Peptide Name
Tesamorelin
Updated February 2026
Tesamorelin Dosing Protocol
Complete tesamorelin (Egrifta) protocol guide covering FDA-approved dosing, Phase III evidence for visceral fat reduction, NAFLD trial context, reconstitution math, and safety monitoring.
Half-life
~26-38 minutes
Dose range
1.28-2 mg daily
Status
FDA-approved (HIV lipodystrophy)
Developer
Theratechnologies
COA-Verified Suppliers Carrying Tesamorelin
Research-grade peptide suppliers vetted for COAs, purity data, and reliability. Tesamorelin is also available as FDA-approved Egrifta (SV and WR) through licensed pharmacies. Use code PEPPALAffiliate disclosure: some outbound supplier links are affiliate links, and we may earn a commission at no extra cost to you.
Quick Reference Card
Aliases
Tesamorelin Acetate, TH9507, Egrifta, Egrifta SV, Egrifta WR
Category / Class
GHRH Analogue (Growth Hormone-Releasing Hormone)
Half-Life
~26-38 minutes (SubQ after 14-day dosing; Grinspoon et al. 2011)
Dosing Frequency
Once daily (subcutaneous)
Dose Range
1.4-2 mg per injection (formulation dependent)
Common Vial Sizes
1mg (discontinued), 2mg (Egrifta SV), 11.6mg (Egrifta WR)
Route of Administration
Subcutaneous (SubQ), abdomen only
Regulatory Status
FDA-approved (November 2010) for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Brand: Egrifta (Theratechnologies).
Developer
Theratechnologies, Inc. (Montreal, Canada)
Key Stat
Only FDA-approved GHRH analogue; Phase III trials showed 15-20% VAT reduction at 26 weeks, and NAFLD trial data reported 32% liver fat reduction at 12 months.
What Is Tesamorelin?
Tesamorelin acetate (Egrifta) is a synthetic 44-amino acid polypeptide analogue of human growth hormone-releasing hormone (GHRH) and the only currently FDA-approved GHRH analogue. Developed by Theratechnologies, it was approved by the U.S. FDA in November 2010 for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy.
Structurally, tesamorelin preserves the full 44-amino acid human GHRH sequence with an N-terminal trans-3-hexenoic acid modification on Tyr1. This improves resistance to DPP-IV degradation and extends functional half-life relative to native GHRH and shorter analogues such as sermorelin, while preserving pulsatile GH physiology.
Tesamorelin has one of the strongest clinical programs in peptide therapeutics, including two large Phase III lipodystrophy trials (LIPO-010, n=412; CTR-1011, n=404) and a landmark Lancet HIV NAFLD study reporting liver-fat and fibrosis-progression benefits in HIV-associated populations.
Beyond labeled use, tesamorelin appears in off-label metabolic and body-composition discussions in regenerative medicine settings. Ongoing research includes metabolic syndrome and cognitive outcomes, but those indications remain investigational and clinician-directed.
Tesamorelin is FDA-approved only for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. All information on this page is educational and research-reference only.
How Tesamorelin Works: Targeted Visceral Fat Reduction Through Pulsatile GH Restoration
Tesamorelin activates pituitary GHRH receptors to restore pulsatile endogenous GH signaling, amplify IGF-1 axis activity, and drive selective visceral-fat lipolysis.
GHRH Receptor Binding and GH Secretion
Tesamorelin binds GRF/GHRH receptors on anterior pituitary somatotrophs, triggering cAMP and PKA signaling that promotes both acute GH release and longer-term GH gene transcription while maintaining endogenous pulse architecture.
IGF-1 Axis Amplification
Downstream GH signaling increases hepatic and peripheral IGF-1 and IGFBP-3. Clinical data reported marked IGF-1 elevation after short-course daily dosing with maintained pituitary-hormone specificity.
Lipolytic and Metabolic Effects
GH-driven pathways preferentially target visceral adipose tissue, suppress hepatic lipogenesis, and improve body-composition biomarkers. Phase III and NAFLD datasets showed VAT and liver-fat reductions consistent with this mechanism.
