Tesamorelin

Tesamorelin is a growth hormone releaser, a synthetic GHRH analog that prompts the pituitary gland to release the body's own growth hormone. It's FDA-approved, sold as Egrifta, to reduce excess deep abdominal fat in adults with HIV-associated lipodystrophy (a fat-redistribution condition linked to HIV treatment) — the only FDA-approved growth hormone releaser currently marketed in the US. The original Egrifta is discontinued, and Egrifta SV is being phased out in favor of Egrifta WR, the current formulation. It's banned in drug-tested sport, and its use outside the approved HIV population is off-label.

Tesamorelin reduces excess deep abdominal fat in people with HIV-associated lipodystrophy, its FDA-approved use. In trials of HIV-infected adults it was associated with a significant reduction in visceral fat, and one trial also reported reduced liver fat. That evidence is specific to the HIV-lipodystrophy population; the broader visceral-fat, fatty-liver, and anti-aging uses people pursue in other populations have not been confirmed in trials for those groups.

FDA-approved for treatment of HIV-associated lipodystrophy with excess visceral abdominal fat in adults — Egrifta originally approved November 10, 2010 under BLA 022505 (Theratechnologies); Egrifta SV approved 2019; Egrifta WR (F8 reformulation) approved March 25, 2025 under BLA 022505 supplement s020, with reduced injection volume ( daily SC concentration). Market status — original Egrifta is discontinued, and Egrifta SV is being phased out and replaced by Egrifta WR as the go-forward formulation (SV and WR are not substitutable); a 2024–25 Egrifta SV supply shortage has since resolved. Not DEA-scheduled. WADA-banned in regulated sport — listed under Section S2.2.4 (Growth Hormone Releasing Factors → GHRH and its analogues) of the 2026 Prohibited List, the same subsection as CJC-1295, sermorelin, and other GHRH analogs. Currently the only FDA-approved GHRH analog for visceral-fat indication; research-community use extends beyond the HIV-lipodystrophy population.

Tesamorelin is FDA-approved and prescription-only for a specific HIV- related condition, and it is banned in regulated sport (WADA). VialWise is a research and educational reference, not medical advice — consult a licensed professional.

⚠️ For research and educational purposes only. Tesamorelin is FDA-approved as a prescription drug for HIV-associated lipodystrophy with excess visceral abdominal fat. Information in this entry is informational, not medical advice. Always confirm dose calculations with the in-app calculator and consult appropriate professional guidance before any protocol decisions.

⚠️ Precision matters at low doses. Tesamorelin is dosed in milligrams at typical reconstitution concentrations producing draws in the range on a U-100 syringe (depending on formulation). At those draw sizes, even a one-unit error is a meaningful percentage of the dose. Always verify draws against the in-app calculator and double-check the unit count on the syringe before injecting.

⚠️ Multiple FDA-approved formulations with different reconstitution and dosing. Tesamorelin has been sold under three FDA-approved formulations with substantially different reconstitution and per-dose volume: - Egrifta (original) — per vial; reconstitute with 2.1 mL diluent → ~; daily SC dose = 2 mL injection (relatively large volume). Discontinued — no longer marketed. - Egrifta SV — per vial; reconstitute with 0.5 mL diluent →; daily SC dose = 0.5 mL injection. Being phased out and replaced by Egrifta WR via a manufacturer patient-transition program. - Egrifta WR (F8 reformulation, approved March 25, 2025) — final concentration; daily SC dose = 0.16 mL injection (≈ on U-100). The go-forward formulation. Note that "WR" refers to weekly reconstitution, not weekly dosing — one reconstituted vial supplies 7 consecutive daily doses. - Research-community vial — typically reconstituted with 3 mL BAC water → ~; per-dose draw varies by target dose Market-availability note (current as of 2026-07-18). Original Egrifta is discontinued and Egrifta SV is being replaced by Egrifta WR; per the manufacturer, Egrifta SV and Egrifta WR are not substitutable — they differ in concentration, per-dose volume, and reconstitution schedule. A 2024–25 Egrifta SV supply shortage (following a contract-manufacturing shutdown) has since resolved, with distribution resumed in February 2025.[⁵] The formulations have meaningfully different injection volumes and concentration profiles. Researchers should be explicit with themselves about which formulation they are using.

