2026 FDA Peptide Status Tracker: Every Major Peptide, Ranked

Peptide regulation moves in small, technical steps that are easy to lose track of. This page is our attempt at a single reference: every major peptide, one row each, five status columns. It is updated as FDA guidance, DEA notices, and WADA list revisions land.

Bookmark it. Share it. If you're a clinician, compounding pharmacist, athletic-commission compliance staffer, laboratory buyer, or researcher, this is meant to be your quick-lookup source.

Editorial scope. All peptides supplied by Enlife Peptides are for in-vitro laboratory research only and are not approved by the FDA for human consumption or therapeutic use. This article summarizes publicly available federal guidance and WADA list content as of mid-2026. Regulatory status changes; check the last-updated date and re-verify before making compliance decisions.

Last updated: July 26, 2026

How to read this tracker

Each peptide is scored across five columns:

• •FDA approval, Does an FDA-approved drug containing this peptide exist? *Approved* / *None*.
• •503A compounding, Can a 503A pharmacy compound it for individual-patient human use? *Eligible* / *Category 2* / *Not eligible*.
• •DEA schedule, Is it a controlled substance? *Unscheduled* / *Schedule I-V*.
• •WADA prohibited, Is it on the WADA prohibited list? *Yes (class)* / *No*.
• •RUO available, Can it be lawfully supplied as research-use-only material? *Yes* / *Restricted*.

A "Yes" in the last column does not mean the substance is safe, effective, or appropriate for any human use. It means the RUO supply pathway is available to laboratories.

The tracker

Regeneration & repair peptides

BPC-157

• •FDA approval: None
• •503A compounding: Category 2 (not eligible for human-use compounding)
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S0, Non-Approved Substances)
• •RUO available: Yes
• •Notes: Reaffirmed Category 2 in 2026 guidance. FDA's Pharmacy Compounding Advisory Committee voted 8-6 (1 abstention) on 2026-07-23 to recommend BPC-157 for the 503A bulks list; this is a non-binding recommendation, and formal rulemaking is still pending. See BPC-157 FDA 2026 explainer, state-by-state legal breakdown, and the July 2026 PCAC vote explained.

KPV

• •FDA approval: None
• •503A compounding: Under review (removed from Category 2 in April 2026)
• •DEA schedule: Unscheduled
• •WADA prohibited: No (not a named substance; the S0 catch-all could still apply for tested athletes)
• •RUO available: Yes
• •Notes: PCAC voted 8-6 (1 abstention) on 2026-07-23 to recommend KPV for the 503A bulks list; formal rulemaking is still pending. See the July 2026 PCAC vote explained.

TB-500 (Thymosin Beta-4 fragment)

• •FDA approval: None
• •503A compounding: Category 2
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2, Peptide Hormones, Growth Factors)
• •RUO available: Yes
• •Notes: Full thymosin β-4 has separate research history; the TB-500 fragment is the commonly supplied form. PCAC voted 8-6 (1 abstention) on 2026-07-23 to recommend TB-500 for the 503A bulks list; formal rulemaking is still pending. See BPC-157 vs TB-500 comparison and the July 2026 PCAC vote explained.

Thymosin Alpha-1

• •FDA approval: None (approved in some non-U.S. jurisdictions as Zadaxin)
• •503A compounding: Under review
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: See thymosin alpha-1 immune support overview.

GHK-Cu (Copper peptide)

• •FDA approval: None as drug; cosmetic ingredient status differs
• •503A compounding: Not currently under active restriction
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: See GHK-Cu research overview.

GLP-1 and metabolic peptides

Semaglutide

• •FDA approval: Approved (Ozempic, Wegovy, Rybelsus)
• •503A compounding: Not eligible post-shortage-list wind-down
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes (as research material only, distinct from the approved drug)
• •Notes: 2023-2024 shortage-driven compounding ended in 2025-2026. See semaglutide research guide.

Tirzepatide

• •FDA approval: Approved (Mounjaro, Zepbound)
• •503A compounding: Not eligible post-shortage-list wind-down
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: See tirzepatide research guide.

