Clinical Trials

Multiple clinical trials evaluate therapeutic, diagnostic, and rehabilitative interventions across diverse indications, including breast cancer, stroke-related hemiplegia, vestibular schwannoma, autism spectrum disorder, mild cognitive impairment, opioid use disorder, and Parkinson's disease. Ranging from Phase 3 to non-interventional or unclassified protocols, these studies are sponsored by major academic medical centers and healthcare networks such as Karolinska University Hospital, King's College Hospital NHS Trust, and the University of California, Los Angeles. Recruitment statuses encompass completed, active, recruiting, and active-not-recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07660978 NOT_YET_RECRUITING
PARKINSON DISEASE (Disorder); Parkinson Disease (PD); Parkinson s Disease; Postural Instability; Postural Instability Gait Disorders; Gait Disorders; Cognitive Dysfunction, Cognitive Disorder
Bezmialem Vakif University
2026-06-20
NCT03883139 ACTIVE_NOT_RECRUITING
Autism Spectrum Disorder
University of California, Los Angeles
2021-03-01
NCT07209982 COMPLETED
Hemiplegia; Hemiplegia Following Ischemic Stroke; Stroke
University of Lahore
2025-01-15
NCT04057976 COMPLETED
Vestibular Schwannoma
King's College Hospital NHS Trust
2019-06-27
NCT05730790 UNKNOWN
Mild Cognitive Impairment
Tan Tock Seng Hospital
2021-03-31
NCT06255119 Completed
Opioid Use Disorder
3D Therapy LLC
2022-10-18 Not Applicable
NCT04057976 Recruiting
Vestibular Schwannoma
King''s College Hospital NHS Trust|Guy''s and St Thomas'' NHS Foundation Trust
2019-06-27 Not Applicable
NCT01751698 COMPLETED
Autism
University of California, Los Angeles
2013-01
NCT00798070 ACTIVE_NOT_RECRUITING
Breast Cancer
Karolinska University Hospital
2007-02 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a small-molecule redox reagent, dithiothreitol reduces intermolecular and intramolecular disulfide bonds within biological macromolecules through thiol-disulfide exchange, thereby disrupting protein tertiary conformation and downstream biochemical activity. This structural denaturation alters redox-sensitive signaling pathways and destabilizes functional protein networks, offering a mechanistic foundation for targeting aberrant protein structures in clinical trial contexts such as breast 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>).

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