Assessment cycle 2025 Q4

Record of documents ratified in the 2025 Q4 assessment cycle.

Consultation on the draft standard for bacterial endotoxin testing of peptide presentations, which specifies the performance a determination must achieve and the…

Consultation on the draft safety review of delayed gastric emptying and residual gastric content in patients receiving an incretin receptor agonist who present for…

Consultation on the draft scoping review of melanocortin receptor agonists, which maps the evidence across approved indications and the uses for which these compounds…

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

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

Consultation on the draft of CEI-MS-08, which specifies the performance a determination must achieve for chromatographic purity and states what the resulting figure does…

Consultation on the draft of this analytical evidence review, which registers the question: What proportion of certificates of analysis supplied with research peptides…

Consultation on the draft of this scoping review, which registers the question: What clinical evidence supports the uses under which growth-hormone secretagogues are…

In adults who have lost weight during treatment with an incretin receptor agonist, what happens to body weight after treatment is withdrawn?

In adults with type 2 diabetes and chronic kidney disease, what is the effect of a glucagon-like peptide-1 receptor agonist on kidney outcomes?

What randomised human evidence exists for BPC-157 in any indication?

Do incretin-based therapies increase the incidence of acute pancreatitis?

How much does a reported chromatographic purity figure vary with the method used to obtain it?

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

In the population defined for cutaneous wound healing and tissue repair, what is the effect of Thymosin beta-4 compared with the comparator used in its contributing…

In the population defined for type 2 diabetes mellitus, 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 Semaglutide compared with the comparator…

In the population defined for primary mitochondrial myopathy and bioenergetic disorders, what is the effect of SS-31 (elamipretide) compared with the comparator used in…

In the population defined for atherosclerotic cardiovascular disease and cardiovascular risk reduction, what is the incidence of adverse events leading to…

In the population defined for cutaneous wound healing and tissue repair, what is the incidence of adverse events leading to discontinuation with GHK-Cu compared with its…

In the population defined for adjunctive therapy in type 1 diabetes, what is the incidence of adverse events leading to discontinuation with Liraglutide compared with…

In the population defined for atherosclerotic cardiovascular disease and cardiovascular risk reduction, what is the incidence of adverse events leading to…

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

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

In the population defined for atherosclerotic cardiovascular disease and cardiovascular risk reduction, what is the incidence of adverse events leading to…

In the population defined for obesity and overweight in adults, is the effect of CagriSema (cagrilintide with semaglutide) maintained across the full duration of the…

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

In the population defined for atherosclerotic cardiovascular disease and cardiovascular risk reduction, is the effect of Exenatide maintained across the full duration of…

In the population defined for cutaneous wound healing and tissue repair, is the effect of Thymosin beta-4 maintained across the full duration of the contributing trials?

In the population defined for type 2 diabetes mellitus, is the effect of CagriSema (cagrilintide with semaglutide) maintained across the full duration of the…

Adiposity above the 95th percentile for age and sex, or above the 120th percentile of the 95th percentile for severe obesity, in individuals under 18 years.

Genetically determined impairment of oxidative phosphorylation producing myopathy, exercise intolerance or multisystem disease.

Dual glucagon and GLP-1 receptor agonist (acylated). Glucagon receptor agonism increases hepatic fatty-acid oxidation, resting energy expenditure and hepatic lipid clearance; GLP-1 receptor agonism…

Acetylated heptapeptide fragment of thymosin beta-4. Thymosin beta-4 is an abundant intracellular actin-sequestering protein with reported extracellular activity in angiogenesis, cell migration and…

Thymic peptide extract of undefined composition. Thymalin is a fractionated calf-thymus extract registered in the Russian Federation as an immunomodulator. Because its composition is not defined, no…

Peptides, SARMs, injectable oils and raw materials.

Peptides, SARMs, injectable oils and raw materials.