Overview
A purine nucleoside that has hypoxanthine linked by the N9 nitrogen to the C1 carbon of ribose. It is an intermediate in the degradation of purines and purine nucleosides to uric acid and in pathways of purine salvage. It also occurs in the anticodon of certain transfer RNA molecules. (Dorland, 28th ed)
Indication
The primary popular claim made for inosine, that it enhances exercise and athletic performance, is refuted by the available research data. There is some preliminary evidence that inosine may have some neurorestorative, anti-inflammatory, immunomodulatory and cardioprotective effects.
Associated Conditions
No associated conditions information available.
Research Report
Inosine (DB04335): A Comprehensive Monograph on a Multifaceted Purine Nucleoside
Executive Summary
Inosine is an endogenous purine nucleoside that occupies a central position in cellular metabolism and molecular biology. As a key intermediate in the degradation of adenosine and the biosynthesis of uric acid, it is fundamental to purine homeostasis. This monograph provides a comprehensive, evidence-based analysis of Inosine (DrugBank ID: DB04335), synthesizing its biochemical roles, complex pharmacological profile, extensive history of clinical investigation, and current regulatory standing.
The report addresses the significant dichotomy between the public perception of Inosine and its scientifically validated effects. It definitively concludes that widespread commercial claims of Inosine as an athletic performance enhancer are unsubstantiated and refuted by controlled clinical trials. The primary focus of modern therapeutic investigation has instead been on its potential as a neuroprotective agent. This research was driven by the "urate hypothesis," which posited that by serving as a precursor to the natural antioxidant uric acid, Inosine could slow the progression of neurodegenerative diseases. This rationale led to major, multi-year clinical trial programs in Parkinson's disease (the SURE-PD and SURE-PD3 trials) and multiple sclerosis. Despite successfully elevating urate levels, these pivotal trials ultimately failed to demonstrate a disease-modifying effect, providing a significant case study in the challenges of translating epidemiological observations and surrogate biomarker modulation into clinical efficacy.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/09/12 | Not Applicable | Recruiting | |||
2024/04/09 | Phase 2 | Completed | |||
2023/05/23 | Phase 1 | Not yet recruiting | |||
2023/04/12 | Phase 2 | Completed | |||
2020/04/24 | N/A | NO_LONGER_AVAILABLE | |||
2018/07/27 | Phase 3 | Withdrawn | Bellerophon Pulse Technologies | ||
2018/01/18 | Phase 2 | Completed | |||
2017/05/30 | Phase 2 | Completed | |||
2017/03/15 | Phase 4 | Completed | |||
2016/10/12 | Phase 2 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Citra Labs, LLC | 23731-7000 | EXTRACORPOREAL | 1.34 g in 50 mL | 2/14/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
THE GROWLING DOG ENERGY MIX oral powder jar/can | 51968 | Medicine | A | 3/23/1995 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
NUTRACEL POMADA | 52814 | POMADA | Sin Receta | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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