Clinical Trials

Multiple clinical trials evaluate pentoxifylline across Phase 1 through Phase 4 and non-applicable designs, with recruitment statuses ranging from completed to currently recruiting or not yet recruiting. Sponsored by academic medical centers and university hospitals, these studies investigate indications including post-ischemic stroke cognitive impairment, liver cirrhosis, neonatal late-onset sepsis, Hodgkin lymphoma, paclitaxel-induced peripheral neuropathy in breast cancer patients, and oral submucous fibrosis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06344390 Recruiting
Cognitive Impairment
The First Hospital of Hebei Medical University
 2024-04-10 Phase 1|Phase 2
NCT06041932 Not yet recruiting
Liver Cirrhosis
Institute of Liver and Biliary Sciences India
 2023-11-01 Not Applicable
NCT05490953 Recruiting
Hodgkin Lymphoma
University of Guadalajara|Hospital Civil de Guadalajara
 2022-07-11 Phase 4
NCT05189535 Completed
Breast Cancer Female|Peripheral Neuropathy
Ain Shams University
 2021-10-03 Phase 2|Phase 3
NCT04152980 Recruiting
Neonatal Late Onset Sepsis
Erasmus Medical Center
 2020-01-12 Phase 3
NCT05660694 Completed
Triamcinolone|Pentoxifylline|Vitamin E|Oral Submucosa Fibrosis|Tumor
Altamash Institute of Dental Medicine
 2020-01-01 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pentoxifylline acts as a competitive, nonselective phosphodiesterase inhibitor that elevates intracellular cyclic AMP levels and activates protein kinase A, which subsequently inhibits downstream tumor necrosis factor and leukotriene biosynthesis. By suppressing pro-inflammatory cytokine generation and innate immune responses, pentoxifylline attenuates vascular and tissue inflammation, providing therapeutic relevance in clinical trial settings such as liver cirrhosis, neonatal sepsis, cognitive impairment, and chemotherapy-induced peripheral neuropathy.

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.