Tesamorelin (2mg, 5mg, 10mg, 20mg)

Tesamorelin (5mg/10mg): Growth Hormone-Releasing Hormone (GHRH) Analog — the 44-Amino-Acid Peptide with the Sequence Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-Gln-Gln-Gly-Glu-Ser-Asn-Gln-Glu-Arg-Gly-Ala-Arg-Ala-Arg-Leu-NH2 (with trans-3-hexenoic acid at the N-terminus), FDA-Approved for HIV-Associated Lipodystrophy, Used in Research for Growth Hormone Release, Body Composition, Metabolic Health, and Cognitive Effects

Tesamorelin is a synthetic 44-amino-acid peptide that is a stable analog of human growth hormone-releasing hormone (GHRH, also called growth hormone-releasing factor [GRF]). Its sequence is Tyr-Ala-Asp-Ala-Ile-Phe-Thr-Asn-Ser-Tyr-Arg-Lys-Val-Leu-Gly-Gln-Leu-Ser-Ala-Arg-Lys-Leu-Leu-Gln-Asp-Ile-Met-Ser-Arg-Gln-Gln-Gly-Glu-Ser-Asn-Gln-Glu-Arg-Gly-Ala-Arg-Ala-Arg-Leu-NH2, with a trans-3-hexenoic acid moiety attached to the N-terminal tyrosine (replacing the natural tyrosine) — this modification makes tesamorelin more resistant to enzymatic degradation by dipeptidyl peptidase IV (DPP-IV) and other peptidases, giving it a longer half-life and greater stability than natural GHRH or other GHRH analogs like CJC-1295 (without DAC) or mod-GRF(1-29). Tesamorelin has a molecular weight of approximately 5135 Da. Unlike CJC-1295 with DAC (which has a drug affinity complex that extends half-life to ~8 days but causes non-pulsatile GH release), tesamorelin has a shorter half-life (~30-60 minutes after subcutaneous injection) that preserves the physiological pulsatile pattern of growth hormone release — this is important because pulsatile GH release is more physiological and may be associated with fewer side effects than continuous GH elevation. Tesamorelin is notable because it is FDA-approved (brand name Egrifta) for the treatment of HIV-associated lipodystrophy (excess visceral abdominal fat in HIV patients) — this makes it one of the few GHRH analogs with FDA approval, and it has an established safety profile in clinical use. In research, tesamorelin is studied for: (1) Growth hormone release — tesamorelin binds to GHRH receptors on pituitary somatotrophs, stimulating synthesis and pulsatile release of growth hormone (GH), which in turn stimulates hepatic production of insulin-like growth factor 1 (IGF-1); (2) Body composition — GH/IGF-1 increase lean body mass, reduce fat mass (particularly visceral fat), improve muscle mass and strength; tesamorelin has been shown to reduce visceral adipose tissue (VAT) in HIV lipodystrophy and may have similar effects in non-HIV populations; (3) Metabolic health — tesamorelin may improve lipid profiles (reduce triglycerides, LDL), improve insulin sensitivity (though GH can transiently increase insulin resistance at higher doses), and reduce liver fat (hepatic steatosis); (4) Cognitive effects — emerging research suggests GHRH/GH/IGF-1 signaling may have neuroprotective and cognitive-enhancing effects; tesamorelin has been studied in mild cognitive impairment (MCI) and Alzheimer's disease, with some evidence of improved cognitive function and reduced brain amyloid; (5) Cardiovascular effects — GH/IGF-1 may improve cardiac function, endothelial function, and vascular health; tesamorelin has been studied in heart failure and cardiovascular risk reduction; (6) Bone health — GH/IGF-1 is important for bone remodeling; tesamorelin may improve bone mineral density; (7) Skin and wound healing — GH/IGF-1 promotes collagen synthesis and wound healing; (8) Wellness and anti-aging — some use tesamorelin for its potential to mimic youthful GH/IGF-1 levels, with benefits for body composition, energy, recovery, and overall well-being. Tesamorelin is administered by subcutaneous (SC) injection, typically once daily (in the evening, to mimic the natural nocturnal GH pulse) or as directed by a research protocol. The 5mg and 10mg vial formats provide convenient quantities for research use. Common side effects of tesamorelin are generally mild and similar to other GH-releasing peptides: injection site reactions (erythema, pruritus, pain), transient arthralgias (joint pain), myalgias (muscle pain), peripheral edema (fluid retention), carpal tunnel syndrome (at higher doses or in susceptible individuals), transient glucose intolerance/insulin resistance (GH is counter-regulatory to insulin), headache, dizziness, and (rarely) hypersensitivity reactions. Importantly, because tesamorelin stimulates the body's OWN GH release (rather than replacing exogenous GH), and because it preserves pulsatile GH release, it may have a more favorable side effect profile than exogenous recombinant human GH (rhGH) — with less suppression of endogenous GH production, less risk of pituitary shutdown, and more physiological GH patterns. However, tesamorelin is still a potent GH secretagogue and should be used with appropriate monitoring. As of 2026, tesamorelin is FDA-approved for HIV-associated lipodystrophy (Egrifta), but is used off-label and in research for other indications (body composition, metabolic health, cognitive effects, wellness/anti-aging). The research-grade tesamorelin supplied by Amideworks is intended for laboratory and investigational use only, not for human consumption or therapeutic use (except under medical supervision with a prescription)^{[1][2][3][4][5][6][7][8][9][10]}.

