Clinical Trials

Numerous clinical trials and non-interventional studies spanning Phase I through Phase IV evaluate DPI across respiratory conditions, such as chronic obstructive pulmonary disease, asthma, and pulmonary arterial hypertension, as well as oncological indications like clear cell renal cell carcinoma and pancreatic ductal adenocarcinoma. Sponsored by academic medical centers, government institutes, and pharmaceutical entities—including GlaxoSmithKline, Debiopharm International SA, and Chiesi Farmaceutici S.p.A.—these protocols range from completed evaluations to actively recruiting Phase I/II studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07282886 RECRUITING
Asthma
University of Alabama at Birmingham
 2026-03-15 PHASE2
NCT07133880 RECRUITING
COPD (Chronic Obstructive Pulmonary Disease)
University of Tennessee Graduate School of Medicine
 2023-12-05 PHASE4
NCT06896890 RECRUITING
NSCLC (advanced Non-small Cell Lung Cancer); Stage IV Lung Cancer
Inhatarget Therapeutics
 2023-06-23 PHASE1; PHASE2
NCT07372573 NOT_YET_RECRUITING
Asthma (Diagnosis)
University of Health Sciences Lahore
 2026-02-01
NCT07344558 COMPLETED
Idiopathic Pulmonary Fibrosis (IPF)
Mannkind Corporation
 2025-12-22 PHASE1
NCT04636814 TERMINATED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2021-07-12 PHASE3
NCT06029595 TERMINATED
Uncontrolled Asthma
Chiesi Farmaceutici S.p.A.
 2023-11-26 PHASE2
NCT04636801 TERMINATED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2021-07-14 PHASE3
NCT07226362 COMPLETED
Safety, and Tolerability
Aspeya Switzerland SA
 2025-06-09 PHASE1
NCT07232264 COMPLETED
Asthma (Diagnosis)
Bugra Kerget
 2025-03-01
NCT06892756 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Chiesi Farmaceutici S.p.A.
 2025-03-18 PHASE1
NCT04266197 COMPLETED
Pulmonary Arterial Hypertension
Respira Therapeutics, Inc.
 2020-09-25 PHASE2
NCT06395610 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2024-03-28 PHASE1
NCT06061679 Not yet recruiting
COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection
Fondazione Policlinico Universitario Agostino Gemelli IRCCS|University of Florence UNIFI University of Florence Florence Italy Florence
 2023-11 Not Applicable
NCT06111664 Recruiting
Mood Disorders
University Hospital Strasbourg France
 2023-05-01 --
NCT05706129 Recruiting
Clear Cell Renal Cell Cancer (ccRCC)|Pancreatic Ductal Adenocarcinoma (PDAC)|Colorectal Cancer (CRC)
Debiopharm International SA
 2023-03-14 Phase 1|Phase 2
NCT05764681 Recruiting
Cerebral Palsy|Chronic Post Surgical Pain
Chantel Burkitt|National Institutes of Health (NIH)|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|University of Minnesota|Nemours Children''s Hospital Delaware|Gillette Children''s Specialty Healthcare
 2023-03-17 --
NCT04769869 COMPLETED
Asthma
AstraZeneca
 2022-07-08 PHASE1
NCT05628740 COMPLETED
Refractory Chronic Cough
Nocion Therapeutics
 2022-02-07 PHASE1
NCT03248128 COMPLETED
Asthma
GlaxoSmithKline
 2017-10-20 PHASE3
NCT04203472 COMPLETED
Asthma; Cough Variant Asthma
Medical University of Warsaw
 2019-01-20
NCT04006288 COMPLETED
Coronary Artery Disease
University of Florida
 2019-09-06 PHASE4
NCT04876677 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2021-05-18 PHASE3
NCT04671355 WITHDRAWN
COPD
Chiesi Farmaceutici S.p.A.
 2021-10-04 PHASE4
NCT04606394 COMPLETED
COPD
Pulmonary Research Institute of Southeast Michigan
 2020-12-02 PHASE4
NCT04739774 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2021-02-22 PHASE1
NCT03376932 WITHDRAWN
Asthma
GlaxoSmithKline
 2019-01-18 PHASE3
NCT03965871 COMPLETED
Bipolar Depression
Celon Pharma SA
 2019-03-28 PHASE2
NCT04124510 TERMINATED
Asthma
Mundipharma Korea Ltd
 2019-11-26 PHASE3
NCT04480879 TERMINATED
Asthma
AstraZeneca
 2020-07-17 PHASE1
NCT03965858 COMPLETED
Major Depressive Disorder
Celon Pharma SA
 2019-02-25 PHASE2
NCT03822455 TERMINATED
Cystic Fibrosis
AlgiPharma AS
 2019-05-16 PHASE2
NCT05343637 COMPLETED
Pulmonary Arterial Hypertension
Respira Therapeutics, Inc.
