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)
Mechanism and Biochemical Profile
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>).
- Senicapoc (ICA-17043) Solubility in DMSO
- Senicapoc (ICA-17043) Stock Solution
- Senicapoc (ICA-17043) Storage
- Senicapoc (ICA-17043) Stability
- Senicapoc (ICA-17043) Molecular Weight
- Senicapoc (ICA-17043) SMILES
- Senicapoc (ICA-17043) CAS Number
- Senicapoc (ICA-17043) Chemical Structure (2D and 3D)
- Senicapoc (ICA-17043) SDS|MSDS