Sermorelin is the one peptide in the growth hormone category where "where to buy" has two lawful answers. A compounding pharmacy can dispense it against a prescription. A research vial cannot, and FDA has said so about sermorelin by name.
Sermorelin sits in the growth hormone peptides category and is the only compound in it absent from FDA's list of bulk substances that may present significant safety risks. The evidence picture — two narrow approvals, a commercial withdrawal, and an adult trial that found nothing downstream of the GH curve — is in sermorelin: the only GH peptide FDA ever approved. For per-injection volume there is the peptide dosing calculator.
What is sermorelin, and why does source quality matter?
Sermorelin is the unmodified first 29 amino acids of human growth hormone-releasing hormone — YADAIFTNSYRKVLGQLSARKLLQDIMSR-NH₂, amidated, CAS 86168-78-7, formula C₁₄₉H₂₄₆N₄₄O₄₂S, molecular weight 3,357.9 g/mol — and it agonises the GHRH receptor, stimulating the pituitary's own GH release. Source quality matters because its nearest market rival, Mod GRF (1-29), sits just 10 daltons away at 3,367.9, a gap that no HPLC purity figure addresses and a rounded nominal mass will not settle.
Property | Value |
|---|---|
Sequence | YADAIFTNSYRKVLGQLSARKLLQDIMSR-NH₂ — native human GHRH(1-29), amidated, unmodified |
CAS | 86168-78-7 (PubChem CID 16132413) |
Formula / MW | C₁₄₉H₂₄₆N₄₄O₄₂S / 3,357.9 g/mol |
ATC codes | H01AC04 (pituitary hormones) and V04CD03 (pituitary function diagnostics) |
Mechanism | GHRH receptor agonist — stimulates the pituitary's own GH release |
The dual ATC coding is a historical artefact worth noticing before you shop, because it explains the compound's unusual position. Sermorelin was classified both as a hormone therapy and as a diagnostic agent because it was approved as both — and neither approval was for adults, body composition or ageing. That distinction survives into the market: a product with a genuine regulatory pedigree is being sold for an indication the pedigree never covered.
The sourcing risk splits cleanly in two, and most buying guides only address the first half. The identity half is the 10-dalton gap to Mod GRF (1-29), a molecule sold under both that name and "CJC-1295" and stocked by many of the same vendors. The quantity half is fill accuracy, where the sermorelin compound page records one vendor's product measuring 12.88 mg against a 10 mg label — a 28.8% overage. Overfill is not generosity; it is evidence that fill accuracy is not controlled, and the same process that runs 28.8% over can run under.
What is the regulatory status of sermorelin?
Sermorelin is the only growth hormone peptide FDA has ever approved, twice — Geref Diagnostic (NDA 019863) on 28 December 1990 and Geref (NDA 020443) on 26 September 1997 — and both approvals were withdrawn effective 18 June 2009 after EMD Serono discontinued the products commercially. FDA formally determined in 2013 that they "were not withdrawn for reasons of safety or effectiveness." As of August 2026 sermorelin appears nowhere on FDA's Category 2 list, and WADA prohibits it at all times under S2.2.4.
GEREF Diagnostic | GEREF | |
|---|---|---|
NDA | 019863 | 020443 |
Approved | 28 December 1990 | 26 September 1997 |
Sponsor | EMD Serono | EMD Serono |
Indication (FDA's words) | "evaluating the ability of the somatotroph of the pituitary gland to secrete growth hormone" | "the treatment of idiopathic growth hormone deficiency (GHD) in children with growth failure" |
The withdrawal sequence matters to a buyer because it is routinely misread as a safety event. EMD Serono notified FDA of discontinuation in letters dated 11 July 2008 and 2 December 2008, requested withdrawal of NDA 019863 on 12 December 2008, and FDA withdrew both approvals effective 18 June 2009. The 2013 determination, at 78 FR 14095–14096, was issued in response to a citizen petition and had the express purpose of clearing the way for generic applications. No generic was ever approved. A drug was approved, sold, discontinued commercially, formally cleared of any safety or effectiveness concern, and then nobody wanted to make it.
