Dosing Guide·9 min read

Tesamorelin Dosage: 1mg/Day, 5 On/2 Off Protocol

Trials used 2mg daily; the current label is 1.4mg. Community protocols run 1mg subQ 5 days on/2 off. Both, plus cycling and IGF-1 monitoring.

Tesamorelin Dosing: 1mg 5on/2off Protocol

Tesamorelin is a synthetic GHRH analog that stimulates endogenous growth hormone production. It is the only FDA-approved treatment for reducing visceral fat in HIV-associated lipodystrophy, with Phase III trial data showing both visceral fat reduction and increased lean body mass.

Research-context information only. Tesamorelin is the active ingredient in an FDA-approved product for HIV-associated lipodystrophy; research-peptide and compounded forms are not FDA-approved and are sold for research purposes only. Protocols, doses, and reactions reported below come from published clinical trials and self-reported community sources. This article reports what has been documented, not what should be done. Consult a licensed physician for personal medical decisions.

FDA-approved for HIV lipodystrophy. Off-label community use is growing but lacks equivalent clinical evidence. This is not medical advice.

Tesamorelin Dosing Table

Match your vial size below — reconstitution and dose math update automatically.

Reconstitute: add 2 mL of bacteriostatic water to the 10 mg vial. Resulting concentration: 5 mg/mL.
1 mg20 units · 0.2 mL
Daily SubQ (5-on/2-off)
Community
2 mg40 units · 0.4 mL
Daily SubQ
FDA-approved dose

Math assumes U-100 insulin syringes (1 mL = 100 units). Verify your syringe matches before injecting. Round half-units to the nearest visible mark.

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Quick Reference: Commonly Reported Community Protocol

Parameter Standard Protocol
Dose 1 mg (20 units on insulin syringe)
Route Subcutaneous injection
Timing AM or PM
Frequency 5 days on, 2 days off
Cycle 8 weeks on, 8 weeks off
Vial size 10 mg
Reconstitution 2 mL bacteriostatic water → 5 mg/mL
Draw amount 20 units on insulin syringe
Storage Refrigerate, use within 28 days

Commonly reported community protocol: 1 mg subcutaneous, 5 days on / 2 days off, for 8 weeks on / 8 weeks off. For the full tesamorelin profile, vendor pricing, and stacking options, see our tesamorelin peptide page.

Cycling Details

The 5on/2off schedule is described in community sources as giving receptors periodic rest while maintaining consistent GH stimulation throughout the work week. The 8-week cycle length is described as balancing efficacy with cost management and receptor sensitivity.

Community protocols describe morning or evening dosing interchangeably; consistent timing is the documented standard approach. Fasted injection is commonly described in community sources as slightly optimizing GH response. Tesamorelin does not use a loading phase; documented protocols describe a direct 1 mg starting dose with no loading phase.

Continuous use versus cycling: what the trials documented

The community 8-on/8-off pattern is one approach; the clinical record describes another. In the Phase 3 program, tesamorelin was dosed at 2 mg subcutaneously every day for 52 continuous weeks with no scheduled breaks. IGF-1 reached its elevated plateau by week 26 and was maintained at that level through week 52, and visceral-fat reduction was sustained across the full year — the trials documented no tachyphylaxis (no loss of response over time) on continuous daily dosing (Falutz et al., 2007; Falutz et al., 2010). Trial data also documented that visceral fat re-accumulated after dosing stopped.

Community sources therefore describe two documented paths. Cycled use (commonly 8 weeks on, 8 weeks off) is typically described in the context of cost management and letting IGF-1 normalize between blocks. Continuous use mirrors the FDA-approved protocol, where the trial evidence for a sustained, non-attenuating response is strongest. In the trials, IGF-1 was monitored against the laboratory reference range, and published protocols described dose reduction when IGF-1 rose above it.

FDA-Approved Clinical Protocol (Higher Dose)

Note: The community protocol above reflects the commonly reported 1 mg dose. The FDA-approved protocol below uses the higher clinical dose.

