Clinical Trials

A clinical trial sponsored by an academic hospital, National Taiwan University Hospital, is actively recruiting participants to evaluate intervention strategies in stroke, physical rehabilitation, and robotic rehabilitation. Classified without a traditional trial phase, the study specifically examines the feasibility and efficacy of end-effector robot-assisted gait training with active-assisted modules in chronic stroke survivors. This research reflects ongoing clinical efforts to optimize functional recovery protocols following ischemic cerebrovascular events.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07034521 RECRUITING
Stroke; Rehabilitation; Robotic Rehabilitation
National Taiwan University Hospital
2025-08-12

(data from https://clinicaltrials.gov, updated on 2026-05-19)

Check the P110 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

P110 functions as a selective inhibitor that directly binds to dynamin-related protein 1 (Drp1), thereby blocking Drp1-mediated GTPase activity and excessive mitochondrial hyperfission. By suppressing pathological mitochondrial fragmentation and preserving cellular bioenergetics, this target inhibition limits neuronal cell death and attenuates tissue damage, which is directly relevant for neuroprotection and functional recovery in stroke rehabilitation.

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.