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imidafenacin, KRP-197/ONO-8025 — Competitive Intelligence Brief
phase 3
Antimuscarinic
M3 receptor
Urology
Small molecule
Live · refreshed every 30 min
Target snapshot
imidafenacin, KRP-197/ONO-8025 (imidafenacin, KRP-197/ONO-8025) — Ono Pharmaceutical Co. Ltd. Imidafenacin is an antimuscarinic agent that acts as a selective M3 receptor antagonist.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| imidafenacin, KRP-197/ONO-8025 TARGET | imidafenacin, KRP-197/ONO-8025 | Ono Pharmaceutical Co. Ltd | phase 3 | Antimuscarinic | M3 receptor | |
| Tudorza Pressair | ACLIDINIUM BROMIDE | Covis | marketed | Anticholinergic | M3 receptors, beta 2 -adrenergic receptors | 2012-01-01 |
| ACLIDINIUM | ACLIDINIUM | marketed | M3 receptors, beta 2 -adrenergic receptors | 2012-01-01 | ||
| TIOTROPIUM | TIOTROPIUM | marketed | M3 receptors, beta2-adrenoceptors | 2004-01-01 | ||
| Budesonide/Glycopyrronium/Formoterol Fumarate | Budesonide/Glycopyrronium/Formoterol Fumarate | AstraZeneca | marketed | Inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) | Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol); muscarinic M3 receptor (glycopyrronium) | |
| FF/UMEC/VI | FF/UMEC/VI | Dr. Grace Parraga | marketed | Triple combination inhaler (ICS/LAMA/LABA) | Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid receptor | |
| umeclidinium 62.5 µg and vilanterol 25 µg | umeclidinium 62.5 µg and vilanterol 25 µg | University of Tennessee Graduate School of Medicine | marketed | Long-acting anticholinergic and long-acting beta-2 agonist combination (LAMA/LABA) | Muscarinic M3 receptor (umeclidinium); Beta-2 adrenergic receptor (vilanterol) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Antimuscarinic class)
- Ono Pharmaceutical Co. Ltd · 1 drug in this class
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Cite this brief
Drug Landscape (2026). imidafenacin, KRP-197/ONO-8025 — Competitive Intelligence Brief. https://druglandscape.com/ci/imidafenacin-krp-197-ono-8025. Accessed 2026-05-18.
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