können eine Bewertung nicht anheben und werden weiter unten separat vermerkt.
- 01The New England Journal of Medicine2007— Pivotal Phase 3 trial: visceral fat and lipids
- Design
- Randomized, double-blind, placebo-controlled, multicenter
- Dosis
- 2 mg subcutaneous once daily
- Dauer
- 26 weeks
412 HIV-infected patients with abdominal fat accumulation on antiretroviral therapy
Visceral adipose tissue decreased 15.2% with tesamorelin versus an increase of 5.0% with placebo (P<0.001). Triglycerides and total-to-HDL cholesterol ratio also improved significantly. IGF-1 rose 81% versus a 5% fall on placebo. Adverse events were similar between groups, though more tesamorelin patients withdrew due to an adverse event.
doi:10.1056/NEJMoa072375 - 02Journal of Acquired Immune Deficiency Syndromes2010— Second pivotal Phase 3 trial, with 12-month extension
- Design
- Randomized, double-blind, placebo-controlled, with a blinded re-randomized extension phase
- Dosis
- 2 mg subcutaneous once daily
- Dauer
- 6-month efficacy phase, 12-month total
404 HIV-infected patients with excess abdominal fat
Visceral fat decreased 10.9% at 6 months versus 0.6% with placebo (P<0.0001), with body-image ratings and waist-to-hip ratio also improving. Patients who continued treatment maintained an 18% visceral-fat reduction at 12 months; those who switched to placebo rapidly regained the fat they had lost.
doi:10.1097/QAI.0b013e3181cbdaff - 03AIDS2008— Long-term safety extension
- Design
- Randomized, double-blind extension of the pivotal trials, with re-randomization at week 26
- Dosis
- 2 mg subcutaneous once daily
- Dauer
- Additional 26 weeks (52 weeks total)
410 HIV-infected patients continuing from the primary 26-week trials
The visceral-fat reduction was sustained at roughly 18% through 52 weeks of continuous treatment without clinically significant worsening of glucose parameters. Discontinuing tesamorelin led to fat reaccumulation, establishing that the drug's effect requires ongoing treatment rather than producing a lasting change.
doi:10.1097/QAD.0b013e32830a5058 - 04AIDS2005— Original dose-ranging trial
- Design
- Randomized, double-blind, placebo-controlled, dose-ranging
- Dosis
- 1 mg or 2 mg subcutaneous once daily, versus placebo
- Dauer
- 12 weeks
61 HIV-infected patients with abdominal fat accumulation
Established the dose-response relationship that led to the 2 mg dose used in every later pivotal trial: IGF-1 rose 65% and trunk fat fell significantly more at 2 mg than at 1 mg, without a significant change in glucose.
doi:10.1097/01.aids.0000180099.35146.30 - 05HIV Medicine2011— Systematic review of GH-axis treatments for HIV lipodystrophy
- Design
- Systematic review and analysis of placebo-controlled RCTs
- Dosis
- Varied by drug; tesamorelin trials used 2 mg subcutaneous daily
- Dauer
- n/a (review)
10 RCTs totaling 1,511 patients across all GH-axis drugs studied for this indication
Across the pooled evidence base, GH-axis treatments — tesamorelin foremost among them — significantly reduced visceral fat and increased lean body mass compared with placebo, confirming the pivotal trials were not an isolated result.
doi:10.1111/j.1468-1293.2010.00906.x
The strong evidence above is specific to one population: people with HIV on antiretroviral therapy who have developed visceral fat accumulation. Nobody has run a comparable randomized trial of tesamorelin for fat loss, muscle gain, or anti-aging in people without HIV — the population most longevity clinics actually prescribe it to. The effect also does not persist: every trial that measured what happens after stopping found visceral fat reaccumulates within months, meaning tesamorelin functions as an ongoing maintenance therapy rather than a fix, with no trial following patients for the many years a genuine anti-aging user would take it. Long-term cancer or cardiovascular risk from sustained IGF-1 elevation has not been directly studied over more than about a year.
