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Annual Report · September 2026 Edition

The State of Peptide Evidence

September 2026. Only 6 of 34 commonly sold peptides rest on replicated human trials. Seven findings, computed from the Peptide Evidence Index and frozen so they can be cited.

September 2026 edition34 compoundsHTML + PDFEducation-only · nothing sold

What This Is

An annual, citable snapshot of how much we actually know

This is the September 2026 edition of the Peptide Evidence Index, frozen as a dated report so it can be cited, compared against next year’s edition, and quoted without the numbers shifting underneath the quote.

It covers the 34 peptides most commonly discussed and sold in the consumer peptide market, each graded by the strongest human clinical evidence that exists for it. Every figure on this page is computed directly from the Index’s graded rows — nothing here is estimated or surveyed.

Scope, stated plainly. This report measures the evidence base, not safety, legality, or effectiveness for any individual. A high tier is not a recommendation. A low tier is not a dismissal. PeptideReport.ai is education-only and sells nothing.

Headline Finding

Only 6 of 34 peptides rest on replicated human trials

That is 18%. The other 82% sit in the Emerging or Preclinical tiers — some human data that has not been replicated at scale, or no human efficacy data at all.

A · 6
B · 17
C · 11
Established 6 · 18% Emerging 17 · 50% Preclinical 11 · 32%

Seven Findings

What the data says, in order of importance

1

Every Established compound got there through a regulator.

All 6 Tier A peptides are, or were, FDA-approved: Semaglutide, Tirzepatide, Tesamorelin, PT-141 (Bremelanotide), Oxytocin hold current approvals; Sermorelin was approved and later discontinued. Not one compound reached the top tier on the strength of independent research alone. In this market, “proven” and “approved” are the same list.

2

11 of 34 (32%) have no meaningful human efficacy data.

The Preclinical tier is entirely animal, cell, or mechanistic work: BPC-157, TB-500 (Thymosin β4), MOTS-c, Humanin, Dihexa, 5-Amino-1MQ, KPV, LL-37, DSIP, Epithalon, Pinealon. Several of these are among the most talked-about peptides in consumer communities — an observation, not a measured statistic, but one anyone who has read a peptide forum will recognize.

3

13 compounds are sold with no approved use anywhere in the world.

Regulatory status “Research only” applies to Ipamorelin, CJC-1295, BPC-157, TB-500 (Thymosin β4), MOTS-c, Humanin, Dihexa, 5-Amino-1MQ, KPV, LL-37, DSIP, Epithalon, Pinealon. That is 38% of the tracked market circulating as “research material” while being used as if it were medicine.

4

4 compounds are approved somewhere — and still not replicated at scale.

Cerebrolysin, Thymosin α-1, Semax, Selank carry approvals outside the U.S. FDA process, largely in Russia or via single-country registrations. Approval abroad turned out to be a weak predictor of evidence strength, which is exactly why this Index reports regulatory status and evidence tier as separate columns.

5

3 compounds ran real human trials — and the trials said no, or maybe.

MK-677 (Ibutamoren), SS-31 (Elamipretide), AOD-9604 all have genuine human trial data with failed or mixed primary endpoints. They remain widely sold. A trial is not an endorsement; sometimes it is the strongest evidence against the marketing.

6

4 investigational compounds have stronger human data than several approved-abroad ones.

Retatrutide, Cagrilintide, SS-31 (Elamipretide), ARA-290 (Cibinetide) are unapproved but carry Phase 2 or later randomized data. Evidence and regulatory status move on different clocks — and the Index tracks both so a reader can see where they diverge.

7

1 compound’s best-documented human evidence is its harm.

Melanotan II carries formal safety warnings; its human record is dominated by adverse-event reports rather than efficacy trials. It is included here because a scorecard that only reports upside is not a scorecard.

Appendix · The Dataset

All 34 compounds, as graded on the review date

Frozen for this edition. The live, searchable version — with a clinician note per row — is the Evidence Index.