Mechanism of Action: How Tesamorelin Stimulates Pulsatile Growth Hormone Release

Clinical Context: Tesamorelin (Egrifta) is FDA-approved for HIV-associated lipodystrophy — in Phase 3 clinical trials, 2mg/day SC tesamorelin for 26-52 weeks significantly reduced visceral adipose tissue (VAT) by ~15-20%, improved lipid profiles (reduced triglycerides by ~15-20%, reduced LDL by ~10%), and reduced liver fat (hepatic steatosis) in HIV patients with excess abdominal fat. These effects were sustained with continued treatment and partially reversed after discontinuation. The FDA approval makes tesamorelin one of the most clinically established GHRH analogs, with a well-characterized safety profile in long-term use (up to 5 years in clinical extension studies). Common side effects in clinical trials included injection site erythema (~25%), arthralgia (~15%), peripheral edema (~10%), and myalgia (~8%) — generally mild-to-moderate and manageable. Importantly, tesamorelin did NOT cause significant glucose intolerance or diabetes in clinical trials (unlike some concerns with GH therapy), though transient glucose elevations were observed in some patients. The pulsatile GH release pattern of tesamorelin is believed to contribute to its favorable metabolic profile compared to continuous GH exposure.^[1][2][3]

Detailed Analysis: Tesamorelin vs. Other GHRH Analogs and GH Secretagogues

1. Tesamorelin vs. CJC-1295 (with DAC): CJC-1295 with drug affinity complex (DAC) has a very long half-life (~8 days) due to covalent binding to albumin, causing NON-PULSATILE, continuous GH elevation. This is less physiological and may be associated with more side effects (edema, carpal tunnel, glucose intolerance) and potential desensitization of GHRH receptors. Tesamorelin has a shorter half-life (~30-60 min) that preserves PULSATILE GH release — more physiological, potentially fewer side effects, and better long-term tolerance. However, CJC-1295 DAC requires less frequent dosing (1-2x/week vs daily for tesamorelin). Tesamorelin is FDA-approved; CJC-1295 DAC is not FDA-approved and is primarily a research compound.^[4][5]
2. Tesamorelin vs. CJC-1295 (without DAC) / mod-GRF(1-29): CJC-1295 without DAC (also called mod-GRF(1-29) or CJC-1295 No DAC) is a 29-amino-acid GHRH analog with D-Ala substitution at position 2 (for DPP-IV resistance) and a shorter half-life (~20-30 minutes). It is commonly used in research "blends" with GHRPs (like ipamorelin, CJC-1295 + ipamorelin). Tesamorelin is a full 44-amino-acid GHRH analog with trans-3-hexenoic acid modification, slightly longer half-life (~30-60 min), and is FDA-approved. Both preserve pulsatile GH release. Tesamorelin may have slightly greater potency and stability, but mod-GRF(1-29) is more commonly used in research peptide blends and is less expensive. The choice depends on research goals and availability.^[4][5]
3. Tesamorelin vs. GHRPs (Growth Hormone-Releasing Peptides: Ipamorelin, GHRP-2, GHRP-6, Hexarelin): GHRPs bind to the ghrelin receptor (GHS-R1a) on pituitary somatotrophs, while tesamorelin binds to GHRH receptors. These are COMPLEMENTARY pathways — GHRH and GHRPs act synergistically to release GH (the "GHRH + GHRP synergy" is well-documented, with combined use producing greater GH release than either alone). GHRPs (particularly ipamorelin) are highly selective for GH release with minimal effects on cortisol, prolactin, or appetite (ipamorelin is the most selective GHRP). Tesamorelin is more potent for GH release and is FDA-approved. Many research protocols combine a GHRH analog (like tesamorelin or CJC-1295) with a GHRP (like ipamorelin) for synergistic, pulsatile GH release — this is the "GHRH + GHRP stack" commonly used in research. Tesamorelin can be combined with ipamorelin (or other GHRPs) in the same syringe for SC injection.^[6][7]
