Dihydroxyfumaric acid hydrate Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Several clinical trials evaluate interventions for viral infectious diseases, specifically dengue fever and severe manifestations such as dengue hemorrhagic fever and dengue shock syndrome. Spanning Phase II research and observational protocols with completed or active-not-recruiting recruitment statuses, these efforts are sponsored by pharmaceutical leaders like Novartis alongside academic institutions including Tan Tock Seng Hospital, National University Hospital Singapore, and St. Jude Children's Research Hospital. These studies focus on evaluating therapeutic efficacy, prognostic biomarkers, and pediatric disease characterization.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06006559	Active not recruiting	Dengue	Novartis Pharmaceuticals\|Novartis	2024-02-20	Phase 2
NCT04048837	Completed	Dengue Hemorrhagic Fever\|Dengue Shock Syndrome\|Severe Dengue	National University Hospital Singapore\|Tan Tock Seng Hospital\|Ng Teng Fong General Hospital	2018-07-30	--
NCT01030211	Completed	Dengue Fever	Tan Tock Seng Hospital\|Singapore General Hospital\|Changi General Hospital\|National University Hospital Singapore\|University of Malaya	2010-01	Not Applicable
NCT00946218	Completed	Dengue Fever	St. Jude Children''s Research Hospital	2009-07	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dihydroxyfumaric acid hydrate acts as an endogenous metabolite and reactive electrophile that interacts with cellular metabolic enzymes, thereby disrupting downstream oxidative pathways and altering mitochondrial redox dynamics. This disruption of key biochemical cascades alters cellular metabolism to limit viral proliferation, offering potential therapeutic relevance in conditions such as dengue and severe dengue fever.

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>).