1,2-Propanediol Clinical Trials

Size	Price	Qty
25ul	USD 97

Clinical Trials

Several clinical trials evaluate formulations and exposure studies associated with 1,2-propanediol, encompassing Phase 2 and non-phase studies for conditions such as analgesia, secondhand tobacco smoke exposure, and mycosis fungoides. Supported by diverse academic, governmental, and industry sponsors—including Bambino Gesù Hospital and Research Institute, Ministero della Salute Italy, University College London, Juul Labs Inc., Inflamax Research Incorporated, and Yaupon Therapeutics—these efforts include both completed studies and those with an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04646135	Unknown status	Analgesia	Bambino Gesù Hospital and Research Institute\|Ministero della Salute Italy\|University College London	2020-12	Phase 2
NCT03605641	Completed	Second Hand Tobacco Smoke	Juul Labs Inc.\|Inflamax Research Incorporated	2018-09-17	Not Applicable
NCT00535470	Completed	Mycosis Fungoides	Yaupon Therapeutics	2007-07	Phase 2

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

Check the 1,2-Propanediol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a synthetic organic diol, 1,2-propanediol acts as a pharmaceutical vehicle that alters solution dielectric properties to solubilize lipophilic active compounds and stabilize liquid formulations. This physicochemical enhancement facilitates transdermal, mucosal, and systemic drug absorption, thereby optimizing therapeutic delivery and bioavailability in clinical applications such as analgesia management, cutaneous therapies for mycosis fungoides, and inhalational exposure studies.

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>).