Clinical Reference · Peptide Protocols

Peptide Compound &
Regulatory Reference

Classification, mechanism of action, regulatory tier, and evidence level for the major research and compounded peptides — organized by category. This guide does not publish dosing amounts, frequencies, cycle lengths, or preparation instructions.

💊 11 Compounds 🔬 5 Categories 📋 3 Regulatory Tiers 📚 Evidence Levels
✍️ Authored by Dr. Scott DelBoccio, DMD — PeptideReport.ai
⚠ Research Compounds — Regulatory Disclaimer

The majority of compounds in this guide are unscheduled research chemicals not approved by the FDA for human therapeutic use. Compounded preparations require a valid physician prescription from a licensed 503A or 503B compounding pharmacy. Research-tier compounds are legal to purchase for in vitro study but are not approved for human administration. This guide describes classification, mechanism, regulatory status, and evidence quality only — it does not publish dosing amounts, frequencies, cycle lengths, reconstitution instructions, or injection technique. Any decision about actual use belongs with a licensed healthcare provider.

Comprehensive Reference

Master Reference Table

All 11 compounds at a glance, by category, general administration class, regulatory tier, and evidence basis. This table does not include dose amounts, frequencies, or cycle lengths — see the full compound profiles for mechanism detail, and a licensed physician for anything related to actual use.

Compound Category Administration Class US Regulatory Status Evidence Basis
Semax Cognitive Intranasal, SQ
Research compound
Russian clinical use; limited independent Western RCTs
Selank Cognitive Intranasal
Research compound
Russian clinical use; limited independent Western RCTs
BPC-157 Recovery SQ, IM, Oral
Research compound
Extensive preclinical/animal evidence; no completed human RCT
TB-500 Recovery SQ, IM
Research compound
Preclinical + Phase II human trials (cardiac: neutral; ocular: positive)
Ipamorelin GH Axis SQ
Compounded Rx
Preclinical + compounded-pharmacy use; limited compound-specific RCT data
CJC-1295 (no DAC) GH Axis SQ
Research compound
Preclinical + compounded-pharmacy use; limited independent RCT data
Sermorelin GH Axis SQ
Compounded Rx
Formerly FDA-approved (Geref, discontinued); current use via compounding
GHK-Cu Longevity SQ, Topical
Research compound
Preclinical + cosmetic/wound-healing human trials
Epithalon Longevity SQ, IV
Research compound
Primarily Russian institutional research; limited independent replication
Thymosin Alpha-1 Longevity SQ
Research / approved elsewhere
Approved (Zadaxin) in 35+ countries for hepatitis/immune indications; not FDA-approved in the US
PT-141 (Bremelanotide) Metabolic / Sexual Nasal (Vyleesi, approved); SQ (research, unapproved)
FDA-Approved (Vyleesi)
Phase III trials support the approved nasal formulation for premenopausal HSDD
FDA-Approved Compounded Rx (503A/503B) Research Compound
🧠
Category
Cognitive / Neuroprotective

Both cognitive peptides in this category are Russian-origin heptapeptides with intranasal delivery as the primary literature route and complementary mechanisms discussed together in research contexts.

Semax
ACTH(4-7)–Pro–Gly–Pro · MW 813 Da · Amidate variant also available
Administration Class Intranasal (primary literature route) · SQ also described
US Status Research compound · not FDA-approved
Evidence Basis Widely used in Russian clinical practice for stroke/cognitive indications; limited independent Western RCTs
Primary Studied Effect BDNF/NGF upregulation · dopaminergic activity · cognitive enhancement research
Selank
Tuftsin analogue Thr–Lys–Pro–Arg–Pro–Gly–Pro · MW 751 Da
Administration Class Intranasal (primary literature route) · SQ less common
US Status Research compound · not FDA-approved
Evidence Basis Russian anxiolytic clinical research; limited independent Western RCTs
Primary Studied Effect Anxiolytic · BDNF · enkephalin modulation · GABAergic
🧠 Semax + Selank: Research Community Combination

Semax (cognitive drive, BDNF) and Selank (anxiolytic stabilization) are frequently discussed together in research-community contexts as mechanistically complementary — the rationale being that Selank's anxiolytic effect may offset the mild stimulatory edge some report with Semax. No dedicated combination trial exists; the pairing is mechanistic extrapolation and anecdotal reporting, not established clinical practice. This page does not publish combined dosing or timing — any such decision belongs with a licensed physician.