What sermorelin is not on is the more useful fact. FDA's Category 2 list — bulk substances that may present significant safety risks, page current 22 April 2026 — includes GHRP-2, GHRP-6, ipamorelin acetate, ibutamoren, kisspeptin-10, CJC-1295, BPC-157, AOD-9604, TB-500, MOTS-c, epitalon, semax, LL-37, PEG-MGF, melanotan II, GHK-Cu and thymosin alpha-1. Sermorelin appears nowhere on it. Every compound it is commonly stacked with does. That contrast is the single most decision-relevant regulatory fact about this molecule, and it is stable rather than pending — sermorelin is not waiting on a nomination outcome, because it qualifies under a different statutory route entirely. Our FDA peptide regulation timeline tracks where each of those nominations actually stands.
In sport, sermorelin is named explicitly at S2.2.4 of WADA's 2026 Prohibited List — "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)" — prohibited at all times, non-specified. Legal to prescribe is not legal to compete on.
Claim you will meet while shopping | What the record says | Verdict |
|---|---|---|
"FDA-approved" | Yes — twice, in 1990 and 1997, both approvals withdrawn in 2009 | True, and narrow |
"Withdrawn because it was unsafe" | FDA formally determined otherwise in 2013 | False — commercial |
"Legal to compound" | Yes, via the approved-drug-component prong | True |
"Validated for diagnosing GH deficiency" | Endocrine Society guideline-grade, at a 4.1 µg/L cut-point | Established |
"Grows children with GHD" | Real but limited; recombinant GH outperformed it on bone-age SDS | Supported, modestly |
"Raises IGF-1 in older adults" | The one sermorelin trial found no IGF-1 change | Not shown |
"Improves body composition in adults" | No change in DEXA fat or lean mass at six weeks | Not shown |
"Improves deep sleep" | GHRH "may even have impaired slow wave sleep" | Contradicted |
"Safer than other GH peptides" | Absent from Category 2, unlike all its neighbours | Regulatorily, yes |
"Approved for adult anti-aging" | Never approved for any adult indication | False |
How do you tell sermorelin from Mod GRF (1-29)?
Mass spectrometry, and a high-resolution result rather than a rounded number. Sermorelin sits at 3,357.9 g/mol and Mod GRF (1-29) at 3,367.9 — 10 daltons apart, invisible to HPLC purity and too close for a nominal mass to settle. The Met27→Leu27 substitution that produces that gap also removes the molecule's only sulfur atom, so the two differ in elemental composition as well as mass: C₁₄₉H₂₄₆N₄₄O₄₂S against C₁₅₂H₂₅₂N₄₄O₄₂. Sulfur present or sulfur absent is a binary a composition report can answer.
Compound | Formula | MW | Sulfur? |
|---|---|---|---|
Sermorelin (native GHRH 1-29 amide) | C₁₄₉H₂₄₆N₄₄O₄₂S | 3,357.9 | Yes (Met27) |
C₁₅₂H₂₅₂N₄₄O₄₂ | 3,367.9 | No | |
CJC-1295 with DAC | C₁₆₅H₂₆₉N₄₇O₄₆ | 3,647.2 | No |
Ten daltons is nothing to a purity certificate and everything to a mass spectrometer. Both molecules are trivial for mass spectrometry and impossible for HPLC purity alone, which is why the useful request is a batch-matched identity result reporting elemental composition, not a single rounded figure. The third row is the easy case: at 3,647.2 the DAC form sits far enough clear of sermorelin that no instrument confuses the two.
