Ipamorelin vs Sermorelin vs Tesamorelin: The Approved Drug, the Compoundable One, and the One FDA Voted 0–12 Against

Three growth hormone peptides, three different answers to "is this legal". Tesamorelin is an approved drug. Sermorelin is compoundable. Ipamorelin is on FDA's Category 2 list. This page resolves approval status against evidence depth, because the two rank the same way.

That alignment is the finding, and it is not obvious in advance — regulatory standing and trial quality could easily have come apart. All three sit in the growth hormone peptides category, with individual records in ipamorelin: the selective secretagogue that failed its only published human trial, sermorelin: the only GH peptide FDA ever approved and tesamorelin: the only GHRH analogue still approved.

Where do ipamorelin, sermorelin and tesamorelin sit on the legality spectrum?

Tesamorelin is an FDA-approved drug still marketed today under BLA 022505, approved 10 November 2010. Sermorelin was approved twice, in 1990 and 1997, withdrawn commercially in 2009, and appears nowhere on FDA's Category 2 list. Ipamorelin acetate is still on that list, added 29 September 2023, and FDA's Pharmacy Compounding Advisory Committee voted 0 in favour and 12 against it in October 2024. Three compounds, three positions.

Read the last two rows together, because they are the two places the spectrum collapses. In sport there is no spectrum at all: WADA's 2026 list names sermorelin and tesamorelin explicitly at S2.2.4 as GHRH analogues, and names ipamorelin explicitly at the same section under growth hormone secretagogues and their mimetics. All three are prohibited at all times and classified as non-specified. Legal to prescribe is not legal to compete on.

The price row collapses the same way for a different reason. An approved drug, a compoundable legacy molecule and a compound FDA declined to allow all trade at within a dollar of each other on the research market, which tells you that legal status is not what the grey market is pricing. It is pricing milligrams.

Everything else on that table separates cleanly, and the rest of this page works down it. Our FDA peptide regulation timeline tracks the dated movements behind the regulatory rows.

Why can a pharmacy compound sermorelin and tesamorelin but not ipamorelin?

Sermorelin and tesamorelin satisfy the same statutory prong: each is a component of an FDA-approved drug, one of three routes open to a bulk substance under 21 U.S.C. § 353a(b)(1)(A). Ipamorelin satisfies none of the three. It has no USP monograph, it is not on the 503A bulks list, and FDA's advisory committee voted 0–12 against it in October 2024. The difference between them is statutory rather than scientific.

The three statutory routes are worth stating plainly, because the whole legality spectrum on this page is generated by them. A bulk substance used in 503A compounding must either comply with a USP monograph, be a component of an FDA-approved drug, or appear on FDA's 503A bulks list — a list containing six substances, none of them peptides.

Sermorelin qualifies under the second prong, and FDA's own 503B bulk substances documentation lists "Sermorelin Acetate" with a footnote marking it as a substance that is a component of FDA approved drugs. That footnote is the strongest direct evidence of the agency's operative position. One honest caveat belongs with it: both Geref approvals were formally withdrawn in 2009, and we found no FDA document expressly resolving whether a withdrawn approval still satisfies that prong. The footnote implies the agency's answer; the final inferential step is not spelled out in an FDA statement, and we are not going to pretend otherwise.

Tesamorelin qualifies under the same prong with none of that ambiguity, because it is a component of a currently marketed approved drug. It also 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. That is an absence rather than a permission. Nothing in the record says FDA 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.

Ipamorelin has the opposite record on every axis. FDA's briefing document for the October 2024 vote is unusually direct for a regulatory filing:

• "FDA has not identified data to support the effectiveness of ipamorelin… for the diagnosis or treatment of GHD."

• "Due to its primary mechanism of action as a ghrelin receptor agonist, ipamorelin… may have behavioral reinforcing properties, which can contribute to development of addiction, and may also negatively affect reproductive health."

• Ipamorelin free base is "not well-characterized from the physical and chemical characterization perspective" — missing impurities, aggregates and endotoxin data.

The direction of travel matters as much as the current position. Ipamorelin was not among the substances whose nominations were withdrawn in April 2026, and it was not on the July 2026 PCAC agenda that advanced BPC-157, KPV, TB-500, MOTS-c, Semax and Epitalon. It stayed on the active list while others moved. "FDA is reconsidering peptides" is true in general and false for this one.

None of the three routes makes a compounded product an approved product, and FDA is blunt about it: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed." What the compounded route buys is a named patient, a licensed pharmacist, API from an FDA-registered establishment and a statutory certificate of analysis on the bulk substance. See compounding pharmacy versus research peptide.

Which of the three has human evidence, and what kind?