Feedback-Preserved Endocrine Control
Unlike exogenous GH administration, tesamorelin preserves hypothalamic-pituitary feedback loops and pulsatile dynamics, which supports physiologic regulation rather than sustained supraphysiologic exposure.
The combined mechanism supports targeted visceral and hepatic fat effects while preserving endogenous hormonal feedback systems.
Tesamorelin Dosing Protocol & Titration Schedule
Egrifta SV
Day 1 onward
1.4 mg daily
Inject 0.35 mL after reconstitution with 0.5 mL diluent. SubQ abdomen only.
Egrifta WR
Day 1 onward
1.28 mg daily
Inject 0.16 mL after reconstitution with 1.45 mL BAC water. SubQ abdomen only.
Legacy Egrifta (discontinued)
Historical reference
2 mg daily
Original trial and label context used 2 mg/day via two 1 mg vials.
Grey market research protocol
Week 1 to 26+
2 mg daily
No titration typically required. Mirrors original Phase III exposure pattern.
Important Dosing Notes
Evidence level: Tesamorelin dosing is FDA-label anchored and supported by Phase III clinical trial data, unlike community-derived titration paradigms used by many other peptides.
No titration required: Label and trial protocols start at full therapeutic dose from day one; escalation schedules are generally not required.
Injection site: Abdominal subcutaneous injection is label-specified. Rotate abdominal sites and avoid scarred or bruised tissue.
Timing: Tesamorelin can be administered at any time of day. FDA trials were not bedtime-only; some protocols use morning administration while others use bedtime timing.
Duration and maintenance: Trial durations ran 26-52 weeks, with reversal trends after discontinuation, suggesting continued therapy is usually required for maintained VAT effects.
Missed dose: Skip missed doses and resume next scheduled injection without doubling.
Formulation note: Grey market tesamorelin often uses 2 mg lyophilized vials with BAC water, which differs from FDA Egrifta SV/WR diluent and preparation instructions.
Tesamorelin Reconstitution Guide
Vial Size: 2mg
BAC Water: 0.5 mL
Concentration: 4,000 mcg/mL
1 mg: 0.25 mL (25 units)
1.4 mg: 0.35 mL (35 units)
2 mg: 0.50 mL (50 units) - full vial
Vial Size: 2mg
BAC Water: 1.0 mL
Concentration: 2,000 mcg/mL
1 mg: 0.50 mL (50 units)
1.4 mg: 0.70 mL (70 units)
2 mg: 1.0 mL (100 units) - full vial
Vial Size: 5mg
BAC Water: 1.0 mL
Concentration: 5,000 mcg/mL
1 mg: 0.20 mL (20 units)
1.4 mg: 0.28 mL (28 units)
2 mg: 0.40 mL (40 units)
Vial Size: 5mg
BAC Water: 2.5 mL
Concentration: 2,000 mcg/mL
1 mg: 0.50 mL (50 units)
1.4 mg: 0.70 mL (70 units)
2 mg: 1.0 mL (100 units)
Vial Size: 10mg
BAC Water: 2.0 mL
Concentration: 5,000 mcg/mL
1 mg: 0.20 mL (20 units)
1.4 mg: 0.28 mL (28 units)
2 mg: 0.40 mL (40 units)
Vial Size: 10mg
BAC Water: 5.0 mL
Concentration: 2,000 mcg/mL
1 mg: 0.50 mL (50 units)
1.4 mg: 0.70 mL (70 units)
2 mg: 1.0 mL (100 units)
Step-by-Step Reconstitution Instructions
- Clean vial stopper and workspace; allow alcohol to dry fully before puncture.
- Draw target volume of bacteriostatic water using a sterile syringe per concentration plan.
- Inject diluent against the vial wall, not directly onto lyophilized powder.
- Allow fluid to flow gently down the side of vial; avoid pressure spraying.
- Roll vial gently for 30-60 seconds until dissolved. Do not shake.
- Inspect solution; use only if clear and colorless without particulate matter.
- Refrigerate at 2-8C and label concentration/date. For Egrifta SV, follow label instruction to use immediately after reconstitution.
Tesamorelin Side Effects - What Clinical Trials Show
Tesamorelin has the most comprehensive safety database of any GHRH analogue, including Phase III data across more than 800 participants.