 2019-07-30 PHASE2
NCT03707678 WITHDRAWN
Asthma
GlaxoSmithKline
 2019-01-21 PHASE2
NCT05567367 COMPLETED
Healthy Volunteer
Respira Therapeutics, Inc.
 2018-07-31 PHASE1
NCT03920644 UNKNOWN
Prevention of Nausea Associated With Motion Sickness; Treatment of Nausea Associated With Motion Sickness
Naval Aeromedical Research Unit, Dayton
 2019-04 PHASE3
NCT03622112 COMPLETED
Asthma
AstraZeneca
 2019-01-02 PHASE2
NCT02924688 COMPLETED
Asthma
GlaxoSmithKline
 2016-10-13 PHASE3
NCT04219982 TERMINATED
Motion Sickness
Repurposed Therapeutics, Inc.
 2018-06-29 PHASE2; PHASE3
NCT03478657 COMPLETED
Asthma
GlaxoSmithKline
 2018-06-18 PHASE4
NCT03590379 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2018-06-15 PHASE2
NCT03373409 COMPLETED
Asthma
Concentrx Pharmaceuticals, Inc.
 2017-11-30 PHASE1
NCT03407872 COMPLETED
Healthy Volunteers
Celon Pharma SA
 2017-12-09 PHASE1
NCT03227445 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2017-09-20 PHASE4
NCT03004417 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2016-10-31 PHASE2
NCT03315559 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2017-11-14 PHASE1
NCT02986321 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2016-12-15 PHASE2
NCT02576626 COMPLETED
COPD
Wouter H. van Geffen
 2015-12 PHASE4
NCT02753712 COMPLETED
Asthma
Mundipharma Research Limited
 2016-06-15 PHASE3
NCT02982187 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2016-12-30 PHASE4
NCT02787967 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2016-08 PHASE2
NCT01924793 COMPLETED
Parainfluenza
Ansun Biopharma, Inc.
 2013-08 PHASE2
NCT02967159 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD); Asthma
AstraZeneca
 2016-11-24 PHASE1
NCT02680197 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Chiesi Farmaceutici S.p.A.
 2016-02-29 PHASE2
NCT02467452 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2015-05 PHASE3
NCT02794480 COMPLETED
Asthma
GlaxoSmithKline
 2016-08-22 PHASE4
NCT02470988 COMPLETED
Chronic Depression
University of Edinburgh
 2015-06
NCT02972905 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2016-10 PHASE1
NCT02777827 COMPLETED
Asthma
AstraZeneca
 2016-06-21 PHASE1
NCT02786927 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2016-06-21 PHASE4
NCT02567708 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2015-10-01 PHASE2
NCT02106832 COMPLETED
Bronchiectasis
Bayer
 2014-04-30 PHASE3
NCT02743013 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2016-04 PHASE1
NCT02691325 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2016-03-14 PHASE1
NCT02275052 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2015-01-23 PHASE4
NCT02648438 COMPLETED
Asthma; Chronic Obstructive Pulmonary Disease (COPD)
AstraZeneca
 2016-01-12 PHASE1
NCT02661438 COMPLETED
Bronchiectasis; Pulmonary Disease, Chronic Obstructive
Bayer
 2016-01-12
NCT01764841 COMPLETED
Bronchiectasis
Bayer
 2013-05-02 PHASE3
NCT02257372 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2014-09-30 PHASE4
NCT01502371 COMPLETED
Asthma
Organon and Co
 2012-01-25 PHASE2
NCT02218723 COMPLETED
Asthma
GlaxoSmithKline
 2014-10-28 PHASE1
NCT02271334 COMPLETED
Asthma
Amphastar Pharmaceuticals, Inc.
 2014-08 PHASE2
NCT02210806 COMPLETED
Asthma
Amphastar Pharmaceuticals, Inc.
 2014-07 PHASE2
NCT01991028 COMPLETED
Cystic Fibrosis
BDD Pharma Ltd
 2014-04 PHASE2
NCT02018549 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2013-12 PHASE2
NCT02119247 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2014-04 PHASE1
NCT01984086 COMPLETED
Asthma
GlaxoSmithKline
 2013-10-21 PHASE1
NCT02000609 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2013-12 PHASE2
NCT01730404 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2012-10 PHASE2
NCT01565785 COMPLETED
Patient Discharge
Medical College of Wisconsin
 2012-02
NCT01857323 COMPLETED
Asthma; Chronic Obstructive Pulmonary Disease (COPD)
Teva Branded Pharmaceutical Products R&D, Inc.
