SANA (MVD1)
SANA, called MVD1 in its first human trial, has extensive mouse data and one tiny 15-day human safety study. About 3% weight loss was observed in six high-dose participants, while two people at the highest single dose developed reversible kidney tubular injury.
Investigational electrophilic nitroalkene small molecule
- Small molecule, not a peptide
- MVD1 was the human trial code
- Human efficacy has not been confirmed
What exact compound and development code were studied?
SANA is a nitroalkene derivative of salicylate developed as a small-molecule thermogenesis activator. The first-in-human study used the code MVD1 for the same program.
The first human trial used the name MVD1 and registry identifier ACTRN12622001519741.
SANA/MVD1 · mouse program and first human trial
Preclinical and phase 1 trial report
Vila et al., Nature Metabolism, 2025
The paper reports mouse metabolic effects and a randomized first-in-human safety study; six high-dose repeat participants had about 3% exploratory weight loss, and two highest single-dose participants had reversible tubular injury.
- Participants / model
- Healthy lean volunteers in single-dose cohorts and healthy volunteers with overweight or obesity in multiple-dose cohorts
- Treatment
- MVD1 single doses of 200 to 800 mg or repeat doses of 200 to 400 mg daily, with placebo
- Follow-up
- Single dose or 15 days
- Study design
- Randomized, double-blind, placebo-controlled phase 1A/B study plus preclinical experiments
The human trial was powered for safety, with tiny cohorts and exploratory metabolic endpoints.
Read the original sourceWhat weight change was observed in people?
In the multiple-dose cohort, six participants receiving MVD1 200 mg every 12 hours for 15 days lost about 3% of body weight on average. The trial was designed and powered for safety, the outcome was exploratory, and the active high-dose group had only six people.
The paper also reports glucose, insulin, HOMA-IR, and fructosamine changes in that cohort. These are preliminary within a very small inpatient experiment, not confirmed weight-loss efficacy.
An exploratory human weight change was observed, but it has not been confirmed.
SANA/MVD1 · mouse program and first human trial
Preclinical and phase 1 trial report
Vila et al., Nature Metabolism, 2025
The paper reports mouse metabolic effects and a randomized first-in-human safety study; six high-dose repeat participants had about 3% exploratory weight loss, and two highest single-dose participants had reversible tubular injury.
- Participants / model
- Healthy lean volunteers in single-dose cohorts and healthy volunteers with overweight or obesity in multiple-dose cohorts
- Treatment
- MVD1 single doses of 200 to 800 mg or repeat doses of 200 to 400 mg daily, with placebo
- Follow-up
- Single dose or 15 days
- Study design
- Randomized, double-blind, placebo-controlled phase 1A/B study plus preclinical experiments
The human trial was powered for safety, with tiny cohorts and exploratory metabolic endpoints.
Read the original sourceWhat was the renal safety signal?
Two participants at the highest single-dose exposure developed definite drug-related reversible tubular injury, shown by proteinuria and glucosuria. Both cases resolved.
Two events in one small dose cohort are not a stable incidence estimate. They are a dose-limiting warning that requires larger, longer study and exposure detail.
SANA/MVD1 · mouse program and first human trial
Preclinical and phase 1 trial report
Vila et al., Nature Metabolism, 2025
The paper reports mouse metabolic effects and a randomized first-in-human safety study; six high-dose repeat participants had about 3% exploratory weight loss, and two highest single-dose participants had reversible tubular injury.
- Participants / model
- Healthy lean volunteers in single-dose cohorts and healthy volunteers with overweight or obesity in multiple-dose cohorts
- Treatment
- MVD1 single doses of 200 to 800 mg or repeat doses of 200 to 400 mg daily, with placebo
- Follow-up
- Single dose or 15 days
- Study design
- Randomized, double-blind, placebo-controlled phase 1A/B study plus preclinical experiments
The human trial was powered for safety, with tiny cohorts and exploratory metabolic endpoints.
Read the original sourceWhat does creatine-dependent thermogenesis mean?
Mouse experiments linked SANA to higher mitochondrial respiration and creatine-dependent energy expenditure in adipose tissue, with less diet-induced weight gain and liver fat. The human study did not directly confirm that pathway as the cause of its exploratory weight change.
