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Reference tracker

FDA Approval Tracker for Peptides & Compounds

Current regulatory status on GLP-1 agonists, retatrutide, GLP-2, athletic recovery peptides and anti-aging compounds. Last updated: .

Updated monthly with the latest FDA regulatory news. Educational reference only — not medical advice.

GLP-1 Agonists

The most heavily prescribed and most heavily counterfeited category. Two approved products, one under review.

Semaglutide

Ozempic, Wegovy — Novo Nordisk

Approved (2021)
FDA approval date
June 2021 (Wegovy, chronic weight management)
Brand names
Wegovy (weight loss), Ozempic (type 2 diabetes)
Indication
Chronic weight management; type 2 diabetes
Mechanism
GLP-1 receptor agonist
Clinical trial data
STEP program, 68 weeks — approximately 15% mean weight loss
Approval path
NDA approved
Current status
Widely available by prescription; shortage status has fluctuated
Monitoring
Ongoing post-market surveillance
Next milestone
Continued long-term cardiovascular and outcome data
Lab test semaglutide — $200 →

Approved does not mean the vial in your hand is genuine.

Tirzepatide

Zepbound, Mounjaro — Eli Lilly

Approved (2023)
FDA approval date
November 2023 (Zepbound, chronic weight management)
Brand names
Zepbound (weight loss), Mounjaro (type 2 diabetes)
Indication
Chronic weight management; type 2 diabetes
Mechanism
Dual GLP-1 and GIP receptor agonist
Clinical trial data
SURMOUNT-1, 72 weeks — approximately 20-22% mean weight loss at higher doses
Approval path
NDA approved
Current status
FDA-approved and rapidly adopted
Monitoring
Post-market surveillance ongoing
Next milestone
Long-term outcome studies and additional indications
Lab test tirzepatide — $200 →

Underdosing was the most common failure mode we found in this class.

Retatrutide

LY3437943 — Eli Lilly

Pending — Phase 3 complete
Approval status
Not FDA-approved for any indication
Current phase
Phase 3 program (TRIUMPH) completed; regulatory submission stage
Mechanism
Triple agonist — GLP-1, GIP and glucagon receptors
Clinical data
Phase 2 reported approximately 24% mean weight loss at 48 weeks
Expected indication
Chronic weight management
Availability
Research-chemical and compounded sources only — no legitimate retail channel
Expected pricing
Unknown; class comparators list in the $1,000-1,400/month range pre-rebate
Next milestone
FDA decision on the pending application

Critical warning

Retatrutide is not approved. Every vial available today comes from an unregulated channel, and it was the highest-failure compound in our own sample testing — long sequence, no reference product, no oversight.

Lab test retatrutide — $200 (critical) →

Highest observed failure rate of any compound we test.

GLP-2 Agonists

One approved analog for a narrow intestinal-failure indication, plus an unapproved research market built on top of it.

Teduglutide

Gattex / Revestive — Takeda

Approved (2012)
FDA approval date
December 2012
Indication
Short bowel syndrome in patients dependent on parenteral support
Mechanism
DPP-4-resistant GLP-2 receptor agonist
Clinical data
Phase 3 trials — significantly more patients achieved a 20%+ reduction in parenteral support volume vs placebo
Approval path
NDA with orphan drug designation
Current status
Available by prescription for the approved indication
Off-label context
Discussed for general gut barrier support; no trials in that population
Required monitoring
Colorectal screening before and during treatment (proliferative signaling)
Lab test teduglutide — $200 →

Long sequences fail on identity more often than short ones.

GLP-2 analogs (research grade)

Unbranded GLP-2 and derivatives

Research phase — not approved
Approval status
No FDA approval for use in healthy adults
Indication
Investigational — intestinal barrier function, nutrient absorption
Clinical data
Animal and mechanistic data; no trials in healthy populations
Safety profile
Not established outside the approved analog's indication
Availability
Research-chemical suppliers; not legitimately compoundable without an approved reference product
Regulatory oversight
None at the product level
Next milestone
No registered trial in a general population

Critical warning

There is no quality oversight in this channel and no human dosing data. Proliferative signaling in intestinal tissue is the specific reason the approved analog requires colonoscopy screening.

Lab test GLP-2 — $200 (essential) →

Identity confirmation by mass spectrometry matters most here.

Performance & Recovery Peptides

No approved products, no human efficacy trials, and the highest counterfeit rates in our dataset.

BPC-157

Body protection compound 157

Not approved — research only
FDA approval
No approved indication in the US
Indication
Investigational — tendon, ligament, muscle and gut healing
Animal data
Extensive rodent evidence across tendon, ligament and gut injury models
Human data
No published randomized trials for musculoskeletal healing
WADA status
Prohibited at all times (S0, non-approved substances)
Availability
Research-chemical market only; excluded from FDA bulk substances compounding list
Regulatory path
No active FDA approval pathway
Product quality
Highly variable — degradation and low purity common

Critical warning

Not approved for human use anywhere in the US, prohibited in tested sport, and produced entirely without manufacturing oversight.