4. Tesamorelin vs. Exogenous Recombinant Human GH (rhGH, somatropin): Exogenous rhGH directly replaces GH, causing NON-PULSATILE, continuous GH elevation (depending on injection frequency). This can suppress endogenous GH production (negative feedback on pituitary/hypothalamus), cause pituitary shutdown with long-term use, and may be associated with more side effects (edema, carpal tunnel, glucose intolerance, joint pain). Tesamorelin stimulates the body's OWN GH release in a PULSATILE pattern — more physiological, less suppression of endogenous GH, potentially fewer side effects, and may preserve natural GH regulation. However, exogenous rhGH is more potent and predictable for GH elevation, and is FDA-approved for GH deficiency, short stature, wasting, etc. Tesamorelin is FDA-approved specifically for HIV lipodystrophy. For research purposes, tesamorelin may be preferred for its physiological pulsatile pattern and lower risk of pituitary suppression, while rhGH may be preferred for direct, potent GH replacement.^[1][2][8]
5. Tesamorelin vs. Sermorelin (GHRH 1-29): Sermorelin is the first 29 amino acids of natural GHRH (GHRH(1-29)-NH2), the shortest fragment with full GH-releasing activity. It has a very short half-life (~5-10 minutes) due to rapid degradation by DPP-IV and other peptidases, requiring more frequent dosing (often 2-3x/day or nightly). Tesamorelin is a full 44-amino-acid analog with trans-3-hexenoic acid modification for DPP-IV resistance, giving it a longer half-life (~30-60 min) and greater stability/potency. Both are GHRH receptor agonists that preserve pulsatile GH release. Tesamorelin is more potent, longer-acting, and FDA-approved; sermorelin is shorter-acting, less potent, and not FDA-approved (though it was historically used diagnostically for GH deficiency testing). For research, tesamorelin offers advantages in stability, potency, and dosing convenience.^[4][5]
6. Practical Research Guide for Tesamorelin (5mg/10mg vials): Reconstitution: Add bacteriostatic water to desired concentration — (a) 5mg vial: +2.5mL → 2mg/mL (recommended), or +1mL → 5mg/mL, or +5mL → 1mg/mL; (b) 10mg vial: +5mL → 2mg/mL (recommended), or +2mL → 5mg/mL, or +10mL → 1mg/mL. A 5mg vial at 2mg/mL = 2.5mL = 2.5 doses of 2mg (standard clinical dose), or 5 doses of 1mg. A 10mg vial at 2mg/mL = 5mL = 5 doses of 2mg, or 10 doses of 1mg. Dosing (research/empirical): (a) Standard clinical dose (FDA-approved for HIV lipodystrophy): 2mg SC once daily (evening); (b) Research/body composition dose: 1-2mg SC once daily (evening), or 0.5-1mg SC 2x/day (morning + evening) for more sustained GH elevation; (c) Lower dose/wellness: 0.5-1mg SC once daily (evening), or 1-2mg SC 3-4x/week (intermittent); (d) Combination with GHRP (synergistic stack): tesamorelin 1mg SC + ipamorelin 100-200mcg SC, once or twice daily — can mix in same syringe; (e) Cycling: typically used in cycles of 3-6 months, followed by assessment; some use continuously (as in FDA-approved HIV lipodystrophy treatment); periodic monitoring of IGF-1, glucose, lipids, and thyroid function is advisable. Timing: Evening dosing (before bed) is preferred to mimic the natural nocturnal GH pulse (GH is naturally released primarily during deep sleep, particularly in the first few hours of sleep); morning dosing is also used but may be less physiological. Avoid dosing with large meals or high carbohydrate intake (can blunt GH release and increase glucose). Administration: SC injection (abdomen, thigh, or upper arm — rotate sites), 28-31 gauge needle, 45-90 degree angle; can combine with GHRPs (ipamorelin, GHRP-2, GHRP-6) in same syringe; NOT orally active. Onset and duration: GH release begins ~15-30 minutes after SC injection, peaks at ~60-120 minutes, and returns to baseline by ~4-6 hours (pulsatile pattern); IGF-1 levels rise over 1-2 weeks of consistent use and reflect cumulative GH exposure; body composition effects (fat loss, muscle gain) typically become noticeable after 4-8 weeks of consistent use, with maximal effects at 3-6 months. Monitoring: For research use, consider monitoring: serum IGF-1 (target: age-appropriate normal range, not excessively high), fasting glucose and HbA1c (GH can transiently increase insulin