Tesamorelin is the only GHRH analogue still approved and still marketed. That makes the research-vial question sharper rather than simpler, because the alternative is not abstinence — it is a drug on a pharmacy shelf, reformulated in March 2025.
Tesamorelin sits in the growth hormone peptides category. The evidence picture — a 15.2% visceral fat reduction in 412 patients, a +22% regain when the injections stop, and a ten-year malignancy study that ended at five and a half — is in tesamorelin: the only GHRH analogue still approved. For the current vial's arithmetic there is the tesamorelin calculator.
What is tesamorelin, and why does source quality matter?
Tesamorelin is a 44-amino-acid analogue of human growth hormone-releasing hormone, molecular weight 5,136 Da, CAS 218949-48-5, modified by a trans-3-hexenoyl group on the N-terminal tyrosine and amidated at the C-terminus, with a plasma half-life of 11 minutes. Source quality matters differently here because tesamorelin is a currently marketed approved drug: a pharmacy version exists, and the research vial competing with it sits 1,778 daltons above sermorelin, so identity is easy and fill accuracy is not.
Property | Value |
|---|---|
Sequence | YADAIFTNSYRKVLGQLSARKLLQDIMSRQQGESNQERGARARL — the full GHRH(1-44), not a fragment |
Modification | trans-3-hexenoyl group on the N-terminal tyrosine; C-terminally amidated |
CAS | 218949-48-5 (PubChem CID 16137828) |
Formula / MW | C₂₂₁H₃₆₆N₇₂O₆₇S / 5,136 Da |
Half-life | 11 minutes (plasma, healthy subjects) |
Approval | BLA 022505, 10 November 2010, Theratechnologies; development code TH9507 |
That single acylation is what protects the molecule from dipeptidyl peptidase-4 degradation, and it is the only subtle thing about this compound's identity. Everything else is wide open: at 5,136 Da tesamorelin sits 1,778 daltons above sermorelin and 1,489 above CJC-1295 with DAC. Those gaps are unmissable on a mass spectrum and invisible on an HPLC purity certificate. A vial sold as tesamorelin that measures around 3,400 Da is sermorelin.
Compound | Length | Formula | MW | Regulatory status |
|---|---|---|---|---|
Tesamorelin | GHRH(1-44), hexenoyl-modified | C₂₂₁H₃₆₆N₇₂O₆₇S | 5,136 | FDA-approved, currently marketed |
GHRH(1-29), unmodified | C₁₄₉H₂₄₆N₄₄O₄₂S | 3,357.9 | Approved 1990/1997, withdrawn 2009 | |
CJC-1295 with DAC | GHRH(1-29) + maleimidopropionyl linker | C₁₆₅H₂₆₉N₄₇O₄₆ | 3,647.2 | Never approved |
So the sourcing risk is not substitution by a neighbour, which any mass spectrometer catches. It is the acylation and the fill. A mass reading around 5,040 is unmodified GHRH(1-44) rather than tesamorelin — the hexenoyl group is roughly the whole difference — and one vendor's sample on this platform tested 23.6% above labelled quantity on a compound titrated to 1.28 mg daily. At that dose, a 23.6% overage is a dosing error rather than a rounding artefact. See mass spectrometry for peptides for what an identity result establishes that a purity percentage cannot.
One database caution belongs with the table. PubChem's CJC-1295 record has had both "CJC1295 With DAC" and "CJC1295 Without DAC" listed as synonyms and subsequently removed them, so treat that record as the DAC form only. Identity and vendor coverage for this compound sit on the tesamorelin compound page.
What is the regulatory status of tesamorelin?
Tesamorelin is an FDA-approved, currently marketed drug, approved on 10 November 2010 under BLA 022505 for one indication only: "the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy." It is not approved for obesity or anti-aging. As of August 2026 it appears on neither of FDA's bulk substances tables — not the 14-substance active Category 2 list, and not the 17-substance "nominated but withdrawn" table, page current 22 April 2026. WADA prohibits it at all times under S2.2.4.
