Assessment cycle 2024 Q1
Documents ratified in the 2024 Q1 assessment cycle, which ran from 1 January 2024 to 31 March 2024 and was ratified on 18 March 2024.
Documents ratified
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Record of documents ratified in the 2024 Q1 assessment cycle.
18 Mar 2024 -
Consultation on the draft monograph for BPC-157. The draft records that the Institute identified no completed randomised controlled trial in humans reporting a clinical…
31 Mar 2024 -
Consultation on the format of the supplier dossier series: what a dossier contains, in what order, and what it declines to contain. The draft fixes a common structure so…
11 Apr 2024 -
Consultation on the draft monograph for Cagrilintide, which the assessment committee released for public comment before ratification. The draft grades the compound's…
29 Mar 2024 -
Consultation on the draft monograph for GHRP-6, which the assessment committee released for public comment before ratification. The draft grades the compound's principal…
01 May 2024 -
Consultation on the draft monograph for Glutathione, which the assessment committee released for public comment before ratification. The draft grades the compound's…
29 Mar 2024 -
Consultation on the draft monograph for Maridebart cafraglutide, which the assessment committee released for public comment before ratification. The draft grades the…
21 Mar 2024 -
Consultation on the draft monograph for Teduglutide, which the assessment committee released for public comment before ratification. The draft grades the compound's…
05 Mar 2024 -
Consultation on the draft of CEI-MS-02, which specifies the performance a determination must achieve for identity and states what the resulting figure does not…
21 Mar 2024 -
Consultation on the draft of this intervention review, which registers the question: In adults with heart failure with preserved ejection fraction and obesity, what is…
11 Mar 2024 -
In adults with heart failure with preserved ejection fraction and obesity, what is the effect of an incretin receptor agonist on symptoms and on heart-failure events?
Moderate11 Oct 2024 -
What is the evidence that glucagon-like peptide-1 receptor agonism increases the risk of medullary thyroid carcinoma in humans?
Low23 Aug 2024 -
What is the effect of reconstitution practice on the dose actually delivered from a lyophilised research peptide?
Moderate05 Nov 2024 -
Use alongside insulin in autoimmune diabetes, where the therapeutic target is postprandial excursion, insulin dose or weight rather than endogenous insulin secretion.
30 Jan 2024 -
Dependence on nicotine-containing products, characterised by craving, tolerance and withdrawal.
09 Jan 2024 -
Dual GIP and GLP-1 receptor agonist (acylated). Tirzepatide engages both incretin receptors from a single molecule. GLP-1 receptor agonism reproduces the insulinotropic, glucagonostatic, gastric…
High16 Jan 2025 -
Recombinant insulin-like growth factor 1 analogue. IGF-1 receptor agonism with greatly reduced binding-protein sequestration. The consequence is a sustained, unbuffered IGF-1 receptor signal. Because…
Very low18 Jun 2024 -
Related-substances profiling and the detection of isobaric impurities
High19 Aug 2024 -
Peptides, SARMs, injectable oils and raw materials. Long-established synthesis operation.
15 Oct 2024 -
Randomised, double-blind, placebo-controlled, phase 3 study of Semaglutide in hfpef and type 2 diabetes randomising 616 participants over 52 weeks. Primary result…
Moderate14 Oct 2024 -
Event-driven kidney outcome trial, phase 3 study of Semaglutide in chronic kidney disease and type 2 diabetes randomising 3,533 participants over median 3.4 years…
High12 Feb 2025 -
Randomised withdrawal, phase 3 study of Tirzepatide in obesity randomising 670 participants over 52 weeks after a 36-week open-label lead-in. Primary result: Continued…
High18 May 2024 -
Randomised, double-blind, placebo-controlled, phase 3 study of Tirzepatide in sleep apnoea and obesity over 52 weeks. Primary result: Substantial reduction in the…
High11 Dec 2024 -
Randomised, double-blind, placebo-controlled, phase 3 study of Tirzepatide in sleep apnoea and obesity over 52 weeks. Primary result: Directionally consistent with the…
High24 Apr 2025 -
Randomised, double-blind, placebo-controlled, phase 3 study of Tirzepatide in hfpef and obesity randomising 731 participants over median 104 weeks. Primary result…
Moderate07 Apr 2025 -
Phase 1 ascending dose, phase 1 study of Cagrilintide in obesity over up to 12 weeks. The Institute holds no reported primary result for this record and publishes no…
Very low09 Aug 2024 -
Phase 1 ascending dose, phase 1 study of Cagrilintide in obesity over up to 20 weeks. The Institute holds no reported primary result for this record and publishes no…
Very low19 Mar 2025 -
Randomised, double-blind, placebo-controlled, phase 2 study of Survodutide in obesity randomising 387 participants over 46 weeks. Primary result: Mean change −18.7 % at…
Moderate12 May 2025 -
Randomised, double-blind, placebo-controlled, phase 2 study of Survodutide in mash randomising 295 participants over 48 weeks. Primary result: Improvement in 62 % to 83…
Low08 Dec 2024 -
Randomised, double-blind, placebo-controlled, phase 2 study of Tirzepatide in mash randomising 190 participants over 52 weeks. Primary result: Resolution in 44 % to 62 %…
Low06 May 2024 -
Phase 1 ascending dose, phase 1 study of Petrelintide in obesity over 16 weeks. Primary result: Weight reduction of approximately 8.6 % at 16 weeks in a phase 1b setting.
Low15 Jun 2024 -
Observational study of Epithalon in ageing over multi-year. Primary result: The Institute has not been able to obtain a protocol, a randomisation procedure or an…
24 Feb 2025 -
Randomised, double-blind, placebo-controlled, phase 2 study of BPC-157 in mucosal barrier over not recorded. Primary result: The Institute has identified references to a…
15 Dec 2024 -
Observational study of Thymalin in immune modulation over not recorded. Primary result: The Institute has not obtained a retrievable protocol or analysis plan and grades…
26 Oct 2024 -
Observational study of Semax in cognition over not recorded. Primary result: Registered in the Russian Federation on a national evidence base the Institute has not been…
20 Nov 2024 -
Observational study of Semax in cognition over not recorded. Primary result: As above. The Institute grades all claims for this compound very low certainty for absence…
12 May 2025 -
Observational study of Selank in cognition over not recorded. Primary result: As for semax. The Institute records the absence of a retrievable controlled trial.
15 Nov 2024 -
Randomised crossover study of DSIP in sleep over not recorded. Primary result: Historical crossover studies in small samples reported inconsistent effects on sleep…
26 Apr 2024 -
Phase 1 ascending dose, phase 1 study of Amycretin in obesity randomising 125 participants over up to 36 weeks. Primary result: Exploratory weight reduction of…
Low04 May 2025 -
Randomised, double-blind, placebo-controlled, phase 3 study of Mazdutide in type 2 diabetes randomising 319 participants over 24 weeks. Primary result: A reduction of…
Moderate14 Mar 2025
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