Assessment cycle 2024 Q4

Record of documents ratified in the 2024 Q4 assessment cycle.

Consultation on how the Institute should label a programme record it has constructed by grouping trials, as distinct from a programme as defined by its sponsor. The…

Consultation on the structure of the document registry: the identifier scheme, the fields carried for every document, and the way a superseded document is represented…

Consultation on the search-strategy template used across the synthesis series: the databases searched, the structure of the strategy, the handling of registry records…

Consultation on the draft monograph for Semaglutide, oral, which the assessment committee released for public comment before ratification. The draft grades the…

Consultation on the draft monograph for Survodutide, which the assessment committee released for public comment before ratification. The draft grades the compound's…

Consultation on the draft of CEI-MS-10, which specifies the performance a determination must achieve for content and states what the resulting figure does not establish…

Consultation on the draft of this intervention review, which registers the question: In adults with type 2 diabetes and chronic kidney disease, what is the effect of a…

Consultation on the draft of this intervention review, which registers the question: In adults with obesity and moderate to severe obstructive sleep apnoea, what is the…

Consultation on the draft of this methodological review, which registers the question: For neuropeptides holding a national marketing registration outside the…

Consultation on the draft of this safety review, which registers the question: Do incretin-based therapies increase the incidence of acute pancreatitis?

In adults at elevated cardiovascular risk, what is the effect of a glucagon-like peptide-1 receptor agonist compared with placebo on major adverse cardiovascular events?

Does an oral presentation of a glucagon-like peptide-1 receptor agonist achieve an efficacy and tolerability profile comparable with an injectable presentation?

What proportion of certificates of analysis supplied with research peptides contain the fields required to interpret the reported purity figure?

What randomised evidence supports mitochondria-targeted peptides in primary mitochondrial disease and in age-related functional decline?

How is access to incretin-based obesity pharmacotherapy distributed, and what does the pattern of unregulated supply indicate about it?

Are the trials in the incretin evidence network sufficiently similar to support indirect comparison?

In the population defined for obesity and overweight in adults, what is the effect of Semaglutide compared with the comparator used in its contributing trials on the…

In the population defined for type 2 diabetes mellitus, what is the effect of Semaglutide compared with the comparator used in its contributing trials on the anchor…

In the population defined for type 2 diabetes mellitus, what is the effect of Mazdutide compared with the comparator used in its contributing trials on the anchor…

In the population defined for growth hormone deficiency and growth-hormone secretagogue pharmacology, what is the effect of Kisspeptin-10 compared with the comparator…

In the population defined for inflammatory bowel disease and mucosal barrier disorders, what is the effect of Larazotide acetate compared with the comparator used in its…

In the population defined for obstructive sleep apnoea with obesity, what is the effect of Tirzepatide compared with the comparator used in its contributing trials on…

In the population defined for obesity and overweight in adults, what is the incidence of adverse events leading to discontinuation with Retatrutide compared with its…

In the population defined for type 2 diabetes mellitus, what is the incidence of adverse events leading to discontinuation with CagriSema (cagrilintide with semaglutide)…

In the population defined for primary mitochondrial myopathy and bioenergetic disorders, what is the incidence of adverse events leading to discontinuation with SS-31…

In the population defined for obstructive sleep apnoea with obesity, what is the incidence of adverse events leading to discontinuation with Tirzepatide compared with…

In the population defined for obesity and overweight in adults, is the effect of Mazdutide maintained across the full duration of the contributing trials?

In the population defined for type 2 diabetes mellitus, is the effect of Mazdutide maintained across the full duration of the contributing trials?

Persistent reduction in estimated glomerular filtration rate or persistent albuminuria in the context of type 2 diabetes, staged by eGFR and urine albumin-to-creatinine…

Abnormal regional fat distribution with excess visceral adipose tissue, in the setting of HIV infection and antiretroviral therapy.

Difficulty initiating or maintaining sleep with daytime consequences, assessed by polysomnography, actigraphy or validated questionnaires.

GLP-1 receptor agonist (exendin-based, short- and extended-release). Exenatide is a naturally DPP-4-resistant GLP-1 receptor agonist. The immediate-release presentation gives short, high peaks that produce a pronounced…

GLP-1 receptor agonist (exendin-based, short-acting). A short-acting prandial GLP-1 receptor agonist. Its dominant pharmacodynamic effect is marked slowing of gastric emptying, which produces substantial…

Growth-hormone secretagogue, non-selective ghrelin receptor agonist (hexapeptide). Ghrelin receptor agonism with pronounced growth-hormone release, marked appetite stimulation, and concomitant elevation of cortisol and…

Sub-visible particulate matter in reconstituted peptide solutions

Residual solvent determination by static headspace gas chromatography