Injection-site reactions: Most common adverse events include erythema, pruritus, pain, swelling, and rash. In CTR-1011, any injection-site condition occurred in 50.7% versus 21.4% on placebo; in LIPO-010, 30.0% versus 24.1%.
Fluid retention and musculoskeletal effects: Peripheral edema, arthralgia, and myalgia can occur due to GH-mediated fluid shifts. Reported edema was 9.9% versus 5.8% in one trial context, with myalgia ranges around 3.7-7.7% versus 1.6-2.2% on placebo.
Glucose metabolism: Phase III data showed higher incidence of HbA1c elevation (>=6.5%) in tesamorelin groups than placebo, and FDA labeling recommends baseline and periodic glucose monitoring.
Antibody development: Anti-tesamorelin IgG antibodies developed in about half of participants at 26-52 weeks. Available analyses showed similar VAT and IGF-1 efficacy signals across antibody-positive and antibody-negative groups.
IGF-1 elevation: IGF-1 elevation is expected pharmacologically. Persistent high levels (for example sustained >3 SDS contexts) may warrant clinician review, dose adjustment, or discontinuation.
Contraindications: Contraindications include active malignancy, pregnancy, known hypersensitivity (including mannitol), and major hypothalamic-pituitary-axis disruption contexts.
Tesamorelin Clinical Trial Results
LIPO-010 (Falutz et al.)
Phase III • 26 weeks + 26-week extension
412 HIV-infected patients with lipodystrophy
VAT reduction around 15.2% at week 26 versus placebo, with favorable lipid and trunk-fat effects.
CTR-1011 (Falutz et al.)
Phase III • 26 weeks + 26-week extension
404 HIV-infected patients with lipodystrophy
VAT reduction around 11.7% at week 26, with increased lean mass and waist changes vs placebo.
Pooled Phase III analysis
Phase III pooled • 26-52 weeks
816 pooled participants
Consistent VAT reductions across trials with maintenance during continued therapy and regression toward baseline after discontinuation.
Stanley et al. 2019 (Lancet HIV)
Phase II investigator-initiated • 12 months
61 HIV-infected patients with NAFLD
Liver-fat reduction around 32% with lower fibrosis-progression rate versus placebo.
Stanley et al. 2014 (JAMA)
Phase II • 6 months
54 HIV-infected patients with abdominal fat
Significant VAT reduction with additional metabolic and hepatic-signal analyses.
Fourman et al. 2020 (JCI Insight)
Mechanistic • 12 months
Paired liver-biopsy subset
Transcriptomic shifts toward oxidative phosphorylation and reduced inflammatory signatures.
Fourman et al. 2021 (Scientific Reports)
Mechanistic • 12 months
NAFLD trial participants
Proteomic profiles identified response pathways tied to inflammation and tissue-remodeling modulation.
Grinspoon et al. 2011
Phase I physiology • 2 weeks
13 healthy men
Increased overnight GH output and pulse-area effects with reversal after withdrawal.
Tesamorelin's clinical evidence base is unusually robust for a peptide therapeutic. Two large Phase III trials (combined n=816) established VAT-reduction efficacy in HIV-associated lipodystrophy and supported FDA approval in November 2010. Across pooled datasets, VAT reduction was generally in the 12-20% range at 26 weeks with maintained effect through continued treatment. Discontinuation analyses showed VAT trending back toward baseline after therapy stopped, supporting maintenance-treatment framing. The 12-month NAFLD trial reported around 32% liver-fat reduction versus placebo with lower fibrosis-progression rates (10.5% versus 37.5%). Active registration context includes ClinicalTrials.gov NCT02196831.
Storage & Handling
Lyophilized Egrifta SV
25C (77F) controlled room temp
Until expiration (15-30C excursions permitted)
Lyophilized grey market vials
-20C (-4F)
Long-term (years)
Lyophilized grey market vials
2-8C (36-46F)
Months
Reconstituted Egrifta SV
Immediate use
Discard if not used immediately
Reconstituted Egrifta WR
2-8C (36-46F)
Up to 28 days
Reconstituted grey market vials
2-8C (36-46F)
Up to 28 days
Storage requirements differ by Egrifta formulation (SV vs WR). Protect from light, keep in original packaging when possible, avoid freezing reconstituted solution, and discard cloudy/discolored solutions.