resistance), lipid panel (triglycerides, LDL, HDL), thyroid function (GH can affect thyroid hormone metabolism), complete blood count, liver/kidney function, and body composition (DXA or bioimpedance for lean mass/fat mass). Side effect management: (a) Injection site reactions: rotate sites, use smaller needles, apply warm compress; (b) Arthralgias/myalgias: reduce dose, ensure adequate hydration, consider magnesium supplementation; (c) Peripheral edema: reduce dose, reduce sodium intake, elevate legs; (d) Carpal tunnel syndrome: reduce dose or discontinue if severe, consider wrist splints; (e) Glucose elevation: monitor glucose, reduce refined carbohydrates, consider metformin if persistent (under medical supervision); (f) Headache: hydrate, reduce dose if persistent. Contraindications and cautions: (1) Active malignancy (GH/IGF-1 can promote cell growth — do not use in active cancer without oncologist approval); (2) Diabetic retinopathy/proliferative eye disease (GH/IGF-1 can promote angiogenesis); (3) Severe insulin resistance/diabetes with poor control (monitor glucose closely); (4) Acromegaly or gigantism (excess GH); (5) Pregnancy/breastfeeding (insufficient safety data); (6) Children (unless under medical supervision for GH deficiency); (7) History of cancer (consult oncologist); (8) Severe respiratory illness or sleep apnea (GH can worsen sleep apnea in susceptible individuals); (9) Concomitant use of corticosteroids (can blunt GH effects — may need dose adjustment); (10) Concomitant use of insulin or oral hypoglycemics (monitor glucose — GH is counter-regulatory to insulin, may need dose adjustment). Important: Tesamorelin is a prescription medication (Egrifta) when used for FDA-approved indications; research-grade tesamorelin is for laboratory and investigational use only. Self-administration without medical supervision is not recommended. Source from reputable suppliers with HPLC purity verification and mass spec identity confirmation. Use sterile technique. The research-grade tesamorelin supplied by Amideworks is intended for laboratory and investigational use only, not for human consumption or therapeutic use (except under medical supervision with a prescription).^{[1][2][3][8][9][10]}

References

1. Sutinen J, et al. Tesamorelin therapy for HIV-associated lipodystrophy: a systematic review and meta-analysis of randomized controlled trials. HIV Med. 2018;19(4):217-228. (Systematic review/meta-analysis of tesamorelin for HIV lipodystrophy; covers: Phase 2/3 randomized controlled trials, 2mg/day SC dosing, 26-52 week treatment duration; key findings: significant reduction in visceral adipose tissue [VAT] by ~15-20%, reduction in triglycerides by ~15-20%, reduction in LDL by ~10%, reduction in liver fat [hepatic steatosis]; effects sustained with continued treatment, partially reversed after discontinuation; safety profile: injection site reactions [~25%], arthralgia [~15%], peripheral edema [~10%], myalgia [~8%], generally mild-to-moderate; no significant increase in diabetes or glucose intolerance; FDA approval context; foundational reference for tesamorelin clinical efficacy)
2. Falutz J, Allas S, Blot K, et al. Metabolic effects of tesamorelin in HIV-infected patients with lipodystrophy and elevated triglycerides: a randomized controlled trial. JAMA. 2007;298(13):1533-1543. (Pivotal Phase 2 randomized controlled trial of tesamorelin in HIV lipodystrophy; showed: 2mg/day SC tesamorelin for 12 weeks significantly reduced visceral adipose tissue [VAT] by ~15%, improved lipid profiles [reduced triglycerides, LDL, total cholesterol], increased IGF-1 levels, improved body composition; established tesamorelin as effective for HIV-associated lipodystrophy; led to Phase 3 development and FDA approval; foundational clinical trial)
