🔬Scientific Data 2024-2026

Peptide Research

Comprehensive review of scientific research, regulatory status, and clinical data on peptides. Information on FDA-approved medications and investigational compounds.

📑Зміст

Peptide Category Overview

Quick overview by regulatory status

NAD+

⚠️ FDA Warning
🩹

Healing Peptides

🔬 Investigational
💪

Growth Hormone Peptides

🚫 Prohibited
💕

Sexual Health

✅ FDA APPROVED
🧬

Mitochondrial

🔬 Investigational
🔬

Bioregulators

🔬 Investigational

FDA-Approved

✅ APPROVED
⚠️ FDA WarningCoenzyme

NAD+ (Nicotinamide Adenine Dinucleotide)

Basic Information

Classification:Coenzyme, not a peptide
Function:Key coenzyme of energy metabolism
FDA:NOT APPROVED
Warning:October 2024 — endotoxin contamination risk
Research:NCT06919328, over 600 clinical studies
Publications:Nature Communications (2025), PMC9495723

Key Characteristics

Mechanism of Action

500+ enzymatic reactions

Cofactor for sirtuins, PARP

Indications

Energy, cognitive function

Anti-aging effects (theoretical)

Side Effects

Tremor, nausea, fatigue

With injections

Side Effects / Risks:

Severe tremorNausea and vomitingFatigueEndotoxin reactions

⚠️ FDA Warning (October 2024)

The FDA issued a safety warning regarding NAD+ injections due to endotoxin contamination risk. Not recommended for injectable use.

🩹
🚫 ProhibitedInvestigational

BPC-157 (Body Protection Compound-157)

Basic Information

Structure:15-amino acid peptide
Source:Isolated from gastric juice
FDA:NOT APPROVED
Compounding status:Temporarily prohibited
Research:Extensive animal data, limited human data
Publications:Arthroscopy Journal (2025), Alternative Therapies (2025)

Key Characteristics

Mechanism of Action

Angiogenesis stimulation

VEGF-2 upregulation

Indications

Accelerated wound healing

Ulcer treatment, injuries

Status

Included in risk list

FDA identified significant risks

Side Effects / Risks:

Limited dataUnknown risksIncluded in FDA list

🚫 Prohibited for compounding

BPC-157 has been included by the FDA in the list of substances posing significant safety risks. Temporarily prohibited for compounding.

🏃
🚫 Prohibited WADAInvestigational

TB-500 (Thymosin Beta-4)

Basic Information

Structure:43-amino acid peptide
Source:Fragment of thymosin beta-4 protein
FDA:NOT APPROVED
WADA:Prohibited for athletes
Research:Limited clinical data in humans
Mechanism:Actin regulation, angiogenesis promotion

Key Characteristics

Mechanism of Action

Actin regulation

Angiogenesis promotion

Effectiveness

Accelerated recovery

Muscle recovery

Status

Prohibited by WADA

Restricted compounding status

Side Effects / Risks:

Limited dataUnknown risks

🚫 Prohibited by WADA

TB-500 is prohibited for use by athletes under WADA. Restricted compounding status.

📈
🚫 ProhibitedDecember 2024

CJC-1295 (Growth Hormone Peptide)

Basic Information

Structure:29-amino acid peptide
Type:Synthetic growth hormone analogue
FDA:NOT APPROVED
Warning:December 2024 — compounding ban
Cause:Cardiovascular reaction risks
Status:Prohibited from 2025

Key Characteristics

Mechanism of Action

GH release stimulation

IGF-1 increase

Risks

Elevated heart rate

Vascular reactions

Status

Prohibited for compounding

Since December 2024

Side Effects / Risks:

Elevated heart rateVascular reactionsUnknown risks

Scientific Publications:

🚫 Prohibited by FDA (December 2024)

The FDA has included CJC-1295 in the list of substances posing significant safety risks due to reports of elevated heart rate and vascular reactions. Prohibited for compounding from 2025.

💪
🚫 Prohibited WADAInvestigational

Ipamorelin

Basic Information

Structure:Pentapeptide (5 amino acids)
Type:Growth hormone secretagogue
FDA:NOT APPROVED
WADA:Prohibited for athletes
Compounding status:Prohibited
Advantages:Safest selective peptide

Key Characteristics

Mechanism of Action

Selective GH stimulation

Without cortisol elevation

Advantages

Muscle mass preservation

Improved body composition

Status

Prohibited by WADA

Prohibited for compounding

Side Effects / Risks:

Limited dataUnknown risks

🚫 Prohibited by WADA and FDA

Ipamorelin is prohibited for use by athletes (WADA) and prohibited for compounding by the FDA.