The Limitations of Use section is unusually explicit for a label, and it rules out the reason most off-label buyers are shopping:
"Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV."
Note the precise claim: weight neutral. Tesamorelin redistributes fat away from the visceral compartment; it does not reduce body weight. Anyone buying it expecting a number on a scale to move is buying it for something the manufacturer's own label rules out.
In sport, WADA's 2026 Prohibited List names tesamorelin explicitly at S2.2.4 — "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)" — prohibited at all times, non-specified.
Claim you will meet while shopping | What the record says | Verdict |
|---|---|---|
"Removes visceral fat" | −15.2% vs +5.0% on placebo in a 412-patient randomised trial (P<0.001); pooled effect −15.4% across 806 patients | Established (human RCT) |
"Causes weight loss" | Label: "not indicated for weight loss management as it has a weight neutral effect" | False — weight neutral |
"Approved for obesity or anti-aging" | One indication: excess abdominal fat in HIV-infected adults with lipodystrophy | False |
"The fat stays off after you stop" | Extension phases: +25 cm² (+22%) and +24 cm² (+16%) regain on switching to placebo | Contradicted |
"Works in people without HIV" | 60-person randomised trial: visceral fat −35 cm² (P=0.003), carotid intima-media thickness −0.04 mm (P=0.02) | Supported, small |
"Reduces liver fat" | Lancet HIV 2019, n=61: hepatic fat −4.1 percentage points, −37% relative (p=0.016) | Supported (human RCT) |
"Long-term cardiovascular safety is established" | Label: "has not been established" | False |
"The long-term cancer surveillance is complete" | NCT01579695 terminated at roughly 5.5 of 10 years, 391 patients, no reason in the record | Incomplete |
"Safe to run indefinitely" | Active malignancy is a contraindication; IGF-1 >2 SDS in 47% at 26 weeks; diabetes hazard OR 3.3 (95% CI 1.4, 9.6) | Monitored, in the approved setting |
What changed with the 11.6 mg vial?
The presentation changed in March 2025 and the daily dose changed with it. EGRIFTA WR moved to an 11.6 mg multi-dose vial reconstituted with 1.3 mL of bacteriostatic water to 8 mg/mL, giving seven doses and discarded after seven days — and it lowered the daily dose from 1.4 mg to 1.28 mg. All three brands are the same application, BLA 022505, changed through supplements rather than new approvals. Most dosing guidance still describes the older presentations.
EGRIFTA (original) | EGRIFTA SV | EGRIFTA WR (current) | |
|---|---|---|---|
Vial | 1 mg and 2 mg | 2 mg, single-dose | 11.6 mg, multi-dose |
Daily dose | 2 mg | 1.4 mg | 1.28 mg |
Reconstitution | — | 0.5 mL diluent | 1.3 mL bacteriostatic water (8 mg/mL) |
Doses per vial | 1 | 1 | 7 |
After mixing | — | — | Discard after 7 days |
EGRIFTA, EGRIFTA SV and EGRIFTA WR are not three approvals. All three are BLA 022505 and all three labels read "Initial U.S. Approval: 2010." The changes arrived through supplements: SUPPL-10 (formulation, March 2019), SUPPL-12 (renamed EGRIFTA SV, July 2019) and SUPPL-20 (renamed EGRIFTA WR, 25 March 2025).
For a buyer this is arithmetic, not trivia. A protocol written for the 2 mg single-dose presentation and applied to an 11.6 mg multi-dose vial gets both the concentration and the daily volume wrong, and the daily dose itself moved. Work from the current figures: 8 mg/mL after reconstitution, 1.28 mg per day, seven days before the vial is discarded. The tesamorelin calculator handles the 8 mg/mL concentration and the reconstitution calculator handles the mixing volume; see also reconstituting peptides step by step. Note that research vials are not sold in the label's presentation, so the concentration you end up with is whatever your own diluent volume produces — which is exactly why the fill-accuracy check below matters more on this compound than on most.