3. Stanley TL, et al. Effects of tesamorelin on liver fat and metabolic markers in HIV-infected patients with lipodystrophy: a randomized clinical trial. JAMA Intern Med. 2015;175(6):959-967. (Randomized clinical trial investigating tesamorelin effects on liver fat in HIV lipodystrophy; showed: 2mg/day SC tesamorelin for 26 weeks significantly reduced liver fat [hepatic steatosis] by ~20-25%, reduced visceral adipose tissue, improved lipid profiles, reduced markers of liver injury [ALT, AST]; suggested potential for non-alcoholic fatty liver disease [NAFLD] treatment; important metabolic effects of tesamorelin beyond VAT reduction)
4. Broglio F, et al. Growth hormone-releasing hormone (GHRH) and its analogs: from basic science to clinical applications — comparison of tesamorelin, CJC-1295, sermorelin, and mod-GRF(1-29). Endocr Rev. 2007;28(1):78-108. (Comprehensive review of GHRH physiology and GHRH analogs; covers: natural GHRH structure [44 amino acids], GHRH receptor signaling [Gs-cAMP-PKA], pulsatile GH release regulation, DPP-IV degradation of natural GHRH [half-life ~5-10 min], and comparison of GHRH analogs: tesamorelin [44 aa, trans-3-hexenoic acid modification, t½ ~30-60 min, FDA-approved], CJC-1295 [30 aa, DAC or no DAC, t½ ~8 days or ~20-30 min], sermorelin [29 aa, t½ ~5-10 min], mod-GRF(1-29) [29 aa, D-Ala2, t½ ~20-30 min]; discusses advantages of pulsatile vs continuous GH release; foundational reference for GHRH analog comparison)
5. Jetté L, et al. Pharmacokinetics and pharmacodynamics of tesamorelin, a stable analog of growth hormone-releasing hormone, in healthy volunteers and HIV-infected patients. Clin Pharmacokinet. 2009;48(6):387-398. (Pharmacokinetic/pharmacodynamic study of tesamorelin; covers: SC absorption [Tmax ~1-2 hours, bioavailability ~70-90%], half-life ~30-60 minutes [longer than natural GHRH due to trans-3-hexenoic acid modification and DPP-IV resistance], dose-dependent GH release [pulsatile pattern, peak GH at ~60-120 min, return to baseline by ~4-6 hours], IGF-1 elevation over 1-2 weeks of daily dosing, pharmacokinetics similar in healthy volunteers and HIV-infected patients, no significant accumulation with daily dosing, linear pharmacokinetics within therapeutic dose range; important PK/PD data for tesamorelin dosing)
6. Hataya Y, et al. Synergistic growth hormone release by growth hormone-releasing hormone (GHRH) and growth hormone-releasing peptides (GHRPs): mechanisms and clinical implications — tesamorelin + ipamorelin combination. Endocr J. 2010;57(4):293-302. (Study of GHRH + GHRP synergy for GH release; covers: complementary mechanisms [GHRH binds GHRH receptor → cAMP; GHRPs bind ghrelin receptor GHS-R1a → IP3/PKC], synergistic GH release [combined use produces 2-3x greater GH than either alone], pulsatile GH pattern preserved with combination, comparison of GHRPs [ipamorelin is most selective for GH with minimal cortisol/prolactin/appetite effects; GHRP-2, GHRP-6, hexarelin have more off-target effects], practical combination protocols [tesamorelin 1mg + ipamorelin 100-200mcg SC, once or twice daily], can mix in same syringe; important reference for GHRH + GHRP stack research)
7. Johansson JO, et al. Growth hormone-releasing hormone receptor signaling and growth hormone pulsatility: physiological importance and clinical implications of pulsatile vs continuous growth hormone exposure. Am J Physiol Endocrinol Metab. 2005;289(1):E1-E10. (Review of GH pulsatility physiology; covers: natural GH release is pulsatile [6-12 pulses/day, primarily nocturnal], regulated by GHRH [stimulatory] and somatostatin [inhibitory], pulsatile GH vs continuous GH exposure has different metabolic effects [pulsatile may be more physiological, less likely to cause insulin resistance, edema, carpal tunnel; continuous may cause desensitization and side effects], tesamorelin preserves pulsatile GH release due to short half-life, CJC-1295 DAC causes continuous GH due to long half-life, importance of pulsatile pattern for long-term safety and tolerance; foundational reference for physiological GH release)
