Peptide Legal & Regulatory Status

The regulatory landscape for peptides varies significantly by jurisdiction and intended use. While a handful of peptides have received FDA approval for specific medical indications, the majority remain classified as investigational or research-only compounds. Many peptides are available internationally under different regulatory frameworks, and some are sold as research chemicals that are not approved for human consumption. This page summarizes the current regulatory standing of the 18 peptides profiled on this site, including FDA status, World Anti-Doping Agency (WADA) classification, and common administration routes.

Peptide	FDA Status	Evidence	WADA Status	Routes	Notes
AOD-9604	Investigational	Level C	Not Listed	Injectable, Oral	FDA GRAS status as food ingredient
BPC-157	Research Only	Level D	Not Listed	Injectable, Oral	—
BPC-157 + TB-500 Combination	Research Only	Level D	Prohibited	Injectable	—
CJC-1295	Investigational	Level C	Not Listed	Injectable	—
Dihexa	Research Only	Level D	Not Listed	Oral, Injectable	—
DSIP	Research Only	Level D	Not Listed	Injectable, Nasal	—
Epithalon	Research Only	Level D	Not Listed	Injectable	—
GHK-Cu	Research Only	Level D	Not Listed	Injectable, Topical	—
Ipamorelin	Investigational	Level C	Not Listed	Injectable	—
KPV	Research Only	Level D	Not Listed	Injectable, Oral, Topical	—
LL-37	Research Only	Level D	Not Listed	Injectable, Topical	—
MK-677	Investigational	Level B	Not Listed	Oral	—
PT-141	FDA-Approved	Level A	Not Listed	Injectable	Vyleesi — approved June 2019 for HSDD in premenopausal women
Selank	Approved Abroad	Level B	Not Listed	Nasal	Registered drug in Russia
Semax	Approved Abroad	Level B	Not Listed	Nasal	Registered drug in Russia and Ukraine
SS-31	FDA-Approved	Level A	Not Listed	Injectable	Forzinity — approved Sept 2025 for Barth syndrome
TB-500	Research Only	Level D	Prohibited	Injectable	—
Thymosin Alpha-1	Approved Abroad	Level B	Not Listed	Injectable	Zadaxin — approved in ~35 countries for hepatitis B/C

AOD-9604

InvestigationalLevel CWADA: Not Listed

Routes: Injectable, Oral
Notes: FDA GRAS status as food ingredient

BPC-157

Research OnlyLevel DWADA: Not Listed

Routes: Injectable, Oral

BPC-157 + TB-500 Combination

Research OnlyLevel DWADA: Prohibited

Routes: Injectable

CJC-1295

InvestigationalLevel CWADA: Not Listed

Routes: Injectable

Dihexa

Research OnlyLevel DWADA: Not Listed

Routes: Oral, Injectable

DSIP

Research OnlyLevel DWADA: Not Listed

Routes: Injectable, Nasal

Epithalon

Research OnlyLevel DWADA: Not Listed

Routes: Injectable

GHK-Cu

Research OnlyLevel DWADA: Not Listed

Routes: Injectable, Topical

Ipamorelin

InvestigationalLevel CWADA: Not Listed

Routes: Injectable

KPV

Research OnlyLevel DWADA: Not Listed

Routes: Injectable, Oral, Topical

LL-37

Research OnlyLevel DWADA: Not Listed

Routes: Injectable, Topical

MK-677

InvestigationalLevel BWADA: Not Listed

Routes: Oral

PT-141

FDA-ApprovedLevel AWADA: Not Listed

Routes: Injectable
Notes: Vyleesi — approved June 2019 for HSDD in premenopausal women

Selank

Approved AbroadLevel BWADA: Not Listed

Routes: Nasal
Notes: Registered drug in Russia

Semax

Approved AbroadLevel BWADA: Not Listed

Routes: Nasal
Notes: Registered drug in Russia and Ukraine

SS-31

FDA-ApprovedLevel AWADA: Not Listed

Routes: Injectable
Notes: Forzinity — approved Sept 2025 for Barth syndrome

TB-500

Research OnlyLevel DWADA: Prohibited

Routes: Injectable

Thymosin Alpha-1

Approved AbroadLevel BWADA: Not Listed

Routes: Injectable
Notes: Zadaxin — approved in ~35 countries for hepatitis B/C

Understanding Regulatory Categories

FDA-Approved

Peptides with at least one FDA-approved indication have undergone rigorous clinical trials demonstrating safety and efficacy for a specific use. FDA approval does not mean the peptide is approved for all potential applications discussed in research literature.

Approved Abroad

Some peptides have received marketing authorization from regulatory bodies outside the United States, such as the European Medicines Agency (EMA) or national health agencies in Russia, Japan, or Australia. These approvals may not transfer across jurisdictions.

Investigational

Investigational peptides are currently or have been studied in human clinical trials but have not yet received regulatory approval. They may be available through clinical trial enrollment or compassionate use programs in some jurisdictions.

Research Only

Research-only peptides are sold exclusively for in vitro or animal research. They have not been approved by any regulatory body for human use. Purchasing or possessing these compounds may be subject to local laws and regulations.

Important Disclaimers

Regulatory classifications can change as new clinical data emerges and government agencies update their guidelines. The information on this page reflects our best understanding as of the date shown below and should not be relied upon as legal advice.

Always verify the current legal status of any peptide in your specific jurisdiction before purchasing, possessing, or using it.
Consult with qualified legal counsel if you have questions about the legality of specific peptides in your country or state.
This page does not constitute medical advice. Consult a licensed healthcare professional before using any peptide for therapeutic purposes.
WADA prohibitions apply to athletes subject to anti-doping testing. If you are a competitive athlete, consult your sport governing body for the most current prohibited list.

Last updated: March 2026