Urolithin A first-in-human: safety and a mitochondrial gene signature (Andreux et al., 2019)
Human RCT — biomarker endpoint
Record verify: verified against primary source
| Design | First-in-human randomized, placebo-controlled safety study (biomarker) |
| DOI | 10.1038/s42255-019-0073-4 |
| Citation status | doi verified via Crossref 2026-07-12 (Nat Metab 2019;1(6):595-603, Andreux et al., 'The mitophagy activator urolithin A is safe and induces a molecular signature of improved mitochondrial and cellular health in humans'). PMID and trial registry ID are not confirmed; see identifier status. |
Identifiers: DOI verified; PMID not reported; trial registry id not reported. Record-level verification and identifier-level status are separate: a record can be verified against its primary publication on one identifier while another is simply not confirmed. No identifier is fabricated, and none is left in a “pending” state.
Five-qualifier claim
| Species / population | Healthy sedentary older adults, first-in-human randomized placebo-controlled study plus a single-dose/repeated-dose safety design. |
| Exposure, route, schedule | Oral urolithin A (single ascending doses and 28-day repeated dosing, up to ~1000 mg/day). |
| Comparator / duration | Placebo-controlled; short (single-dose and 4-week) exposure. |
| Endpoint / numeric result | Urolithin A was safe and bioavailable and induced a molecular (gene-expression) signature of improved mitochondrial and cellular health in skeletal muscle; no adverse safety signal. |
| What it did NOT establish | A safety/biomarker first-in-human study — no functional or clinical efficacy endpoint met, and no lifespan or healthy-aging outcome. |
Interventions
What this trial administered
These are the compounds this trial administered, nothing more. MitoiX does not rank products, name a best one, or suggest a dose — read the record above and the primary reference, then talk to a clinician.
- Urolithin A (Mitopure) — Urolithin A (Mitopure)
Studied form: Mitopure, 500-1000 mg/day in the human trials
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Primary reference
https://doi.org/10.1038/s42255-019-0073-4
Exact identifier confirmed against the primary record via Crossref/ClinicalTrials.gov where stated in the citation status names the source and the date. An identifier that is not confirmed is named as such in the identifier row above, never filled in from a secondary source.