Retatrutide

• •FDA approval: None (Phase III investigational under Lilly IND)
• •503A compounding: Not eligible (investigational)
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S0, Non-Approved Substances)
• •RUO available: Yes
• •Notes: See retatrutide triple-agonist research.

AOD-9604

• •FDA approval: None
• •503A compounding: Under review
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2)
• •RUO available: Yes
• •Notes: See AOD-9604 research guide.

Cagrilintide

• •FDA approval: None (Investigational, NDA filed December 2025 as CagriSema, paired with semaglutide)
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S0, Non-Approved Substances)
• •RUO available: Yes
• •Notes: FDA review of the CagriSema NDA is ongoing in 2026 with no decision yet. See GLP-1 receptor agonists explained.

Survodutide

• •FDA approval: None (Investigational, Phase III complete)
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S0, Non-Approved Substances)
• •RUO available: Yes
• •Notes: Holds FDA breakthrough therapy designation for MASH; approval not expected before 2027. See GLP-1 receptor agonists explained.

Mazdutide

• •FDA approval: None in the U.S. (approved in China by the NMPA in 2025 for obesity and type 2 diabetes)
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S0, Non-Approved Substances)
• •RUO available: Yes
• •Notes: U.S. Phase II trials ongoing; FDA approval unlikely before 2028-2029. See GLP-1 receptor agonists explained.

Growth-hormone-axis peptides

Ipamorelin

• •FDA approval: None
• •503A compounding: Category 2
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2, GHRP)
• •RUO available: Yes
• •Notes: See Ipamorelin + CJC-1295 stack.

CJC-1295 (with and without DAC)

• •FDA approval: None
• •503A compounding: Category 2
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2, GHRH analog)
• •RUO available: Yes

Sermorelin

• •FDA approval: Historically approved (Geref); not currently marketed
• •503A compounding: Eligible in some indications
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2)
• •RUO available: Yes
• •Notes: See growth hormone peptides explained.

Tesamorelin

• •FDA approval: Approved (Egrifta) for HIV-associated lipodystrophy
• •503A compounding: Not needed (approved drug available)
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2)
• •RUO available: Yes

Hexarelin

• •FDA approval: None
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2)
• •RUO available: Yes
• •Notes: See hexarelin vs ipamorelin comparison.

Longevity peptides

Epitalon (Epithalon)

• •FDA approval: None
• •503A compounding: Not currently under active restriction
• •DEA schedule: Unscheduled
• •WADA prohibited: No (not specifically listed; S0 catch-all could apply)
• •RUO available: Yes
• •Notes: PCAC voted 7-4 (1 abstention) on 2026-07-24 to recommend Epitalon for the 503A bulks list; formal rulemaking is still pending. See epitalon longevity peptide guide and the July 2026 PCAC vote explained.

MOTS-c

• •FDA approval: None
• •503A compounding: Under review; RUO marketing enforcement flagged in 2026 guidance
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S0)
• •RUO available: Yes
• •Notes: PCAC voted 7-5 (2 abstentions) on 2026-07-23 to recommend MOTS-c for the 503A bulks list; formal rulemaking is still pending. See MOTS-c mitochondrial peptide guide and the July 2026 PCAC vote explained.

NAD+ (nucleotide, not a peptide)

• •FDA approval: None as drug
• •503A compounding: Currently compounded in some formulations
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: Included for completeness, NAD+ is a nucleotide, often grouped with longevity peptides. See NAD cellular energy overview.

Nootropic peptides

Selank

• •FDA approval: None in the U.S.
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: See Selank vs Semax comparison.

Semax

• •FDA approval: None in the U.S.
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: PCAC voted 8-5 (1 abstention) on 2026-07-24 to recommend Semax for the 503A bulks list; formal rulemaking is still pending. See the July 2026 PCAC vote explained.

Cerebrolysin

• •FDA approval: None in the U.S. (approved in some non-U.S. jurisdictions)
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes (as research material)

Sexual health and pigmentation peptides

PT-141 (Bremelanotide)

• •FDA approval: Approved (Vyleesi) for HSDD in premenopausal women
• •503A compounding: Not needed (approved drug available); compounded copies restricted
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: See PT-141 research guide.

Melanotan II (MT-II)

• •FDA approval: None
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: See Melanotan MT-2 research overview.

