Skip to content
Peptide Spencer
Partner

Growth hormone axis

Tesamorelin

Also known as Tesamorelin acetate, Egrifta SV, Egrifta WR, TH9507

FDA-approved productTier A applies only to reduction of excess abdominal fat in HIV-infected adults with lipodystrophy, and only to the branded SV and WR formulations. The labels bridge doses by bioavailability: 1.4 mg SV, 1.28 mg WR and 2 mg of the original formulation give similar exposure, and absolute SC bioavailability is under 4%. Tier A therefore does not carry over to compounded 10 mg or 20 mg vials. Use outside HIV is off-label and rests on small RCTs (tier B).

Growth hormone-releasing factor (GHRH) analog

FDA-approved as Egrifta SV and Egrifta WR. Compounded tesamorelin is not FDA-approved. Source, Jul 31, 2026

Identity. Tesamorelin is a synthetic growth hormone-releasing factor (GRF/GHRH) analog, as the FDA label describes it. A formulary product named 'tesamorelin' most likely denotes this same molecule. Formulary vials are 10 mg and 20 mg. The branded vials are 2 mg (Egrifta SV) and 11.6 mg (Egrifta WR). The two branded formulations are labeled 'not substitutable', so label mg doses and mL volumes cannot be carried over to compounded vials. No bioequivalence between compounded product and either brand is established. Blends that contain tesamorelin deliver every co-ingredient with each injection. Dose by the tesamorelin mg/mL on the blend label, account for each co-ingredient's dose per injection, and do not apply single-agent monograph volumes. No human data on blends were found. The 2 mg trial dose refers to the original EGRIFTA 1 mg/vial formulation, not to the current SV (1.4 mg) or WR (1.28 mg) label doses.

At a glance

These dosages are a helpful guide, not a prescription. Every clinician is expected to do their own due diligence before prescribing.

  1. Start

    1.4 mg subcutaneously once daily (EGRIFTA SV)1

    Approved label
Frequency
Once daily1
Route
Subcutaneous injection into the abdomen, rotating sites1
Course
Pivotal trials: 26 weeks plus a 26-week extension1
Label doses apply only to branded EGRIFTA vials; recalculate volume for compounded vials from the pharmacy's labeled mg/mL.
Calculate this dose

Dosing detail

Approved label

Approved label

  • EGRIFTA SV (2 mg vial): HIV-infected adults with lipodystrophy and excess abdominal fat

    1.4 mg mg1

    Route
    Subcutaneous injection into the abdomen, rotating sites
    Frequency
    Once daily
    Duration
    Not limited in the label sections read. Pivotal trials were 26 weeks plus a 26-week extension.
    n
    Not applicable (label)
    Design
    FDA label, section 2.1. The label bridges the 1.4 mg SV dose to the earlier 2 mg EGRIFTA dose through 'comparable bioavailability'.
    Source quote
    Reconstitute 1 vial of EGRIFTA SV lyophilized powder with 0.5 mL of diluent (2 mg per 0.5 mL).

    Finding. Label dose for reducing excess abdominal fat. Not indicated for weight loss. Long-term cardiovascular safety is not established. The label's 0.35 mL volume applies only to EGRIFTA SV 2 mg/0.5 mL (4 mg/mL) vials and must not be transferred to compounded vials. Show mg only on any dosing surface, and take volume per injection from the calculator using the pharmacy's labeled mg/mL. For example, 0.35 mL of a 1 mg/mL compounded vial would be 0.35 mg, and 0.35 mL of a 10 mg/1 mL vial would be 3.5 mg, 2.5 times the label dose.

  • EGRIFTA WR (11.6 mg vial, weekly reconstitution): HIV-infected adults with lipodystrophy

    1.28 mg mg2

    Route
    Subcutaneous
    Frequency
    Once daily
    Duration
    Each reconstituted vial is discarded 7 days after mixing. Treatment length is not limited in the label sections read.
    n
    Not applicable (label)
    Design
    FDA label, section 2.1 and 2.2
    Source quote
    The recommended dosage of EGRIFTA WR is 1.28 mg subcutaneously once daily.