One database caution follows from the same table. Querying "CJC-1295" in chemical databases returns the DAC form at 3,647.2, so a vendor selling "CJC-1295" at 3,367.9 is selling Mod GRF (1-29) under a name that belongs to a different molecule. A buyer who has been sold that product and now wants sermorelin is comparing two vials that look identical on every document except the one that matters. See mass spectrometry for peptides for what an identity result establishes that a purity percentage cannot.
7 things to check before ordering sermorelin
Seven checks cover sermorelin, and two of them exist because of a 10-dalton gap. High-resolution mass spectrometry at 3,357.9 Da, an elemental composition showing sulfur present, third-party HPLC against a 99.34 benchmark, net peptide content, fill accuracy on a compound with a 28.8% overage on record, an LAL endotoxin result that is largely absent across this compound's listings, and a pricing check across a 15× spread. Three of those are readable before any laboratory is involved.
High-resolution mass spectrometry at 3,357.9 Da. Not 3,367.9, which is Mod GRF (1-29), and not 3,647.2, which is CJC-1295 with DAC. Ask for a batch-matched result rather than a specimen certificate from an earlier lot, and treat a nominal mass reported without a decimal place as insufficient for a 10-dalton discrimination.
Elemental composition showing sulfur present. This is the check that converts an ambiguous 10 daltons into a yes-or-no answer. Sermorelin's Met27 residue gives it C₁₄₉H₂₄₆N₄₄O₄₂S; Mod GRF (1-29) is C₁₅₂H₂₅₂N₄₄O₄₂ with no sulfur at all. A composition matching the second formula is not sermorelin regardless of what the label says. See how to read peptide lab test results.
Third-party HPLC purity from a named laboratory. This platform records sermorelin at 99.34 against a composite of 99.50 — below the platform norm rather than above it, which is unusual in this category and worth knowing before "above 98%" sounds reassuring. A vendor's own in-house document is not third-party testing.
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, and salts and residual water sit inside the difference. Ask separately for a net content or amino acid analysis figure (why 10 mg isn't 10 mg).
Fill accuracy, in both directions. One vendor's sermorelin measured 12.88 mg against a 10 mg label — a 28.8% overage. Read that as a process-control failure rather than a bonus: a fill line that runs 28.8% over is a fill line that is not being measured, and the same absence of control produces shortfalls. Quantitative content testing is the check, and large overages belong in the red-flag column with shortfalls.
An LAL endotoxin result. Endotoxin data is largely absent across sermorelin listings — most entries report nothing at all. An absent LAL result means the batch was not tested for pyrogens rather than that it passed, and on injectable material that is a meaningful gap. See peptide endotoxin testing and the LAL assay.
The pricing reality check, and what no certificate establishes. Sermorelin runs from a $1.00/mg low to a $7.00/mg median — a 15× spread at nominally comparable purity — and a dollar-a-milligram outlier deserves scepticism rather than enthusiasm on a compound where fill accuracy is already documented as uncontrolled. Beyond that, a flawless certificate confirms a 29-residue peptide of the right mass and composition at the stated quantity. It does not confer any of the statutory protections attached to a compounded prescription, and it does not make "for research use only" a legal category. See how to verify peptide quality before you buy.
Check | What it confirms | How to verify | Red flag |
|---|---|---|---|
Mass spectrometry | Sermorelin at ~3,358 Da, not Mod GRF (1-29) at ~3,368 Da | Batch-matched CoA with the MS result | HPLC purity only — 10 daltons is invisible to it |
Sulfur present | The Met27 residue that Mod GRF lacks | Elemental composition on the MS report | A composition matching C₁₅₂H₂₅₂N₄₄O₄₂ |
Fill accuracy | The vial contains what the label says | Quantitative content testing | Large overages as well as shortfalls — 28.8% is on record |
Net peptide content | Actual peptide versus salts and water | Net content or amino acid analysis | Purity quoted as if it were quantity |
Endotoxin (LAL) | No pyrogens in injectable material | LAL result on the batch | Not tested — common for this compound |
HPLC purity | Proportion of intended peptide | Third-party CoA from a named lab | Below the 99.34 benchmark; vendor's own document only |
Where does sermorelin rank on Peptigrity's lab test database?