Parameter FDA-Approved Protocol
Dose 2 mg daily in trials (original formulation); 1.4 mg daily on the current label
Frequency Every day (continuous)
Cycle Continuous under medical supervision
Indication HIV-associated lipodystrophy
Evidence Phase III RCT: ~15% visceral fat reduction at 26 weeks (~18% at 52 weeks)

The trial protocol ran continuously at 2 mg/day (the current label doses the newer formulation at 1.4 mg/day for similar exposure). Community protocols use 1 mg with cycling to manage cost and receptor sensitivity, with community sources reporting GH elevation; this dose has no Phase III data. In the Phase III extension, visceral fat re-accumulated after 2 mg dosing was discontinued. To estimate your total spend per cycle, see our tesamorelin cycle cost calculator. When you're ready to source, the tesamorelin buying guide covers which 4 of 7 vendors publish COA with mass spec verifying the 5,196 Da identity, plus vial-size selection (5mg vs 10mg).

Routes of Administration

Subcutaneous (only route): Trial protocols and FDA labeling describe rotating injection sites between left and right abdomen, with documented avoidance of scar tissue and the navel area. Community reconstitution guides note 27–30 gauge, ½ inch needle use.

Tesamorelin Injection Routes

Reconstitution Quick Reference

Vial Size BAC Water Concentration 1 mg Dose 2 mg Dose
10 mg 2 mL 5 mg/mL 20 units 40 units

10 mg vial + 2 mL BAC water = 5 mg/mL. At that dilution, a 1 mg dose corresponds to 20 units on an insulin syringe. One vial lasts 10 doses.

Community protocols describe gentle swirling — not shaking — to avoid degradation, with storage at 2–8°C and use within 28 days.

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Where These Numbers Come From

Tesamorelin has robust Phase III clinical trial data — unusual among peptides covered here.

Pivotal Phase III Trial (Falutz et al., 2007): 412 HIV-infected patients received 2 mg daily SC for 26 weeks. Visceral adipose tissue fell ~15% (versus a ~5% rise on placebo), IGF-1 rose ~81%, lipids improved, and there was no significant glucose perturbation. A pooled analysis of two Phase 3 trials (806 patients) confirmed the effect and carried it through 52 weeks of continuous dosing without loss of response (Falutz et al., 2010). A separate safety-extension trial documented that visceral fat re-accumulated when dosing stopped (Falutz et al., 2010).

Metabolic Benefits (Stanley et al., 2012): In a post hoc analysis of the two Phase 3 trials, patients whose visceral fat fell by at least 8% had greater triglyceride reductions, improved adiponectin, and preserved glucose control over 52 weeks compared with non-responders. Lean body mass also rose 1.3 kg versus placebo on DXA in the second Phase 3 trial (Falutz et al., 2010).

Liver Benefits (Stanley et al., 2014): In a 50-patient RCT, 6 months of 2 mg daily reduced liver fat (net treatment effect −2.9% lipid-to-water ratio) alongside visceral fat. ALT did not change significantly; AST fell modestly versus placebo.

The community standard of 1 mg represents a 50% reduction from the FDA dose, accounting for cost management and community sources' view that GHRH analogs show effects across a range of doses; the Phase III data cover only 2 mg. The 5-on/2-off schedule gives receptors periodic rest within the work week; the trial-validated alternative, described above, is continuous daily dosing.

Stacking Protocols

Tesamorelin + Ipamorelin (GHRH + GHRP)

Peptide Dose Route Timing Purpose
Tesamorelin 1 mg SC AM, fasted GHRH receptor activation
Ipamorelin 100-200 mcg SC Pre-bed, fasted Ghrelin receptor activation (clean, no cortisol)

Synergistic GH release through complementary pathways. Pairing tesamorelin with another GHRH analog (sermorelin, CJC-1295) is generally described as redundant rather than synergistic — they act on the same GHRH receptor, so a second analog adds little once one saturates the response. The documented supra-additive effect comes from the GHRH + GHRP pairing above.

Tesamorelin + Semaglutide

Peptide Dose Route Timing Purpose
Tesamorelin 1 mg SC AM Visceral fat via GH pathway
Semaglutide Per protocol SC Per protocol Appetite suppression via GLP-1

Dual approach to body composition — different mechanisms, complementary effects.