Tesamorelin has by far the strongest human evidence: 806 patients across a pooled analysis of two randomised trials, with visceral fat measured by CT. Sermorelin's best evidence is diagnostic rather than therapeutic — guideline-grade for detecting GH deficiency, plus 43 randomised children for growth. Ipamorelin has an eight-man pharmacokinetic study, one randomised trial that missed its endpoint at p = 0.15, and a 320-patient trial that never reported anything.

None of these comparisons is head-to-head. No trial has put any two of these three compounds against each other, so every row above is being read across different populations, durations, endpoints and eras — HIV lipodystrophy against prepubertal growth failure against postoperative bowel resection. Placing them in one table is a way of showing how much evidence each compound has, not a way of ranking effect sizes.

Three specific qualifications attach, one per compound.

Tesamorelin's numbers have two legitimate versions. FDA's label reports the same 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.

Sermorelin's therapeutic evidence is thinner than its approval implies. Prakash and Goa characterised it in their own words: "Limited data suggest that once daily subcutaneous sermorelin 30 µg/kg bodyweight is effective in promoting growth in some prepubertal children." A December 2020 report prepared for FDA by the University of Maryland CERSI examined sermorelin's nomination for compounding and found two peer-reviewed studies meeting inclusion criteria — both 1996 diagnostic studies — zero survey responses, and no clinical practice guideline recommending sermorelin.

Ipamorelin's silence is itself information. A completed 320-patient trial whose results were never released is not what a positive result usually looks like. Across the two registered studies, the public record contains one negative endpoint and one silence.

Does any of them change adult body composition?

Only tesamorelin, and only in one population and one compartment. Tesamorelin reduced visceral fat by 15.2% against a 5.0% increase on placebo in HIV lipodystrophy, and its label states it "is not indicated for weight loss management as it has a weight neutral effect." Sermorelin produced no change in DEXA fat, lean mass, weight or BMI in the one adult trial. Ipamorelin has no human body-composition study at all.

Two entries in that table deserve more than a row.

Tesamorelin's regain finding reframes what the drug is. In the extension phases of both pivotal trials, patients switched from tesamorelin to placebo regained 25 cm² and 24 cm² of visceral adipose tissue, recovering most of what the first 26 weeks removed. The JAIDS authors put it plainly: the benefit was "rapidly lost in those switching from tesamorelin to placebo." That makes tesamorelin indefinite therapy rather than a course of treatment — which matters because its label carries active malignancy as an absolute contraindication, IGF-1 exceeded two standard deviations of normal in 47% of patients at 26 weeks, and the diabetes hazard odds ratio was 3.3 (95% CI 1.4, 9.6).

Sermorelin's adult failure has a citation trap attached. The favourable adult results usually attributed to sermorelin — rising IGF-1, increased lean body mass — come from Khorram et al. (JCEM, 1997), which studied [Nle27]GHRH(1-29)NH₂, a norleucine-27 analogue. Different molecule. It is the most common substitution error in sermorelin content anywhere. Ipamorelin has its own version: a paper titled "Ipamorelin for postoperative ileus: results of phase II/III trials" circulates attributed to PMID 11600700, which is actually "The role of acetylation in rDNA transcription," a 2001 molecular biology paper in Nucleic Acids Research.

How different is the dosing burden between them?

Tesamorelin is the only one of the three with a validated adult regimen, and it is the heaviest: 1.28 mg subcutaneously every day, indefinitely, from an 11.6 mg multi-dose vial discarded after seven days. Sermorelin's validated doses are diagnostic and paediatric, not adult. Ipamorelin has no validated human dosing protocol at all — both published exposures were intravenous, and neither supports the subcutaneous convention in circulation.

That half-life row is honest rather than tidy. Our sermorelin fact base does not carry a half-life figure, so this page does not print one.

Two practical consequences follow. Tesamorelin's presentation changed in March 2025 and most dosing guidance still describes the old one: EGRIFTA WR moved to the 11.6 mg multi-dose vial and lowered the daily dose from 1.4 mg to 1.28 mg, through SUPPL-20 rather than a new approval — EGRIFTA, EGRIFTA SV and EGRIFTA WR are all BLA 022505, all reading "Initial U.S. Approval: 2010." A protocol written for the 2 mg single-dose presentation gets both the concentration and the daily volume wrong.

Sermorelin's own trial authors identified the regimen as the problem. Vittone's conclusion reads: "These data suggest that single nightly doses of GHRH are less effective than multiple daily doses of GHRH in eliciting GH- and/or IGF-I-mediated effects." The one adult trial used the regimen its own authors called weaker.