7 things to check before ordering tesamorelin
Seven checks cover tesamorelin, and the identity check is unusually decisive because 5,136 Da sits 1,778 daltons above sermorelin. Mass spectrometry at 5,136, confirmation of the hexenoyl modification rather than unmodified GHRH(1-44) at around 5,040, third-party HPLC against a 99.41% benchmark, net peptide content, fill accuracy against a 23.6% overage on record, an LAL endotoxin result absent from most entries, and a pricing check read within a single vial-size band.
Mass spectrometry at 5,136 Da. This gap is the widest in the growth hormone category: sermorelin is 3,357.9 and CJC-1295 with DAC is 3,647.2, so anything reading in the 3,000s is not tesamorelin regardless of the label. Ask for a batch-matched result rather than a specimen certificate from an earlier lot, which describes a different vial.
Confirmation of the hexenoyl modification. A mass around 5,040 is unmodified GHRH(1-44), not tesamorelin — the trans-3-hexenoyl group on the N-terminal tyrosine is what confers DPP-4 resistance, and it is the only part of this molecule's identity that a careless synthesis can quietly omit while still producing a 44-residue peptide.
Third-party HPLC purity from a named laboratory. This platform's tesamorelin figure of 99.41% comes from 497 independent tests by Bioviridian, Kovera, ILS and Freedom Diagnostics, so "above 98%" describes a standard the market already clears. A vendor's own in-house document is not third-party testing (third-party peptide testing labs).
Net peptide content. Purity reports the proportion of a sample that is one species; it says nothing about how much of that species is in the vial, with acetate salt and residual water sitting inside the difference. Ask separately for a net content or amino acid analysis figure (why 10 mg isn't 10 mg).
Fill accuracy, because the dose is small. One vendor's sample tested 23.6% above labelled quantity. On a compound titrated to 1.28 mg daily, that is a real dosing error rather than a tolerance — and a fill process that runs 23.6% over is a fill process that is not being measured, which produces shortfalls just as readily. Quantitative content testing is the check.
An LAL endotoxin result. Endotoxin results are absent from most tesamorelin entries on this platform. An absent LAL figure means the batch was not tested for pyrogens rather than that it passed, and this is injectable material dosed daily and indefinitely. See peptide endotoxin testing and the LAL assay.
The pricing check, read within a vial-size band — and what no certificate establishes. Vial size drives most of the per-milligram variation here: 2–5 mg vials run a median $10.00/mg against $7.00/mg for 10–20 mg, and offers range to $22.00/mg. Beyond that, a flawless certificate confirms a 44-residue acylated peptide at the stated quantity. It does not tell you that the fat stays off — it returns at +22% and +16% in the two extension studies — and it does not replace the IGF-1 monitoring the label requires, on a drug whose ten-year malignancy cohort, NCT01579695, terminated at roughly five and a half years with no reason given. See red flags in peptide certificates of analysis.
Check | What it confirms | How to verify | Red flag |
|---|---|---|---|
Mass spectrometry | Tesamorelin at 5,136 Da, not sermorelin (3,358) or CJC-1295 with DAC (3,647) | Batch-matched CoA with the MS result | HPLC purity only |
Hexenoyl modification | The N-terminal acylation that makes it DPP-4 resistant | MS mass matching the modified form | A mass reading around 5,040 — unmodified GHRH(1-44) |
Fill accuracy | The vial matches the label, at a 1.28 mg daily dose | Quantitative content testing | +23.6% is on record |
Net peptide content | Peptide versus acetate salt and water | Net content or amino acid analysis | Purity quoted as if it were quantity |
Endotoxin (LAL) | No pyrogens on an injectable dosed daily | LAL result on the batch | Field blank — common here |
HPLC purity | Proportion of intended peptide | Third-party CoA from a named lab | Below the 99.41% benchmark; vendor's own document only |
Where does tesamorelin rank on Peptigrity's lab test database?
