Key Summary
- MHRA approved world's first lower-carbon beclometasone inhalers for asthma.
- These new versions will be available in the UK later in 2026.
- There are no changes to the active ingredient, recommended dosing, or the clinical indications.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for new versions of Clenil Modulite 100 microgram and Clenil Modulite 200 microgram inhalers, which contain beclometasone dipropionate, for long‑term asthma management in adults and children.
This approval represents the world’s first authorisation of pressurised metered‑dose inhalers (pMDIs) formulated with the next‑generation propellant HFA‑152a. The propellant itself is not an active drug; it is the medium used to disperse the inhaled dose.
The updated inhaler variants are slated to be available in the UK later in 2026. Until then, patients will continue to have access to the current Clenil Modulite formulations.
Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said: “Keeping patients safe and enabling their access to high-quality, safe and effective medicines are key priorities for us.
“Asthma inhalers play a vital role in helping millions of patients manage their condition and maintain their quality of life.
“This approval marks the world’s first authorisation of an inhaler using the next-generation propellant HFA-152a. It demonstrates how innovation can support both patient care and environmental sustainability while maintaining the high standards of quality, safety and effectiveness patients expect.
“As with all medicines, we will continue to monitor its safety and effectiveness closely.”
The medicine is delivered by a pressurised metered‑dose inhaler and is intended for regular use to prevent asthma symptoms.
The active substance, beclometasone dipropionate, is a corticosteroid that reduces airway inflammation and helps lower the risk of exacerbations.
There are no changes to the active ingredient, the recommended dosing, or the clinical indications. The MHRA’s decision is backed by evidence showing that the new formulations perform similarly to the currently authorised products while maintaining the same standards of quality, safety and therapeutic benefit.
Common adverse effects associated with beclometasone inhalers include oral thrush, hoarseness and throat irritation. A complete list of side effects for the existing product is available in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC).
