NCT04545580 (OVADER) is a Phase 2 clinical trial of BAY1817080 in Overactive Bladder, sponsored by Bayer.

Who is sponsoring NCT04545580?

NCT04545580 is sponsored by Bayer.

What drugs are being tested in NCT04545580?

Interventions in NCT04545580: Placebo, BAY1817080.

What condition does NCT04545580 study?

NCT04545580 studies Overactive Bladder.

Is NCT04545580 still recruiting?

NCT04545580 is currently completed. Last updated 22 December 2022.

Last reviewed 2022-12-22 · How we verify

NCT04545580: OVADER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB)

Completed Phase 2 Last updated 22 December 2022

What this trial tests

Phase 2 trial testing Placebo in Overactive Bladder in 99 participants. Completed in 21 January 2022.

Timeline

16 September 2020

Primary endpoint
22 December 2021

21 January 2022

Quick facts

Lead sponsor	Bayer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	99
Start date	16 September 2020
Primary completion	22 December 2021
Estimated completion	21 January 2022
Sites	28 locations across New Zealand, Austria, Sweden, Germany, Poland, Australia, Portugal, Singapore

Drugs / interventions tested

Placebo
BAY1817080 — full drug profile →

Conditions studied

Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to determine how well the drug BAY1817080 works in OAB patients with urgency urinary incontinence (UUI), defined as involuntary leakage of urine, accompanied or immediately preceded by a sudden compelling desire to void. BAY1817080 is a new drug under development which blocks proteins expressed on the sensory nerves in the bladder. These nerves seem to overreact in OAB patients. This study will test if the treatment with BAY1817080 will reduce the frequency of OAB symptoms. The frequency of OAB symptoms before the treatment and the frequency after 4, 8 and 12 weeks of treatment will be compared. Another important objective of this study will be the assessment of BAY1817080 safety and tolerability in this patient population. BAY1817080 will be compared to a "placebo". A placebo tablet looks like the study drug but does not have any medicine in it. Using a placebo helps to learn if the study drug works. Each participant is expected to take part in the study for about 5 months (around 20-22 weeks).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Eliapixant is a selective P2X3 receptor antagonist for the treatment of disorders associated with hypersensitive nerve fibers.
Davenport AJ, Neagoe I, Bräuer N, Koch M, et al · · 2021 · cited 36× · PMID 34615939 · DOI 10.1038/s41598-021-99177-0
P2X3 Receptor Ligands: Structural Features and Potential Therapeutic Applications.
Spinaci A, Buccioni M, Dal Ben D, Marucci G, et al · · 2021 · cited 18× · PMID 33927627 · DOI 10.3389/fphar.2021.653561
First-in-human study of eliapixant (BAY 1817080), a highly selective P2X3 receptor antagonist: Tolerability, safety and pharmacokinetics.
Klein S, Gashaw I, Baumann S, Chang X, et al · · 2022 · cited 16× · PMID 35437837 · DOI 10.1111/bcp.15358
Safety, Pharmacodynamics, and Pharmacokinetics of P2X3 Receptor Antagonist Eliapixant (BAY 1817080) in Healthy Subjects: Double-Blind Randomized Study.
Friedrich C, Francke K, Gashaw I, Scheerans C, et al · · 2022 · cited 14× · PMID 35624408 · DOI 10.1007/s40262-022-01126-1
Pharmacological Management of Urinary Incontinence: Current and Emerging Treatment.
Gandi C, Sacco E. · · 2021 · cited 9× · PMID 34858068 · DOI 10.2147/cpaa.s289323
Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis.
Fletcher MC. · · 2022 · cited 6× · PMID 34978027 · DOI 10.1007/s11302-021-09831-5
Pharmacology of P2X Receptors and Their Possible Therapeutic Potential in Obesity and Diabetes.
Cabral-García GA, Cruz-Muñoz JR, Valdez-Morales EE, Barajas-Espinosa A, et al · · 2024 · cited 5× · PMID 39458933 · DOI 10.3390/ph17101291
Efficacy and Safety of Eliapixant in Overactive Bladder: The 12-Week, Randomised, Placebo-controlled Phase 2a OVADER Study.
Ewerton F, Cruz F, Kapp M, Klein S, et al · · 2024 · cited 5× · PMID 37563004 · DOI 10.1016/j.euf.2023.07.008

Verify or expand the search:

Other trials of BAY1817080

Trials testing the same drug.

NCT04802343 — A Trial to Learn How BAY1817080 Moves Into, Through and Out of the Body and How Safe it is in Healthy Chinese Men · Phase 1 · completed
NCT04614246 — Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Compari · Phase 2 · terminated
NCT04641273 — A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants Wit · Phase 2 · terminated
NCT04562155 — Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patient · Phase 2 · completed
NCT04471337 — Study on the Safety of BAY1817080 How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Stud · Phase 1 · completed

Other recruiting trials for Overactive Bladder

Currently open trials in the same condition.

NCT06201013 — Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet · NA · recruiting
NCT05895045 — Yoga for Treatment of Overactive Bladder in Pediatric Patients · NA · recruiting
NCT07209397 — Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women · NA · recruiting
NCT06921746 — Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients · recruiting
NCT06935240 — Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity · NA · recruiting

Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04545580 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 22 December 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04545580.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing