Peptide FDA Status Tracker

72 peptides · regulatory reference as of 2026 · not medical advice

If you’ve spent any time exploring the world of peptides, wellness optimization, or research compounds, you already know how fast the landscape moves. New compounds emerge constantly, scientific studies are published weekly, and regulatory guidelines shift beneath your feet.

For researchers, practitioners, and wellness enthusiasts alike, keeping track of what is legally permissible, what is under FDA review, what is flagged for safety, and what status a compound holds can feel like a full-time job.

That is precisely why Peptide Review Hub has put together this guide: to break down how to evaluate FDA regulatory statuses and bring clarity to a complex space.

10 - FDA Approved

6 - Compoundable

56 - Research Only

11 - Banned from Compounding

Name

Category

FDA Status

503A Ban

Rx Required

Telehealth

BPC-157

Pentadecapeptide BPC 157

Healing & Recovery

Research Only

Yes

No

—

TB-500

Thymosin Beta-4 Fragment

Healing & Recovery

Research Only

Yes

No

—

GHK-Cu

Copper Peptide GHK

Skin & Aesthetics

OTC Cosmetic

—

No

✓

Sermorelin

GHRH 1-29

GH Secretagogues

FDA Approved

—

Yes

✓

CJC-1295

CJC-1295 DAC

GH Secretagogues

Compoundable

—

Yes

✓

Ipamorelin

NNC 26-0161

GH Secretagogues

Compoundable

—

Yes

✓

Tesamorelin

Egrifta

GH Secretagogues

FDA Approved

—

Yes

✓

GHRP-6

Growth Hormone Releasing Peptide-6

GH Secretagogues

Research Only

—

No

—

GHRP-2

Pralmorelin

GH Secretagogues

Research Only

—

No

—

Hexarelin

Examorelin

GH Secretagogues

Research Only

—

No

—

Semaglutide

Ozempic / Wegovy / Rybelsus

GLP-1 & Metabolic

FDA Approved

—

Yes

✓

Tirzepatide

Mounjaro / Zepbound

GLP-1 & Metabolic

FDA Approved

—

Yes

✓

Retatrutide

LY3437943

GLP-1 & Metabolic

Phase 3

Yes

No

—

AOD-9604

HGH Fragment 176-191

GLP-1 & Metabolic

Research Only

—

No

✓

Liraglutide

Victoza / Saxenda

GLP-1 & Metabolic

FDA Approved

—

Yes

✓

PT-141

Bremelanotide / Vyleesi

Sexual Health

FDA Approved

Yes

Yes

✓

Melanotan II

MT-II

Sexual Health

⚠️ Not Approved — Caution

Yes

No

—

Epithalon

Epitalon / Epithalamin

Longevity & Anti-Aging

Research Only

—

No

—

Thymosin Alpha-1

Tα1 / Zadaxin

Immune Support

Compoundable (US) — Approved Internationally

—

Yes

✓

MOTS-c

Mitochondrial ORF of 12S rRNA type-c

Mitochondrial

Research Only

—

No

✓

Humanin

HN / Humanin-G (HNG)

Mitochondrial

Research Only

—

No

—

SS-31

Elamipretide / Szeto-Schiller Peptide 31

Mitochondrial

Phase 3

—

No

—

LL-37

Cathelicidin hCAP18

Antimicrobial

Research Only

—

No

—

KPV

α-MSH C-terminal tripeptide

Immune Support

Research Only

—

No

✓

VIP

Vasoactive Intestinal Peptide

Immune Support

Compoundable

—

Yes

✓

Dihexa

PNB-0408

Neurological & Cognitive

Research Only

—

No

—

Semax

ACTH(4-10)-Pro-Gly-Pro

Neurological & Cognitive

Intl. Approved (Russia)

—

No

—

Selank

Tuftsin Analog TP-7

Neurological & Cognitive

Intl. Approved (Russia)

—

No

—

DSIP

Delta Sleep-Inducing Peptide

Neurological & Cognitive

Research Only

—

No

—

FOXO4-DRI

Senolytic Peptide FOXO4

Longevity & Anti-Aging

Research Only

—

No

—

PEG-MGF

PEGylated Mechano Growth Factor

Healing & Recovery

Research Only

—

No

—

IGF-1 LR3

Long R3 IGF-1

GH Secretagogues

Research Only

—

No

—

IGF-1 DES

des(1-3)IGF-1 / Truncated IGF-1

GH Secretagogues

Research Only — Preclinical Evidence

—

No

—

ACE-031

Ramatercept / ActRIIB-Fc

Healing & Recovery

Research Only — Development Halted

—

No

—

HGH (Somatropin)

Human Growth Hormone / rhGH

Hormonal & Endocrine

FDA Approved (indication-specific)