💕
✅ FDA APPROVEDJune 2019

PT-141 (Bremelanotide / Vyleesi)

Basic Information

Trade name:Vyleesi
Developer:Palatin Technologies
FDA:APPROVED (June 2019)
Indications:HSDD in premenopausal women
Research:NCT01382719, over 1,200 women
Publications:PMC6819021 (cited 158 times)

Key Characteristics

Mechanism of Action

Melanocortin receptor

MC3R, MC4R — acts on CNS

Effectiveness

Only FDA-approved

For sexual health

Side Effects

Nausea (40%), flushing (20%)

Headache (11%)

Side Effects / Risks:

Nausea (40% of patients)Flushing (20%)Headache (11%)Skin darkening at injection site

Fully FDA-approved

PT-141 (bremelanotide) is the first and only FDA-approved peptide for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

🧬
InvestigationalDiscovered 2012

MOTS-c (Mitochondrial Peptide)

Basic Information

Structure:16-amino acid peptide
Source:Mitochondrial
FDA:NOT APPROVED
Developer:University of Southern California
Status:Positioned as an "investigational substance"
Research:Limited human data

Key Characteristics

Mechanism of Action

Metabolic regulation

Increased insulin sensitivity

Research

Metabolic syndrome

Potential geroprotective effects

Status

No license

Research use only

Side Effects / Risks:

Limited dataUnknown risks

🔬 Investigational substance

MOTS-c has no license for medical use and is not FDA-approved. It may only be used in the context of clinical research.

🧠
InvestigationalDiscovered 2001

Humanin (Mitochondrial Peptide)

Basic Information

Structure:24-amino acid peptide
Source:Mitochondrial
FDA:NOT APPROVED
Developer:Buck Institute
Research:Open animal studies
Mechanism:Neuron protection against Alzheimer's disease

Key Characteristics

Mechanism of Action

Neuroprotection

Alzheimer's protection

Status

Early stages

Open studies

Potential

Geroprotection

Neuroprotection

Side Effects / Risks:

No data availableUnknown risks

🔬 Early research stages

Humanin is in early stages of research. Clinical trial data in humans is not available.

🛡️
InvestigationalRussian

Thymalin (Peptide Bioregulator)

Basic Information

Type:Peptide bioregulator
Source:Isolated from thymus
Developer:Institute of Gerontology, RAS
Research:Over 40 years in Russia
Publications:PMC8654498 (2021) — COVID-19
Status:Limited data outside Russia

Key Characteristics

Mechanism of Action

Immunomodulation

Thymus function regulation

Research

40+ years in Russia

Limited data outside

Potential

Geroprotective effects

Immunomodulation

Side Effects / Risks:

Limited dataUnknown risks

🔬 Limited data outside Russia

Thymalin has extensive research in Russia (40+ years), but limited clinical data outside Russia.

🌙
InvestigationalRussian

Epitalon (Epithalamin)

Basic Information

Type:Pineal gland peptide
Structure:Tetrapeptide Ala-Glu-Asp-Gly
Developer:Russian researchers (Khavinson group)
Research:ResearchGate (2025)
Publications:Peptide bioregulators: the new class of geroprotectors
Status:Limited clinical data

Key Characteristics

Mechanism of Action

Pineal gland regulation

Geroprotection

Classification

Peptide bioregulator

New class of geroprotectors

Status

Limited data

Outside Russia

Side Effects / Risks:

Limited dataUnknown risks

🔬 Limited clinical data

Epitalon has limited clinical data outside Russia. Classified as a peptide bioregulator.

✅ FDA APPROVEDLimited

Sermorelin (Geref)

Basic Information

Trade name:Geref
FDA:APPROVED (limited)
Indications:Diagnostic tests of pituitary function
Initial approval:1990s
Status:Discontinued in 2008
Availability:Compounding pharmacies only

Key Characteristics

FDA Status

Limited approval

For diagnostics

Availability

Discontinued

2008

Usage

Not first-line

For adults

Side Effects / Risks:

Limited data

ℹ️ Limited approval

Sermorelin has limited FDA approval for diagnostic tests. Discontinued in 2008 for commercial reasons. Now available only through specialized compounding pharmacies.

📊Conclusions and Regulatory Status (2024-2026)

Fully FDA-Approved

  • GLP-1 agonists (semaglutide, tirzepatide)
  • PT-141 (bremelanotide)
  • Sermorelin (limited)

⚠️ FDA Warnings

  • NAD+ injections (October 2024)
  • CJC-1295 prohibited (December 2024)
  • Expanded list of prohibited substances

🔬 Investigational

  • BPC-157, TB-500
  • MOTS-c, Humanin
  • Peptide bioregulators

Key Conclusions:

  1. 1.GLP-1 agonists are the only peptides with full FDA approval for broad medical use.
  2. 2.Peptide therapy remains largely an investigational field with limited regulatory approvals.
  3. 3.The FDA has tightened control over compounded peptides in 2024-2026.
  4. 4.The safety and efficacy of most peptides have not been demonstrated in large clinical trials.
  5. 5.Patients should consult with qualified physicians when considering peptide therapy.

Questions About Regulatory Status

Everything you need to know about safety and approvals

Анастасія Шаповал

Fully FDA-approved: GLP-1 agonists (semaglutide, tirzepatide) for diabetes and obesity, PT-141 (bremelanotide) for sexual health in women, and sermorelin (limited) for diagnostics. Most other peptides do not have full FDA approval.

Анастасія Шаповал

Спеціаліст з метаболічних програм та контролю ваги

💬

Important: Specialist Consultation

Before starting any peptide therapy, be sure to consult with qualified physicians. Understand the regulatory status, risks, and benefits of each peptide.

Information provided based on current data as of February 2026. Regulatory status may change.