For the arithmetic, use the tesamorelin calculator for the 8 mg/mL concentration, the CJC-1295 and ipamorelin calculator for ipamorelin volumes and the peptide dosing calculator for sermorelin, each alongside the reconstitution calculator. Those tools answer a volume question rather than a dose-selection question, and for two of these three compounds nothing in the literature answers the second.

What does each cost, and does legality show up in the price?

Legality does not show up in the price. Ipamorelin's median is $6.00/mg, sermorelin's $7.00/mg and tesamorelin's $7.00/mg (verified August 2026) — an approved drug, a compoundable molecule and a compound with no legal route, priced within a dollar of one another. What does show up is dispersion: sermorelin carries a 15× spread, ipamorelin 7×, and tesamorelin's spread is driven mostly by vial size.

Ipamorelin price data, sermorelin price data and tesamorelin price data are the live sources for those figures. Read each within a single vial-size band, since fixed per-vial costs push the per-milligram figure down as fill size rises.

A dollar-a-milligram sermorelin offer deserves scepticism rather than enthusiasm, particularly on a compound where fill accuracy is already documented as uncontrolled. The price spread is carrying information the purity figure is not — most plausibly about fill quantity, testing burden and endotoxin control, none of which appear in an HPLC percentage.

One comparison we are not going to complete. Tesamorelin is the only one of the three where a pharmacy product exists to compare against, and we do not hold a verified pharmacy price for it. 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 IGF-1 monitoring requirement and an FDA-approved manufacturing chain. For converting per-milligram figures into per-dose figures, the cost-per-dose calculator does the arithmetic.

Which of the three is hardest to verify in a vial?

Sermorelin, by a wide margin, and for a reason that has nothing to do with its regulatory standing. Sermorelin sits 10 daltons from Mod GRF (1-29) at 3,357.9 against 3,367.9 — too close for a rounded nominal mass. Ipamorelin at 711.9 g/mol sits 106 to 175 daltons below everything it is sold beside. Tesamorelin at 5,136 Da sits 1,778 daltons above sermorelin. Two of the three are trivial; one is not.

The verification asymmetry runs the opposite way to the regulatory one, which is the most useful thing on this page for anyone actually buying. The compound with no legal route is the easiest to confirm. Ipamorelin is the only member of its own class without the Trp-Trp core, using Aib and D-2-naphthylalanine instead, so a single low-resolution mass number separates it from GHRP-2, GHRP-6 and hexarelin at once. The compound with the cleanest regulatory pedigree is the hardest. Sermorelin's 10-dalton gap to Mod GRF (1-29) is invisible to HPLC, and the Met27→Leu27 substitution that produces it also removes the molecule's only sulfur atom — which is what makes elemental composition, rather than a rounded mass, the useful request.

Tesamorelin sits in between: identity is wide open at 5,136 Da, but the trans-3-hexenoyl group on the N-terminal tyrosine is the one part a careless synthesis can quietly omit while still producing a 44-residue peptide. A vial sold as tesamorelin that measures around 3,400 Da is sermorelin.

Platform data, all verified August 2026. The Purity Index records ipamorelin at 99.65 across 323 recency-weighted tests from 21 laboratories, sermorelin at 99.34 across 208 recency-weighted tests from 17 laboratories, and tesamorelin at 99.41% average HPLC purity across 497 independent tests from Bioviridian, Kovera, ILS and Freedom Diagnostics across 227 verified vendors — against a platform composite of 99.50. The ipamorelin compound page separately shows 407 total tests averaging 99.66% across 229 shops, the difference being recency weighting and exclusions. Price data shows 63 ipamorelin shops in stock at a $6.00/mg median and a $2.00/mg low, 45 sermorelin shops at a $7.00/mg median and a $1.00/mg low, and 60 tesamorelin shops at a $7.00/mg median and a $3.50/mg low. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing.

Note the ordering: sermorelin, the only one of the three with a genuine compounding route, tests below the platform composite while the other two test above it. 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 purity equally at 50% each in every trust score. Individual results are searchable in the lab test database, the sermorelin compound page and the tesamorelin compound page carry vendor-level detail, and the method reading is mass spectrometry for peptides and why 10 mg isn't 10 mg.

So which should you choose?

On evidence, tesamorelin wins outright and it is not close — 806 randomised patients against 43 children and eight men. On legal route, tesamorelin and sermorelin both have one and ipamorelin has none. On adult body composition specifically, the honest answer is none of the three, because tesamorelin's evidence is confined to HIV lipodystrophy, sermorelin's adult trial found nothing downstream of the GH curve, and ipamorelin has no body-composition data whatsoever.

Three closing qualifications, one per compound, because a verdict without them is a recommendation and this platform does not make those.

