Draft monograph: orforglipron
Consultation on the draft monograph for orforglipron, an oral non-peptide glucagon-like peptide-1 receptor agonist. The draft assesses a compound whose phase 3 programme was reporting during the consultation window, and grades the principal assessed outcome…
§1Consultation and window
§1.1Window
- Opened
- 13 April 2026
- Closed
- 12 June 2026
- Duration
- 60 days
- Status
- Closed — the disposition is published
- Document under consultation
- Monograph: Orforglipron
- Submissions received
- 10
§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 the moderate certainty rating correctly drawn given the maturity of the contributing evidence at the search date?
- Is the distinction between a peptide agonist and a non-peptide small-molecule agonist drawn clearly enough for a reader applying the analytical section?
- Are the evidence gaps recorded in the monograph complete, in particular in relation to outcomes beyond weight and glycaemia?
§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 analytical section now states that the peptide standards in the Institute series do not apply to a non-peptide small molecule and directs the reader to the relevant small-molecule methods, and the search date is stated on the face of the certainty rating.
The disposition table, listing each submission with its disposition and the resulting amendment, is at §3.