Clinical Trials

Several clinical trials—encompassing Phase 1 and non-applicable phase designs—are currently not yet recruiting to evaluate interventions across chronic obstructive pulmonary disease, ovarian and lung cancers, attention deficit hyperactivity disorder, and sleep disturbances. Supported by academic, foundation, government, and industry sponsors such as the University of Pittsburgh, The Klingenstein Third Generation Foundation, the VA Office of Research and Development, and Novartis Pharmaceuticals, these studies address diverse areas including virtual care delivery, radiopharmaceutical safety, and sensory impacts on sleep.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05986214 Not yet recruiting
Chronic Obstructive Pulmonary Disease
VA Office of Research and Development
2026-03-01 Not Applicable
NCT06376253 Not yet recruiting
Ovarian Cancer|Lung Cancer
Novartis Pharmaceuticals|Novartis
2024-09-06 Phase 1
NCT06406309 Not yet recruiting
Attention Deficit Hyperactivity Disorder|Sleep Disturbance
University of Pittsburgh|The Klingenstein Third Generation Foundation
2024-09 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Iodoacetamide acts as an alkylating agent that covalently binds to the sulfhydryl groups of reactive cysteine residues, thereby blocking downstream enzyme activity and essential cellular biochemical pathways. This irreversible thiol modification leads to widespread protein dysfunction and cellular toxicity, which underpins its potential biological relevance in oncology applications such as lung and ovarian cancers as well as respiratory conditions.

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.