Grade A — etabliert. For its actual FDA-approved indication — reducing visceral fat in HIV-associated lipodystrophy — tesamorelin has genuinely strong evidence: two pivotal, multicenter, placebo-controlled Phase 3 trials totaling over 800 patients, replicated findings, functional and body-image outcomes (not just biomarkers), and a published safety extension out to 52 weeks. That earns the top grade for that specific claim. It does not carry over to the off-label use most visitors are actually curious about — general fat loss, muscle gain, or anti-aging in people without HIV — which has no dedicated randomized trial evidence at all. Read the grade as 'A for HIV-associated lipodystrophy,' not 'A for anti-aging.' Wie wir Evidenz bewerten.
Nebenwirkungen & Sicherheit
- Reported in trials
- Injection-site reactions (redness, itching, or bruising) are the most common issue. Joint pain (arthralgia), peripheral swelling, and headache — recognized effects of raising GH and IGF-1 — occurred more often than with placebo, and were the leading reasons some patients withdrew.
- Glucose and diabetes risk
- Growth hormone axis stimulation can worsen insulin resistance. The pivotal trials found no clinically meaningful change in glucose measures over 52 weeks, but tesamorelin's US label carries a warning about glucose intolerance and is not recommended for people with poorly controlled diabetes.
- The honest caveat
- This is a strong safety and efficacy record for HIV-associated lipodystrophy specifically. It has not been established for long-term, off-label anti-aging use in people without HIV, at unknown treatment durations, which is a materially different risk calculation.
Wechselwirkungen mit Medikamenten
Der Abschnitt, den die meisten Longevity-Seiten auslassen. Wenn Sie verschreibungspflichtige Medikamente nehmen, lesen Sie dies vor allem anderen auf dieser Seite.
Tesamorelin raises IGF-1 and can reduce insulin sensitivity. The FDA label specifically advises monitoring blood glucose, and dose adjustment of diabetes medication may be needed.
Oral estrogens have been shown to blunt tesamorelin's effect on IGF-1 and visceral fat reduction in trial subgroup analyses. This is a specific, documented interaction — not a general caution.
Tesamorelin is a growth hormone secretagogue and is prohibited under the World Anti-Doping Agency's list (class S2), regardless of the medical justification for prescribing it.
Ist Tesamorelin in Ihrem Land legal?
Der Zulassungsstatus wird pro Markt erfasst und zum angegebenen Datum überprüft. Ist eine Substanz nicht zugelassen, verlinkt diese Seite nicht auf Verkäufer.
FDA-approved as Egrifta (2010) and its successor formulations Egrifta SV and Egrifta WR (approved March 2025), specifically for reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Prescribing for any other purpose, including general anti-aging or fat loss, is off-label.
Quelle: US Food and Drug Administration
No UK marketing authorisation exists for tesamorelin. It is not available through the NHS or licensed UK pharmacies for any indication.
Quelle: MHRA
The manufacturer withdrew its EU marketing authorisation application for Egrifta (tesamorelin) in 2012 after the CHMP indicated the submitted data did not support a positive benefit-risk balance, citing insufficient long-term safety data. No EU marketing authorisation has been granted since.
Quelle: European Medicines Agency (CHMP)
Le fabricant a retiré sa demande d'autorisation de mise sur le marché de l'Egrifta (tésamoréline) dans l'UE en 2012, le CHMP ayant estimé que le rapport bénéfice-risque n'était pas suffisamment établi. Aucune autorisation n'a été délivrée depuis.
Quelle: ANSM / Agence européenne des médicaments
El fabricante retiró su solicitud de autorización de comercialización de Egrifta (tesamorelina) en la UE en 2012, tras la opinión del CHMP de que los datos no respaldaban una relación beneficio-riesgo positiva. No se ha concedido autorización desde entonces.
Quelle: AEMPS / Agencia Europea de Medicamentos
Der Hersteller zog den Zulassungsantrag für Egrifta (Tesamorelin) in der EU 2012 zurück, nachdem der CHMP ein positives Nutzen-Risiko-Verhältnis auf Basis der vorgelegten Daten verneint hatte. Seitdem besteht keine Zulassung.