Peptigrity's Purity Index records sermorelin at 99.34 across 208 recency-weighted tests from 17 laboratories (verified August 2026), below the platform composite of 99.50. Sermorelin price data shows 45 shops in stock, a median of $7.00/mg and a lowest tracked price of $1.00/mg on a 10 mg vial (verified August 2026) — a 15× spread at nominally comparable purity. One vendor's product measured 12.88 mg against a 10 mg label, a 28.8% overage.
Below-composite is the honest framing and it is worth stating plainly rather than quoting 99.34 without a benchmark. Seventeen laboratories and 208 recency-weighted tests is real coverage, and the resulting number still sits under the platform-wide figure. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing.
Two gaps in the record deserve naming rather than glossing. No individual laboratories are named in our sermorelin coverage, so a buyer cannot check whether the testing behind that 99.34 came from one lab or seventeen in any particular vendor's case — search the lab test database and the community-verified shop reviews for the specific shop instead of relying on the compound average. And endotoxin data is largely absent across sermorelin listings, which means the purity figure is describing one axis of a product that has at least three. 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.
The 15× price spread carries information the purity number does not. A $1.00/mg offer and a $7.00/mg median sit inside the same nominal purity band, so the difference is being made somewhere HPLC does not look — most plausibly fill quantity, testing burden and pyrogen control, exactly the three axes where this compound's record is weakest. Compare within a single vial size, since fixed per-vial costs push the per-milligram figure down as fill size rises, and the low here is quoted on a 10 mg vial.
The trial that would settle this is not a testing study. The vial questions are answerable today; the question sermorelin's entire adult market rests on has never been asked properly.
Element | Requirement | Why |
|---|---|---|
Population | Adults seeking body-composition change | All approval-grade evidence is paediatric or diagnostic |
Design | Randomised, placebo-controlled | The one adult sermorelin trial was open-label, n=11 |
Regimen | Multiple daily doses, not once nightly | Vittone's authors concluded once-nightly was the weaker regimen |
Primary endpoint | DEXA body composition plus function | GH curves are not the outcome anyone wants |
Duration | Beyond six weeks | Six weeks produced no downstream change |
Comparator | Tesamorelin | The approved GHRH analogue is the benchmark |
Is a compounded prescription different from a research vial?
Compounded sermorelin is a genuine legal route, unlike almost everything it gets stacked with. Sermorelin qualifies under 21 U.S.C. § 353a(b)(1)(A) as a component of an FDA-approved drug, and FDA's own 503B bulk substances documentation lists "Sermorelin Acetate" with a footnote to that effect. A compounded prescription requires a named patient, a licensed pharmacist in a state-licensed pharmacy, API from an FDA-registered establishment and a valid certificate of analysis for the bulk substance. A research vial has none of it.
The statutory detail is worth understanding rather than memorising, because it explains why this compound is different from its neighbours. A bulk substance used in 503A compounding must do one of three things: comply with a USP monograph, be a component of an FDA-approved drug, or appear on FDA's 503A bulks list. Sermorelin has no USP monograph and is not on the bulks list — which contains six substances, none of them peptides, and sermorelin was never even nominated. It qualifies under the second prong, and that is the whole of its legal advantage.
One honest caveat belongs here. 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 503B 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.
