Dual H1 and 5-HT2A Receptor Modulators for Sleep Fragmentation

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Solution Overview

Problem

Current pharmacological options are limited for treating sleep fragmentation, a common sleep disorder that affects a significant portion of the population, leading to various health and economic implications.

Innovation Solution

Development of piperazine substituted azapine derivatives with dual H1 inverse agonist and 5-HT2A antagonist activity, which can be used to modulate H1/5-HT2A receptors, thereby addressing sleep fragmentation by promoting better sleep quality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If existing pharmacological options are used for treating sleep fragmentation, then some sleep disorder symptoms may be addressed, but the treatment options remain limited and insufficient for effective management of sleep fragmentation

Engineering Contradiction:
Improvepharmacological treatment optionsVSAvoideffectiveness in treating sleep fragmentation
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent combines two distinct pharmacological activities (H1 inverse agonist and 5-HT2A antagonist) into a single compound molecule. This dual-action approach merges the benefits of both receptor modulations to effectively treat sleep fragmentation, addressing the limitation of existing single-action pharmacological options.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The compound of Formula (I) is designed to perform multiple functions simultaneously by modulating both H1 and 5-HT2A receptors. This multi-functionality allows a single agent to address multiple aspects of sleep fragmentation pathology, expanding the versatility of pharmacological treatment options.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If new compounds with dual H1/5-HT2A activity are developed, then treatment effectiveness for sleep fragmentation is improved, but the complexity of compound design and synthesis increases

Engineering Contradiction:
Improveeffectiveness in treating sleep fragmentationVSAvoidcompound structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The compound design is segmented into distinct functional components: a core azepine/oxazepine/thiazepine/diazepine structure (providing 5-HT2A antagonist activity) and a piperazine substituent with carboxylic acid side chain (providing H1 inverse agonist activity). This segmentation allows systematic optimization of each component's contribution to overall efficacy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent systematically varies structural parameters of the compound including different azepine ring substitutions (R1-R6), side chain length (R7-R9), and functional group configurations to optimize the balance between H1 and 5-HT2A receptor affinity, thereby managing complexity through controlled parameter variation.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4048667B13-(4-(11h-dibenzo[b,e][1,4]azepin-6-yl)piperazin-1-yl)- and 3-(4-(dibenzo[b,f][1,4]oxazepin/thiazepin/diazepin-11-yl)piperazin-1-yl)-propanoic acid derivatives as h1 and 5-HT2a-receptor modulators for the treatment of sleep disorders
Publication Date: 2024.07.03 ALAIRION INC
  • EP4048667B1 patent drawingFigure 1~2
  • EP4048667B1 patent drawingFigure 3~4
  • EP4048667B1 patent drawingFigure 5~6

AI summary

The present disclosure relates to 3-(4-(llH-dibenzo[b,e][l,4]azepin-6- yl)piperazin-l-yl)-, 3-(4-(dibenzo[b,f][l,4]oxazepin-ll-yl)piperazin-l- yl)-, 3-(4-(dibenzo[b,f][l,4]thiazepin-ll-yl)piperazin-l-yl)- and 3- (4-(dibenzo[b,f][l,4]diazepin-ll-yl)piperazin-l-yl)-propanoic acid derivatives of the formulae (I), (II1) and (II): wherein X is CR7R8, O, S or NR7, and to their pharmaceutically acceptable salts, pharmaceutical compositions, methods for their preparation, as well as to the compounds for use in methods of medical treatment. The compounds disclosed herein are useful for modulating HI and 5- HT2Areceptors and are to be used in the treatment of sleep disorders such as sleep fragmentation, disturbed sleep/arousals, and arousal threshold. The present description discloses the synthesis and characterisation of exemplary compounds as well as pharmacological data thereof (e.g. pages 143 to 224; examples 1 to 33; compounds 1 to 39; tables A to R). An exemplary compound is e.g. 3-(4-(7-chloro-3-methyldibenzo[b,f] [l,4]oxazepin-ll-yl)piperazin-l-yl)-2, 2-dimethyl propanoic acid (example 1, compound 1):