Hormones & metabolism Mitochondrial-derived peptide
Humanin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
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This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information.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.
Key takeaway
Humanin is a small peptide encoded within the mitochondria, studied for longevity and brain protection, and sold on the "research peptide" market. Its evidence is preclinical and observational, with no trials testing it as a treatment in people. As of 2026 it is not FDA-approved.
At a glance
- FDA status
- Non-FDA-approved peptide sold in the wellness/gray market
- What it is
- Naturally occurring mitochondrial-derived peptide studied in aging and neuroprotection
- Research
- Evidence is animal and observational; there are no interventional human trials
- Approval status
- Not approved anywhere as a therapy
- Evidence strength
- Low research
Summary
Humanin is a mitochondria-encoded peptide studied for aging and brain protection. Learn what research shows, why evidence is limited, and its FDA status.
What is humanin?
Humanin is a naturally occurring 24-amino acid peptide encoded within the mitochondria, the energy-producing structures of cells. It belongs to a family of "mitochondrial-derived peptides" and has drawn research interest in aging and neuroprotection. It is sold through wellness and "research peptide" channels for longevity, and it is not an approved medicine.
How does it work?
Humanin is proposed to:
- Protect cells
- Support nerve-cell survival
- Reduce programmed cell death
- Improve insulin sensitivity and metabolic signaling
Its levels are reported to decline with age in some studies and to rise in others, and are reported lower in some diseases. In laboratory and animal work it protected neurons and, in worms and mice, was associated with extended lifespan and healthspan. These are preclinical findings. This describes the proposed mechanism, separate from demonstrated benefit in people.
Is it FDA-approved?
Safety note
Status: Non-FDA-approved peptide sold in the wellness/gray market
Category: Wellness and performance · Primary body area: Hormones & metabolism
No. Humanin is not approved by the FDA or any regulator as a therapy; it is studied as a research tool and sold through gray-market channels. It is not on FDA compounding lists and was not among the peptides reviewed at the 2026 FDA compounding advisory meetings.
What does the research show?
Editor’s note
Evidence strength: Low research
There is rich mechanistic, animal, and human biomarker data, but no interventional human trials, so efficacy for any wellness use is unestablished.
The evidence is preclinical and observational. The table below summarizes what each type of study, as indexed on PubMed, has found.
| Type of evidence | What it shows |
|---|---|
| Laboratory work | Humanin is released by support cells in the brain and can prevent loss of connections between neurons (here) |
| Animal studies | Report lifespan and healthspan effects (here) |
| Human observational studies | Humanin can be measured in blood, and studies disagree on whether levels fall or rise with age, an observational association rather than a treatment effect |
| Human interventional trials | None of humanin as a therapy, so its marketed benefit is unproven in people |
Sources: laboratory and animal studies of humanin in synapse protection (Zárate et al., Frontiers in Aging Neuroscience, 2019, DOI: 10.3389/fnagi.2019.00123) and lifespan/healthspan (Yen et al., Aging, 2020, DOI: 10.18632/aging.103534), indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
- [4]
- [5]
- [6]
- [7]
- [8]
- [9]
- [10]
- [11]
- [12]
- [13]
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