Tesamorelin Dosing Guide: Protocols (2026)

Tesamorelin is a synthetic analog of human growth hormone-releasing hormone (GHRH) that stimulates endogenous GH production. It is the only FDA-approved treatment specifically indicated for reducing excess abdominal fat in HIV-associated lipodystrophy.

An FDA-approved GHRH analog: Tesamorelin has Phase III clinical trial data supporting efficacy and safety at 2 mg daily. Off-label use is growing but lacks equivalent evidence. This is not medical advice.

Quick Reference: Dosing

FDA protocol: 2 mg subcutaneous daily, continuous use under medical supervision. Community off-label: 1–2 mg daily, cycled 8–16 weeks to manage cost and receptor sensitivity.

For GHRH analog comparisons, see our CJC-1295 vs Sermorelin guide and Sermorelin Dosing Guide.

Loading vs Maintenance

Tesamorelin does not use loading phases in any protocol:

FDA-approved approach: 2 mg daily continuously. Phase III trials assessed efficacy at 26 weeks with extension studies to 52 weeks. Discontinuation leads to visceral fat regain.

Community off-label approach:

• Weeks 1–2: Start at 1 mg daily to assess GH response and tolerance
• Weeks 3–16: Increase to 2 mg daily for full protocol
• Off period: 4–8 weeks to manage cost, assess sustained benefits, and maintain receptor sensitivity

Timing Considerations

• Morning injection: Aligns with natural GHRH pulsatility and avoids interference with nocturnal GH
• Fasted preferred: Though less critical than with GHRPs, fasted administration may optimize GH response
• Consistent timing: Same time daily for steady GH stimulation pattern
• Before exercise: Some users time injection 30–60 min before training

Routes of Administration

Subcutaneous Injection (Only Route)

Tesamorelin is administered exclusively via subcutaneous injection:

• Injection site: Abdomen — the FDA-approved site; rotate left/right sides
• Avoid: Do not inject into scar tissue, bruises, or the navel area
• Volume: 1–2 mL depending on reconstitution
• Needle: 27–30 gauge, ½ inch

Prescription vs Research Grade

Reconstitution Guide

Where These Numbers Come From: Clinical Context

Tesamorelin is unique among peptides covered here — it has robust Phase III clinical trial data.

Phase III Trial Results

Falutz et al. (2010) conducted the pivotal randomized, double-blind, placebo-controlled trial:

• 816 HIV-infected patients with abdominal fat accumulation
• 2 mg daily SC for 26 weeks with safety extension
• ~18% reduction in visceral adipose tissue (CT-measured)
• Improved body image distress scores
• No significant perturbation of glucose metabolism
• Effects reversed upon discontinuation

(Falutz et al., 2010)

Metabolic Benefits

Stanley et al. (2012) showed that visceral fat reduction with tesamorelin was associated with improved metabolic profiles, including beneficial changes in triglycerides and cholesterol ratios in HIV patients (Stanley et al., 2012).

Liver Benefits

Tesamorelin treatment was associated with reduced liver fat and improved liver enzymes (ALT), suggesting hepatoprotective effects beyond visceral fat reduction (Falutz et al., 2014).

FDA Approval

Tesamorelin received FDA approval in November 2010 as the first and only treatment specifically indicated for HIV-associated lipodystrophy (Adrian & Bhatt, 2012).

Off-Label Gap

While Phase III data is strong for HIV lipodystrophy, no equivalent trials exist for off-label use in general obesity or body composition optimization. Community protocols extrapolate from the HIV lipodystrophy data.

Mechanism of Action

Tesamorelin works through the physiological GHRH pathway:

GHRH receptor agonism — Tesamorelin binds the GHRH receptor on pituitary somatotroph cells, stimulating synthesis and pulsatile release of endogenous growth hormone. The trans-3-hexenoic acid modification increases metabolic stability compared to native GHRH (Wellington & Goa, 2011).

Endogenous GH release — Unlike exogenous GH (somatropin), tesamorelin stimulates the body's own GH production. This maintains the pulsatile release pattern and preserves negative feedback regulation through IGF-1.

Visceral fat lipolysis — GH preferentially mobilizes visceral adipose tissue through upregulation of lipolytic enzymes and beta-adrenergic receptor sensitivity in visceral adipocytes. This explains the selective visceral fat reduction without subcutaneous fat loss.

IGF-1 elevation — Tesamorelin-stimulated GH release increases hepatic IGF-1 production. Phase III trials showed IGF-1 elevation within the normal physiological range.