💪
Category
Recovery / Tissue Repair

Both recovery peptides act through distinct pathways — BPC-157 via GABAergic and nitric-oxide signaling locally, TB-500 via systemic actin sequestration — making them mechanistically complementary rather than redundant.

BPC-157
Body Protection Compound · 15 amino acids · MW 1419 Da
Administration Class SQ, IM · Oral (studied for GI-specific effects)
US Status Research compound · not FDA-approved
Evidence Basis Extensive preclinical/animal evidence across GI, tendon, and CNS injury models; no completed human RCT
Primary Studied Effect Tendon/ligament repair · GI healing · angiogenesis · nitric-oxide pathway
TB-500
Thymosin Beta-4 fragment · Ac-LKKTETQ · MW ~900 Da
Administration Class SQ, IM (research literature) · IV (clinical trial route)
US Status Research compound · not FDA-approved · WADA Prohibited List S2.2
Evidence Basis Preclinical + Phase II human trials: cardiac (RGN-352, did not meet primary endpoint), ocular (RGN-259, positive)
Primary Studied Effect Actin sequestration · systemic repair · anti-inflammatory · cardiac/neural progenitor activation
💪 BPC-157 + TB-500: Research Community Combination

BPC-157 and TB-500 are the two most commonly co-administered research peptides in the recovery space. BPC-157 acts locally (tendon, GI, muscle) via nitric-oxide signaling; TB-500 acts systemically via actin sequestration and VEGF-driven angiogenesis. The two target different pathways with no documented antagonism, which is the mechanistic basis for combined use discussed in research communities. No direct head-to-head or combination human trial exists; synergy data is extrapolated from complementary mechanisms and anecdotal reporting, not established clinical protocol. This page does not publish combined dosing — any such decision belongs with a licensed physician.

📈
Category
GH Axis Peptides

GH secretagogues stimulate endogenous growth hormone release rather than replacing it — preserving the natural pulsatile physiology and feedback regulation that exogenous HGH bypasses. Sermorelin (GHRH analogue) and Ipamorelin/CJC-1295 (GHRH + GHS-R synergy) are distinct mechanistic approaches.

Ipamorelin
GHS-R agonist · pentapeptide · selective GH release without cortisol
Administration Class SQ
US Status Compounded Rx · 503A/503B
Evidence Basis Preclinical + compounded-pharmacy clinical use; limited compound-specific RCT data
Primary Studied Effect Selective GH secretagogue via GHS-R without meaningful cortisol elevation
CJC-1295 (no DAC)
Modified GRF(1-29) · short-acting GHRH analogue · half-life 30 min
Administration Class SQ
US Status Research compound · not FDA-approved
Evidence Basis Preclinical + compounded-pharmacy clinical use; limited independent RCT data
Note The DAC (long-acting) variant has a substantially different pharmacokinetic and risk profile from CJC-1295 no-DAC
Sermorelin
GHRH(1-29)NH₂ · 29-amino-acid · oldest GHRH analogue in clinical use
Administration Class SQ
US Status Compounded Rx · 503A/503B
Evidence Basis Formerly FDA-approved (Geref, discontinued for commercial reasons); longest clinical track record of the GH secretagogues
Primary Studied Effect GHRH-receptor agonism · endogenous pulsatile GH release
📊 IGF-1 Monitoring for GH Axis Peptides

Serum IGF-1 is the standard biomarker used by physicians to monitor GH-axis peptide therapy — a baseline reading followed by periodic retesting lets a prescriber assess response and stay within a normal physiological range. GH axis peptides should not be used during active malignancy, and any protocol involving them warrants ongoing physician oversight rather than self-directed dose or schedule adjustment.

