DTP3 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple Phase IV clinical trials conducted by the Bandim Health Project evaluate health outcomes associated with DTP3 administration, focusing on adverse events, infant morbidity and mortality, hospitalization, and non-specific effects of vaccines such as BCG. A completed study investigated overall mortality, child survival, and hospitalization rates following vaccination protocols. Additionally, a trial currently enrolling by invitation assesses female infant survival and morbidity following BCG revaccination in conjunction with DTP3.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07005726	ENROLLING_BY_INVITATION	Infant Morbidity; Infant Mortality; Non-Specific Effects of Vaccines; BCG	Bandim Health Project	2025-05-09	PHASE4
NCT00244673	COMPLETED	Mortality; Hospitalization; Adverse Events	Bandim Health Project	2005-10	PHASE4

(data from https://clinicaltrials.gov, updated on 2025-06-12)

Check the DTP3 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DTP3 selectively disrupts the interaction between GADD45β and MKK7, thereby restoring downstream MKK7 and JNK kinase activation while blocking the cancer-selective NF-κB pro-survival signaling cascade to induce apoptotic cell death. By suppressing pro-survival pathways and promoting programmed cell death, this target inhibition provides a therapeutic approach to improve clinical outcomes, including reducing mortality and morbidity evaluated across clinical trials.

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>).