{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T01:53:48Z","timestamp":1789610028247,"version":"build-2803163510"},"reference-count":17,"publisher":"Korean Continence Society","issue":"2","license":[{"start":{"date-parts":[[2022,6,30]],"date-time":"2022-06-30T00:00:00Z","timestamp":1656547200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"name":"Dong-A ST Co., Ltd.","award":["DA-8010"],"award-info":[{"award-number":["DA-8010"]}]}],"content-domain":{"domain":["einj.org"],"crossmark-restriction":true},"short-container-title":["Int Neurourol J"],"published-print":{"date-parts":[[2022,6,30]]},"abstract":"<jats:p>Purpose: DA-8010 is a novel muscarinic M3 receptor antagonist with significant selectivity for bladder over salivary gland in preclinical studies. We evaluated the clinical efficacy and safety of DA-8010 in overactive bladder (OAB) patients.Methods: This phase 2, randomized, double-blind, parallel-group, active reference- and placebo-controlled trial was conducted at 12 centers in South Korea (NCT03566134). Patients aged \u226519 years with OAB symptoms for \u22653 months were enrolled. Three hundred six patients (30.07% male) were randomized to 12 weeks of treatment among 4 groups; 2 experimental groups (DA-8010 2.5 or 5 mg), an active reference group (solifenacin 5 mg), and a placebo group. The change from the baseline of (=\u2206) 24-hour frequency at 12 weeks (primary endpoint), episodes of urgency, overall\/urgency urinary incontinence, average\/ maximum voided volume, nocturia, and patients\u2019 subjective responses were analyzed.Results: In the full analysis set, the mean (standard deviation) [median] values for \u2206 24-hour frequency at 12 weeks were -1.01 (2.44) [-1.33] for placebo, -1.22 (2.05) [-1.33] for DA-8010 2.5 mg, and -1.67 (2.25) [-1.67] for DA-8010 5 mg; DA-8010 5 mg showed a significant decrease compared with placebo (P=0.0413). At 4 and 8 weeks, both DA-8010 2.5 mg (P=0.0391 at 4 weeks, P=0.0335 at 8 weeks) and DA-8010 5 mg (P=0.0001 at 4 weeks, P=0.0210 at 8 weeks) showed significant decrease in \u2206 24-hour frequency compared with placebo. DA-8010 5 mg achieved a significant decrease in \u2206 number of urgency episodes, compared with placebo at 4 (P=0.0278) and 8 (P=0.0092) weeks. Adverse drug reactions (ADRs) were observed in 3.95% of placebo, 6.67% of DA-8010 2.5 mg, 18.42% of DA-8010 5 mg, and 17.33% of solifenacin 5 mg groups. No serious ADRs were observed in any patient.Conclusions: Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial.<\/jats:p>","DOI":"10.5213\/inj.2142382.191","type":"journal-article","created":{"date-parts":[[2022,6,29]],"date-time":"2022-06-29T04:15:21Z","timestamp":1656476121000},"page":"119-128","update-policy":"https:\/\/doi.org\/10.5213\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and Safety of DA-8010, a Novel M3 Antagonist, in Patients With Overactive Bladder: A Randomized, Double-Blind Phase 2 Study"],"prefix":"10.5213","volume":"26","author":[{"given":"Hee Seo","family":"Son","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8794-1855","authenticated-orcid":true,"given":"Cheol 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Hwan","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"3166","reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410x.2007.07205.x"},{"key":"ref2","first-page":"5","volume-title":"The effects of antimuscarinic treatments in overactive bladder: a systematic review and 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