Compound monograph · §4

Danuglipron — safety

Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.

Document identifier: CEI-MN-012/4
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

§4Safety

§4.1Adverse events reported in controlled trials

Table 4. Adverse events for Danuglipron as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.

Event	Active, %	Comparator, %	Difference, pp	Source
Nausea	73.0	18.0	+55.0	Phase 2b obesity, highest dose
Vomiting	47.0	6.0	+41.0	Phase 2b obesity
Diarrhoea	25.0	12.0	+13.0	Phase 2b obesity
Discontinuation for adverse events	50.0	40.0	+10.0	Phase 2b obesity — high in both arms
Hepatic transaminase elevation	—	—	—	A case of drug-induced liver injury contributed to the discontinuation decision
A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here.

Figure 4. Gastrointestinal adverse events for Danuglipron as reported in the contributing safety tables. Incidences of this kind are dose- and titration-rate-dependent and attenuate with continued exposure in most but not all participants.

§4.2Contraindications

Not applicable — development discontinued

§4.3Warnings and precautions

A hepatic safety finding contributed to programme discontinuation
Gastrointestinal intolerance at efficacious doses was severe

§4.4What this section does not establish

What this document does not establish

Rare events. A trial programme of the size available for this compound could not detect an event occurring at a rate below approximately one in several hundred exposed participants. The absence of such an event in the tables above is uninformative, not reassuring.
Long-latency events. The longest randomised exposure in the contributing evidence is measured in months to a small number of years. Outcomes with a longer latency are outside what any contributing trial could observe.
Harms of the supplied material as distinct from the compound. Every incidence above was measured in a trial using material manufactured under a regulated quality system. Harms attributable to impurities, counter-ion load, endotoxin or incorrect content in research-supply material are not represented in any of these figures.

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.

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
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.

Compound Evidence Institute · CEI-MN-012/4 · https://compoundevidence.com/monographs/danuglipron/safety/ · retrieved 30 July 2026