Assessment cycle 2026 Q3 — page 7
Documents ratified in the 2026 Q3 assessment cycle, which ran from 1 July 2026 to 30 September 2026 and was ratified on 18 September 2026.
Documents ratified
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An analysis reporting the proportion of participants reaching a defined threshold. Reported by the Institute alongside the mean because a mean conceals the distribution…
30 Jul 2026 -
The outcome the Institute designates as primary for an indication across its whole document set, so that estimates for different compounds in that indication are…
30 Jul 2026 -
An effect expressed as the difference between the change in the active arm and the change in the placebo arm. The only form in which the Institute reports a within-arm…
30 Jul 2026 -
Any untoward occurrence in a participant, whether or not attributed to treatment. Ascertained by spontaneous report in most trials, which underestimates incidence…
30 Jul 2026 -
An adverse event that results in death, is life-threatening, requires hospitalisation, produces persistent disability or is a congenital anomaly. A regulatory…
30 Jul 2026 -
Cessation of randomised treatment because of an adverse event. Reported by the Institute in the summary-of-findings table alongside efficacy outcomes rather than in a…
30 Jul 2026 -
The reciprocal of the absolute risk increase for a harm. Reported alongside the number needed to treat wherever both are estimable.
30 Jul 2026 -
A ligand that binds a receptor and produces a response. Full agonists produce the maximal response the system can give; partial agonists produce less at full occupancy.
30 Jul 2026 -
A ligand producing a submaximal response at full receptor occupancy. May behave as an antagonist in the presence of a full agonist.
30 Jul 2026 -
A ligand that binds a receptor without producing a response and prevents an agonist from doing so.
30 Jul 2026 -
Preferential activation of one signalling pathway over another from the same receptor. Proposed as a means of separating a desired effect from receptor internalisation…
30 Jul 2026 -
The time for a plasma concentration to fall by half during the terminal elimination phase. Determines dosing interval, time to steady state and the time required for…
30 Jul 2026 -
The condition in which the amount of a compound entering the body equals the amount leaving it. Reached after approximately four to five half-lives of repeated dosing.
30 Jul 2026 -
The fraction of an administered dose reaching the systemic circulation unchanged. Low and variable for orally administered peptides, which is the constraint every oral…
30 Jul 2026 -
An excipient that increases absorption across a mucosal surface. In the oral peptide presentation in this document set it transiently raises local pH and increases…
30 Jul 2026 -
The apparent volume into which a compound distributes, computed from dose and plasma concentration. A small value indicates confinement to the circulation, as expected…
30 Jul 2026 -
The fraction of a compound bound to circulating protein and therefore not immediately available to distribute or be eliminated. Reversible albumin binding is the…
30 Jul 2026 -
The volume of plasma cleared of a compound per unit time. Together with volume of distribution it determines half-life.
30 Jul 2026 -
The time from administration to the maximum observed plasma concentration. For a subcutaneously administered acylated peptide this is measured in days rather than hours.
30 Jul 2026 -
The relationship between dose and the magnitude of effect. A monotonic relationship supports causal attribution; a non-monotonic one is reported by the Institute as…
30 Jul 2026 -
Rapid attenuation of response with repeated administration. Documented for several growth-hormone secretagogues and material to any claim about sustained effect.
30 Jul 2026 -
Reduction in receptor responsiveness following sustained stimulation, often through receptor internalisation. The pharmacological reason that non-pulsatile…
30 Jul 2026 -
A gut-derived hormone that potentiates insulin secretion in response to nutrient intake. The two principal human incretins are glucagon-like peptide-1 and…
30 Jul 2026 -
A compound activating the glucagon-like peptide-1 receptor, a class B G protein-coupled receptor signalling principally through Gαs. Effects include glucose-dependent…
30 Jul 2026 -
Glucose-dependent insulinotropic polypeptide, the second human incretin. Its contribution to the effects of dual agonists is substantially supported and not fully…
30 Jul 2026 -
A single molecule engineered to activate two receptors. In this document set the combinations of interest are GIP with GLP-1, and glucagon with GLP-1, which produce…
30 Jul 2026 -
A single molecule activating three receptors, in this set GIP, GLP-1 and glucagon. The glucagon component contributes an energy-expenditure effect and a hepatic effect…
30 Jul 2026 -
A pancreatic hormone co-secreted with insulin that slows gastric emptying and promotes satiation through the area postrema. Amylin analogues act on a mechanism largely…
30 Jul 2026 -
A compound activating amylin and calcitonin receptors, producing meal-related satiation. Combined with an incretin agonist in at least one fixed-combination product in…
30 Jul 2026 -
Attachment of a fatty-acid chain to a peptide, most often to mediate reversible albumin binding and thereby extend half-life. The structural feature underlying weekly…
30 Jul 2026 -
A circumventricular structure lacking a complete blood–brain barrier, accessible to circulating peptides and central to both the satiety and the nausea effects of this…
30 Jul 2026 -
The rate at which stomach contents pass into the duodenum. Delayed by GLP-1 receptor agonism, with partial attenuation on continued dosing, and relevant to both…
30 Jul 2026 -
Breakdown of a peptide by proteases, principally dipeptidyl peptidase-4 for incretins. Resistance is engineered by substitution at the cleavage site.
30 Jul 2026 -
Dipeptidyl peptidase-4, the protease that cleaves native glucagon-like peptide-1 within minutes. Every long-acting analogue in this set is protected against it…
30 Jul 2026 -
Separation on a hydrophobic stationary phase under an acidified aqueous–organic gradient, with ultraviolet detection at 214 nanometres. The Institute’s reference method…
30 Jul 2026 -
The area of the main peak as a percentage of total integrated area under stated conditions. A relative measure that assumes comparable molar absorptivity across species…
30 Jul 2026 -
The retention-time range over which peak areas are summed. Changing the window changes the reported purity without changing the material, which is why the Institute…
30 Jul 2026 -
The programmed change in mobile-phase composition over a chromatographic run. A shallow gradient resolves close-eluting species that a steep gradient co-elutes, and the…
30 Jul 2026 -
A property of a method that separates the intact compound from its degradation products, demonstrated by forced-degradation study. A purity method that is not…
30 Jul 2026 -
Deliberate exposure of a sample to heat, light, acid, base and oxidant to generate degradation products against which a method’s specificity is demonstrated.
30 Jul 2026
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