Lab test BPC-157 — $200 (critical) →

Degradation and low purity dominated our failures here.

TB-500

Thymosin beta-4 fragment

Not approved — research only
FDA approval
No approved indication in the US
Indication
Investigational — tissue repair and recovery
Mechanism
Actin-binding fragment of thymosin beta-4; promotes cell migration and angiogenesis
Clinical data
Preclinical only; no adequate human trials
WADA status
Prohibited at all times
Availability
Research-chemical market only
Regulatory path
No established FDA pathway
Product quality
Frequently mislabeled — fragment sold as full-length thymosin beta-4

Critical warning

Long-term safety is unknown and label-versus-contents mismatch is the single most common finding in this compound.

Lab test TB-500 — $200 (critical) →

Confirm which molecule you actually received.

Supplements & OTC

Regulated as dietary supplements rather than drugs, which means no pre-market approval and no mandated potency testing.

NAD+ precursors

NR (nicotinamide riboside), NMN (nicotinamide mononucleotide)

OTC dietary supplements
Regulatory category
Dietary supplements — no pre-market FDA approval required
FDA oversight
Post-market only; NMN's supplement status in the US has been contested
Clinical data
Reliably raise blood NAD+; clinical outcome benefits inconsistent
Safety
Well tolerated in trials up to about one year
Availability
Over the counter, no prescription
Product quality
Independent testing repeatedly finds label claims that do not match contents
Injectable NAD+
No controlled human trials; adds sterility and concentration risk
Lab test a NAD+ product — $200 →

Content-versus-label is the practical question in this category.

Regulatory summary

Every compound covered on this site, at a glance.

FDA approval status by compound, with approval year and notes
StatusCompoundYearNotes
ApprovedSemaglutide2021Well established; extensive post-market data
ApprovedTirzepatide2023Established; strongest trial weight-loss results in class
ApprovedTeduglutide2012Short bowel syndrome indication only
OTCNAD+ precursorsN/ASupplement pathway; no pre-market approval
PendingRetatrutidePendingPhase 3 complete; FDA decision outstanding
ResearchGLP-2 analogsN/ANo trials in healthy adults
Not approvedBPC-157N/AAnimal data only; high failure rate
Not approvedTB-500N/APreclinical only; frequently mislabeled

What this means for you

Approval status changes your legal route, your risk level, and how much verification is warranted.

If you are buying an approved medication

Semaglutide, tirzepatide, teduglutide · Risk level: Moderate

  • A prescription is legally required
  • Pharmacy-dispensed or eligible compounded preparations only
  • Counterfeits exist but are less common than in unapproved categories
  • Lab verification recommended — underdosing is the usual failure

If you are buying a pending compound

Retatrutide · Risk level: High

  • Not approved — there is no legitimate retail channel
  • Every source is a research-chemical or gray-market supplier
  • Highest observed failure rate in our testing
  • Lab verification critical before any use

If you are buying a research peptide

BPC-157, TB-500, GLP-2 analogs · Risk level: Very high

  • No approval for human use and zero product-level oversight
  • Prohibited at all times for tested athletes
  • Identity, purity and content all unverified by anyone in the chain
  • Lab verification essential — do not use unverified material

If you are buying a supplement

NR, NMN, oral NAD+ · Risk level: Moderate

  • No prescription needed
  • No pre-market approval and no mandated potency testing
  • Quality varies widely between manufacturers
  • Content testing recommended if you are spending meaningfully

Verification recommendations by category

Approved medications

Semaglutide, tirzepatide

  • Free label readStart here
  • Quick Analysis — $75Recommended
  • Lab Verification — $200Recommended

Pending approval

Retatrutide

  • Quick Analysis — $75Highly recommended
  • Lab Verification — $200Essential

Research peptides

BPC-157, TB-500, GLP-2 analogs

  • Lab Verification — $200Absolutely critical
  • Do not use unverified materialOur position

Supplements

NR, NMN, NAD+

  • Lab Verification — $200Recommended
  • Quality varies by manufacturerContext

Protect yourself from fakes

FDA approval status matters. But approval does not guarantee the vial in your hand is real. Get it verified.

Verify any peptide — start free →Quick Analysis — $75Lab Testing — $200

Updates & monitoring

This page is reviewed monthly for:

  • New FDA decisions and label changes
  • Retatrutide application status
  • Counterfeit and recall alerts
  • New human trial publications
  • Safety communications affecting these compounds

Last updated: · Next scheduled review: September 2026

Regulatory status can change between reviews. Always confirm current approval status with official FDA sources and a licensed clinician before making any decision about a medication or research compound.

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