Category
Longevity / Anti-Aging

Three mechanistically distinct compounds: GHK-Cu (copper peptide, collagen and wound signaling), Epithalon (telomere biology and pineal), and Thymosin Alpha-1 (immune modulation). Evidence quality varies substantially; caveat noted per compound.

GHK-Cu
Glycyl-L-histidyl-L-lysine copper(II) · naturally occurring tripeptide
Administration Class SQ injection · topical (separate formulations)
US Status Research compound (SQ) · topical cosmetic use widespread
Evidence Basis Preclinical + cosmetic/wound-healing human trials; systemic SQ effects extrapolated largely from animal studies
Primary Studied Effect Collagen synthesis · wound healing · antioxidant · skin remodeling
Epithalon
Epitalon · Ala-Glu-Asp-Gly · tetrapeptide · pineal gland origin
Administration Class SQ (research literature) · IV used in Russian trials
US Status Research compound · not FDA-approved
Evidence Basis Limited human trials · primarily Russian institutional data · biomarker effects best documented, independent replication limited
Primary Studied Effect Telomerase activation · melatonin regulation · circadian rhythm · longevity biomarkers
Thymosin Alpha-1 (TA-1)
28-amino-acid peptide · N-terminally acetylated · derived from thymosin fraction 5
Administration Class SQ
US Status Research / approved elsewhere
Evidence Basis Approved (Zadaxin) in 35+ countries for viral hepatitis and immunodeficiency; not FDA-approved in the US — off-label longevity use is extrapolation from the approved indications
Primary Studied Effect Immune modulation · T-cell differentiation
⚠ Evidence Caveat — Longevity Category

The longevity peptides carry the thinnest clinical evidence base in this guide. GHK-Cu has robust preclinical data and modest human cosmetic/wound trials; systemic effects in humans are extrapolated from animal studies. Epithalon's longevity claims rest almost entirely on Russian institutional research with limited independent replication. Thymosin Alpha-1 has the strongest regulatory precedent (approved in 35+ countries for specific indications) but off-label longevity use is extrapolation beyond its approved indications. Physician oversight is appropriate given the evidence-to-enthusiasm ratio in this category, and this guide does not publish dosing for any of the three.

🔥
Category
Metabolic / Sexual Function

PT-141 (bremelanotide) is the only compound in this guide with FDA approval for human therapeutic use in its approved indication — as Vyleesi, for premenopausal HSDD. Unapproved SQ research use follows a different, unregulated risk profile that this guide does not detail.

PT-141 (Bremelanotide / Vyleesi)
Melanocortin receptor agonist (MC1R, MC3R, MC4R) · cyclic heptapeptide · derived from Melanotan II

FDA-Approved Product (Vyleesi)

Formulation 1.75 mg fixed-dose auto-injector — the FDA-approved product ships in a single, non-adjustable dose
Route Subcutaneous (Vyleesi auto-injector)
Indication Premenopausal HSDD · prescription only

Unapproved Research-Route Use (SQ)

US Status Not FDA-approved in this form or route; not a substitute for the approved product
On dosing This guide does not publish amounts, titration schedules, or timing for unapproved research-route use
⚠ Cardiovascular Caution — PT-141

PT-141 causes transient but measurable increases in blood pressure and decreases in heart rate. It is contraindicated with high cardiovascular risk, recent cardiovascular events, or concurrent use of antihypertensives or nitrates. Vyleesi's FDA prescribing information requires avoidance of spontaneous use by patients with uncontrolled hypertension or known cardiovascular disease — the same cardiovascular caution applies with equal or greater force to unsupervised, unapproved research-route use.