Compounded prescription | Research vial | |
|---|---|---|
Legal basis | 21 U.S.C. § 353a(b)(1)(A), component-of-an-approved-drug prong | None — sold as "not for human use" |
Patient | Named patient, valid prescription | Anyone with a payment method |
Who makes it | Licensed pharmacist, state-licensed pharmacy | Unregulated supplier |
API sourcing | FDA-registered establishment | Unspecified |
Certificate | Valid CoA on the bulk substance, by statute | Marketing certificate on a finished vial, if any |
Sterility standards | USP <795> and <797>, with beyond-use dating and documented stability | None required |
CGMP | Required of 503B outsourcing facilities; not of 503A pharmacies | Not applicable |
FDA approval | No — compounded drugs are not FDA-approved | No |
Note the last row, because the comparison is not between a regulated product and an unregulated one. FDA is blunt about the limits of the route it permits: "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." The compounded route buys a chain of custody, a prescriber and a statutory paperwork standard. It does not buy an approval. For the general structural version of this comparison, see compounding pharmacy versus research peptide.
The "research use only" disclaimer has been tested on this exact compound, and it failed. A Warning Letter dated 10 December 2024 to Xcel Research LLC named seven products including sermorelin. Despite labelling reading "FOR RESEARCH USE ONLY" and "NOT INTENDED FOR HUMAN USE," FDA held the products were unapproved new drugs in violation of sections 505(a) and 301(d) of the Food, Drug and Cosmetic Act, because website evidence established human intended use. The disclaimer is not a legal shield, and sermorelin is the compound FDA chose to demonstrate that with.
Frequently Asked Questions
What purity standard should sermorelin meet?
This platform records sermorelin at 99.34 across 208 recency-weighted tests from 17 laboratories (verified August 2026), below the platform composite of 99.50. Purity is also the second question for this compound, not the first: an HPLC percentage cannot distinguish sermorelin from Mod GRF (1-29) ten daltons away, so an identity result at 3,357.9 Da with elemental composition comes first.
How much does sermorelin cost?
Price data shows 45 shops in stock, a median of $7.00/mg and a lowest tracked price of $1.00/mg on a 10 mg vial (verified August 2026) — a 15× spread at nominally comparable purity. Compare within a single vial-size band. Those figures exclude shipping, taxes and customs, coupon codes, bulk tiers, multi-vial kits and account-gated pricing, and a dollar-a-milligram outlier deserves scepticism rather than enthusiasm.
Is sermorelin legal, and can a pharmacy compound it?
Yes to both, with limits. Sermorelin qualifies as a component of a previously FDA-approved drug, one of the three statutory routes for a bulk substance in 503A compounding, and it is absent from FDA's Category 2 list, unlike CJC-1295, ipamorelin, GHRP-2 and GHRP-6. It is nonetheless prohibited in sport at all times under WADA S2.2.4.
How do I know the vial contains sermorelin and not Mod GRF (1-29)?
Mass spectrometry with elemental composition. Sermorelin is 3,357.9 g/mol with a sulfur atom at Met27; Mod GRF (1-29) is 3,367.9 with none. Ten daltons is invisible to HPLC purity and too close for a rounded nominal mass, but sulfur present versus sulfur absent is a binary that a composition report answers outright.
Does sermorelin do anything for adults?
The one controlled trial in older adults gave 11 men aged 64 to 76 two milligrams nightly for six weeks. Nocturnal GH release rose, but IGF-1, IGFBP-3, GH-binding protein, weight, BMI, waist-to-hip ratio and DEXA-measured muscle and fat were all unchanged. The favourable adult results usually attributed to sermorelin come from a study of [Nle27]GHRH(1-29)NH₂, a different molecule. The category-level comparison is in ipamorelin vs sermorelin vs tesamorelin.
Does "for research use only" protect the seller or the buyer?
Neither, on this compound. FDA's December 2024 warning letter to Xcel Research LLC named sermorelin among seven products and held them to be unapproved new drugs under sections 505(a) and 301(d) despite labelling that read "FOR RESEARCH USE ONLY" and "NOT INTENDED FOR HUMAN USE," because website evidence established human intended use.
Browse the growth hormone peptides category, or our complete peptide guide with 118 compounds (verified August 2026). For per-injection volume, use 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.
