Assessment cycle 2025 Q2

Record of documents ratified in the 2025 Q2 assessment cycle.

Consultation on the second version of the tirzepatide monograph, which incorporates the obesity evidence from SURMOUNT-1, reported in the New England Journal of Medicine…

Consultation on the draft safety review of the rodent thyroid C-cell signal observed with glucagon-like peptide-1 receptor agonists and its relevance to humans. The…

Consultation on the comparison table that presents supplier dossiers side by side. The draft table shows only fields verified from a document the Institute holds, and…

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

Consultation on the draft monograph for TB-500, which the assessment committee released for public comment before ratification. The draft grades the compound's principal…

Consultation on the draft of CEI-MS-09, which specifies the performance a determination must achieve for physical quality and states what the resulting figure does not…

Consultation on the draft of this methodological review, which registers the question: To what extent does a change in body weight predict a change in the clinical…

What is the incidence of gastrointestinal adverse events and of discontinuation for adverse events with incretin receptor agonists compared with placebo?

What is known about bacterial endotoxin content in peptides supplied for research and injected in practice?

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

In the population defined for obesity and overweight in adults, what is the effect of CagriSema (cagrilintide with semaglutide) compared with the comparator used in its…

In the population defined for atherosclerotic cardiovascular disease and cardiovascular risk reduction, what is the effect of Exenatide compared with the comparator used…

In the population defined for cutaneous wound healing and tissue repair, what is the effect of GHK-Cu compared with the comparator used in its contributing trials on the…

In the population defined for adjunctive therapy in type 1 diabetes, what is the effect of Liraglutide compared with the comparator used in its contributing trials on…

In the population defined for atherosclerotic cardiovascular disease and cardiovascular risk reduction, what is the effect of Semaglutide, oral compared with the…

In the population defined for obesity and overweight in adults, what is the incidence of adverse events leading to discontinuation with CagriSema (cagrilintide with…

In the population defined for growth hormone deficiency and growth-hormone secretagogue pharmacology, what is the incidence of adverse events leading to discontinuation…

In the population defined for type 2 diabetes mellitus, what is the incidence of adverse events leading to discontinuation with Liraglutide compared with its comparator?

In the population defined for heart failure with preserved ejection fraction and obesity, what is the incidence of adverse events leading to discontinuation with…

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

In the population defined for inflammatory bowel disease and mucosal barrier disorders, is the effect of Teduglutide maintained across the full duration of the…

In the population defined for growth hormone deficiency and growth-hormone secretagogue pharmacology, is the effect of CJC-1295 maintained across the full duration of…

Oral non-peptide GLP-1 receptor agonist. Small-molecule GLP-1 receptor agonism with a short half-life requiring twice-daily administration. The Institute includes this monograph specifically…

Endogenous decapeptide, KISS1 receptor agonist. Kisspeptin acts on KISS1 receptors on hypothalamic gonadotropin-releasing hormone neurons to stimulate GnRH secretion, and thereby luteinising…