Tesamorelin vs. Sermorelin vs. CJC-1295
Receptor Target
Tesamorelin: GHRH receptor
Sermorelin: GHRH receptor
CJC-1295 (DAC): GHRH receptor
Peptide Length
Tesamorelin: 44 amino acids (modified)
Sermorelin: 29 amino acids
CJC-1295 (DAC): 29 amino acids + DAC
Half-Life
Tesamorelin: 26-38 minutes
Sermorelin: 11-12 minutes
CJC-1295 (DAC): ~6-8 days
Dosing Frequency
Tesamorelin: Once daily
Sermorelin: Once nightly
CJC-1295 (DAC): 1-2x weekly
FDA Status
Tesamorelin: Approved (2010; Egrifta)
Sermorelin: Previously approved; discontinued
CJC-1295 (DAC): Not FDA-approved
Phase III Trial Data
Tesamorelin: Yes (n=816 pooled)
Sermorelin: No adult Phase III VAT datasets
CJC-1295 (DAC): No
Visceral Fat Reduction
Tesamorelin: 15-20% at 26 weeks
Sermorelin: Not formally studied in RCTs
CJC-1295 (DAC): Not formally studied in RCTs
Liver Fat Reduction
Tesamorelin: 32% at 12 months (NAFLD study)
Sermorelin: Not studied
CJC-1295 (DAC): Not studied
Unique Advantage
Tesamorelin: Only FDA-approved GHRH analogue with strongest trial depth
Sermorelin: Longest historical clinical track record
CJC-1295 (DAC): Longest-acting weekly dosing convenience
Typical Research Dose
Tesamorelin: 2 mg daily
Sermorelin: 200-300 mcg nightly
CJC-1295 (DAC): 1-2 mg weekly
Tesamorelin is differentiated by active FDA status plus robust Phase III efficacy evidence, including validated visceral-fat outcomes.
Sermorelin and CJC-1295 share receptor targeting but differ in half-life, evidence depth, and regulatory history.
For protocol-specific context, compare dosing math and outcomes against Sermorelin and CJC-1295 pages.
See the Sermorelin protocol and CJC-1295 protocol for compound-specific guides.
Tesamorelin Stacking Protocols
Stack 1
Tesamorelin + Ipamorelin Stack
Dual-pathway GH protocol concept combining GHRH receptor signaling (tesamorelin) with ghrelin-receptor activation (ipamorelin).
This model is often discussed for amplified GH-pulse dynamics, though clinical validation for stack outcomes is limited versus monotherapy trial evidence.
See the compound-specific See Ipamorelin protocol for additional context.
View stack protocolStack 2
Tesamorelin + Metformin (Metabolic Focus)
Some practitioners pair tesamorelin with insulin-sensitization strategies to manage GH-driven glucose impacts while pursuing visceral-fat outcomes.
This is not a standardized protocol page and should remain clinician-directed with glucose monitoring.
View stack protocolFrequently Asked Questions - Tesamorelin
Q1: What is the starting dose of Tesamorelin?
Label dosing starts at full therapeutic dose from day one: 1.4 mg (Egrifta SV), 1.28 mg (Egrifta WR), or historically 2 mg in original formulation trials. Routine titration is generally not required, and abdominal SubQ injection site rotation is standard.
Q2: What is Tesamorelin's half-life?
Published measurements vary by formulation and cohort. Commonly cited ranges are around 26-38 minutes in HIV multi-dose datasets, with shorter means reported in some healthy-volunteer analyses. Downstream GH/IGF-1 effects persist beyond plasma clearance.
Q3: What results can be expected from Tesamorelin?
Controlled trials demonstrated visceral-fat reduction (roughly 12-20% depending on cohort), lean-mass and waist improvements, and favorable lipid/hepatic changes. NAFLD data reported around 32% liver-fat reduction and lower fibrosis progression, with strongest effects observed over sustained 6-12 month treatment.
Q4: How do you reconstitute Tesamorelin?
For research vials, add measured bacteriostatic water slowly against the vial wall, roll gently to dissolve, avoid shaking, and refrigerate as directed. For custom concentration math use https://www.peppal.app/calculator.
