Clinical Trials
Dapansutrile is currently being evaluated across multiple clinical trials spanning Early Phase 1 through Phase 3 development. Supported by industry sponsors such as Olatec Therapeutics alongside academic and medical institutions, these studies target diverse inflammatory, metabolic, neurodegenerative, cardiovascular, and oncological conditions, including acute gout flares, type 2 diabetes, systolic heart failure, Parkinson's disease, Schnitzler syndrome, and melanoma. Recruitment statuses across the trial portfolio encompass completed, active recruiting, active-not-recruiting, terminated, and planned protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05880355 | NOT_YET_RECRUITING | Myocardial Infarction |
University of Virginia |
2026-04-01 | EARLY_PHASE1 |
| NCT06047262 | RECRUITING | Diabetes Mellitus, Type 2 |
Marc Donath |
2024-07-09 | PHASE2 |
| NCT07157735 | RECRUITING | Parkinson Disease |
Cambridge University Hospitals NHS Foundation Trust |
2026-02-02 | PHASE2 |
| NCT04971499 | ACTIVE_NOT_RECRUITING | Melanoma |
April Salama, M.D. |
2022-09-06 | PHASE1; PHASE2 |
| NCT05658575 | RECRUITING | Acute Gout Flare; Gout Attack; Gout Flare; Gouty Arthritis; Gout; Arthritis; Joint Pain |
Olatec Therapeutics, Inc. |
2023-01-06 | PHASE2; PHASE3 |
| NCT06047262 | Not yet recruiting | Diabetes Mellitus Type 2 |
University Hospital Basel Switzerland|European Union (Horizon Europe Programme)|State Secretariat for Education Research and Innovation Switzerland|Olatec Therapeutics LLC |
2024-05 | Phase 2 |
| NCT05658575 | Recruiting | Acute Gout Flare|Gout Attack|Gout Flare|Gouty Arthritis|Gout|Arthritis|Joint Pain |
Olatec Therapeutics LLC |
2023-01-06 | Phase 2|Phase 3 |
| NCT04540120 | TERMINATED | Covid19; Cytokine Release Syndrome |
Olatec Therapeutics, Inc. |
2020-09-24 | PHASE2 |
| NCT03534297 | COMPLETED | Systolic Heart Failure |
Olatec Therapeutics, Inc. |
2018-05-16 | PHASE1 |
| NCT03595371 | TERMINATED | Schnitzler Syndrome |
Olatec Therapeutics, Inc. |
2018-05-15 | PHASE2 |
| NCT03595371 | Terminated | Schnitzler Syndrome |
Olatec Therapeutics LLC|Radboud University Medical Center |
2018-05-15 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2025-06-04)
Compliance for Clinical Use
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>).