Preserved feedback — Because tesamorelin works through GHRH receptors rather than directly replacing GH, the hypothalamic-pituitary feedback loop remains intact. Somatostatin still regulates GH release, preventing supraphysiological levels.

Side Effects & Safety

Tesamorelin has the most comprehensive safety data of any peptide in this category:

Common Side Effects (From Phase III Trials)

• Injection site reactions — Erythema, pruritus, irritation (most common, ~10% of patients)
• Arthralgia — Joint pain, mild to moderate
• Peripheral edema — Mild fluid retention in extremities
• Myalgia — Muscle pain, typically transient
• Paresthesias — Tingling/numbness in hands (carpal tunnel-like, GH-mediated)

Metabolic Considerations

• Glucose metabolism — Phase III trials showed no significant glucose perturbation at 26 weeks, though GH can antagonize insulin action
• IGF-1 monitoring — Levels should be monitored; FDA labeling recommends periodic assessment
• HPA axis — No significant cortisol disruption observed (unlike GHRP-6)

Contraindications (FDA Label)

• Active malignancy — GH/IGF-1 axis stimulation is contraindicated with active cancer
• Pregnancy — Category X; contraindicated
• Hypersensitivity — To tesamorelin or mannitol (excipient)
• Hypothalamic-pituitary disruption — Conditions affecting GH axis may reduce efficacy

Discontinuation

• Visceral fat regain occurs after stopping tesamorelin
• No withdrawal symptoms or rebound effects reported
• GH and IGF-1 levels return to baseline

Stacking Tesamorelin

As an FDA-approved GHRH analog, tesamorelin is sometimes combined with other peptides in community protocols:

Tesamorelin + Ipamorelin (GHRH + GHRP)

Synergistic GH release through complementary pathways:

• Tesamorelin → GHRH receptor activation
• Ipamorelin → ghrelin receptor activation (clean, no cortisol/prolactin)

Tesamorelin + Semaglutide

Dual approach to body composition:

• Tesamorelin → visceral fat reduction via GH pathway
• Semaglutide → appetite suppression and overall weight loss via GLP-1

Tesamorelin + BPC-157

GH release with gut health support:

• Tesamorelin → GH stimulation, visceral fat reduction
• BPC-157 → GI mucosal healing, systemic anti-inflammatory

Stacking Considerations

• Medical supervision strongly recommended — Tesamorelin is a prescription medication
• IGF-1 monitoring — Especially important when combining GH secretagogues
• Cost factor — Tesamorelin is expensive; stacking adds to financial burden
• Don't combine multiple GHRH analogs — Tesamorelin, sermorelin, CJC-1295 all target the same receptor

Frequently Asked Questions

What is the FDA-approved tesamorelin dose?

2 mg subcutaneous once daily, continuous use. This is the only dosing protocol supported by Phase III clinical trials in HIV-associated lipodystrophy.

Can tesamorelin be used off-label for general fat loss?

It's increasingly used off-label, but clinical trial evidence exists only for HIV lipodystrophy. General obesity/body composition trials have not been completed.

How quickly does tesamorelin reduce visceral fat?

Phase III trials measured ~18% visceral fat reduction at 26 weeks. Some response may be detectable by 8–12 weeks, but the full effect requires sustained use.

Does tesamorelin affect subcutaneous fat?

Minimal. Tesamorelin preferentially targets visceral fat. Trials showed significant visceral reduction without meaningful changes in subcutaneous fat, limb fat, or total body weight.

How does tesamorelin compare to sermorelin?

Both are GHRH analogs. Tesamorelin has FDA approval, Phase III data, and a stability modification. Sermorelin is older, less potent, but significantly cheaper. Both stimulate endogenous GH through the same receptor.

How do I reconstitute tesamorelin?

For research-grade: add 2 mL BAC water to a 2 mg vial (1 mg/mL). Full vial = 2 mg dose. For prescription formulations, follow the provided diluent instructions.

Related Guides

• Sermorelin Dosing Guide — Alternative GHRH analog, lower cost
• CJC-1295 + Ipamorelin Guide — GHRH + GHRP combination protocols
• Ipamorelin Dosing Guide — Clean GHRP for stacking with GHRH analogs
• Semaglutide Dosing Guide — GLP-1 approach to body composition
• GHRH vs GHRP — Understanding the two GH-releasing pathways

References

For educational and research purposes only. This is not medical advice. Tesamorelin is FDA-approved for HIV-associated lipodystrophy; off-label use should be discussed with a physician.