⚠️ FDA-approved indication is HIV-associated lipodystrophy specifically. Research-community use extends beyond this population. The published RCT efficacy data (Falutz 2007, Falutz 2010 pooled phase 3, Stanley 2014, Stanley 2019) is exclusively in HIV-infected adults with excess abdominal fat. Research-community use of tesamorelin in non-HIV populations (general visceral fat reduction, NAFLD/MASLD, post-incretin-cycle visceral-fat targeting, anti-aging contexts) operates outside the FDA-approved indication and outside the published RCT evidence base for those non-HIV populations. The tesamorelin RCT efficacy data does not necessarily generalize to non-HIV populations — visceral fat accumulation in HIV-lipodystrophy has distinct mechanisms (antiretroviral-related metabolic disruption) that may not parallel general-population visceral adiposity.

Tesamorelin (development code TH9507) is a synthetic 44-amino-acid analog of growth hormone-releasing hormone (GHRH 1-44) with a trans-3-hexenoic acid (caproyl) modification at the N-terminus. The modification protects the peptide from rapid enzymatic degradation by dipeptidyl peptidase-4 (DPP-4) — analogous in concept to the strategy used in CJC-1295's amino-acid substitutions, though structurally different. Tesamorelin's mechanism is otherwise pharmacologically similar to native GHRH and to other GHRH-analog peptides (CJC-1295 no-DAC, sermorelin): GHRH receptor agonism at pituitary somatotrophs produces pulsatile GH release, which in turn drives downstream IGF-1 elevation and metabolic effects.

Mechanism — visceral fat targeting. Why tesamorelin reduces visceral fat preferentially over subcutaneous fat is incompletely understood, but the working model is: pulsatile GH release stimulates lipolysis broadly, with a mechanistic preference for visceral adipose tissue (VAT) due to differences in adipocyte GH-receptor density, lipolytic enzyme expression, and blood flow between visceral and subcutaneous depots. The effect is consistent across the published trials — VAT decreases significantly without parallel subcutaneous fat reduction.[¹][²] Stanley 2014 demonstrated that VAT reduction was also associated with reduced liver fat,[³] and Stanley 2019 reported reduced hepatic fat in participants with HIV and NAFLD,[⁷] suggesting the mechanism extends to ectopic fat depots beyond the visceral compartment.

Pivotal clinical evidence. The Falutz 2007 NEJM trial — the foundational tesamorelin RCT — randomized 412 HIV-infected adults with excess abdominal fat tesamorelin daily SC vs placebo for 26 weeks. In that trial, VAT decreased 15.2% in the tesamorelin arm vs a 5.0% increase in the placebo arm, without significant adverse effects on glycemic measures.[¹] The subsequent pooled analysis of two phase 3 trials (Falutz 2010) reported a −15.4% treatment effect on VAT.[²] Stanley 2014 (JAMA) demonstrated that the visceral-fat reduction extended to liver fat in HIV-infected adults with abdominal fat accumulation, supporting the broader "ectopic fat reduction" mechanism,[³] and Stanley 2019 (Lancet HIV) extended that finding to a NAFLD-specific endpoint in people with HIV.[⁷]

Regulatory status (US). Tesamorelin received FDA approval as Egrifta under BLA 022505 on November 10, 2010, for treatment of excess abdominal fat in HIV-infected adults with lipodystrophy.[⁴] Egrifta SV (a same-active-ingredient reformulation with simpler reconstitution and smaller injection volume) was approved in 2019 under supplement s010. Egrifta WR (the F8 reformulation final concentration and daily dose) was approved March 25, 2025 under supplement s020, and is the go-forward formulation.[⁵]

Market availability (as of this revision). The original Egrifta is discontinued. Egrifta SV is being phased out and replaced by Egrifta WR through a manufacturer patient-transition program; per Theratechnologies, the two products are not substitutable — they differ in concentration, injection volume, and reconstitution schedule. Egrifta SV also went through a supply disruption after a contract-manufacturing voluntary shutdown announced in early 2025; distribution resumed in February 2025 and the shortage has resolved.[⁵] Note that the "WR" designation refers to weekly reconstitution — dosing remains subcutaneously once daily, with one reconstituted vial supplying 7 consecutive daily doses. Tesamorelin is not a DEA controlled substance — it is prescription-only but does not carry the controlled-substance regulatory framework that applies to testosterone or HGH.

Regulatory status (sport — WADA). Tesamorelin is explicitly listed in the WADA 2026 Prohibited List under Section S2.2.4 (Growth Hormone Releasing Factors), in the GHRH-analogues subsection alongside CJC-1293, CJC-1295, and sermorelin. Verbatim from the canonical PDF: *"growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)."*[⁶] Prohibited at all times in regulated sport.