    Finding. Reconstitute with 1.3 mL diluent (8 mg per mL). One dose is 1.28 mg in 0.16 mL, a volume that applies only to WR mixed this way. Not substitutable with EGRIFTA SV.

Human studies

Human study

  • HIV with abdominal fat accumulation, phase 2 dose-ranging

    1 and 2 (two tesamorelin arms) mg3

    Route
    Subcutaneous
    Frequency
    Once daily
    Duration
    12 weeks
    n
    61
    Design
    Randomized, double-blind, placebo-controlled, three arms
    Source quote
    Participants were randomized to placebo or 1 or 2 mg TH9507 subcutaneously, once daily for 12 weeks.

    Finding. IGF-I rose 48% (1 mg) and 65% (2 mg). Trunk fat fell significantly only with 2 mg (-9.2% vs +0.8% placebo, P = 0.014). 1 mg gave -4.6%, not significant versus placebo. No change in glucose.

  • HIV with abdominal fat accumulation, phase 3 (Study 1)

    2 mg4

    Route
    Subcutaneous injection
    Frequency
    Daily
    Duration
    26 weeks
    n
    412
    Design
    Randomized, double-blind, placebo-controlled
    Source quote
    We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks.

    Finding. Visceral adipose tissue fell 15.2% on tesamorelin versus a 5.0% rise on placebo. Triglycerides fell 50 mg/dL. IGF-I rose 81.0%.

  • HIV with central fat accumulation, 26-week extension phase (52 weeks total)

    2 mg5

    Route
    s.c.
    Frequency
    Daily
    Duration
    26 weeks initial phase, then tesamorelin-arm patients re-randomized to 2 mg or placebo for a further 26 weeks (52 weeks total)
    n
    410 randomized initially (273 tesamorelin, 137 placebo)
    Design
    Randomized, double-blind, placebo-controlled with re-randomization at week 26 of patients originally on tesamorelin
    Source quote
    HIV patients with central fat accumulation in the context of antiretroviral therapy were randomized to tesamorelin 2 mg (n = 273) or placebo (n = 137) s.c. daily for 26 weeks.

    Finding. VAT change was sustained at -18% over 52 weeks of treatment. VAT reaccumulated after discontinuation.

  • Antiretroviral-treated HIV with abdominal fat accumulation; visceral and liver fat endpoints

    2 mg6

    Route
    Subcutaneous
    Frequency
    Daily
    Duration
    6 months
    n
    50 (tesamorelin 28, placebo 22)
    Design
    Double-blind, randomized, placebo-controlled, single center
    Source quote
    Participants were randomized to receive tesamorelin, 2 mg (n=28), or placebo (n=22), subcutaneously daily for 6 months.

    Finding. VAT change was -34 cm2 versus +8 cm2 with placebo. Liver fat fell. Fasting glucose rose at 2 weeks but not at 6 months.

  • Pooled phase 3 analysis, HIV with excess abdominal fat: predictors of response

    2 mg7

    Route
    Subcutaneous
    Frequency
    Daily
    Duration
    6 months
    n
    806 (tesamorelin 543, placebo 263)
    Design
    Pooled analysis of two randomized phase 3 studies, 2:1 randomization
    Source quote
    HIV-infected patients with excess abdominal fat were randomized in a 2:1 ratio to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) subcutaneously daily for 6 months

    Finding. Odds of VAT reduction to below 140 cm2 were 3.9 times greater with tesamorelin than placebo.

  • People with HIV and metabolic dysfunction-associated steatotic liver disease, subgroup on integrase-inhibitor regimens

    2 mg8

    Route
    Not stated in the abstract
    Frequency
    Once daily
    Duration
    12 months
    n
    61 in parent trial; 38 on INSTI regimens at baseline (15 tesamorelin and 16 placebo completed)
    Design
    Secondary analysis of a randomized double-blind placebo-controlled trial
    Source quote
    Among 38 participants on INSTI-based regimens at baseline, 15 individuals on tesamorelin and 16 individuals on placebo completed the 12-month study.

    Finding. Median visceral fat changed by -25 versus +14 cm2 and hepatic fat by -4.2% versus -0.5%. Adverse events were similar between arms.

