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Peptides
Research peptides, clinic marketing, access and quality risk coverage
Peptide regulatory status tracker
Where each peptide stands with FDA: its 503A bulks-list status, any FDA-approved product, advisory committee votes and anti-doping status, with the source for every change.
- Not FDA-approved Brain & sleep
Cerebrolysin
Cerebrolysin is a pig-brain peptide mixture used for stroke and dementia in some countries. See what trials show and why it is not FDA-approved.
- In clinical trials Brain & sleep
Davunetide
Davunetide is an investigational neuroprotective peptide that failed its pivotal trial in progressive supranuclear palsy. See how it works and where it stands.
- Not FDA-approved Brain & sleep
Dihexa
the Research Peptide
Dihexa is an experimental angiotensin IV-derived peptide with no human trials and a retracted mechanism paper. See what the research shows and its legal status.
- Not FDA-approved Brain & sleep
DSIP
Delta Sleep-Inducing Peptide
DSIP is a naturally occurring nine-amino-acid peptide linked to sleep in early research. Learn its history, what studies show, and its unapproved status.
- Not FDA-approved Brain & sleep
Epitalon
Epitalon is a synthetic four-amino acid peptide sold for anti-aging and sleep. See what limited human research exists and where it stands with the FDA in 2026.
- In clinical trials Brain & sleep
NNZ-2591
NNZ-2591 is an investigational oral peptide studied for rare neurodevelopmental disorders. Learn how it works and what its early trial data show.
- Not FDA-approved Brain & sleep
PT-141
PT-141 is the gray-market name for bremelanotide. Learn how it works in the brain, what Vyleesi is approved for, and why the evidence for broader use is thin.
- Not FDA-approved Brain & sleep
Selank
Selank is a synthetic peptide approved for anxiety in Russia but not by the FDA. Learn how it is proposed to work and how limited the human evidence is.
- Not FDA-approved Brain & sleep
Semax
Semax is a synthetic peptide approved in Russia but not by the FDA. See how it is thought to work and what the limited human research shows.
- In clinical trials Brain & sleep
Trofinetide (Predecessor Programs)
DAYBUE and DAYBUE STIX
Before Rett syndrome approval, trofinetide was studied for Fragile X and traumatic brain injury. Here is what those investigational programs found.
| Peptide | Status | 503A bulks list | FDA-approved product | WADA |
|---|---|---|---|---|
| Cerebrolysin | Not FDA-approved Research use only | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
| Davunetide | Not FDA-approved Investigational | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
| Dihexa the Research Peptide | Not FDA-approved Research use only | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
| DSIP Delta Sleep-Inducing Peptide | Not FDA-approved Research use only | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
| Epitalon | Not FDA-approved Research use only | Advisory committee voted to include Since July 22, 2026, as of Oct. 27, 2026 | None | Not listed |
| NNZ-2591 | Not FDA-approved Investigational | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
| PT-141 | Not FDA-approved Research use only | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
| Selank | Not FDA-approved Research use only | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
| Semax | Not FDA-approved Research use only | Advisory committee voted to include Since July 22, 2026, as of Oct. 27, 2026 | None | Not listed |
| Trofinetide (Predecessor Programs) DAYBUE and DAYBUE STIX | Not FDA-approved Investigational | Not nominated Since Sept. 28, 2026, as of Oct. 27, 2026 | None | Not listed |
Source: FDA 503A bulks-list categories, PCAC meeting materials and the WADA Prohibited List
Status labels Not FDA-approved Research use only FDA-approved Investigational Compounded (503A)
What each label means
- Not FDA-approved
- No FDA approval for any use in humans.
- Research use only
- Sold as a "research chemical" not for human use. Not FDA-approved; FDA considers such products unapproved new drugs when marketed for human use.
- FDA-approved
- FDA has approved this drug or biologic as safe and effective for its labeled use.
- Investigational
- Being studied in clinical trials; not approved by FDA for any use.
- Compounded (503A)
- Prepared by a state-licensed 503A pharmacy for an individual patient prescription. Compounded drugs are not FDA-approved.
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Methodology
Data sources
What we include
- Peptides that are marketed to consumers through telehealth, compounding pharmacies or “research use only” sellers, or that FDA or its advisory committee has reviewed for the 503A bulks list.
- The 503A status is the one on FDA’s published lists on the “status as of” date; advisory committee votes are recorded as non-binding recommendations.
How we verify
- Every status change is dated and linked to the FDA page or meeting materials it comes from.
- Profiles are reviewed by a clinician or pharmacist on our medical review panel.
Known gaps
- 503B (outsourcing facility) status is recorded only when FDA has stated it.
- Advisory committee outcomes are sometimes reported before FDA posts minutes; those records say so.
- Human trial counts cover registered trials we reviewed, not every published study.
Update frequency: Checked at least weekly and whenever FDA updates its 503A lists or holds a PCAC meeting.
CSV columns (19)
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profile_url - Peptide profile on this site.
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name - Peptide name.
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synonyms - Other names, separated by semicolons.
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status_503a - 503A bulks-list status code.
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status_503a_label - 503A bulks-list status in plain English.
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status_503b - 503B (outsourcing facility) status, when known.
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fda_approved - true when an FDA-approved drug product contains the peptide.
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approved_product - The FDA-approved product, when there is one.
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wada - World Anti-Doping Agency status (Prohibited, Not listed, Not assessed).
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dea_schedule - DEA controlled-substance schedule, when assessed.
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status_labels - Status Label codes shown on the page, separated by semicolons.
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last_status_change - Date of the current 503A status (YYYY-MM-DD): the advisory committee vote, FDA listing or bulks-list effective date, by status.
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status_source_url - FDA document for the current status.
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status_as_of - Date we last verified the status.
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human_trial_count - Registered human trials we reviewed on ClinicalTrials.gov.
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trial_ids - ClinicalTrials.gov NCT numbers, separated by semicolons.
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unii - FDA Unique Ingredient Identifier.
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last_reviewed - Date of the last medical/editorial review (YYYY-MM-DD).
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last_updated - When this record last changed (ISO 8601).
“Peptide regulatory status tracker.” Tele Launched (dataset). Updated Oct. 27, 2026. Accessed Nov. 7, 2026. https://telelaunched.com/peptides/