Peptigrity's Purity Index records tesamorelin at 99.41% average HPLC purity across 497 independent tests from Bioviridian, Kovera, ILS and Freedom Diagnostics, across 227 verified vendors (verified August 2026). Price data shows 60 shops in stock, a median of $7.00/mg and a lowest tracked price of $3.50/mg on a 20 mg vial, across 73 comparable offers ranging to $22.00/mg (verified 8 August 2026). One vendor's sample tested 23.6% above labelled quantity, which on a 1.28 mg daily dose is a real dosing error.
Vial size | Median price per mg |
|---|---|
2–5 mg | $10.00/mg |
10–20 mg | $7.00/mg |
Lowest tracked offer | $3.50/mg, on a 20 mg vial |
Highest of 73 comparable offers | $22.00/mg |
Vial size drives most of that spread, because fixed per-vial costs fall away as fill size rises — which means a per-milligram comparison across bands is not a like-for-like comparison. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing.
Two flags sit in the tesamorelin data and both are about quantity rather than identity. The 23.6% overage is the first. Endotoxin results are absent from most entries is the second, and on a drug the label describes as continuing therapy that absence covers a lot of injections. Naming the four laboratories matters for the same reason: a reader can weigh where 497 tests came from rather than take a bare percentage, and can search the lab test database and community-verified shop reviews for a specific vendor rather than relying on the compound-level average. Peptigrity tracks 530 shops and 11,852 independent lab tests across 118 peptides, with 1,283 community reviews (verified August 2026), weighting community reviews and independently verified HPLC purity equally at 50% each, with no financial relationships influencing the ranking — the methodology is documented at how we calculate trust scores.
One number-handling warning applies whenever you compare a vendor's marketing against the literature. FDA's label reports the two pivotal trials as −18% versus +2% and −14% versus −2%, while the published abstracts report −15.2% and −10.9%. These are different analysis populations of the same data, not contradictory findings. Cite one source per figure and say which — mixing them produces numbers that appear nowhere.
The trial that would settle this is not a testing study. On tesamorelin the vial is verifiable and the long-term exposure is not.
Element | Requirement | Why |
|---|---|---|
Population | Non-HIV adults with visceral adiposity | The only non-HIV VAT trial enrolled 60 people |
Publish NCT03375788 | The completed MASLD trial's results exist only in a registry | It is the strongest non-HIV liver signal available |
Duration | Beyond 12 months | Every trial stops before the discontinuation question matters |
Withdrawal arm | Pre-specified | VAT regain of +22% is the defining practical fact |
Long-term malignancy surveillance | Complete what NCT01579695 started | Terminated at ~5.5 of 10 years, with no replacement |
Cardiovascular | Any outcome trial | The label has said "not established" since 2010 |
What about compounded tesamorelin?
Compounded tesamorelin has a statutory route, and it is the sharpest version of this question in the growth hormone category because the pharmacy product itself exists. Because tesamorelin is a component of a currently marketed FDA-approved drug, it satisfies one of the three statutory routes under 21 U.S.C. § 353a(b)(1)(A) — a legal pathway for a licensed pharmacy compounding for a named patient. That is not an endorsement, and it does not extend to a research vial.
The reason the route stays open is an absence rather than a permission. Tesamorelin appears on neither of FDA's bulk substances tables — not the 14-substance active Category 2 list of substances that may present significant safety risks, and not the 17-substance "nominated but withdrawn" table, page current 22 April 2026. Nothing in that record says the agency has evaluated compounded tesamorelin favourably. It says the statutory prong is satisfied and the substance has not been flagged. Those are different claims, and vendors tend to collapse them. For the structural comparison of what each route carries, see compounding pharmacy versus research peptide.