—

Yes

✓

Oxytocin

Pitocin / Love Hormone

Hormonal & Endocrine

FDA Approved

—

Yes

✓

Gonadorelin

GnRH / Factrel

Hormonal & Endocrine

FDA Approved / Compoundable

—

Yes

✓

Follistatin 344

FST344 / Myostatin Inhibitor

Healing & Recovery

Research Only — Extreme Caution

—

No

—

Cerebrolysin

FPE 1070

Neurological & Cognitive

Intl. Approved

—

No

—

NAD+

Nicotinamide Adenine Dinucleotide

Longevity & Anti-Aging

Supplement / Clinical Use

—

No

✓

Mod GRF 1-29

CJC-1295 (no DAC) / GRF 1-29

GH Secretagogues

Research Only

—

No

—

5-Amino-1MQ

NNMT Inhibitor

GLP-1 & Metabolic

Research Only

—

No

—

SLU-PP-332

ERR Pan-Agonist

GLP-1 & Metabolic

Research Only

—

No

—

MK-677

Ibutamoren

GH Secretagogues

Research Only

—

No

—

Pinealon

EDR Peptide

Longevity & Anti-Aging

Research Only

—

No

—

Cartalax

Cartilage Bioregulator

Healing & Recovery

Research Only

—

No

—

Ovagen

Ovarian Bioregulator

Hormonal & Endocrine

Research Only

—

No

—

Adamax

Semax-family Analog

Neurological & Cognitive

Research Only

—

No

—

ARA-290

Cibinetide

Neurological & Cognitive

Investigational (Phase 2)

—

No

—

Melanotan I

Afamelanotide-related

Sexual Health

Caution: Indication-Specific Approval

—

Yes

—

Pentosan Polysulfate

PPS

Immune Support

FDA Approved / Other Indications

—

Yes

✓

Kisspeptin

Kisspeptin-10

Hormonal & Endocrine

Research Only

—

No

—

SNAP-8

Acetyl Octapeptide-3

Skin & Aesthetics

OTC Cosmetic

—

No

—

CagriSema

Cagrilintide + Semaglutide

GLP-1 & Metabolic

Phase 3

—

No

—

Cagrilintide

AM833

GLP-1 & Metabolic

Phase 3 Program

—

No

—

CJC-1295 (no DAC)

Modified GRF 1-29

GH Secretagogues

Research Only

—

No

—

Glutathione

GSH

Longevity & Anti-Aging

Clinical / Compoundable

—

No

✓

Larazotide

AT-1001

Healing & Recovery

Investigational

—

No

—

Enclomiphene

Androxal

Hormonal & Endocrine

Investigational / Rx

—

Yes

✓

Clomiphene

Clomid

Hormonal & Endocrine

FDA Approved (indication-specific)

—

Yes

✓

BPC-157 (Oral)

Oral BPC-157

Healing & Recovery

Research Only

Yes

No

—

TB-500 Fragment

TB4 Fragment

Healing & Recovery

Research Only

Yes

No

—

P21

Nootropic Peptide Candidate

Neurological & Cognitive

Research Only

—

No

—

RU-58841

RU58841

Skin & Aesthetics

Research Only

—

No

—

Collagen Peptides

Hydrolyzed Collagen

Skin & Aesthetics

Supplement

—

No

—

BPC-157 Stable

BPC-157 Stable Capsule

Healing & Recovery

Research Only

Yes

No

—

L-Carnitine

Levocarnitine

Longevity & Anti-Aging

Supplement / Rx forms

—

No

✓

CDP-Choline

Citicoline

Neurological & Cognitive

Supplement / Drug (region-dependent)

—

No

✓

ITPP

Myo-inositol trispyrophosphate

GLP-1 & Metabolic

Research Only

—

No

—

Wolverine Blend

Wolverine Stack · BPC-157 + TB-500

Healing & Recovery

Research Only

Yes

No

—

GLOW Blend

GLOW Stack · GHK-Cu + BPC-157

Skin & Aesthetics

Research Only

Yes

No

—

KLOW Blend

KLOW Stack · BPC-157 + TB-500 + GHK-Cu + KPV

Healing & Recovery

Research Only

Yes

No

—

The Challenge: Information is Scattered and Complex

When looking into peptide regulations, users are usually met with a frustrating mix of:

  • Dense, legalistic FDA documentation and Federal Register notices.

  • Confusing distinctions between FDA-approved drugs, bulk compounding lists (Section 503A and 503B), and enforcement discretion policies.

  • Constantly shifting rules regarding safety categories and agency reviews.

  • Conflicting claims across forums, vendor marketing sites, and secondary blogs.

Deciphering whether a specific peptide can be legally compounded, whether it has active approvals, or where it stands on the regulatory radar shouldn't require a law degree. Yet, having clear, transparent access to this data is vital for anyone trying to stay informed and compliant.

Key Regulatory Frameworks to Watch

Understanding where a compound stands requires tracking a few core criteria:

  1. FDA Approval Status: Distinguishing between fully FDA-approved pharmaceutical drugs, components of approved treatments, and non-approved research compounds.

  2. Compounding & Bulk Substance Lists: Tracking positions under 503A/503B bulk drug substance lists, Category 1/Category 2/Category 3 designations, and interim enforcement policies.

  3. WADA & Athletic Prohibitions: Highlighting compounds restricted or banned under competitive sport regulations.

  4. Safety & Warning Signals: Monitoring official agency safety alerts, import alerts, and regulatory dockets.

Built for Education, Not Medical Advice

At Peptide Review Hub, our core philosophy centers around transparency, education, and objective evaluation.

This guide is designed purely as an educational resource to help you make sense of the regulatory landscape. It does not constitute medical, legal, or pharmaceutical advice, nor does it endorse, recommend, or encourage the use of any specific substance. Regulatory status is fluid, and decisions regarding health and treatment protocols should always be made in direct consultation with a licensed healthcare professional.

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