Clinical Trials

Multiple clinical trials investigate therapeutic strategies for immune thrombocytopenia, primary immune thrombocytopenia, and related hematologic blood platelet disorders. These studies span Phase 1, Phase 2, and Phase 4 designs alongside observational cohort protocols, with recruitment status ranging from active participant enrollment to preparation prior to study initiation. Prominent trial sponsors include industry developers such as Hutchmed alongside academic medical centers, specifically the Institute of Hematology & Blood Diseases Hospital in China and affiliated regional hospitals.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06291415 Recruiting
Immune Thrombocytopenia|Blood Platelet Disorder|Hematologic Diseases|Purpura Thrombocytopenic|Purpura|Blood Coagulation Disorder|Thrombotic Microangiopathies|Hemorrhagic Disorders|Autoimmune Diseases|Immune System Diseases|Hemorrhage|Pathologic Processes|Skin Manifestations|Thrombocytopenia|Purpura Thrombocytopenic Idiopathic|Primary Immune Thrombocytopenia|ITP - Immune Thrombocytopenia
Hutchmed
2024-04-02 Phase 1
NCT06287567 Not yet recruiting
Idiopathic Thrombocytopenic Purpura|Immune Thrombocytopenia
Institute of Hematology & Blood Diseases Hospital China
2024-03-20 Phase 4
NCT06281327 Recruiting
Immune Thrombocytopenia|Treatment
Institute of Hematology & Blood Diseases Hospital China|Henan Cancer Hospital|Tianjin Medical University Second Hospital|Tianjin Children''s Hospital|The Second Affiliated Hospital of Kunming Medical University
2024-03 Phase 2
NCT06094881 Recruiting
Immune Thrombocytopenia|Treatment
Institute of Hematology & Blood Diseases Hospital China
2023-12 Phase 2
NCT06168851 Recruiting
Immune Thrombocytopenia|Treatment
Institute of Hematology & Blood Diseases Hospital China
2023-12-28 Phase 2
NCT06107582 Recruiting
Primary Immune Thrombocytopenia
Institute of Hematology & Blood Diseases Hospital China|Beijing Children''s Hospital|Tianjin People''s Hospital|Henan Cancer Hospital|Tianjin Medical University Second Hospital|The First Affiliated Hospital of Xiamen University|The Second Affiliated Hospital of Kunming Medical University
2023-11-01 --

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

Check the Inosine 5′-triphosphate trisodium salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Inosine 5′-triphosphate binds purinergic receptors and nucleotide-utilizing enzymes to disrupt downstream purine nucleotide metabolism and ATP/GTP deamination processes. This alteration inhibits cellular purinergic signaling pathways to modulate immune cell activity and survival, providing potential clinical relevance in mitigating platelet destruction in autoimmune conditions such as immune thrombocytopenia.

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>).

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