A process for preparing 4-methyl-2-propan-2-yl-pyridine-3-carbonitrile

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Solution Overview

Problem

There is a need for an efficient, scalable, and cost-effective process to manufacture 4-methyl-2-propan-2-yl-pyridine-3-carbonitrile (Compound A), a synthetic intermediate in the production of the KRAS G12C inhibitor sotorasib, which is currently hindered by high raw material costs and the use of hazardous solvents and specialized equipment in existing synthetic routes.

Innovation Solution

A [3+3] cycloaddition process involving Compound B or its salt and crotonaldehyde in the presence of an acid catalyst or organocatalyst, or a combination thereof, to form Compound A with high yield and purity, avoiding halogenated solvents and chromatography, and reducing the number of synthesis steps.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If existing synthetic routes are used to manufacture Compound A, then the compound can be produced, but high raw material costs and hazardous solvents are required

Engineering Contradiction:
Improvemanufacturing costVSAvoidhazardous solvents
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent changes the reaction parameters by using a catalytic system (metal catalyst with ligand) to enable the reaction to proceed under milder conditions, avoiding hazardous solvents while maintaining high yield and purity of Compound A

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces a catalytic intermediary system consisting of a metal catalyst and ligand that facilitates the formation of Compound A from simpler, safer starting materials, eliminating the need for hazardous solvents in the process

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If existing synthetic routes are used to manufacture Compound A, then the compound can be produced, but specialized equipment and multiple steps are required

Engineering Contradiction:
Improvesynthesis efficiencyVSAvoidequipment requirements
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent segments the synthesis process into a single step using a catalytic system, eliminating the need for multiple steps and specialized equipment while maintaining high productivity and purity of Compound A

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catalytic system serves multiple functions simultaneously: it catalyzes the formation of Compound A, enables mild reaction conditions, and eliminates the need for specialized equipment, thereby improving productivity while reducing device complexity

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

3Quantity of substance

If conventional synthesis methods are used, then Compound A can be obtained, but high raw material costs and minimal scalability are observed

Engineering Contradiction:
ImproveyieldVSAvoidscalability
Core Design Contradiction:
Quantity of substanceVSEase of manufacture

Solution Approach 1:

The patent changes the reaction parameters by using a catalytic system that maintains high yield at scale, enabling the process to be scaled up while maintaining cost-effectiveness and productivity

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The catalytic intermediary system enables scalable synthesis by facilitating efficient reactions that can be scaled up without compromising yield or increasing raw material costs, making the process both high-yielding and manufacturable at large scale

Inventive Principle:
Principle #24Intermediary (Mediator)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The process provides Compound A in high yield and purity with minimal side products, reducing raw material costs and environmental impact, and is suitable for large-scale synthesis of sotorasib intermediates.

Implementation Method 1

in the presence of a catalytic reagent to form Compound A, wherein the catalytic reagent comprises an acid catalyst, an organocatalyst, or a combination thereof

Methodology Applied
Scientific EffectCatalysis: Catalysis

Data Source

PatentEP4490146B1A process for preparing 4-methyl-2-propan-2-yl-pyridine-3-carbonitrile
Publication Date: 2026.02.18 AMGEN INC
  • EP4490146B1 patent drawingFigure 1A
  • EP4490146B1 patent drawingFigure 1B
  • EP4490146B1 patent drawingFigure 2A

AI summary

Provided herein are processes for preparing Compound A or a salt thereof, comprising admixing Compound B or a salt thereof and crotonaldehyde in the presence of an acid catalyst and a solvent to form Compound A