Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 alongside non-interventional studies have evaluated inosine across diverse applications, including chronic hepatitis C, HIV, COVID-19, cerebral ischemia, renal transplantation, gallstone disease, obstructive jaundice, refractory solid tumors, and healthy volunteer physiological assessments. Sponsored by academic medical centers and industry entities such as Hoffmann-La Roche, Novartis, and the National Cancer Institute, these trials encompass completed, recruiting, and withdrawn recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04890808 NOT_YET_RECRUITING
Superficial Siderosis
Superficial Siderosis Research Alliance Inc.
 2023-05
NCT07170475 RECRUITING
Parkinson's Disease (PD)
Fujita Health University
 2025-06-27 PHASE1
NCT06355024 COMPLETED
Triple-negative Breast Cancer
Fudan University
 2024-05-11 PHASE2
NCT05935787 COMPLETED
Stroke
POLYSAN Scientific & Technological Pharmaceutical Company
 2023-06-30 PHASE3
NCT04631484 COMPLETED
Head Trauma,Closed
POLYSAN Scientific & Technological Pharmaceutical Company
 2020-11-22 PHASE3
NCT04476238 COMPLETED
Healthy Volunteers
University Hospital, Basel, Switzerland
 2022-02-28
NCT05809336 COMPLETED
Advanced Solid Tumor
Beijing Friendship Hospital
 2019-05-01 PHASE2; PHASE3
NCT04476238 Completed
Healthy Volunteers
University Hospital Basel Switzerland
 2022-02-28 Not Applicable
NCT04649203 COMPLETED
Diabetic Neuropathies
POLYSAN Scientific & Technological Pharmaceutical Company
 2020-11-25 PHASE3
NCT04360122 UNKNOWN
Coronavirus Disease (COVID-19)
Ain Shams University
 2020-05-20 PHASE3
NCT04383717 UNKNOWN
Respiratory Tract Infections
Cairo University
 2020-05-05 PHASE3
NCT03418935 COMPLETED
Jaundice, Obstructive
POLYSAN Scientific & Technological Pharmaceutical Company
 2017-04-03 PHASE3
NCT03168711 COMPLETED
Amyotrophic Lateral Sclerosis
Massachusetts General Hospital
 2017-10-01 PHASE2
NCT03403309 COMPLETED
Multiple System Atrophy
Yonsei University
 2018-05-02 PHASE2
NCT02642393 COMPLETED
Parkinson's Disease
Michael Alan Schwarzschild
 2016-06 PHASE3
NCT02090374 COMPLETED
Allergic Rhinitis; Asthma; Latent Tuberculosis
Imperial College London
 2014-03
NCT02614469 COMPLETED
Healthy
Michael Alan Schwarzschild
 2015-03 PHASE1
NCT02288091 COMPLETED
Amyotrophic Lateral Sclerosis
Massachusetts General Hospital
 2015-01 PHASE1
NCT00833690 COMPLETED
Parkinson Disease
The Parkinson Study Group
 2009-06 PHASE2
NCT01726400 Completed
Hepatitis C
Fremantle Hospital and Health Service
 2012-12 --
NCT00893724 UNKNOWN
Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
Mid-Atlantic Retina Consultations, Inc.
 2009-06
NCT01675427 Completed
Hepatitis C Chronic
Hoffmann-La Roche
 2011-08 Phase 4
NCT01639534 Completed
Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood|Ischemia/Hypoperfusion of Brain
Virginia Commonwealth University
 2011-03 --
NCT00978965 Completed
Renal Transplantation
Medical University of Vienna|Novartis
 2009-10 --
NCT00923728 Withdrawn
Refractory Solid Tumors
Vertex Pharmaceuticals Incorporated|National Cancer Institute (NCI)
 2009-04 Not Applicable
NCT00000672 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000979 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000671 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002296 COMPLETED
Lymphatic Disease; HIV Infections
Newport Pharmaceuticals International
NCT00002061 COMPLETED
Lymphatic Disease; HIV Infections
Newport Pharmaceuticals International
NCT00000657 COMPLETED
AIDS Dementia Complex; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00000969 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000954 COMPLETED
Sarcoma, Kaposi; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00067327 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
National Center for Complementary and Integrative Health (NCCIH)
 2002-02 PHASE2
NCT00000656 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002035 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00001997 COMPLETED
HIV Infections
Chiron Corporation
NCT00002280 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00000669 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00000699 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00002059 COMPLETED
HIV Infections
Newport Pharmaceuticals International
NCT00002060 COMPLETED
HIV Infections
Newport Pharmaceuticals International
NCT00000637 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE3
NCT00002099 UNKNOWN
HIV Infections
AJI Pharma USA
 PHASE2
NCT00002001 COMPLETED
HIV Infections
Glaxo Wellcome
NCT00000710 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00001267 COMPLETED
AIDS-Related Complex; Acquired Immunodeficiency Syndrome
National Cancer Institute (NCI)
 1990-10 PHASE3
NCT00002028 COMPLETED
HIV Infections
Bristol-Myers Squibb
NCT00000963 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002098 COMPLETED
HIV Infections
AJI Pharma USA
 PHASE1
NCT00002014 COMPLETED
HIV Infections
Glaxo Wellcome
 PHASE1
NCT00000971 COMPLETED
Mycobacterium Avium-intracellulare Infection; HIV Infections
Abbott
 PHASE1
NCT00002274 COMPLETED
HIV Infections; Leukoencephalopathy, Progressive Multifocal
Bristol-Myers Squibb
NCT00002297 COMPLETED
Lymphatic Disease; HIV Infections
Newport Pharmaceuticals International
NCT00000652 COMPLETED
HIV Infections
National Cancer Institute (NCI)
 PHASE1
NCT00002295 COMPLETED
HIV Infections
Newport Pharmaceuticals International

(data from https://clinicaltrials.gov, updated on 2022-05-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous purine nucleoside, inosine binds to purinergic adenosine receptors and integrates into intracellular purine salvage pathways, thereby modulating downstream cyclic AMP signaling and cellular energy metabolism. This biochemical sequence regulates inflammatory mediators and cellular survival pathways, providing a mechanistic basis for its clinical evaluation in viral infections, ischemic brain injury, and solid tumors.

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.