Sleep and immune peptides

DSIP (Delta Sleep-Inducing Peptide)

• •FDA approval: None
• •503A compounding: Not eligible
• •DEA schedule: Unscheduled
• •WADA prohibited: No
• •RUO available: Yes
• •Notes: PCAC voted 6-7 (1 abstention) on 2026-07-24 against recommending Emideltide, the FDA's regulatory name for DSIP, for the 503A bulks list, citing thin supporting evidence. See sleep peptides overview and the July 2026 PCAC vote explained.

Thymosin Beta-4 (full-length)

• •FDA approval: None (investigational for corneal indications historically)
• •503A compounding: Category 2 (fragment TB-500 also Category 2)
• •DEA schedule: Unscheduled
• •WADA prohibited: Yes (S2)
• •RUO available: Yes

Change log

• •July 26, 2026. Added Cagrilintide, Survodutide, and Mazdutide to the GLP-1 and metabolic section. Added KPV to the regeneration and repair section. Noted the July 23-24, 2026 PCAC vote recommending BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax for the 503A bulks list, and rejecting Emideltide (DSIP). See the full PCAC vote breakdown.
• •July 2026 (initial publication). Baseline snapshot after the 2026 FDA guidance package. BPC-157 and TB-500 confirmed Category 2. Compounded semaglutide/tirzepatide wind-down formalized. MOTS-c and epitalon flagged for RUO marketing enforcement.

We update this page whenever the FDA publishes a bulks-list change, DEA publishes a scheduling notice, or WADA revises its prohibited list.

How to use this tracker

• •Clinicians and compounding pharmacists. Filter for "503A compounding: Category 2", those are the substances you can no longer produce for human use.
• •Laboratory buyers. Filter for "RUO available: Yes", those are lawfully supplied for research work.
• •Athletic compliance staff. Filter for "WADA prohibited: Yes", subject athletes should treat those as banned regardless of legal status.
• •Journalists and analysts. The five-column framework is the underlying scaffolding for any accurate peptide-regulation story.

Sources and further reading

• •FDA 503A bulks list docket and 2026 compounding guidance
• •WADA Prohibited List (current-year edition)
• •DEA Diversion Control scheduling notices
• •Our BPC-157 FDA 2026 explainer, state-by-state legal breakdown, research vs. compounded peptides in 2026, and the July 2026 PCAC vote explained

Frequently Asked Questions

Is this tracker legally authoritative?

No. It is a plain-language reference synthesizing publicly available FDA, DEA, and WADA guidance as of the last-updated date. Always verify against primary sources before making compliance decisions.

How often is this tracker updated?

Whenever a material regulatory change lands, FDA bulks-list revision, DEA scheduling notice, or WADA prohibited-list update. Check the "Last updated" date at the top.

What does "Category 2" mean?

It means the substance is on Category 2 of the FDA 503A bulks list, not eligible for human-use compounding while under safety review. Category 2 is a compounding restriction, not a criminal prohibition or a scheduling action. See our BPC-157 FDA 2026 explainer.

Why is a WADA-prohibited peptide still available as RUO?

WADA is a private anti-doping body governing subject-to-testing athletes. Its prohibited list is independent of criminal law and drug-approval status. Many substances that are lawful to purchase and possess for laboratory research are prohibited for competitive athletes.

What about peptides not listed here?

This tracker covers the peptides most commonly asked about. If a peptide you care about is missing, message us and we'll add it in the next update.

Where should a researcher start?

Read our safe buying guide, COA reading guide, and reconstitution guide.

Related reading

• •BPC-157 FDA 2026: what the reclassification actually means
• •Is BPC-157 legal in 2026? Federal + state-by-state breakdown
• •Research peptides vs. compounded prescription peptides: what changed in 2026
• •How to buy research peptides safely (USA)
• •Peptide purity: reading a certificate of analysis

Editorial note & disclaimer. Reviewed by the Enlife Peptides research team. Informational only; not legal or medical advice. Regulatory status changes; verify against primary FDA, DEA, and WADA sources before making compliance decisions. All peptides referenced are intended strictly for in-vitro laboratory research and are not approved by the FDA for human consumption or therapeutic use.