Clinical Trials

GSK has announced that in 2024 it intends to start phase 3 trials of a low carbon version of its metered-dose inhaler (MDI) Ventolin (salbutamol) using a next-generation propellant.

If successful, GSK’s development of a carbon neutral inhaler could reduce greenhouse gas emissions from its use by approximately 90%, which would contribute significantly to the company’s net-zero climate targets.

GSK has been investing in an R&D programme for the redevelopment of the inhaler with the lower carbon propellant, which has been under technical development for several years and has been tested extensively for its suitability for MDIs and patient use. Data from recent early clinical trials has supported this progression to phase 3 trials, with the dosing of patients intended to be carried out in the first half of 2024.

According to the company’s press release: ‘The development of this low carbon inhaler is complex and involves clinical and non-clinical programmes, as well as establishing new manufacturing facilities. We recently confirmed our plan to invest in our Evreux site to manufacture the inhaler, so that we are ready to start supply quick ly, should clinical trials and regulatory processes be successful. Evreux is a key GSK site in France – it is driving sustainability as part of the site strategy and has strong expertise in respirator y inhaler manufacturing.’

Emma Walmsley, GSK’s chief executive officer, commented: “As countries work to decarbonise their health systems, companies have an important role to play – and addressing the carbon emissions from inhalers is a key part of this. Harnessing our deep respirator y expertise, we have developed an innovative low carbon inhaler and I am delighted that we are now progressing this programme into phase 3 trials. If successful this could lead to regulatory submissions in 2025, supporting the health of asthma and COPD patients and making a significant positive impact on our transition to a more environmentally sustainable future.”

If the trials are successful, regulatory submissions are expected to follow in 2025.