  • Abdominally obese adults without HIV and with reduced GH secretion

    2 mg9

    Route
    Not stated in the abstract
    Frequency
    Once daily
    Duration
    12 months
    n
    60
    Design
    Randomized, double-blind, placebo-controlled
    Source quote
    Subjects received tesamorelin, a GHRH(1-44) analog, 2 mg once daily, or placebo for 12 months.

    Finding. VAT changed by -16 vs +19 cm2 (treatment effect -35 cm2). Triglycerides, C-reactive protein and carotid intima-media thickness improved. IGF-I rose 86 ug/L. Fasting glucose, 2-h glucose and HbA1c did not change. There were no serious adverse events and no between-group differences in adverse events.

  • Older adults without HIV (ages 55 to 87; 66 with mild cognitive impairment)

    1 mg10

    Route
    Subcutaneous (self-administered)
    Frequency
    Daily, 30 minutes before bedtime
    Duration
    20 weeks
    n
    152
    Design
    Randomized, double-blind, placebo-controlled
    Source quote
    Participants self-administered daily subcutaneous injections of tesamorelin (Theratechnologies Inc),a stabilized analog of human GHRH (1 mg/d), or placebo 30 minutes before bedtime for 20 weeks.

    Finding. IGF-1 rose 117% and stayed within the physiological range. Percent body fat fell 7.4%. Fasting insulin rose 35% in the MCI group. Adverse events were mild and were reported by 68% on tesamorelin vs 36% on placebo.

  • Type 2 diabetes without HIV

    1 and 2 (two tesamorelin arms) mg11

    Route
    Not stated in the abstract; the 2026 Frontiers review lists '1 or 2 mg SC once daily' across human studies
    Frequency
    Not stated in the abstract
    Duration
    12 weeks
    n
    53
    Design
    Randomized, placebo-controlled, three arms (placebo, 1 mg, 2 mg)
    Source quote
    A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes. Three treatment groups: placebo, 1 and 2 mg tesamorelin.

    Finding. Insulin response and glycemic control did not differ significantly. Total and non-HDL cholesterol fell about 0.3 mmol/L in the 2 mg arm versus placebo.

Clinical practice

Clinical practice

Practice numbers are thin. The peer-reviewed review labels its dosing table as self-reported online patterns that are 'not clinical recommendations.' The only clinic protocol found is a single aesthetic-medicine clinic page. Its 1 mg per injection, 5 days a week, is below the label-equivalent daily exposure, and 1 mg/d did not significantly reduce trunk fat versus placebo in the HIV dose-ranging trial (Falutz 2005). Use outside HIV-associated abdominal fat (body composition, recovery, anti-aging) is off-label, and no trial supports those endpoints. The same review calls such claims 'marketing narratives rather than established clinical effects.' Compounded 10 mg and 20 mg vials are not label vials, so recalculate volume per injection from the pharmacy's stated concentration.

Start
Label starts at the full dose (1.4 mg SV / 1.28 mg WR); the label has no ramp. One clinic protocol (Perfect B) uses a fixed 1 mg per injection: a 10 mg vial plus 2.5 mL bacteriostatic water gives 4 mg/mL, and 25 units (0.25 mL) on a U-100 syringe equals 1 mg. Never express this dose as syringe units without the mg and concentration; on a 10 mg/1 mL vial 25 units would be 2.5 mg and on a 20 mg/1 mL vial 5 mg.
Titration
None in any source reviewed. Label: single fixed dose. Perfect B clinic: 'There is no ramp and no titration ladder.'
Typical
Label doses (1.4 mg SV, 1.28 mg WR) and the 2 mg trial dose are formulation-specific exposures bridged by the label (1.4 mg SV = 1.28 mg WR = 2 mg of the original formulation; SC bioavailability under 4%), not interchangeable numbers. Equivalence of any compounded tesamorelin to these doses is unestablished, and the 2 mg trial dose refers to the original 1 mg/vial product. A 2026 peer-reviewed review lists 1 or 2 mg SC once daily as the dose in published human studies and 2 mg SC once daily for 8 to 12 weeks as the self-reported online pattern.
Ceiling
No source sets a practice ceiling. 2 mg once daily is the highest dose in the trials reviewed, and it refers to the original formulation, so it is not an established ceiling for compounded vials.
Frequency
Once daily per label and trials. Clinic variant: 5 days on, 2 days off.
Route
Subcutaneous. Label: abdomen, rotating sites.
Timing
Label specifies no time of day. Bedtime dosing was used in an RCT (30 minutes before bedtime, Baker 2012). Clinic protocol: before bedtime, at least 2 hours after the last meal.
Cycle
Label and trials: continuous (26 to 52 weeks studied; visceral fat returns after stopping). Clinic variant: 3-month active cycle then 2-month rest. Self-reported online pattern: 8 to 12 weeks.

