Clinical Trials

Numerous Phase 1, Phase 2, and Phase 3 clinical trials sponsored by corporate and academic entities—including Icagen, Biossil Inc., Vejle Hospital, and the University of California, Davis—evaluate the therapeutic potential of Senicapoc. These studies encompass diverse hematologic, respiratory, neurological, and oncologic conditions, including sickle cell disease, asthma, dehydrated hereditary stomatocytosis, idiopathic pulmonary fibrosis, severe COVID-19-related acute respiratory distress, glioblastoma, and prodromal Alzheimer's disease. Currently, these trials exhibit varying recruitment statuses, including completed, recruiting, unknown, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07282210 RECRUITING
Sickle Cell Disease; Sickle Cell Anaemia; Sickle Cell Anemia
Biossil Inc.
2026-08-13 PHASE2
NCT06714123 RECRUITING
Pulmonary Fibrosis, Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis
Vejle Hospital
2025-08-01 PHASE2
NCT07284069 RECRUITING
Glioblastoma
Aarhus University Hospital
2026-03-01 EARLY_PHASE1
NCT04804241 RECRUITING
Mild Cognitive Impairment; Alzheimer Disease
University of California, Davis
2022-03-18 PHASE2
NCT04372498 COMPLETED
Dehydrated Hereditary Stomatocytosis
Boston Children's Hospital
2021-04-15 PHASE1; PHASE2
NCT04594668 UNKNOWN
ARDS, Human; COVID
University of Aarhus
2020-04-24 PHASE2
NCT00861185 COMPLETED
Exercise Induced Asthma
Icagen
2009-03 PHASE2
NCT00861211 COMPLETED
Atopic Asthma
Icagen
2008-10 PHASE2
NCT00040677 COMPLETED
Sickle Cell Disease; Sickle Cell Anemia
Icagen
2002-02 PHASE2
NCT00102791 TERMINATED
Sickle Cell Disease
Icagen
2005-02 PHASE3
NCT00294541 TERMINATED
Sickle Cell Disease; Sickle Cell Anemia
Icagen
2006-02 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-17)

Check the Senicapoc (ICA-17043) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Senicapoc selectively binds to and inhibits the Gardos channel (KCa3.1), blocking calcium-activated potassium efflux and the accompanying loss of intracellular water. This inhibition prevents erythrocyte dehydration and hemolysis, thereby mitigating cellular sickling and maintaining microvascular tissue perfusion in clinical trial conditions such as sickle cell disease and hereditary stomatocytosis.

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>).

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