Danuglipron — compound monograph
Oral non-peptide GLP-1 receptor agonist. Discontinued. The Institute assesses 2 outcomes for this compound and grades the strongest at low certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Danuglipron
- Compound class
- Oral non-peptide GLP-1 receptor agonist
- Assessment series
- Incretin receptor agonists
- Synonyms and codes
- PF-06882961 · danuglipron (INN)
- Route as evaluated
- Oral, twice daily in the phase 2b programme
§1.2Chemistry
Chemical identifiers are reproduced where they are public. Where a structure has not been published the monograph records not disclosed rather than constructing one.[1]
- CAS registry number
- 2230198-02-2
- Molecular formula
- C31H32N6O4
- Average mass
- 552.6
- Monoisotopic mass
- 552.25
- ATC classification
- not assigned
§1.3Sequence and structural notes
A non-peptide GLP-1 receptor agonist. Development was discontinued by the sponsor after a hepatic safety finding in a phase 2b programme and after tolerability limitations at the doses required for efficacy.
§1.4Assessment status
The Institute assesses Danuglipron across 2 indications and grades the strongest of them at low certainty. Clinical development was terminated. The Institute treats a discontinued programme as evidence.
Table 1. Assessed outcomes for Danuglipron, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Type 2 diabetes mellitus | −1.16 % HbA1c at 16 weeks with 120 mg twice daily versus placebo | Moderate | 1 |
| Obesity and overweight in adults | −8.0 to −13.0 % body weight at 32 weeks across doses, with discontinuation rates above 50 % in some arms | Low | 1 |
| Effects are reproduced as the contributing trials reported them. Where a confidence interval is held it appears on the per-indication extract rather than in this summary table. | |||
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.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
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.