Sources

  • Clinical practicePeer-reviewed review12
    Tesamorelin 1 or 2 mg SC once daily, for 2 weeks or 12 weeks or 12 months
  • Clinical practicePeer-reviewed review12
    Bodybuilding-related forum: 2 mg SC once daily; typical cycle: 8–12 weeks

What clinics and vendors publish

These ranges come from clinic and vendor publications, not studies.

Clinic-reported
  • Clinic-reportedPharmacy or clinic protocol13
    The standard tesamorelin dose at Perfect B is 25 units per injection
  • Clinic-reportedPharmacy or clinic protocol13
    Add 2.5 mL of BAC Water to the 10 mg vial for a concentration of 4 mg/mL.
  • Clinic-reportedPharmacy or clinic protocol13
    At that concentration 25 units (0.25 mL) on an insulin syringe is exactly 1 mg.
  • Clinic-reportedPharmacy or clinic protocol13
    Patients inject 5 days on, 2 days off, every month
  • Clinic-reportedPharmacy or clinic protocol13
    on a 3-month active cycle followed by a 2-month rest period before repeating
  • Clinic-reportedPharmacy or clinic protocol13
    Tesamorelin is injected before bedtime, at least 2 hours after your last meal

Safety

Serious warnings

  • No boxed warning appears on the EGRIFTA SV or EGRIFTA WR labels as read; none was found.1
  • Increased risk of neoplasms (label section 5.1): preexisting malignancy must be inactive and treated before starting. The label says to 'Carefully consider the decision to start treatment with EGRIFTA SV based on the increased background risk'. Discontinue if there is evidence of recurrent malignancy. Do not treat patients with active malignancy.1
  • Elevated IGF-1 (section 5.2): 'Consider discontinuing EGRIFTA SV in patients with persistent elevations of IGF-1 levels (e.g., >3 SDS)'. Monitor IGF-1 levels during therapy.1
  • Fluid retention (section 5.3): 'Fluid retention may occur during EGRIFTA SV therapy and is thought to be related to the induction of GH secretion.' It may include edema, arthralgia and carpal tunnel syndrome.1
  • Glucose intolerance or diabetes mellitus (section 5.4): 'EGRIFTA SV treatment can result in glucose intolerance.' Evaluate glucose status before initiating and monitor periodically. If glucose intolerance or diabetes develops, consider discontinuing in patients who 'do not show a clear efficacy response.' In trials, HbA1c >=6.5% developed in 5% on tesamorelin vs 1% on placebo (hazard ratio 3.3, CI 1.4 to 9.6).2
  • Hypersensitivity (section 5.5): 'Hypersensitivity reactions occurred in 4% of patients treated with EGRIFTA in clinical trials.'1
  • Injection site reactions (section 5.6): 'The incidence of injection site reactions was 25% in EGRIFTA treated patients and 14% in placebo-treated patients during the first 26 weeks of treatment in clinical trials.' Rotate injection sites across the abdomen.1
  • Increased mortality in patients with acute critical illness (section 5.7): consider discontinuing in critically ill patients.1
  • Immunogenicity: 'anti-tesamorelin IgG antibodies were detected in 50% of patients who received EGRIFTA for 26 weeks' (original 1 mg/vial trials).1

Contraindications

  • 'Patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma.'1
  • Patients with active malignancy.1
  • Patients with known hypersensitivity to tesamorelin or the excipients in EGRIFTA SV.1
  • Pregnancy: 'Pregnant women because modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm' (same wording on the SV and WR labels).1
  • Specific populations: mothers 'should not breastfeed' on EGRIFTA SV; 'EGRIFTA SV is not indicated for use in pediatric patients with open or closed epiphyses'; 'There is no information on the use of EGRIFTA SV in patients greater than 65 years of age.' Renal and hepatic pharmacokinetics were not established in the sources read.1