Side Effects & Safety

  • Injection site reactions — erythema, pruritus, irritation (~10% in trials)
  • Arthralgia — joint pain, mild to moderate
  • Peripheral edema — mild fluid retention
  • Paresthesias — tingling/numbness in hands (carpal tunnel-like, GH-mediated)
  • Glucose monitoring — GH can antagonize insulin; no significant perturbation at 26 weeks in trials
  • IGF-1 monitoring — FDA labeling describes periodic IGF-1 monitoring
  • Contraindicated with active malignancy, pregnancy, and hypothalamic-pituitary disruption

mg to Units Conversion

On a standard 100-unit insulin syringe, each "unit" equals 0.01 mL (so 100 units = 1 mL). Once tesamorelin is reconstituted, the conversion from a target dose to syringe units depends on the chosen dilution.

The two reconstitution ratios most often described in community protocols are below.

Reconstitution A: 10 mg vial + 2 mL BAC water (5 mg/mL) — the standard dilution from the Quick Reference above.

Dose (mg) Volume (mL) Units (insulin syringe)
0.5 mg 0.1 mL 10 units
1 mg 0.2 mL 20 units
1.5 mg 0.3 mL 30 units
2 mg 0.4 mL 40 units

Reconstitution B: 10 mg vial + 1 mL BAC water (10 mg/mL) — less BAC water for a lower total volume, so smaller draws and less fridge space.

Dose (mg) Volume (mL) Units (insulin syringe)
0.5 mg 0.05 mL 5 units
1 mg 0.1 mL 10 units
1.5 mg 0.15 mL 15 units
2 mg 0.2 mL 20 units

These conversions reflect the dilutions documented in community reconstitution protocols. They report how the math is described, not a recommended dosing schedule.

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Frequently Asked Questions

What is the standard tesamorelin dose?
Community-documented protocols describe 1 mg subcutaneous, 5 days on / 2 days off, cycled 8 weeks on / 8 weeks off. At the standard dilution (10 mg vial + 2 mL BAC water yielding 5 mg/mL), 1 mg corresponds to 20 units on an insulin syringe.
What is the FDA-approved tesamorelin dose?
The Phase III trials and the original FDA approval used 2 mg subcutaneous once daily, continuous use, for HIV-associated lipodystrophy. This is the only clinically validated dosing protocol with Phase III trial data. The currently labeled 2 mg/vial formulation is dosed at 1.4 mg once daily, which FDA labeling reports gives systemic exposure similar to 2 mg of the original 1 mg/vial formulation.
How quickly does tesamorelin reduce visceral fat?
Phase III trials showed approximately 15% reduction in visceral adipose tissue at 26 weeks with daily 2 mg dosing, and about 18% in patients who continued for 52 weeks. Community sources and trial interim assessments describe early visible response at 8–12 weeks, with significant visceral fat reduction documented at 26 weeks in Phase III trials.
Does tesamorelin affect subcutaneous fat?
Tesamorelin preferentially targets visceral (organ) fat. Phase III trials showed significant visceral fat reduction with minimal changes in subcutaneous fat, limb fat, or overall body weight.
How does tesamorelin compare to sermorelin?
Both are GHRH analogs, but tesamorelin has a trans-3-hexenoic acid modification that increases stability and potency. Tesamorelin has FDA approval and Phase III data; sermorelin has older clinical data and is typically less expensive.
What reconstitution ratios are documented for tesamorelin?
Community protocols document reconstitution with 2 mL bacteriostatic water added to a 10 mg vial, yielding 5 mg/mL. At that dilution, 1 mg corresponds to 20 units on an insulin syringe. Refrigerated storage is described as lasting up to 28 days.

References

Citation Topic PMID
Falutz et al., N Engl J Med (2007) Pivotal Phase 3 RCT (412 patients): ~15% visceral fat reduction at 26 weeks 18057338
Falutz et al., J Clin Endocrinol Metab (2010) Pooled Phase 3 (806 patients) with 52-week data: sustained response, no tachyphylaxis 20554713
Falutz et al., JAIDS (2010) Safety-extension RCT (404 patients): visceral fat re-accumulates after discontinuation 20101189
Stanley et al., Clinical Infectious Diseases (2012) Visceral fat reduction associated with improved metabolic profile 22495074
Spooner & Olin, Annals of Pharmacotherapy (2012) Tesamorelin review: FDA-approved GHRH analog for HIV lipodystrophy 22298602
Dhillon, BioDrugs (2011) Spotlight on tesamorelin mechanism and clinical profile 22050344
Stanley et al., JAMA (2014) Tesamorelin effects on visceral fat and liver fat, RCT 25038357

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.