Astellas Korea said Thursday it has launched Vesomni CR (6/0.4 mg) -- a fixed-dose combination therapy for benign prostatic hyperplasia (BPH) -- following a two-day launch symposium held last Saturday and Sunday at the Grand Mercure Imperial Palace Seoul Gangnam.
Vesomni combines solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg in a single once-daily tablet. The drug received approval from the Ministry of Food and Drug Safety on Sept. 5, 2025, for the treatment of moderate-to-severe storage symptoms -- such as urinary frequency and urgency -- and voiding symptoms associated with BPH in adult men who have shown an inadequate response to tamsulosin monotherapy.
It was subsequently listed for reimbursement under the national health insurance on April 1, enabling a full commercial rollout.
Vesomni CR’s launch symposium was held last Saturday at the Grand Mercure Imperial Palace Seoul Gangnam. (Courtesy of Astellas Korea)
BPH is a common age-related condition, affecting around 45 percent of men over 45 and up to 80 percent of those aged 70 and above. In Korea, about 1.58 million patients were diagnosed with BPH as of 2024. According to prescription data from UBIST, some 28 percent of these patients also require treatment for overactive bladder (OAB), suggesting that roughly 440,000 patients need concurrent management of both conditions.
The launch symposium brought together around 70 urologists from across the country. The first day focused on Vesomni’s clinical profile, key advantages, and its potential impact on the evolving treatment paradigm for BPH.
As of April 2026, Vesomni is the only approved combination therapy in Korea that includes both solifenacin and tamsulosin, with indications for both BPH and OAB. Its dual mechanism of action enables complementary therapeutic effects in treating lower urinary tract symptoms (LUTS) associated with BPH and OAB.
Clinical benefits of Vesomni were highlighted based on results from the global phase 3 NEPTUNE study. The trial evaluated the efficacy and safety of Vesomni compared with placebo and tamsulosin monotherapy in patients with moderate-to-severe OAB and voiding symptoms.
Results showed that Vesomni effectively managed both voiding and storage symptoms, helping patients improve daily functioning and quality of life. The study demonstrated non-inferiority to tamsulosin in changes to the International Prostate Symptom Score (IPSS) total score (p<0.001), while showing superiority in improvements to the Total Urgency and Frequency Score (TUFS) (p=0.025). Improvements in OAB symptoms were also correlated with better health-related quality of life (HRQoL).
Long-term data from a 52-week extension study further showed sustained symptom relief and quality-of-life improvements, along with a favorable tolerability profile. Notably, the incidence of acute urinary retention (AUR) — a concern with antimuscarinic agents — was 0.7 percent (8 of 1,208 patients), significantly lower than the annual incidence rate of 1.83 percent to 3.59 percent observed in untreated LUTS patients.
The once-daily single-tablet regimen was emphasized as a key advantage, particularly for chronic management. Compared with the separate administration of BPH and OAB medications, Vesomni demonstrated improved treatment persistence and adherence. European real-world evidence (RWE) indicated that patients taking Vesomni had a median treatment duration approximately four times longer, with an over 50 percent reduction in the risk of discontinuation at 12 months. Adherence rates were also higher in the Vesomni group.
Kim Jun-il, general manager of Astellas Korea, said, “Vesomni is the first new product introduced by Astellas Korea in the urology field in 11 years. With an aging population, the number of patients suffering from lower urinary tract symptoms continues to grow, increasing demand for more convenient treatment options.”
Kim added, “We will continue to collaborate with healthcare professionals in Korea to build and improve a patient-centered treatment environment.”
Astellas Korea has maintained leadership in the BPH and OAB treatment market for nearly two decades, following the launch of tamsulosin-based Harnal D in 2006, solifenacin-based Vesicare in 2007, and Betamiga in 2015.
Lee Han-soo
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