Adverse effects

  • Most commonly reported adverse reactions on the label (>5%): arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia. In the label's Table 1 as flattened on the page, arthralgia reads 13 (EGRIFTA, N=543) versus 11 (placebo, N=263), presumed percentages. Exact rates were not confirmed from the label text, so verify Table 1 on the label before displaying figures.1
  • A 2026 meta-analysis of five RCTs: 'Tesamorelin was associated with adverse events, including arthralgia, myalgia, paresthesia, and injection-site reactions like erythema.'14
  • In the 2007 pivotal NEJM trial, adverse events did not differ significantly between groups, but more patients in the tesamorelin group withdrew because of an adverse event.4
  • In the 2014 JAMA trial, fasting glucose increased at 2 weeks (mean change 9 mg/dL with tesamorelin versus 2 mg/dL with placebo, P = .03) but not significantly at 6 months.6
  • Older-adult RCT (1 mg/d, 20 weeks): adverse events in 68% on tesamorelin vs 36% on placebo. Fasting insulin rose 35% in adults with MCI.10
  • A 2026 review of GH-IGF-1 axis peptides reports 'endocrine and metabolic disturbances (including prolactin and cortisol elevations, appetite changes, and dysglycaemia), fluid retention syndromes, musculoskeletal symptoms (myalgia/arthralgia), and injection-site reactions'. It describes mitogenic concerns as biologically plausible but unproven.12

Monitoring

  • Check baseline glucose status (fasting glucose and HbA1c) before starting, and recheck periodically. Diabetes (HbA1c >=6.5%) developed in 5% vs 1% on placebo. Consider stopping if glucose intolerance develops without a clear efficacy response.1
  • Monitor IGF-1 during therapy. Consider discontinuation for persistent elevation (e.g., >3 SDS).1
  • Examine the retina in patients with diabetes (the label advises monitoring for retinopathy).1
  • Review glucocorticoid replacement dosing in patients with hypoadrenalism after starting.1
  • Preexisting malignancy must be inactive and treated before starting. Discontinue if recurrence is evident.1

Interactions

  • Label section 7.1: monitor for potential interactions with other drugs, because growth hormone may alter clearance of CYP450-metabolized drugs. Label section 7.2: patients on glucocorticoid replacement for hypoadrenalism 'may require an increase in maintenance or stress doses following initiation of EGRIFTA SV'.1

Handling

Reconstitution

EGRIFTA SV: 'Reconstitute 1 vial of EGRIFTA SV lyophilized powder with 0.5 mL of diluent (2 mg per 0.5 mL)'. Roll gently, do not shake, inject 0.35 mL immediately and discard the remainder. SV volumes apply to the 2 mg vial only. EGRIFTA WR: 'Reconstitute 1 vial of EGRIFTA WR lyophilized powder with 1.3 mL of diluent (8 mg per mL)'. One dose is 1.28 mg in 0.16 mL, for WR only. No source was found for reconstituting compounded 10 mg or 20 mg vials, so follow the pharmacy's label. One clinic protocol reconstitutes a 10 mg vial with 2.5 mL bacteriostatic water (4 mg/mL).

Storage before mixing

'Store EGRIFTA SV 2 mg vial at room temperature at 20°C to 25°C (68°F to 77°F)'. 'Protect EGRIFTA SV from light by keeping in the original box until time of use.' The EGRIFTA WR 11.6 mg vial has the same room-temperature range on its label. Compounded product storage was not sourced, so follow the pharmacy's label.

