Clinical Trials

Multiple Phase 1 clinical trials, sponsored entirely by Bayer, have been completed to evaluate the selective compound Eliapixant (BAY 1817080). These early-stage investigations primarily characterized the drug's pharmacokinetics, safety, tolerability, drug-drug interactions, and cardiac safety in healthy volunteers and sub-populations with impaired hepatic or renal function. Furthermore, the clinical program assessed potential efficacy contexts, including refractory or unexplained chronic cough, endometriosis-related pain, overactive bladder, and diabetic neuropathic pain.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04802343 Completed
Healthy Volunteers
Bayer
 2021-04-02 Phase 1
NCT04487431 Completed
Endometriosis Related Pain|Overactive Bladder|Diabetic Neuropathic Pain|Refractory or Unexplained Chronic Cough
Bayer
 2020-08-05 Phase 1
NCT04471337 Completed
Endometriosis Related Pain|Overactive Bladder|Diabetic Neuropathic Pain|Refractory or Unexplained Chronic Cough
Bayer
 2020-08-12 Phase 1
NCT04454424 Completed
Endometriosis Related Pain|Overactive Bladder|Diabetic Neuropathic Pain|Refractory or Unexplained Chronic Cough
Bayer
 2020-07-23 Phase 1
NCT04423744 Completed
Cough|Endometriosis|Overactive Bladder
Bayer
 2020-06-18 Phase 1
NCT04252300 Completed
Drug Interactions
Bayer
 2020-03-02 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Eliapixant product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eliapixant (BAY1817080) functions as a highly potent and selective antagonist of the P2X3 receptor with a mean IC50 of 8 nM, blocking extracellular ATP-mediated ion channel opening and preventing intracellular calcium influx in primary sensory neurons. By suppressing ATP-driven peripheral nerve hyperexcitability, this targeted inhibition diminishes afferent signaling pathways associated with conditions such as refractory chronic cough, overactive bladder, and neurogenic or endometriosis-related pain.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.