ATX-304 dosage in published studies and labels
These are the doses used for ATX-304 in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
ATX-304 (formerly O304) has been given to people in two small placebo-controlled trials: 1,000 mg once daily by mouth for 28 days in a 65-patient phase 2a trial in type 2 diabetes, and 400 mg once daily for 8 weeks in a 23-person phase 1b trial in obesity with prediabetes. These were short exploratory studies of an investigational drug, not an established therapeutic regimen, and no product containing it is approved anywhere. It is also not a peptide: it is a small-molecule AMPK activator.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 400–1,000 mg orally once daily (two trials, different formulations) |
| Route | Oral |
| Frequency | Once daily |
| Duration studied | 28 days to 8 weeks in the trials, with an optional open-label extension to 16 weeks in the phase 1b |
| Titration | None reported. Each trial used a single fixed dose. |
| Half-life | Long; plasma levels did not reach steady state until about day 14 of daily dosing. No numeric human half-life has been published. |
| Evidence level | Limited Human Evidence |
| Last reviewed | 2026-10-05 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| Steneberg et al., 2018 — TELLUS phase 2aClinical trial · Randomised, double-blind, placebo-controlled phase 2a | Adults with type 2 diabetes on metformin (n=65, ATX-304 and placebo arms) | 1,000 mg | Oral suspension | Once daily | 28 days | Fasting plasma glucose, HOMA-IR, blood pressure and calf-muscle microvascular perfusion; safety | Steneberg P et al. PAN-AMPK activator O304 improves glucose homeostasis and microvascular perfusion in mice and type 2 diabetes patients. JCI Insight. 2018. |
| Thieroff-Ekerdt et al., 2026 — phase 1b (conference abstract)Clinical trial · Randomised, double-blind, placebo-controlled phase 1b; ADA 2026 abstract | Adults with obesity and prediabetes (n=23, randomised 2:1 to ATX-304 or placebo) | 400 mg | Oral tablets (sodium salt) | Once daily | 8 weeks, with an optional open-label extension to 16 weeks | Safety, pharmacokinetics, adiponectin, liver and visceral fat by MRI, resting metabolic rate | Thieroff-Ekerdt RI et al. 1782-P: Phase 1b Study of AMPK/Mitochondrial Activator ATX-304 in Prediabetic Obese Participants. Diabetes. 2026;75(Supplement_1). |
Preclinical and analog research
Not human dosing evidence. Listed for completeness and never extrapolated to a human dose.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| Preclinical — aged micePreclinical · Rodent study | Aged mice | 0.25 or 0.5 mg per gram of diet; not convertible to a human dose | Oral (in feed) | — | 12 months | Metabolic and cardiac function, exercise capacity | Ericsson M et al. AMPK activator O304 improves metabolic and cardiac function, and exercise capacity in aged mice. Commun Biol. 2021. |
| Preclinical — diet-induced fatty liver disease (MASLD)Preclinical · Rodent study | Mice on a choline-deficient high-fat diet | 1 mg per gram of diet; not convertible to a human dose | Oral (in feed) | — | — | Fat mass, blood cholesterol, liver steatosis and fibrosis | Holm E et al. AMPK activator ATX-304 reduces oxidative stress and improves MASLD via metabolic switching. JCI Insight. 2025. |
Where sources disagree
- The two trials used different formulations (an oral suspension in 2018, sodium-salt tablets in the phase 1b), so 1,000 mg and 400 mg are not directly comparable exposures. Neither trial compared doses, so neither identifies an optimal one.
- The phase 1b results are so far published only as a conference abstract and company announcements, not a full peer-reviewed paper. The abstract reports resting metabolic rate rising up to 33% from baseline; the company's announcement reports an 8% increase. Minimal weight loss was reported at 400 mg daily.
- The 2018 paper lists two ClinicalTrials.gov numbers for the TELLUS trial (NCT00508287 and NCT01167881), but both belong to unrelated trials by other sponsors. The phase 1b is registered in the EU Clinical Trials Information System as 2023-505967-36-00.
- ATX-304 is not named on the WADA Prohibited List, but section S4.4.1 prohibits AMPK activators as a class at all times (its examples are AICAR, BAM15 and MOTS-c).
- Products sold online as ATX-304 or O-304 are research chemicals, not the trial material. Their identity, purity and salt form are unverified, and trial doses describe the trial formulations only.