Opella has received approval to make Cialis available without a prescription in Japan, expanding over-the-counter access to the erectile dysfunction treatment in one of the world’s largest pharmaceutical markets.

The approval follows similar regulatory switches in the UK and Norway and means the medicine will be available through pharmacies under Japan’s pharmacist-supervised non-prescription framework.

Erectile dysfunction affects millions of men worldwide and is associated with a range of physical and psychological factors. In addition to its impact on sexual health, studies have suggested it can be an early indicator of underlying cardiovascular disease, highlighting the importance of appropriate medical assessment and treatment.

According to Opella, the non-prescription approval in Japan aims to improve access to regulated treatment options while helping to reduce reliance on counterfeit or unauthorised medicines purchased online.

Josephine Fubara, chief science officer at Opella, said: “This approval for non-prescription status in Japan represents more than just a local milestone, it is a crucial step forward in our broader mission to make healthcare more accessible on a global scale.”

She added: “Following the successful switch in Norway and the UK, we are committed to bringing this trusted treatment to men by expanding over-the-counter access. By shifting proven treatments from prescription to pharmacy shelves, we are fundamentally changing how men access care, putting science-backed solutions directly into their hands, safely guided by pharmacist expertise.”

Cialis has been available as a prescription medicine in Japan for around 20 years and is approved in more than 100 countries. Under the new classification, it will be sold as a pharmacist-intervention required medicine, allowing patients to receive advice from a healthcare professional at the point of purchase.

The approval was granted to SSP Co Ltd, an Opella company, with commercial launch preparations now underway. The company has not confirmed a specific launch date but said the product is expected to reach pharmacy shelves in the coming months.

The move reflects a broader trend towards reclassifying selected medicines from prescription-only to over-the-counter status where regulators consider there to be sufficient evidence of safety and efficacy for supervised self-care. Such switches can improve patient access while reducing pressure on primary care services, provided appropriate safeguards remain in place.

Alberto Hernandez, chief growth officer at Opella, said: “Rx-to-OTC switches are an important pillar of Opella’s growth strategy and by successfully launching Cialis without a prescription in markets like Japan and Norway, we demonstrate our ability to unlock new categories and bring trusted self-care brands directly to the consumers who need it.”

The Japanese approval marks another step in the global expansion of non-prescription erectile dysfunction treatments and could encourage further consideration of pharmacy-based access models in other regulated markets.