Combined Use

Combination Research Rationale

Research communities frequently discuss combining peptides on the basis of complementary mechanisms. No combination in this guide has been formally studied as a unit in a human clinical trial — these are mechanistic rationales assembled from individual compound data and anecdotal reporting, not established or physician-directed protocols, and this page does not publish combined dosing, timing, or sequencing for any of them.

Cognitive Performance Combination
Semax Selank

Semax upregulates BDNF and NGF, enhances dopaminergic tone, and is associated with improved focus in the research literature. Selank modulates enkephalins and provides anxiolytic stabilization, which research-community reporting suggests may offset the mild stimulatory edge Semax can produce alone. No dedicated combination trial exists.

Healing Combination
BPC-157 TB-500

BPC-157 acts locally via nitric-oxide signaling; TB-500 acts systemically via actin sequestration and VEGF-driven angiogenesis. Different binding targets with no documented antagonism form the mechanistic basis for combined discussion in research communities — this is the most commonly referenced combination in the recovery space, though it carries the same lack of dedicated trial data as the others here.

GH-Axis Combination
Ipamorelin CJC-1295 (no DAC)

Ipamorelin (GHS-R agonist) and CJC-1295 no DAC (GHRH analogue) act through distinct receptors; combining GHRH and ghrelin-mimetic signaling is a well-established physiological synergy in the growth hormone axis, which is the mechanistic basis for their frequent co-administration in compounded-pharmacy practice.

Neurological Recovery Combination
Semax BPC-157

Discussed in post-injury or post-infectious cognitive contexts: Semax drives BDNF/NGF upregulation and neuroprotection, while BPC-157 is studied for local blood-flow and nerve-repair support via nitric-oxide and VEGF pathways. Increasingly referenced in discussions of post-viral cognitive symptoms. Not studied together in any clinical trial; rationale is purely mechanistic and warrants physician review before any use is considered.

Comprehensive Recovery + GH-Axis Combination
BPC-157 TB-500 Ipamorelin

A three-compound combination sometimes discussed for comprehensive injury recovery with concurrent GH-axis support: BPC-157 for local repair, TB-500 for systemic anti-inflammatory and actin-mediated effects, Ipamorelin for GH-pulsatility-linked tissue anabolism during sleep. This is the most complex combination referenced in this guide, and it correspondingly carries the least direct evidence — physician oversight, laboratory monitoring, and individualized medical judgment are non-negotiable at this level of complexity, not an optional add-on.

Reference Glossary

Regulatory Tiers & Evidence Levels

These are the classification systems used throughout this guide and across PeptideReport.ai compound profiles.

FDA-Approved

The compound (in a specific formulation, dose, and indication) has completed FDA review and is approved as a prescription drug for that indication. Use outside the approved formulation, dose, or indication is not covered by that approval.

Compounded Rx

Available only through a valid prescription from a licensed 503A or 503B compounding pharmacy. Not independently FDA-approved as a finished drug product; pharmacy compounding is subject to its own regulatory framework and physician oversight.

Research Compound

Sold as a research chemical, not approved by the FDA for human use in any form. Purity, dosing accuracy, and manufacturing quality are not independently verified or guaranteed by any regulatory body.

Evidence Basis — What It Means

The "Evidence Basis" column and rows throughout this guide summarize the type and strength of data behind a compound's mechanism claims — animal/preclinical data, Phase I/II human trials, institutional data from outside the US, or full regulatory approval. It is not a safety or efficacy endorsement, and it does not scale with how popular a compound is in research-community discussion.

⚠ On Reconstitution, Injection Technique, and Non-Response

This guide intentionally does not include reconstitution math, preparation instructions, injection technique, or self-directed dose-adjustment guidance for any compound. Reconstitution and preparation of any compounded or research peptide should be handled by a licensed compounding pharmacy or physician, not assembled from a public reference page. Similarly, a perceived lack of response to any protocol is a reason to consult the prescribing or supervising physician — about source quality, preparation, or candidacy — not a reason to independently increase dose or frequency.

