Tesamorelin vs Sermorelin: Mechanisms, Efficacy, Dosing, Safety, and Cost

Overview: What Are Tesamorelin and Sermorelin?

Tesamorelin is an FDA‑approved growth‑hormone–releasing factor (GHRF) analog indicated to reduce excess abdominal fat in adults with HIV‑associated lipodystrophy and is not indicated for weight loss in the general population; its current U.S. labeling also includes dosing and safety monitoring guidance. See the EGRIFTA SV Prescribing Information for full details. Sermorelin (GHRH 1–29) previously held approvals for pediatric GH diagnostics/therapy but was discontinued by the sponsor; the FDA determined these products were not withdrawn for reasons of safety or effectiveness, and today access is typically via compounding rather than an approved brand. See the Federal Register determination for context.

How They Work (Mechanism of Action)

Tesamorelin is a stabilized analog of growth hormone–releasing hormone (GHRH) that binds pituitary GHRH receptors to trigger pulsatile GH release, secondarily increasing hepatic IGF‑1; the U.S. label describes GHRH‑mediated GH synthesis/release with downstream metabolic effects in clinical use (see EGRIFTA SV Prescribing Information ). Sermorelin is the GHRH 1–29 fragment—the minimum biologically active sequence—so it works upstream of the pituitary as well, amplifying physiologic GH pulses rather than replacing GH outright; for a primer on GHRH physiology and pulsatility, review NCBI Bookshelf: Normal Physiology of Growth Hormone for background.

Pharmacokinetics & Half-Life

Tesamorelin exhibits rapid systemic clearance after subcutaneous injection; the WR label reports a mean elimination half‑life around 11 minutes, contrasting with longer downstream GH/IGF‑1 effects (see EGRIFTA WR Prescribing Information ). By comparison, sermorelin’s plasma half‑life is approximately 6–7 minutes after IV administration with peak GH responses near 30 minutes and effects lasting 2–3 hours; details appear in the HPRA SmPC for sermorelin .

Evidence & Outcomes

Tesamorelin has the most robust outcome data: two pivotal randomized, double‑blind trials in HIV‑associated lipodystrophy demonstrated clinically meaningful visceral adipose tissue (VAT) reduction at 26 weeks, with effects maintained to 52 weeks in extensions; these trials underpin the U.S. indication and are summarized in the EGRIFTA WR Prescribing Information . A representative RCT reported ~15% VAT decrease with tesamorelin versus a ~5% increase on placebo over 26 weeks, along with lipid improvements and stable glycemic measures in the studied population; see Falutz et al., JAIDS 2010 for methods and endpoints.

Dosing & Administration

For tesamorelin, the current U.S. label specifies 1.4 mg subcutaneously once daily, injected into the abdomen with site rotation to minimize local reactions; clinicians should monitor IGF‑1 and assess glycemic status in patients at risk for glucose intolerance. Full reconstitution, injection, and monitoring instructions appear in the EGRIFTA Prescribing Information . By contrast, sermorelin currently lacks an FDA‑approved finished drug product; access is typically through compounding so doses, schedules, and monitoring are individualized by the prescriber. The FDA notes that compounded drugs are not FDA‑approved; see FDA: Compounding and the FDA (Q&A) for the regulatory context.

Safety & Side Effects

Major warnings for tesamorelin include glucose intolerance or diabetes risk, fluid retention and edema, carpal‑tunnel–like neuropathy, hypersensitivity, and a caution to discontinue in acute critical illness; it is contraindicated in pregnancy and in active malignancy. The complete safety profile and monitoring recommendations appear in the FDA label for EGRIFTA SV . Common reactions include injection‑site erythema, itching, and pain, arthralgia/myalgia, paresthesias, and GI upset; patient‑facing summaries echo these effects and advise prompt evaluation for worsening glucose control or neuropathic symptoms; see MedlinePlus: Tesamorelin Injection for a lay summary.

Cost & Access

Tesamorelin is a specialty, brand‑only drug dispensed via specialty pharmacies; out‑of‑pocket costs vary widely by insurance and benefit phase. Tools describing coverage patterns include the GoodRx Egrifta SV Medicare coverage page , but real costs are plan‑specific. Sermorelin is generally obtained as a compounded preparation rather than an FDA‑approved finished drug; pricing and coverage therefore vary by provider. For principles on compounded products, review FDA: Human Drug Compounding overview to understand quality and regulatory differences.

Tesamorelin vs Sermorelin vs Ipamorelin (Context)

Ipamorelin is a growth‑hormone secretagogue that activates the ghrelin (GHS‑R1a) receptor, increasing GH in a pulse‑like, dose‑dependent manner—distinct from GHRH‑receptor agonists such as tesamorelin and sermorelin. For a physiology comparison of GHRH and ghrelin/GHS pathways, see NCBI Bookshelf: Regulation of Growth Hormone Secretion . Ipamorelin currently lacks any FDA‑approved finished drug; when used, it is typically sourced via compounding, which carries the usual caveats discussed in FDA human drug compounding guidance and should be considered carefully with a clinician.

Tesamorelin is best aligned to adults with HIV‑associated lipodystrophy and excess visceral adipose tissue, where randomized trials show VAT reduction. It is not indicated for general weight loss and should be avoided in pregnancy or active malignancy; clinicians typically monitor IGF‑1 and glucose during therapy. For formal indications and cautions, consult the EGRIFTA label . Sermorelin may be considered only under clinician supervision when the goal is to support physiologic GH pulsatility after appropriate endocrine evaluation; evidence for VAT loss is limited versus tesamorelin, and dosing/quality vary with compounding.

Disclaimer

Disclaimer: This website connects patients with licensed healthcare providers who can evaluate medical conditions and prescribe medications when appropriate. Some medications available through this service may be compounded drugs, which are customized formulations prepared by a pharmacy. The FDA does not conduct premarket review for compounded drugs to evaluate their safety, effectiveness, or quality. (See here: https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved). Individual results may vary, and these medications should only be used under the guidance of a qualified healthcare professional. The information in this article is for educational purposes only and should not be considered medical advice. Always consult your healthcare provider before starting any new treatment.