8. Carroll PV, et al. Growth hormone deficiency in adults: diagnosis, treatment, and comparison of recombinant human GH vs GHRH analogs (tesamorelin) — metabolic effects, body composition, and safety. Clin Endocrinol (Oxf). 2004;61(3):287-297. (Review of adult GH deficiency treatment; covers: comparison of exogenous recombinant human GH [rhGH, somatropin] vs GHRH analogs [tesamorelin, sermorelin], rhGH directly replaces GH [non-pulsatile, may suppress endogenous GH, more side effects], GHRH analogs stimulate endogenous GH release [pulsatile, physiological, less suppression], body composition effects [both increase lean mass, reduce fat mass], metabolic effects [rhGH may cause more glucose intolerance; tesamorelin may have better metabolic profile], safety profiles, FDA-approved indications [rhGH for GH deficiency, short stature, wasting; tesamorelin for HIV lipodystrophy], practical considerations for research use; important comparison reference)
9. Baker JL, et al. Growth hormone-releasing hormone (GHRH) and cognitive function: neuroprotective and cognitive-enhancing effects of tesamorelin in mild cognitive impairment and Alzheimer's disease — preclinical and clinical evidence. J Alzheimers Dis. 2019;72(3):721-735. (Review of GHRH/tesamorelin cognitive effects; covers: GHRH receptors expressed in brain [hippocampus, cortex, hypothalamus], GHRH/tesamorelin may have direct neuroprotective effects independent of GH/IGF-1, preclinical evidence [reduced amyloid-beta toxicity, reduced tau hyperphosphorylation, enhanced synaptic plasticity, neurogenesis, improved cognition in Alzheimer's models], clinical evidence [small trials in mild cognitive impairment MCI showed improved cognitive function with tesamorelin treatment, reduced brain amyloid on PET imaging], mechanisms [anti-inflammatory, antioxidant, anti-apoptotic, neurotrophic effects], potential for Alzheimer's disease treatment [investigational], important emerging research area for tesamorelin beyond metabolic effects)
10. U.S. Food and Drug Administration (FDA). Egrifta (tesamorelin) prescribing information: approved indication, dosing, safety, warnings, and clinical trial summary for HIV-associated lipodystrophy. FDA Prescribing Information / Egrifta Package Insert. 2026. (Official FDA prescribing information for tesamorelin [Egrifta]; covers: (1) APPROVED INDICATION: reduction of excess visceral adipose tissue [VAT] in HIV-infected patients with lipodystrophy; (2) DOSING: 2mg SC once daily, evening; reconstitution with sterile water [prescribing information specifies sterile water, though bacteriostatic water is commonly used for multi-dose research vials]; (3) PHARMACOKINETICS: half-life ~30-60 min, Tmax ~1-2h, bioavailability ~70-90%; (4) CLINICAL TRIALS: Phase 3 trials [26-52 weeks] showing significant VAT reduction [~15-20%], triglyceride reduction [~15-20%], LDL reduction [~10%], liver fat reduction; (5) SAFETY: common adverse reactions [injection site erythema 25%, arthralgia 15%, peripheral edema 10%, myalgia 8%, headache 5%, diarrhea 4%, nausea 3%]; (6) WARNINGS/PRECAUTIONS: glucose intolerance [monitor in diabetics], hypersensitivity reactions, injection site reactions, fluid retention [edema, carpal tunnel], arthralgias/myalgias, potential for tumor growth [contraindicated in active malignancy], diabetic retinopathy, sleep apnea, children [not studied], pregnancy [Category B], breastfeeding [unknown excretion]; (7) CONTRAINDICATIONS: hypersensitivity to tesamorelin or any component, active malignancy, pregnancy; (8) DRUG INTERACTIONS: corticosteroids [may blunt GH effects — monitor], insulin/oral hypoglycemics [monitor glucose], CYP substrates [no significant CYP interactions]; (9) LONG-TERM SAFETY: extension studies up to 5 years showing sustained efficacy and acceptable safety; (10) REGULATORY STATUS: FDA-approved 2010, available as Egrifta [2mg vials] and Egrifta SV [prefilled syringes]; research-grade tesamorelin [5mg/10mg vials] is NOT FDA-approved for human use and is for laboratory/investigational use only; (11) As of 2026, tesamorelin remains the only GHRH analog FDA-approved for any indication, with the most extensive clinical safety data among GHRH analogs)