What the approved route carries that a vial does not is written into the label, and on this compound it is not paperwork. Active malignancy is an absolute contraindication, not a caution. IGF-1 monitoring throughout therapy is a labelled requirement, and it exists because IGF-1 exceeded two standard deviations of normal in 47% of patients at 26 weeks and three standard deviations in 36%. The label instructs prescribers to "consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue" — an instruction that only makes sense because the visceral fat returns at +22% when dosing stops, which makes this indefinite therapy rather than a course. A research vial delivers the molecule and none of the monitoring.
On cost, we will not complete the comparison we cannot source. This platform's verified figures are research-market figures: a $7.00/mg median, a $3.50/mg low on a 20 mg vial and offers to $22.00/mg (verified 8 August 2026). We do not hold a verified pharmacy price for the approved product, and rather than estimate one to make the table symmetrical, we are naming the gap. What can be said without a price is structural: the approved product comes with a prescriber, a labelled monitoring requirement and an FDA-approved manufacturing chain, and the research vial comes with a certificate of analysis whose quality you have just spent seven checks establishing.
Frequently Asked Questions
What purity standard should tesamorelin meet?
This platform records tesamorelin at 99.41% average HPLC purity across 497 independent tests from Bioviridian, Kovera, ILS and Freedom Diagnostics, across 227 verified vendors (verified August 2026). Against a market clearing that high, "above 98%" promises less than the norm. Purity is also only one axis: the two flags in our tesamorelin data are a 23.6% overage and endotoxin results absent from most entries.
How much does tesamorelin cost?
Price data shows 60 shops in stock, a median of $7.00/mg and a lowest tracked price of $3.50/mg on a 20 mg vial, across 73 comparable offers ranging to $22.00/mg (verified 8 August 2026). Vial size drives most of that: 2–5 mg vials run a median $10.00/mg against $7.00/mg for 10–20 mg. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing.
Is tesamorelin legal, and does it need a prescription?
Tesamorelin is an FDA-approved prescription drug, approved 10 November 2010 under BLA 022505 for one indication: reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. It appears on neither of FDA's bulk substances tables, and because it is a component of a currently marketed approved drug it satisfies one of the three statutory routes for 503A compounding for a named patient. It is prohibited in sport at all times under WADA S2.2.4.
How do I know the vial contains tesamorelin?
Mass spectrometry at 5,136 Da. Tesamorelin sits 1,778 daltons above sermorelin and 1,489 above CJC-1295 with DAC, so anything reading in the 3,000s is a different molecule. The subtler check is the trans-3-hexenoyl modification: a mass around 5,040 is unmodified GHRH(1-44), which is a 44-residue peptide that will not resist DPP-4 degradation the way tesamorelin does.
What dose does the current vial actually deliver?
Since March 2025 the approved presentation is an 11.6 mg multi-dose vial reconstituted with 1.3 mL of bacteriostatic water to 8 mg/mL, giving seven doses and discarded after seven days, at a daily dose of 1.28 mg rather than the earlier 1.4 mg or 2 mg. Most dosing guidance in circulation still describes the older presentations, so check which one any protocol was written for. The category-level comparison is in ipamorelin vs sermorelin vs tesamorelin.
What happened to the ten-year malignancy study?
NCT01579695 was a Phase 4, observational, multicentre, ten-year prospective cohort study whose primary outcome was time to development of malignancies against an unexposed control group. It enrolled 391 patients, ran from February 2013 to August 2018, and is listed as terminated with no reason in the record. We are not asserting why it ended; what is verifiable is that it did not run to term and no published result replaced it.
Browse the growth hormone peptides category, or our complete peptide guide with 118 compounds (verified August 2026). For the 11.6 mg vial math, use the tesamorelin calculator alongside the reconstitution calculator. Compare shops through independent lab tests and community-verified shop reviews.
This article is for educational and informational purposes only and does not constitute medical advice. Peptides discussed may be investigational compounds not approved by the FDA (or equivalent regulators in your jurisdiction) for human use. Always consult a qualified healthcare provider before using any peptide or research compound. Peptigrity is an independent review platform and does not sell, endorse, or recommend specific products or vendors.