Common research interests. Tesamorelin is used in three meaningfully distinct contexts:

1. HIV-associated lipodystrophy (FDA-approved indication). Adult HIV-infected patients with antiretroviral-related visceral fat accumulation. This is the population in which the published RCT evidence was generated.[¹][²][³] 2. Visceral fat / NAFLD reduction in non-HIV populations (off-label; expanding research-community use). Increasingly studied for general visceral adiposity and non-alcoholic fatty liver disease (now sometimes termed MASLD — metabolic dysfunction-associated steatotic liver disease) in non-HIV populations. The published NAFLD trial evidence is still in the HIV population — Stanley 2019 (Lancet HIV) randomized 61 people with HIV and NAFLD and reported a reduction in hepatic fat fraction over 12 months;[⁷] it was not a non-HIV study. The broader research-community pattern of tesamorelin use for general visceral-fat targeting predates — and is not covered by — that evidence base.[⁸][⁹] 3. Adjunct to GLP-1 / GIP / glucagon agonist weight-loss cycles (off-label, research-community pattern). Some protocols add tesamorelin during incretin-driven weight-loss cycles specifically for visceral-fat targeting on top of the broader incretin-driven weight loss. Mechanistic rationale is plausible (visceral-fat-preferential lipolysis from tesamorelin + total-weight loss from incretin) but not validated in any published combination trial. A 2026 review discusses tesamorelin among agents studied for lean-body-mass preservation during incretin-driven weight loss,[¹⁰] and a 2026 clinical review contrasts tesamorelin with GLP-1 receptor agonists for excess visceral fat in people with HIV,[¹¹] but both are reviews/case-level reports rather than combination-trial evidence. `[citation needed]`

Tesamorelin vs CJC-1295 vs Sermorelin — the GHRH-analog landscape. All three are GHRH analogs acting on the same pituitary GHRH receptor; the practical differences are pharmacokinetic and regulatory: - CJC-1295 no-DAC (Mod GRF 1-29): 29-amino-acid GHRH(1-29) fragment with stabilization substitutions; ~30 minute half-life; not FDA-approved; commonly used in research-community GH-secretagogue stacks; see [cjc-1295.md](./cjc-1295.md). - CJC-1295 with DAC: same 29-aa fragment plus albumin-binding linker; ~6–8 day half-life; ConjuChem Phase 2 program halted 2006; not FDA-approved; see [cjc-1295.md](./cjc-1295.md). - Sermorelin: 29-amino-acid GHRH(1-29) fragment without stabilization; ~10–20 minute half-life; was FDA-approved as Geref (Serono) for pediatric GH deficiency but withdrawn from US market in 2008; available via compounding pharmacies; will eventually be its own Vialwise entry. - Tesamorelin: 44-amino-acid GHRH(1-44) with N-terminal trans-3-hexenoic acid; ~26 minute half-life; FDA-approved (the only FDA-approved GHRH analog currently marketed in the US); this entry.

The functional consequence of this landscape: tesamorelin is the only GHRH analog with FDA-approved indication and substantial RCT evidence — researchers selecting between GHRH analogs based on regulatory status and evidence quality will land on tesamorelin; researchers selecting on cost and research-community adoption will more often land on CJC-1295 no-DAC.

Commonly reported

• Injection site reactions — local pain, redness, mild swelling; the daily-injection regimen produces more frequent site exposure than weekly-cycled compounds
• Arthralgia / joint pain — reported in tesamorelin trials at higher rates than placebo; typically mild
• Myalgia / muscle pain — also reported at higher rates than placebo
• Peripheral edema / fluid retention — particularly in the first 1–2 weeks of dosing; typically resolves with continued use or dose adjustment
• Carpal tunnel-like symptoms — uncommon but reported with sustained GH elevation; consistent with the GH-class side-effect profile
• Hypersensitivity / anaphylactic reactions — rare but documented in post-marketing surveillance
• Glucose intolerance / IGF-1-mediated insulin resistance — typically modest in the trial populations; the Falutz 2007 trial reported no significant adverse effect on glycemic measures, but post-marketing data has documented occasional dysglycemia, particularly at higher doses or with longer use[¹][⁴]

Serious

• Severe injection site reaction with systemic symptoms — possible hypersensitivity/anaphylaxis
• New or worsening glucose intolerance / hyperglycemia
• Visual field changes — relevant in patients with prior pituitary disease
• Symptoms suggesting fluid overload (pulmonary edema, severe peripheral edema)
• New-onset arrhythmias or atrial fibrillation — uncommon but reported with sustained GH elevation

Disruption of the hypothalamic-pituitary axis (hypophysectomy, hypopituitarism, pituitary tumor, pituitary surgery, head irradiation, head trauma) — tesamorelin requires intact pituitary function to mediate its GH-releasing effect

Active malignancy — GH/IGF-1 elevation may accelerate malignancy progression

Pregnancy — Category X; contraindicated due to lack of clinical benefit in HIV-lipodystrophy during pregnancy and theoretical fetal-development risks

Hypersensitivity to tesamorelin or any product component (mannitol)

Pregnancy and lactation: contraindicated. Discontinue if pregnancy is detected.