 2013-05 PHASE3
NCT01479621 COMPLETED
Asthma
Teva Branded Pharmaceutical Products R&D, Inc.
 2012-01 PHASE2
NCT01576718 COMPLETED
Asthma
Teva Branded Pharmaceutical Products R&D, Inc.
 2012-04 PHASE2
NCT01650441 COMPLETED
Asthma
University Hospital, Antwerp
 2012-04 PHASE2
NCT01689571 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2012-10 PHASE2
NCT01252758 WITHDRAWN
Asthma
Acerus Pharmaceuticals Corporation
 2012-11 PHASE2
NCT01210170 COMPLETED
Asthma
University of Miami
 2010-10
NCT01641081 COMPLETED
Asthma
AstraZeneca
 2012-06 PHASE2
NCT01738087 COMPLETED
Asthmatic
Chiesi Farmaceutici S.p.A.
 2012-11 PHASE2
NCT01651650 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2012-06 PHASE2
NCT01468272 COMPLETED
Asthma in Children
Chiesi Farmaceutici S.p.A.
 2011-11 PHASE2
NCT01581177 COMPLETED
Asthma
Amphastar Pharmaceuticals, Inc.
 2012-04 PHASE2
NCT01521377 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2011-12-19 PHASE1
NCT01495442 COMPLETED
Adult Healthy Volunteers
University of North Carolina, Chapel Hill
 2011-12
NCT01426009 COMPLETED
Chronic Obstructive Pulmonary Disease
Sunovion Respiratory Development Inc.
 2011-08 PHASE2
NCT01258803 COMPLETED
Asthma
Organon and Co
 2010-12 PHASE2
NCT01191424 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2010-10 PHASE2
NCT01345916 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2011-03 PHASE3
NCT01349257 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2011-05 PHASE2
NCT01189396 COMPLETED
Asthma; Bronchospasm; Chronic Obstructive Pulmonary Disease (COPD)
Amphastar Pharmaceuticals, Inc.
 2010-07 PHASE2
NCT01174732 COMPLETED
Asthma; Bronchospasm
Amphastar Pharmaceuticals, Inc.
 2010-07 PHASE2
NCT01176747 COMPLETED
Pulmonary Disease, Chronic Obstructive; Asthma
Chiesi Farmaceutici S.p.A.
 2010-08 PHASE1; PHASE2
NCT00901368 COMPLETED
Asthmatic Patients
Chiesi Farmaceutici S.p.A.
 2009-05 PHASE4
NCT00497237 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2007-04 PHASE3
NCT00862394 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2009-02 PHASE3
NCT00702325 COMPLETED
Asthma
AstraZeneca
 2008-06 PHASE4
NCT00868023 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2009-02 PHASE2
NCT00442117 COMPLETED
Asthma
Organon and Co
 2007-06 PHASE3
NCT00635882 COMPLETED
Asthma; Airway Inflammation
Organon and Co
 2008-02 PHASE2
NCT00746330 COMPLETED
Asthma
Novartis
 2008-08 PHASE2
NCT00521599 COMPLETED
Asthma
Organon and Co
 2007-05 PHASE4
NCT00424008 COMPLETED
Asthma
Organon and Co
 2007-04 PHASE3
NCT00476099 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2006-12 PHASE3
NCT00478738 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2007-06 PHASE2
NCT00563056 COMPLETED
Asthma Bronchiale
Mundipharma Research Limited
 2007-09 PHASE3
NCT00448435 COMPLETED
Bronchial Asthma
GlaxoSmithKline
 2007-04 PHASE3
NCT00565591 COMPLETED
Allergic Asthma
Respirics Inc.
 2007-11 PHASE1
NCT00515502 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2007-06-21 PHASE2
NCT00279019 COMPLETED
Pulmonary Disease, Chronic Obstructive
GlaxoSmithKline
 2005-12-12 PHASE1
NCT00972140 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2005-08 PHASE3
NCT00742248 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2004-09 PHASE2
NCT00835094 COMPLETED
Asthma
Organon and Co
 2002-10-01 PHASE4
NCT00263874 TERMINATED
Pulmonary Disease, Chronic Obstructive
Pfizer
 2005-11 PHASE2
NCT00975741 COMPLETED
Asthma
Mantecorp Industria Quimica e Farmaceutica Ltd.
 2002-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diphenyleneiodonium chloride directly binds to and irreversibly inhibits NADPH oxidase and nitric oxide synthases (iNOS/eNOS), which blocks electron transfer and severely diminishes intracellular reactive oxygen species production. This reduction in oxidative stress and inflammatory signaling attenuates airway hyper-responsiveness and abnormal cellular proliferation, providing potential therapeutic utility in inflammatory respiratory conditions such as chronic obstructive pulmonary disease and solid tumors like renal cell 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>).

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