Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Compound monograph · §2

Danuglipron — pharmacology

Molecular targets, mechanism of action, pharmacokinetics and interactions as characterised in humans.

Document identifier
CEI-MN-012/2
Series
Compound monograph
Version
4.3
Published
20 May 2025
Last reviewed
20 Jul 2026
Next review
20 Jul 2028
Identifier
10.71829/cei.mono.12
Certainty
Low
Cycle
2025 Q2

§2Pharmacology

§2.1Molecular targets

Table 2. Molecular targets recorded for Danuglipron, with the character of the interaction and the potency where the Institute holds it.

TargetInteractionNote
GLP-1 receptor (GLP1R)AgonistOrthosteric-adjacent binding; full cyclic-AMP efficacy reported in vitro

§2.2Mechanism of action

Small-molecule GLP-1 receptor agonism with a short half-life requiring twice-daily administration. The Institute includes this monograph specifically because a discontinued programme is evidence, and because the reasons for discontinuation — tolerability at effective doses and a hepatic signal — are directly relevant to the interpretation of other oral non-peptide agents in development.[1,2]

§2.3Pharmacokinetics

Terminal half-life
≈4–5 h
Time to maximum concentration
2–4 h
Volume of distribution
not published
Plasma protein binding
high
Clearance
not published
Bioavailability
adequate for oral dosing

Hepatic metabolism. The short half-life necessitated twice-daily dosing, which the Institute notes contributed to the tolerability profile by producing repeated peak exposures.

Reconstructed plasma concentration–time profilePlasma concentration plotted against time after dosing, reconstructed from published pharmacokinetic parameters.0.00.20.40.60.805101520Time after first dose (hours)Relative concentrationt max ≈ 2 ht½ ≈ 5 h
Modelled profileSimulated observationsDose administration
Figure 2. Illustrative. Plasma concentration–time profile reconstructed by the Institute from the published half-life and time-to-maximum-concentration parameters using a one-compartment model with first-order absorption. The curve is not digitised from a published figure and its vertical scale is relative. It is published to convey the shape of the profile and the approach to steady state, not to supply a concentration at any time point.

§2.4Interactions

  • Not fully characterised

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

  1. Saxena AR, Frias JP, Brown LS, Gorman DN, Vasas S, Tsamandouras N, Birnbaum MJ. Efficacy and safety of oral small molecule glucagon-like peptide 1 receptor agonist danuglipron for glycemic control among patients with type 2 diabetes: a randomized clinical trial. JAMA Network Open 2023;6(5):e2314493. doi:10.1001/jamanetworkopen.2023.14493 · PMID 37237090
  2. Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.

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