5-Acetylsalicylic acid Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials evaluate this compound across Phase 1, Phase 2, and observational protocols for indications such as ulcerative colitis and colorectal cancer, as well as in healthy volunteers. Sponsored by academic institutions like Beth Israel Deaconess Medical Center alongside pharmaceutical corporations including Bayer, Shire (Takeda), and SOFAR S.p.A., these registered investigations encompass both completed and terminated studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02246686	Terminated	Colitis Ulcerative	Bayer	2014-11	Phase 2
NCT02125292	Completed	Healthy	Shire\|Takeda	2014-06-02	Phase 1
NCT02077777	Completed	Colorectal Cancer	SOFAR S.p.A.	2012-10	Phase 2
NCT01678300	Completed	Ulcerative Colitis	Beth Israel Deaconess Medical Center	2012-08	--

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

Check the 5-Acetylsalicylic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a nonsteroidal anti-inflammatory drug, 5-acetylsalicylic acid inhibits cyclooxygenase enzymes to suppress pro-inflammatory eicosanoid biosynthesis, thereby reducing local cytokine production and mucosal cellular inflammation. This suppression of inflammatory signaling pathways attenuates tissue damage and colonic epithelial hyperproliferation, providing therapeutic potential in the management of ulcerative colitis and colorectal cancer.

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>).