Concurrent corticosteroid use: caution; corticosteroids may interfere with tesamorelin's GH-stimulating effect.

Diabetes / impaired glucose tolerance: monitor glucose carefully; tesamorelin may worsen glucose tolerance in some patients.

Active or recent malignancy: contraindicated due to GH/IGF-1 elevation theoretical concern.

Regulatory note (US): Tesamorelin is prescription-only but not a DEA-scheduled controlled substance. This is a different regulatory category from testosterone (Schedule III) and HGH (Schedule III).

Regulatory note (sport): Tesamorelin is explicitly listed in WADA 2026 Prohibited List Section S2.2.4 alongside other GHRH analogs; prohibited at all times in regulated sport.[⁶]

Peptide

A short chain of amino acids, the building blocks of proteins. Many compounds in this library are peptides.

Growth hormone secretagogue

A compound that signals the body to release its own growth hormone, rather than supplying growth hormone directly.

Visceral fat

deep abdominal fat stored around the internal organs.

Subcutaneous

An injection into the fatty layer just under the skin, rather than into a muscle or vein.

WADA Prohibited List

The list of substances banned in regulated sport by the World Anti-Doping Agency.

1. Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. The New England Journal of Medicine, 357(23):2359–2370.(PMID 18057338)
2. Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. (2010). Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. The Journal of Clinical Endocrinology & Metabolism, 95(9):4291–4304.(PMID 20554713)
3. Stanley TL, Feldpausch MN, Oh J, Branch KL, Lee H, Torriani M, Grinspoon SK. (2014). Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trial. JAMA, 312(4):380–389.(PMID 25038357)
4. Theratechnologies. Egrifta SV (tesamorelin for injection) prescribing information. US Food and Drug Administration. BLA 022505, originally approved November 10, 2010. Egrifta SV approved 2019.
5. Theratechnologies. Egrifta WR (tesamorelin F8 reformulation) prescribing information. US Food and Drug Administration. BLA 022505 supplement s020; F8 reformulation approved March 25, 2025.
6. World Anti-Doping Agency. The 2026 Prohibited List, International Standard (effective 1 January 2026). Canonical PDF: wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf (linked from the WADA landing page at wada-ama.org/en/prohibited-list; local archival copy in `docs/legal/wada-2026-prohibited-list.pdf`). Tesamorelin is named explicitly under Section S2.2.4 (Growth Hormone Releasing Factors) — the same subsection as CJC-1295 and other GHRH analogs. Verbatim from the canonical PDF, page 8: "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)." Prohibited at all times.
7. Stanley TL, Fourman LT, Feldpausch MN, et al. (2019). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet HIV, 6(12):e821–e830.(PMID 31611038 · NCT02196831)
8. Dominikowski A, et al. (2026). The emerging landscape of performance-enhancing peptides modulating the GH-IGF1 axis. Frontiers in Endocrinology, 17:1822475.(PMID 42395176)
9. Mendias CL, Awan TM. (2026). Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Medicine.(PMID 41966639)
10. Arora G, et al. (2026). Pharmacologic Treatments for the Preservation of Lean Body Mass During Weight Loss. Journal of Clinical Medicine, 15(2):541.(PMID 41598480)
11. Beach R, et al. (2026). Differing Presentations of Excess Visceral Abdominal Fat in People Living With HIV — Tesamorelin and GLP-1 Receptor Agonists. Clinical Infectious Diseases, 82(Suppl 4):S87–S91.(PMID 42139091)
12. Erlandson KM, et al. (2026). Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol. BMJ Open, 16(7):e120740.(PMID 42419889 · NCT06554717)

• CJC-1295 / Ipamorelin Blend — discussed together in this entry's stacks section
• AOD-9604 — discussed together in this entry's stacks section
• Testosterone — discussed together in this entry's stacks section
• CJC-1295 — same mechanism class
• GHRP-2 — same mechanism class
• GHRP-6 — same mechanism class