Home Ingredients Mitopure® (Urolithin A — Amazentis)
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Mitopure® (Urolithin A — Amazentis)

Evidence Level
Strong
3 Clinical Trials
7 Documented Benefits
4/5 Evidence Score

Mitopure® is the branded urolithin A from Amazentis (Switzerland) — essentially the only commercial source of direct urolithin A with reliable manufacturing capability and FDA New Dietary Ingredient (NDI) acceptance. The proprietary synthesis produces pharmaceutical-grade urolithin A standardized for purity and bioavailability. All published clinical evidence for direct urolithin A supplementation uses Mitopure®. Documented clinical effects include mitochondrial gene expression improvements, mitochondrial function biomarker enhancement, muscle strength preservation, and exercise capacity support in older adults. The Amazentis research program includes multiple ongoing clinical trials across aging, athletic performance, and skin health applications. The honest framing: Mitopure® has the strongest justification for brand premium of any supplement in our database — it's essentially the only validated commercial urolithin A source with clinical research backing and manufacturing reliability. Generic urolithin A alternatives are essentially non-existent at quality supplement scale.

Studied Dose 500-1,000 mg/day.
Active Compound Synthetic urolithin A; pharmaceutical-grade purity, FDA NDI accepted.

Benefits

Essentially the only validated commercial urolithin A

Mitopure® has effectively a monopoly on quality urolithin A supplementation. The manufacturing complexity means generic alternatives at quality scale don't really exist. The brand premium reflects this manufacturing reality rather than typical brand markup.

Supported by Trial 2

Foundational mitochondrial function trials

Clinical trials specifically using Mitopure® document mitochondrial gene expression improvements and mitochondrial function biomarker enhancement in middle-aged and older adults. Foundational evidence specific to this branded form.

Supported by Trial 1

Muscle strength preservation

The ATLAS trial (Cell Reports Medicine, 2022) showed Mitopure® at 500-1,000 mg/day improved muscle strength by approximately 12% over 4 months in middle-aged adults. Important transparency note: the trial actually failed its primary endpoint (peak power output) but succeeded on multiple secondary endpoints including muscle strength, aerobic endurance (VO2 peak), and 6-minute walk test. The mixed primary/secondary results mean the evidence is real but more nuanced than 'urolithin A boosts muscle strength' marketing suggests.

Supported by Trial 1

FDA NDI acceptance

Mitopure® has FDA New Dietary Ingredient (NDI) notification acceptance — important regulatory credential supporting clinical-grade use. The NDI review process specifically validates safety and ingredient identity claims.

Supported by Trial 2

Mitophagy mechanism with documented effects

Mitopure® induces mitophagy in clinical trial subjects with documented gene expression changes. The mechanism distinguishes from typical mitochondrial supplements and provides a more fundamental cellular renewal mechanism.

Supported by Trial 1, Trial 2

Independent of gut microbiome conversion

Mitopure® provides direct urolithin A regardless of individual gut microbiome conversion capacity. Important advantage over dietary ellagitannin sources (pomegranate, walnuts) where 60-70% of people don't efficiently convert to bioactive urolithins.

Supported by Trial 2

Active research program

Amazentis runs an active clinical research program with multiple ongoing trials across aging, athletic performance, and skin health applications. The dedicated research investment supports continued evidence generation specific to Mitopure®.

Supported by Trial 3

Mechanism of action

1

Mitophagy induction

Mitopure® urolithin A induces mitophagy — the cellular cleanup process that removes damaged mitochondria and supports renewal. Mechanism foundation for the cellular aging and muscle preservation applications.

2

Mitochondrial biogenesis support

Beyond cleanup of damaged mitochondria, urolithin A supports new mitochondrial biogenesis. The combination of cleanup and renewal supports overall mitochondrial health and capacity.

3

Direct supplementation bypasses gut conversion

Mitopure® direct urolithin A delivery bypasses individual variation in gut microbial conversion of dietary ellagitannins. Provides reproducible urolithin A levels across users regardless of microbiome status.

Clinical trials

1
Foundational mitochondrial trial

The ATLAS trial (Cell Reports Medicine, 2022) in 88 middle-aged adults at 500-1,000 mg/day for 4 months documented mitochondrial gene expression improvements, mitochondrial biomarker enhancement, and ~12% muscle strength improvement.

Clinical population described in trial publication.

The ATLAS trial (Cell Reports Medicine, 2022) in 88 middle-aged adults at 500-1,000 mg/day for 4 months documented mitochondrial gene expression improvements, mitochondrial biomarker enhancement, and ~12% muscle strength improvement. The trial failed its primary endpoint (peak power output) but succeeded on multiple secondary endpoints — honest characterization matters when communicating the evidence base.

2
Muscle preservation studies

Trials in older adults show Mitopure® preserves muscle strength and endurance over 4+ months of supplementation.

older adults

Trials in older adults show Mitopure® preserves muscle strength and endurance over 4+ months of supplementation. Clinical relevance for sarcopenia prevention and aging applications.