Common Questions

Frequently Asked Questions

Straight answers to the regulatory and classification questions readers ask most about compound status on this page. Answers stay at the same classification level as the rest of the guide — no dosing, reconstitution, or injection detail.

What's the difference between an FDA-approved drug and a compounded peptide?

An FDA-approved drug — in this guide, that's PT-141 as the branded product Vyleesi — has completed the FDA's full drug-review process in a specific formulation, dose, and indication. A compounded peptide, like Ipamorelin or Sermorelin here, is available only through a valid prescription filled by a licensed 503A or 503B compounding pharmacy, and has not independently completed that same FDA approval process as a finished drug product. Both require a physician's prescription, but the two sit in different regulatory tiers with different oversight and evidence requirements.

What does “research compound” status mean for a peptide?

A research compound — the classification used for most entries in this guide, including Semax, Selank, BPC-157, and TB-500 — is sold for research purposes and is not approved by the FDA for human use in any form. Because these products fall outside FDA drug-manufacturing oversight, their purity, dosing accuracy, and manufacturing quality are not independently verified or guaranteed by any regulatory body. This status describes legal and regulatory classification only, not a judgment about scientific promise.

What is a 503A/503B compounding pharmacy, and which peptides in this guide fall into that tier?

A 503A or 503B compounding pharmacy prepares a peptide product to fill a valid, individualized physician prescription; this guide groups both together as the “Compounded Rx” tier because pharmacy compounding operates under its own regulatory framework rather than the standard FDA new-drug approval pathway. On this page, Ipamorelin and Sermorelin are both classified in this tier. That route is distinct from a direct research-chemical purchase: it requires a prescription and physician oversight rather than an unregulated vendor transaction.

Which peptides in this guide are FDA-approved today?

Of the 11 compounds covered, only PT-141 (bremelanotide) has current FDA approval, marketed as Vyleesi for premenopausal HSDD in its approved fixed-dose subcutaneous auto-injector formulation. Sermorelin was formerly FDA-approved as Geref before that product was discontinued for commercial reasons, and is now available only through compounding pharmacies. Every other compound in this guide — Semax, Selank, BPC-157, TB-500, CJC-1295, GHK-Cu, Epithalon, and Thymosin Alpha-1 — is classified as a research compound and is not FDA-approved for human use.

What does “Evidence Basis” mean in this guide, and why doesn't it indicate safety or approval?

“Evidence Basis” summarizes the type and strength of data behind a compound's mechanism claims — ranging from animal and preclinical data to Phase I/II human trials, institutional research from outside the US, or full regulatory approval. It is not a safety or efficacy endorsement, and strong evidence in one context, such as TB-500's Phase II ocular trial, does not translate into approval for a different use or route. Evidence strength also does not scale with how popular a compound is in research-community discussion — thin evidence and heavy online interest can coexist, as with Epithalon.

Why doesn't this guide publish dosing, reconstitution, or injection instructions?

This guide intentionally limits itself to classification, mechanism, regulatory tier, and evidence basis, and does not include dosing amounts, frequencies, cycle lengths, reconstitution math, or injection technique for any compound. Reconstitution and preparation of a compounded or research peptide should be handled by a licensed compounding pharmacy or physician, not assembled from a public reference page. Any decision about actual use, dose adjustment, or a perceived lack of response belongs with a licensed healthcare provider familiar with peptide pharmacology.

SD
Dr. Scott DelBoccio, DMD
Physician-Author · PeptideReport.ai

This reference was assembled and reviewed by Dr. Scott DelBoccio, DMD, founder of PeptideReport.ai. It reflects published research and regulatory status only; it is not a dosing or protocol manual. This content is for educational purposes only and does not constitute medical advice. Any decision about actual peptide use should be made with a licensed healthcare provider familiar with peptide pharmacology.