Tesamorelin's win comes with the heaviest conditions. Active malignancy is an absolute contraindication rather than a caution, IGF-1 monitoring is a labelled requirement, the fat returns at +22% when dosing stops, and the ten-year malignancy surveillance study — NCT01579695, 391 patients, February 2013 to August 2018 — is listed as terminated at roughly five and a half years with no reason in the record. The label still says long-term cardiovascular safety "has not been established," sixteen years after approval.

Sermorelin's advantage is entirely regulatory. The approvals were real, the 2013 safety determination was real, and the absence from Category 2 is real. None of them is evidence for what it is currently sold to do.

Ipamorelin's defence rests on a species boundary. Its selectivity — no rise in ACTH or cortisol at more than 200 times its own GH ED₅₀ — was demonstrated in conscious swine by Raun et al. in 1998. No human study measuring cortisol or prolactin after ipamorelin was located.

The trial that would settle this

No head-to-head trial of these three compounds exists, and none is required to settle the regulatory question, which is already answered. What is missing is the clinical comparison: a randomised study in adults seeking body-composition change, dosed subcutaneously at the doses people actually use, running past six months with a withdrawal arm, and measuring cortisol and prolactin in humans for ipamorelin. Every comparison on this page is currently cross-trial.

Frequently Asked Questions

Which of the three is legal?

Tesamorelin is an FDA-approved prescription drug, approved 10 November 2010 under BLA 022505 for one indication. Sermorelin has no current approval but can be compounded, because it qualifies as a component of a previously approved drug. Ipamorelin has no approval and no compounding route: FDA's advisory committee voted 0 in favour, 12 against, with 1 abstention in October 2024.

Can a pharmacy compound any of them?

Sermorelin and tesamorelin, yes, for a named patient with a valid prescription. Both satisfy the component-of-an-FDA-approved-drug prong of 21 U.S.C. § 353a(b)(1)(A). Ipamorelin, no. Note that compounded drugs are not FDA-approved either — FDA does not verify their safety, effectiveness or quality before marketing.

Which one has actually been shown to reduce fat?

Only tesamorelin, and only visceral fat, and only in HIV-associated lipodystrophy: 15.2% reduction against a 5.0% increase on placebo in 412 patients. Its label states it is not indicated for weight loss because the effect is weight neutral, and the visceral fat returns at +22% within the extension phases after switching to placebo.

Is sermorelin safer than ipamorelin?

Regulatorily, yes — sermorelin is absent from FDA's Category 2 list of bulk substances that may present significant safety risks, while ipamorelin acetate is on it. That is a statement about FDA's filing rather than a head-to-head safety comparison, and no trial has compared the two. FDA separately flags addiction potential and reproductive concerns for ipamorelin.

Are any of them allowed in sport?

No. WADA's 2026 Prohibited List names sermorelin and tesamorelin explicitly at S2.2.4 as GHRH analogues, and names ipamorelin at the same section under growth hormone secretagogues and their mimetics. All three are prohibited at all times and classified as non-specified, in and out of competition, regardless of dose.

Which is hardest to tell apart in a vial?

Sermorelin. It sits ten daltons from Mod GRF (1-29) — 3,357.9 against 3,367.9 — which no HPLC purity figure and no rounded nominal mass can resolve. The useful check is elemental composition, because sermorelin's Met27 residue gives it a sulfur atom that Mod GRF (1-29) does not have. Ipamorelin and tesamorelin are both trivial by comparison.

Where the legality spectrum leaves the three

The regulatory ranking and the evidence ranking are the same ranking, which is the least interesting possible outcome and also the true one. Tesamorelin has an approval and 806 randomised patients. Sermorelin has a compounding route and a diagnostic pedigree. Ipamorelin has neither, plus a 0–12 advisory vote and a 320-patient trial that never reported. Nothing on this page required choosing between legality and evidence.

What the spectrum does not do is answer the question most buyers arrive with. Adult body recomposition is not an approved indication for any of the three, was not demonstrated for sermorelin in the one trial that asked, and has never been studied for ipamorelin at all. Tesamorelin's fat reduction is real, confined to one compartment in one population, weight neutral by the manufacturer's own label, and reversible on withdrawal.

The most decision-relevant asymmetry on this page runs backwards. The compound with the strongest regulatory position is the one whose long-term surveillance study stopped at year five and a half. The compound with the cleanest legal route is the hardest to identify in a vial. And the compound FDA declined 0–12 is the one you can confirm to the dalton for the price of a single mass number.

Browse the growth hormone peptides category, or our complete peptide guide with 118 compounds (verified August 2026). For per-injection volume, use the tesamorelin calculator, the CJC-1295 and ipamorelin calculator or the peptide dosing 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.