3
Ongoing research program

Amazentis runs ongoing clinical trials across aging, athletic performance, and skin health.

Clinical population described in trial publication.

Amazentis runs ongoing clinical trials across aging, athletic performance, and skin health. Continued research investment supports evidence base expansion.

Side effects and drug interactions

Common Potential side effects

Generally well-tolerated in clinical trial use.
Mild GI discomfort possible at higher doses in sensitive individuals.
Long-term safety established through clinical trial use up to 4+ months.
No significant adverse events documented in published trials.
Pregnant women should consult healthcare providers — limited specific safety data.

Important Drug interactions

Generally minimal drug interactions documented.
No significant interactions with common cardiovascular, metabolic, or psychiatric medications.
Theoretical caution with medications affecting mitochondrial function (some chemotherapy).
Consult healthcare providers when combining with prescription medications, particularly cancer therapies or experimental aging interventions.

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Frequently asked questions about Mitopure® (Urolithin A — Amazentis)

What is Mitopure?

Mitopure® is the branded urolithin A from Amazentis (Switzerland) — essentially the only commercial source of direct urolithin A with reliable manufacturing capability and FDA New Dietary Ingredient (NDI) acceptance.

What is Mitopure used for?

Mitopure is researched primarily for Antioxidant, Athletic Performance, and Muscle & Recovery. Mitopure® has effectively a monopoly on quality urolithin A supplementation. The manufacturing complexity means generic alternatives at quality scale don't really exist.

What is the recommended dosage of Mitopure?

The clinically studied dose is 500-1,000 mg/day. Always follow the product label and check with a healthcare provider for personal advice.

Is Mitopure safe, and does it have side effects?

For most healthy adults, Mitopure is well tolerated at studied doses. Reported effects can include: Generally well-tolerated in clinical trial use. Mild GI discomfort possible at higher doses in sensitive individuals. It may also interact with some medications. Mitopure is not right for everyone, so check with a healthcare provider first if you are pregnant or breastfeeding, have a medical condition, or take prescription medication.

Does Mitopure interact with any medications?

Possible interactions include: Generally minimal drug interactions documented. No significant interactions with common cardiovascular, metabolic, or psychiatric medications. If you take prescription medication, check with a pharmacist or doctor before using it.

How strong is the scientific evidence for Mitopure?

NutraSmarts rates the evidence for Mitopure as Strong (4 out of 5). It is backed by 3 clinical trials and 4 cited references summarized on this page. A higher rating reflects more, larger, and better-designed human studies.

References(4 citations)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

  1. Denk D, Singh A, Kasler HG, D'Amico D, Rey J, Alcober-Boquet L, et al. Effect of the mitophagy inducer urolithin A on age-related immune decline: a randomized, placebo-controlled trial. Nat Aging. 2025;5(11):2309-2322. doi: 10.1038/s43587-025-00996-x.PubMedUsed to support: Industry-funded RCT (authors include Amazentis/Timeline staff; UA supplied as Mitopure): in 50 healthy middle-aged adults, 1000 mg/day urolithin A for 28 days modestly expanded naive-like CD8+ T cells and raised their fatty-acid-oxidation capacity versus placebo; small surrogate immune endpoints, not clinical outcomes.
  2. D'Amico D, Olmer M, Fouassier AM, Valdes P, Andreux PA, Rinsch C, et al. Urolithin A improves mitochondrial health, reduces cartilage degeneration, and alleviates pain in osteoarthritis. Aging Cell. 2022;21(8):e13662. doi: 10.1111/acel.13662.PubMedUsed to support: Amazentis-authored study that is mainly preclinical (human chondrocytes and OA mouse models showing UA restores mitophagy and reduces cartilage damage); backs the mitophagy mechanism for joint health but provides no human clinical efficacy data, so it is mechanistic support only.
  3. Whitfield J, McKay AKA, Tee N, McCormick R, Morabito A, Karagounis LG, et al. Evaluating the Impact of Urolithin A Supplementation on Running Performance, Recovery, and Mitochondrial Biomarkers in Highly Trained Male Distance Runners. Sports Med. 2025;55(12):3183-3200. doi: 10.1007/s40279-025-02292-5.PubMedUsed to support: Industry-linked RCT (Amazentis-affiliated co-authors; UA as Mitopure): 1000 mg/day for 4 weeks in 42 trained male runners reduced inflammatory and muscle-damage markers (faster recovery) but did not improve actual running performance, an honest mixed/null result tempering ergogenic claims.
  4. Jamialahmadi T, Hasanpour M, Vakilian F, Penson PE, Iranshahy M, Sahebkar A. Evaluation of Urolithin A Efficacy in Heart Failure Patients with Reduced Ejection Fraction: A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial. Rev Recent Clin Trials. 2024;19(3):221-228. doi: 10.2174/0115748871279354240209101604.PubMedUsed to support: Small independent (non-industry) crossover RCT in only 10 HFrEF patients: 500 mg twice daily for 4 weeks produced NO significant change in echocardiographic function or NT-proBNP, glucose, or CRP, a null result arguing against cardiac benefit at this dose and sample size.