Clinical Trials

Multiple clinical trials evaluate this compound profile across Phase 1/2, Phase 2, and unspecified design phases, with recruitment statuses ranging from active recruitment to withdrawn or unknown status. The investigated indications encompass acute renal failure, in situ simulation, and neurodegenerative and dysautonomic conditions, including Parkinson disease, multiple system atrophy, progressive supranuclear palsy, Menkes disease, and occipital horn syndrome. These therapeutic and observational studies are sponsored by academic and medical centers—such as Loma Linda University, Nationwide Children's Hospital, University of Liege, and University Hospital Strasbourg—in collaboration with industry partners including H. Lundbeck A/S.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03446807 Withdrawn
Parkinson Disease|Multiple System Atrophy|Progressive Supranuclear Palsy
Loma Linda University|H. Lundbeck A/S
 2021-12 Phase 2
NCT04977388 Recruiting
Menkes Disease|Occipital Horn Syndrome
Stephen G. Kaler MD|Nationwide Children''s Hospital
 2021-07-12 Phase 1|Phase 2
NCT04922203 Enrolling by invitation
in Situ Simulation
Jean François Brichant|University of Liege
 2021-05-28 Not Applicable
NCT04682236 Unknown status
Acute Renal Failure
University Hospital Strasbourg France
 2020-11-25 --

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

Check the Bis(2-ethylhexyl) phthalate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bis(2-ethylhexyl) phthalate interacts with cellular macromolecular structures to induce DNA strand breaks and disrupt essential transcriptomic networks, leading to impaired genomic integrity and cellular stress responses. This cascade of genotoxicity and altered gene expression compromises cellular viability and tissue homeostasis, providing crucial mechanistic insights relevant to systemic pathologies such as acute renal failure and neurodegenerative 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>).

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Note: Technical data last updated: Sep 1, 2026.