Paris, June 9, 2026. Opella announces the non-prescription approval of Cialis® in Japan, a significant milestone that facilitates access to erectile dysfunction (ED) treatment for millions of men1. This follows the recent successful switch of Cialis® to an over-the-counter (OTC) medicine in Norway and the UK, reinforcing Opella's commitment to empowering consumers with trusted self-care solutions globally.
ED is a common yet often under-discussed condition, with an estimated 322 million men2 living with the condition globally. In Japan alone, approximately 1 in 2 men are living with ED. Beyond its impact on sexual health, clinical research increasingly identifies ED as a hallmark and potential early warning sign of underlying cardiovascular disease3. The transition of Cialis® to an OTC product aims to provide a safe and reliable option for men, helping to combat the risks associated with purchasing counterfeit or unauthorized treatments online, by bringing patients back into the regulated healthcare system.
Recent global research4 across six countries highlights a critical gap in understanding the condition. While 70-80% of men in the U.S. and Sweden understand the medical definition of ED, awareness is significantly lower in other markets. Yet, the desire for solutions is universal, with 90% of people globally viewing sexual wellbeing as vital to overall happiness. By expanding OTC access, Opella aims to bridge this education gap, break down societal stigmas, and empower men to reclaim their wellbeing.
Dr Josephine Fubara, Chief Science Officer at Opella:
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. 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.
According to a study by the Global Self-Care Federation (GSCF), self-care practices currently save global healthcare systems nearly $120 billion annually and free up 1.8 billion physician hours5. By moving proven, well-established treatments from the clinic to pharmacy shelves, it can alleviate the strain on primary care providers, while enabling individuals to take faster, more autonomous action over their health.
After 20 years of trusted use as a prescription ED treatment in Japan and over 100 countries globally, Cialis® will soon be available over-the-counter. The non-prescription approval was granted to SSP Co., Ltd., an Opella company, with launch planning currently underway to bring the medicine to shelves in the coming months. Classified as a 'Pharmacist-Intervention Required Medicine,' the switch ensures that men will receive the necessary guidance and information directly from a healthcare professional at the point of purchase.
Alberto Hernandez, Chief Growth Officer at Opella:
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.
For Opella, non-prescription switch is a strategic growth driver. Backed by rigorous safety and efficacy data submitted to national health authorities, well-targeted switches like those in the UK, Norway and Japan, advance Opella's commitment to simplifying healthcare and expanding access to trusted treatments.
About Opella.
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified globally, we are active players in the journey towards healthier people and planet.
Find out more about our mission at www.opella.com.
Press contacts.
Justine Rohée. justine.rohee@sanofi.com. +33 6 86 47 85 60.
Natacha Kalasa. natacha.kalasa@sanofi.com. +33 6 72 16 64 61.
Philippa Carnohan. philippa.carnohan@opella.com. +33 6 31 14 82 36.
Cialis PR Office (Japan). cialis_pr@vectorinc.co.jp. +81 3-5572-6071.
In your pocket.
pdf version.
- Survey on ED and Sexual Well-being, including 4,000 men and 1,000 women aged 20–69 in Japan. The results suggested that approximately one in two Japanese men may have ED.
- https://www.hopkinsmedicine.org/health/conditions-and-diseases/erectile-dysfunction
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8161068/
- Survey on ED and Sexual Well-being, including 4,000 men and 1,000 women aged 20–69 in Japan, and 1,000 men and women aged 20-69 each in the USA, Italy, Sweden, South Korea, and Thailand.
- https://www.selfcarefederation.org/sites/default/files/media/documents/2022-05/GSCF%20Socio-Economic%20Research%20Executive%20Summary%20v16%20CDG.pdf