CompoundTierHighest human evidenceRegulatory status
SemaglutideA · EstablishedPhase 3 RCTs (STEP, SUSTAIN)FDA-approved (Ozempic, Wegovy, Rybelsus)
TirzepatideA · EstablishedPhase 3 RCTs (SURMOUNT, SURPASS)FDA-approved (Mounjaro, Zepbound)
TesamorelinA · EstablishedPhase 3 RCTsFDA-approved 2010 (Egrifta)
PT-141 (Bremelanotide)A · EstablishedPhase 3 RCTsFDA-approved 2019 (Vyleesi)
OxytocinA · EstablishedExtensive human RCTsFDA-approved (Pitocin)
SermorelinA · EstablishedHuman trialsFormerly FDA-approved (Geref); now compounded
RetatrutideB · EmergingLarge Phase 2 RCT (NEJM 2023); Phase 3 ongoingInvestigational — not FDA-approved
CagrilintideB · EmergingPhase 2 RCTsInvestigational
MK-677 (Ibutamoren)B · EmergingMultiple human RCTsInvestigational — never approved
SS-31 (Elamipretide)B · EmergingPhase 2–3 trialsInvestigational
CerebrolysinB · EmergingNumerous human RCTsApproved in some countries; not FDA-reviewed
Thymosin α-1B · EmergingHuman trialsApproved abroad (Zadaxin); not FDA
SemaxB · EmergingHuman studies (mostly Russian)Approved in Russia; research elsewhere
SelankB · EmergingHuman studies (mostly Russian)Approved in Russia; research elsewhere
KisspeptinB · EmergingHuman research trialsInvestigational
NAD+B · EmergingHuman trials of precursors (NR, NMN)Supplement / research
IpamorelinB · EmergingSmall human GH studiesResearch only
CJC-1295B · EmergingSmall human PK studiesResearch only
GHK-CuB · EmergingHuman topical / cosmetic studiesCosmetic ingredient; injectable is research only
AOD-9604B · EmergingHuman RCTs (obesity)Investigational — failed endpoints
ARA-290 (Cibinetide)B · EmergingPhase 2 RCTsInvestigational
VIPB · EmergingSmall human / research studiesInvestigational (e.g. aviptadil studied)
Melanotan IIB · EmergingLimited human dataNot approved; safety warnings issued
BPC-157C · PreclinicalAnimal studies onlyResearch only
TB-500 (Thymosin β4)C · PreclinicalAnimal studiesResearch only
MOTS-cC · PreclinicalAnimal / mechanisticResearch only
HumaninC · PreclinicalAnimal / cellResearch only
DihexaC · PreclinicalAnimal studiesResearch only
5-Amino-1MQC · PreclinicalAnimal / cellResearch only
KPVC · PreclinicalAnimal / cellResearch only
LL-37C · PreclinicalResearch-stageResearch only
DSIPC · PreclinicalSparse, decades-old human / animalResearch only
EpithalonC · PreclinicalSmall, older studiesResearch only
PinealonC · PreclinicalSmall, older studiesResearch only

Method

How the grades were assigned

Each compound was run through the same fixed question set: Is there human RCT evidence? Is it replicated? Is it approved anywhere, and for what? What does the strongest study show — and what did it fail to show? The answers place it in a tier before any narrative is written. Enthusiasm doesn’t bump a compound up; unfamiliarity doesn’t push one down.

Tier A — Established: replicated human randomized controlled trials. Tier B — Emerging: some human clinical data — single or small trials, mixed results, or non-Western literature — not replicated at scale. Tier C — Preclinical: no meaningful human efficacy trials.

Regulatory status is recorded separately and never used to set the tier. Where a landmark program or approval defines the evidence (STEP, SURMOUNT, Egrifta, Vyleesi), it is named so the grade can be checked against the primary source. Specific citations were not invented for compounds where the evidence is diffuse; the evidence type is stated instead.

Full framework: How Peptides Are Chosen.

Cite This Edition

Take it with you

This edition is frozen. Quote its numbers with the edition name and they will still be checkable next year, after the live Index has moved on.

DelBoccio, S. (2026). The State of Peptide Evidence: September 2026 Edition. PeptideReport.ai. https://peptidereport.ai/research/state-of-peptide-evidence-2026/

Download the PDF →

Next edition: September 2027, or sooner if Phase 3 readouts for retatrutide or cagrilintide move a row. Journalists and researchers may reproduce the figures with attribution.

Common Questions

About this edition

Is this the same as the Evidence Index?
It is a dated, frozen edition of it. The Index is live and changes as the science does; this report is a snapshot you can cite and compare against future editions.
Where do the numbers come from?
Every figure is computed from the 34 graded rows in the Evidence Index on the review date. Nothing is surveyed, modeled, or estimated. The appendix reproduces the dataset.
Does “Established” mean a peptide is safe?
No. It means the compound has replicated human randomized-trial evidence. Safety, suitability, and legality are separate questions for you and your physician.
Why are so few in the top tier?
Because replicated human RCTs are expensive, slow, and usually run only when a company is pursuing approval. In this market, the Established list and the approved list turned out to be the same list.
Can I quote this report?
Yes, with attribution to PeptideReport.ai and the edition name. The canonical URL is on the Cite This Edition card.

About the Author

SD
Dr. Scott DelBoccio, DMD
Founding Author · PeptideReport.ai

Dr. DelBoccio is a clinician with thirty years of practice and a focus on peptide pharmacology. He built the Peptide Evidence Index — and this annual edition of it — to hold every compound to the same evidentiary standard rather than the one the market wishes applied. PeptideReport.ai is education-only and sells nothing.

Full Disclaimer

This page is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. The compounds discussed are research/investigational and require physician supervision. PeptideReport.ai does not manufacture, sell, or endorse any preparation. Content addresses adults 21 and older. Evidence and regulatory status continue to evolve.