Assessment cycle 2025 Q3

Record of documents ratified in the 2025 Q3 assessment cycle.

Consultation on the draft synthesis of weight trajectory after an incretin receptor agonist is stopped. The contributing evidence is drawn principally from the…

Consultation on the draft analytical evidence review of published surveys of unregulated peptide supply. The review assesses what such surveys establish, and records…

Consultation on the draft monograph for danuglipron, an oral non-peptide glucagon-like peptide-1 receptor agonist whose development programme was discontinued. The draft…

Consultation on the draft monograph for CagriSema (cagrilintide with semaglutide), which the assessment committee released for public comment before ratification. The…

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

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

Consultation on the draft monograph for NAD+ (nicotinamide adenine dinucleotide), which the assessment committee released for public comment before ratification. The…

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

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

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

Consultation on the draft of CEI-MS-12, which specifies the performance a determination must achieve for content and states what the resulting figure does not establish…

In adolescents with obesity, what is the effect of an incretin receptor agonist on body-mass index, and what is known about growth, bone accrual and pubertal outcomes?

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

In the population defined for hiv-associated lipodystrophy and excess visceral adiposity, what is the effect of Tesamorelin compared with the comparator used in its…

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

In the population defined for type 2 diabetes mellitus, what is the incidence of adverse events leading to discontinuation with Orforglipron 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 type 2 diabetes mellitus, is the effect of Dulaglutide maintained across the full duration of the contributing trials?

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

A reproductive-endocrine disorder defined by combinations of ovulatory dysfunction, clinical or biochemical hyperandrogenism, and polycystic ovarian morphology.

Insufficient endogenous growth-hormone secretion, or the pharmacological stimulation of the growth-hormone axis, assessed here principally through provocative testing…

Persistently reduced sexual desire or impaired erectile function causing distress, assessed by validated instruments.

Loss of skeletal muscle mass and function, considered here principally as a consequence of rapid weight reduction under incretin therapy.

Growth-hormone C-terminal fragment analogue. The proposed mechanism is stimulation of lipolysis and inhibition of lipogenesis in adipose tissue without the growth-hormone-receptor-mediated…

Endogenous nonapeptide. DSIP was isolated on the hypothesis that it mediated sleep induction. Subsequent work has not established a receptor, a consistent pharmacological…

Small-molecule nicotinamide N-methyltransferase inhibitor. NNMT methylates nicotinamide, diverting it from NAD+ salvage and generating 1-methylnicotinamide. Inhibiting NNMT is proposed to raise cellular NAD+…

Bacterial endotoxin determination in peptide preparations intended for parenteral use

Photostability assessment of light-sensitive peptides

Peptides, SARMs, injectable oils and raw materials.

Research peptides with a declared GLP-1 specialty, SARMs and injectable oils. Factory-direct model.