The paper reports that the mouse effect was independent of UCP1 and AMPK. That mechanistic distinction remains preclinical.
SANA/MVD1 · mouse program and first human trial
Preclinical and phase 1 trial report
Vila et al., Nature Metabolism, 2025
The paper reports mouse metabolic effects and a randomized first-in-human safety study; six high-dose repeat participants had about 3% exploratory weight loss, and two highest single-dose participants had reversible tubular injury.
- Participants / model
- Healthy lean volunteers in single-dose cohorts and healthy volunteers with overweight or obesity in multiple-dose cohorts
- Treatment
- MVD1 single doses of 200 to 800 mg or repeat doses of 200 to 400 mg daily, with placebo
- Follow-up
- Single dose or 15 days
- Study design
- Randomized, double-blind, placebo-controlled phase 1A/B study plus preclinical experiments
The human trial was powered for safety, with tiny cohorts and exploratory metabolic endpoints.
Read the original sourceHas SANA been approved or followed by a larger efficacy trial?
The cited records include the first-in-human study but no exact-name FDA approval or posted larger efficacy result under SANA, MVD1, or ACTRN12622001519741.
The SANA and MVD1 aliases and ACTRN12622001519741 identify the relevant program.
SANA status · MVD1 and ACTRN12622001519741
US approval and trial status
Drugs@FDA, openFDA, PubMed, and ClinicalTrials.gov.
The cited records include the first-in-human study but no exact-name FDA approval or posted larger efficacy result under SANA, MVD1, or ACTRN12622001519741.
SANA is ambiguous, so the MVD1 alias and ACTRN12622001519741 identify the relevant program.
Read the original sourceDoes matching a short semaglutide time point prove comparable efficacy?
No. The paper notes that its roughly 3% 15-day change resembled a short semaglutide time point, but that is an across-study observation involving six active participants. It does not compare long-term efficacy, safety, discontinuation, or clinical outcomes.
SANA/MVD1 · mouse program and first human trial
Preclinical and phase 1 trial report
Vila et al., Nature Metabolism, 2025
The paper reports mouse metabolic effects and a randomized first-in-human safety study; six high-dose repeat participants had about 3% exploratory weight loss, and two highest single-dose participants had reversible tubular injury.
- Participants / model
- Healthy lean volunteers in single-dose cohorts and healthy volunteers with overweight or obesity in multiple-dose cohorts
- Treatment
- MVD1 single doses of 200 to 800 mg or repeat doses of 200 to 400 mg daily, with placebo
- Follow-up
- Single dose or 15 days
- Study design
- Randomized, double-blind, placebo-controlled phase 1A/B study plus preclinical experiments
The human trial was powered for safety, with tiny cohorts and exploratory metabolic endpoints.
Read the original sourceStudies and sources
SANA/MVD1 · mouse program and first human trial
Preclinical and phase 1 trial report
Vila et al., Nature Metabolism, 2025
The paper reports mouse metabolic effects and a randomized first-in-human safety study; six high-dose repeat participants had about 3% exploratory weight loss, and two highest single-dose participants had reversible tubular injury.
- Participants / model
- Healthy lean volunteers in single-dose cohorts and healthy volunteers with overweight or obesity in multiple-dose cohorts
- Treatment
- MVD1 single doses of 200 to 800 mg or repeat doses of 200 to 400 mg daily, with placebo
- Follow-up
- Single dose or 15 days
- Study design
- Randomized, double-blind, placebo-controlled phase 1A/B study plus preclinical experiments
The human trial was powered for safety, with tiny cohorts and exploratory metabolic endpoints.
Read the original sourceSANA status · MVD1 and ACTRN12622001519741
US approval and trial status
Drugs@FDA, openFDA, PubMed, and ClinicalTrials.gov.
The cited records include the first-in-human study but no exact-name FDA approval or posted larger efficacy result under SANA, MVD1, or ACTRN12622001519741.
SANA is ambiguous, so the MVD1 alias and ACTRN12622001519741 identify the relevant program.
Read the original sourceWhy is SANA (MVD1) in B tier?
B reflects a published first-in-human report with an exploratory metabolic signal. The study included six high-dose participants, and two people at the highest single dose developed reversible kidney tubular injury.