Clinical Trials

A clinical trial evaluated therapeutic and surgical interventions for patients presenting with otitis media and cleft palate. Sponsored by academic and government research bodies—specifically the University of Pittsburgh and the National Institute on Deafness and Other Communication Disorders—the study was classified under a phase status of Not Applicable. Having completed recruitment, this investigation contributes valuable clinical insights into the management of structural and inflammatory ear and palatal disorders.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01535131 Completed
Otitis Media|Cleft Palate
University of Pittsburgh|National Institute on Deafness and Other Communication Disorders (NIDCD)
 2012-02-28 Not Applicable

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

Check the DT-061 (SMAP) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DT-061 functions as a synthetic small-molecule activator of protein phosphatase 2A (PP2A), binding the phosphatase enzyme complex to enhance its catalytic activity and promote downstream dephosphorylation of key signaling cascades to attenuate cellular viability. Through this targeted activation of phosphatase pathways and inhibition of pro-inflammatory cellular signaling, PP2A modulation offers potential therapeutic relevance in regulating inflammatory pathologies such as otitis media and associated cleft palate complications.

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>).

Jump to

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