Quelle: BfArM / Europäische Arzneimittel-Agentur
We found no evidence of a MOHAP-registered tesamorelin product. Use, where it occurs, would be through a licensed clinic under physician supervision rather than over the counter; we could not independently verify a specific MOHAP position.
Quelle: UAE Ministry of Health and Prevention (MOHAP)
We found no evidence of an SFDA-registered tesamorelin product. No legitimate consumer or over-the-counter route to the compound was identified.
Quelle: Saudi Food and Drug Authority (SFDA)
L'azienda produttrice ha ritirato la domanda di autorizzazione all'immissione in commercio per Egrifta (tesamorelina) nell'UE nel 2012, dopo che il CHMP aveva ritenuto insufficienti i dati sul rapporto beneficio-rischio. Nessuna autorizzazione è stata concessa da allora.
Quelle: Ministero della Salute / Agenzia europea per i medicinali
De fabrikant trok de aanvraag voor een EU-handelsvergunning voor Egrifta (tesamoreline) in 2012 in, nadat het CHMP had geoordeeld dat de gegevens geen positieve baten-risicoverhouding onderbouwden. Sindsdien is geen vergunning verleend.
Quelle: CBG-MEB / Europees Geneesmiddelenbureau
Não identificamos registro de tesamorelina (Egrifta) na Anvisa. Não existe via legal de comercialização como medicamento ou suplemento identificada para este mercado.
Quelle: Agência Nacional de Vigilância Sanitária (ANVISA)
Dosierung & Einnahmezeitpunkt
The exact dose used in every pivotal Phase 3 trial and the only dose with an FDA label. Reconstituted from powder and injected into the abdomen, rotating sites to avoid lipohypertrophy.
Clinics prescribing tesamorelin for general fat loss or anti-aging in people without HIV are using the approved dose in an untested population and duration — there is no trial establishing an effective or safe protocol for that use case specifically.
Every trial that stopped tesamorelin saw visceral fat return within a few months. The approved use is a maintenance therapy, not a short course with a lasting effect.
Fragen, die tatsächlich gestellt werden
Is tesamorelin FDA-approved?
Yes — as Egrifta, approved in 2010 specifically to reduce excess visceral abdominal fat in adults with HIV-associated lipodystrophy. An improved, easier-to-mix formulation (Egrifta SV, later Egrifta WR) has since been approved for the same indication. It is not FDA-approved for general fat loss, bodybuilding, or anti-aging use in people without HIV — that is off-label prescribing.
Does tesamorelin actually increase growth hormone in humans?
Yes, substantially and reliably — IGF-1 rose 65-108% above placebo across the pivotal trials. This is one of the most consistently replicated pharmacodynamic findings for any peptide on this site.
Is tesamorelin approved in Europe?
No. The manufacturer withdrew its EU marketing authorization application for Egrifta in 2012 after the European Medicines Agency's CHMP indicated it could not conclude on a positive benefit-risk balance, citing insufficient long-term safety data. Tesamorelin is not licensed for sale in the EU or UK.
What's the difference between tesamorelin and sermorelin?
Both are GHRH analogs that prompt the pituitary to release its own GH, but tesamorelin uses the full 44-amino-acid GHRH sequence with a stabilizing modification, while sermorelin uses a shorter 29-amino-acid fragment. Tesamorelin has a current, actively marketed FDA approval (Egrifta) with large trials behind it; sermorelin's FDA approval was for a different, now-discontinued product.
Does tesamorelin work for weight loss or muscle gain in people without HIV?
That specific question has not been tested in a randomized trial. Every controlled trial behind tesamorelin's evidence base enrolled people with HIV-associated visceral fat accumulation — a distinct metabolic picture from general aging-related fat gain. Extrapolating the HIV-lipodystrophy results to a general population is a real evidence gap, not a settled question.