Draft monograph: danuglipron
Consultation on the draft monograph for danuglipron, an oral non-peptide glucagon-like peptide-1 receptor agonist whose development programme was discontinued. The draft records the discontinuation and treats the resulting evidence as informative about the…
§1Consultation and window
§1.1Window
- Opened
- 14 July 2025
- Closed
- 25 August 2025
- Duration
- 42 days
- Status
- Closed — the disposition is published
- Document under consultation
- Monograph: Danuglipron
- Submissions received
- 3
§1.2Consultation questions
The secretariat put the following questions. A submission was not required to address them and several did not; the questions record what the Institute was uncertain about rather than restricting what a respondent could raise.
- Is a discontinued programme correctly treated as evidence rather than as an absence of evidence?
- Is the reason for discontinuation reported with appropriate attribution, given that it is drawn from sponsor announcements rather than from a trial report?
- Does the monograph state clearly enough what remains unreported from the programme?
§1.3How a submission is handled
- Every submission is signed. The Institute publishes no anonymous submission.
- Every submission carries a declared interest. A declaration of no interest is itself a declaration and is recorded as one. A declaration is not a disqualification and the Institute has never given a submission less weight on that ground.
- A submission from an employee of a marketing-authorisation holder is identified as an industry submission on its face, following a unanimous consultation on the conflicts policy.
- Every submission receives a secretariat response and a disposition. Submissions that are not accepted remain published in full; the Institute does not remove a submission because it disagrees with it.
- There is no voting, no reputation score, no reply thread and no editing after receipt.
§1.4Outcome
The monograph was amended before ratification. The discontinuation is attributed to the sponsor announcement with its date, the trials that reported and those that did not are listed separately, and the unreported set is recorded as an evidence gap.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.