Q5: Is Tesamorelin FDA-approved?
Yes. Tesamorelin (Egrifta) is FDA-approved for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Other indications are off-label.
Q6: What are the most common side effects of Tesamorelin?
Most common are injection-site reactions, fluid-retention manifestations (edema/arthralgia/myalgia), and glucose-related monitoring shifts in susceptible patients. Antibody development is common but did not clearly eliminate VAT efficacy in trial analyses.
Q7: How does Tesamorelin compare to Sermorelin and CJC-1295?
Tesamorelin has stronger regulatory and efficacy evidence, sermorelin is shorter-acting with historical use, and CJC-1295 (DAC) is longer-acting but lacks comparable controlled VAT-efficacy trial depth.
Q8: What vial sizes is Tesamorelin available in?
Current FDA products include Egrifta SV (2 mg vial) and Egrifta WR (11.6 mg vial), while research channels commonly offer 2 mg, 5 mg, and 10 mg vials.
Q9: How much bacteriostatic water should be added to Tesamorelin?
For research vials, common setups include 0.5-1 mL for 2 mg, 1-2.5 mL for 5 mg, and 2-5 mL for 10 mg depending on preferred concentration. Use https://www.peppal.app/calculator for exact unit math.
Q10: What is the maximum dose of Tesamorelin studied?
Human clinical programs primarily studied up to 2 mg daily. Dose-finding and registration development informed later reformulation to 1.4 mg (SV) and 1.28 mg (WR) with comparable delivered exposure. Robust human data above 2 mg/day are limited.
Q11: How should reconstituted Tesamorelin be stored?
Storage depends on formulation: Egrifta SV is immediate-use after reconstitution, whereas Egrifta WR and research BAC-reconstituted solutions are typically refrigerated at 2-8C up to 28 days.
Q12: What clinical trials have been conducted on Tesamorelin?
Tesamorelin has Phase III lipodystrophy RCTs (LIPO-010 and CTR-1011), pooled analyses, NAFLD-focused interventional studies, and mechanistic transcriptomic/proteomic follow-up publications, including ClinicalTrials.gov registration NCT02196831.
Sources & Research
- Falutz J, et al. "Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in HIV-infected patients with excess abdominal fat: pooled analysis of two multicenter Phase 3 trials with safety extension data." Journal of Clinical Endocrinology & Metabolism, 2010 PubMed.
- Stanley TL, Fourman LT, Feldpausch MN, et al. "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial." Lancet HIV, 2019 PubMed.
- Fourman LT, Stanley TL, et al. "Effects of tesamorelin on hepatic transcriptomic signatures in HIV-associated NAFLD." JCI Insight, 2020 JCI Insight.
- Fourman LT, Stanley TL, et al. "Delineating tesamorelin response pathways in HIV-associated NAFLD using a targeted proteomic and transcriptomic approach." Scientific Reports, 2021 Nature.
- Grinspoon S, et al. "Effects of a Growth Hormone-Releasing Hormone Analog on Endogenous GH Pulsatility and Insulin Sensitivity in Healthy Men." Journal of Clinical Endocrinology & Metabolism, 2011 PMC.
- Ishida J, et al. "Growth hormone secretagogues: history, mechanism of action, and clinical development." JCSM Rapid Communications, 2020 DOI: 10.1002/rco2.9.
- Egrifta SV (tesamorelin) FDA prescribing information (2024). FDA PDF.
- Egrifta WR (tesamorelin) FDA prescribing information (2025). FDA PDF.
- Drugs.com: Tesamorelin Monograph for Professionals. Drugs.com.
- LiverTox: Tesamorelin. NCBI Bookshelf.
- ClinicalTrials.gov - Tesamorelin Effects on Liver Fat and Histology in HIV (NCT02196831). ClinicalTrials.gov.
- Falutz J, McLaughlin T, et al. "Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors." AIDS, 2024 PubMed.
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The information on this page is for educational and research reference purposes only. Tesamorelin (Egrifta) is FDA-approved for reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Use for other indications is off-label and requires medical supervision. No compounds discussed on this site are intended for human consumption outside FDA-approved indications. This is not medical advice.
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