Storage after mixing

EGRIFTA WR is the only product with a labeled multi-day in-use condition: 'Store reconstituted EGRIFTA WR at room temperature at 20°C to 25°C (68°F to 77°F). Discard unused solution of EGRIFTA WR 7 days after mixing. Do not freeze.' EGRIFTA SV: do not freeze or refrigerate the reconstituted solution. Use it right away after mixing and discard the remainder. No source supports beyond-use dating for reconstituted compounded tesamorelin. Follow the compounding pharmacy's labeled beyond-use date and storage, and size vials so in-use time does not exceed it (at 1 to 2 mg/day a 10 or 20 mg vial lasts roughly 5 to 20 days).1213

Evidence

Egrifta SV and Egrifta WR are FDA-approved for reducing excess abdominal fat in HIV-infected adults with lipodystrophy. Randomized placebo-controlled trials (2 mg SC daily, 6 to 12 months) show visceral fat reduction, and a 2026 meta-analysis of five RCTs agrees. Non-HIV RCTs are few and small: obese adults with reduced GH secretion (2 mg/d for 12 months, n=60), older adults with and without MCI (1 mg/d for 20 weeks, n=152), and type 2 diabetes (1 or 2 mg for 12 weeks, n=53). None studied recovery or anti-aging endpoints. In the HIV dose-ranging trial, only 2 mg significantly reduced trunk fat. 1 mg did not.

Mechanism

Tesamorelin is a synthetic analog of growth hormone-releasing factor. It stimulates endogenous growth hormone secretion and raises IGF-1. In the pivotal trial, mean IGF-I rose 81.0% versus a 5.0% fall on placebo at 26 weeks. The label states that fluid retention is thought to be related to induction of GH secretion.14

Availability

Amounts offered

  • 10 mg
  • 20 mg

Custom strengths on request.

References

According to PubMed

  1. 1EGRIFTA SV (tesamorelin) kit, full prescribing information (DailyMed SPL version 9, published Jul 31, 2026; label Revised 2/2024)DailyMed, National Library of Medicine / Theratechnologies Inc., 2026
  2. 2EGRIFTA WR (tesamorelin) kit, full prescribing information (DailyMed SPL version 2, published Aug 3, 2026)DailyMed, National Library of Medicine / Theratechnologies Inc., 2026
  3. 3A placebo-controlled, dose-ranging study of a growth hormone releasing factor in HIV-infected patients with abdominal fat accumulationAIDS 19(12):1279-87, 2005
  4. 4Metabolic effects of a growth hormone-releasing factor in patients with HIVN Engl J Med 357(23):2359-70, 2007
  5. 5Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulationAIDS 22(14):1719-28, 2008
  6. 6Effect of tesamorelin on visceral fat and liver fat in HIV-infected patients with abdominal fat accumulation: a randomized clinical trialJAMA 312(4):380-9, 2014
  7. 7Predictors of Treatment Response to Tesamorelin, a Growth Hormone-Releasing Factor Analog, in HIV-Infected Patients with Excess Abdominal FatPLoS One 10(10):e0140358, 2015
  8. 8Efficacy and safety of tesamorelin in people with HIV on integrase inhibitorsAIDS 38(12):1758-1764, 2024
  9. 9Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trialJ Clin Endocrinol Metab 97(12):4769-79, 2012
  10. 10Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trialArch Neurol 69(11):1420-9, 2012
  11. 11Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trialPLoS One 12(6):e0179538, 2017
  12. 12The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administrationFront Endocrinol (Lausanne) 17:1822475 (PMC13322892), 2026
  13. 13Tesamorelin Dosage and Injection Protocol: The Exact Schedule We Use (Perfect B Aesthetic Medicine; medically reviewed by Valeria Marulanda, FNP-BC; updated October 13, 2026)Perfect B Aesthetic Medicine (clinic web page), 2026
  14. 14Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trialsObes Res Clin Pract 20(1):2-12, 2026
  15. 1521 U.S.C. 353a (FD&C Act section 503A), pharmacy compoundingCornell Legal Information Institute, 2026
  16. 16Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (content current as of 05/14/2026); tesamorelin not mentioned on the pageU.S. Food and Drug Administration, 2026
  17. 17Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of 04/22/2026); tesamorelin not mentioned on the pageU.S. Food and Drug Administration, 2026
  18. 18Peak Performance Peptides - 735127 - 08/24/2026 (FDA warning letter citing tesamorelin products as unapproved new drugs)U.S. Food and Drug Administration, CDER, 2026

Last reviewed 2026-10-14. 32 figures checked against their sources. How this works