(R)-(-)-Ibuprofen Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate ibuprofen-related regimens across Phase 1 through Phase 4 for indications such as postoperative pain, acute kidney injury, orthopaedic surgical complications, and adult acute respiratory distress syndrome. Sponsoring organizations include academic institutions like the University of New Mexico, healthcare centers, and industry entities such as Dompé Farmaceutici S.p.A. Ranging from completed studies on renal biomarkers to actively recruiting Phase 2 and Phase 4 trials, these investigations demonstrate ongoing clinical evaluation across surgical, renal, and pulmonary conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06146491	Recruiting	Pain Postoperative	B.P. Koirala Institute of Health Sciences	2023-08-10	Phase 4
NCT05928520	Not yet recruiting	Pain Management	Al-Azhar University	2023-08-01	Phase 3
NCT06247462	Completed	Acute Kidney Injury	University of New Mexico	2023-06-01	Phase 1
NCT05575700	Recruiting	Pain Acute\|Hip Arthropathy\|Knee Arthropathy\|Safety Issues\|Analgesia\|Analgesic Adverse Reaction\|Postoperative Pain\|Postoperative Complications	Naestved Hospital	2023-04-17	Phase 4
NCT05496868	Recruiting	Acute Respiratory Distress Syndrome Adult	Dompé Farmaceutici S.p.A	2023-02-07	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

(R)-(-)-Ibuprofen targets and suppresses nuclear factor kappa B (NF-κB) activation downstream of T-cell stimulation, thereby inhibiting the transcription of pro-inflammatory mediators and blunting inflammatory signaling cascades. This molecular pathway inhibition leads to reduced tissue swelling and attenuated peripheral nociceptive signaling, mitigating acute postoperative pain and inflammatory damage in clinical settings.

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>).