1-Phenylbiguanide Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate interventions across metabolic and endocrine conditions, including polycystic ovary syndrome, type 2 diabetes mellitus, and obesity with functional neuroimaging. Encompassing Phase 3, Phase 4, non-applicable, and unassigned trial phases, these studies are sponsored by institutions such as Shanghai 10th People's Hospital, Nanjing First Hospital at Nanjing Medical University, and Chia Tai Tianqing Pharmaceutical Group Co. Ltd. Recruitment statuses across the protocols range from recruiting and active not recruiting to completed and unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06047574	Recruiting	Polycystic Ovary Syndrome	Shanghai 10th People''s Hospital	2023-09-18	--
NCT05856578	Active not recruiting	Type 2 Diabetes Mellitus	Nanjing First Hospital Nanjing Medical University	2022-03-15	Phase 4
NCT05892224	Recruiting	Obesity\|Functional Neuroimaging	Shanghai 10th People''s Hospital	2022-01-01	--
NCT04690634	Completed	Polycystic Ovary Syndrome	Shanghai 10th People''s Hospital	2020-05-01	Not Applicable
NCT04700839	Completed	Polycystic Ovary Syndrome	Shanghai 10th People''s Hospital	2020-05-01	Phase 4
NCT04373967	Unknown status	Type 2 Diabetes	Chia Tai Tianqing Pharmaceutical Group Co. Ltd.	2020-04-29	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

1-Phenylbiguanide acts as a selective agonist of the 5-hydroxytryptamine 3 (5-HT3) receptor with an EC50 of 3.0 μM, inducing ligand-gated ion channel opening, extracellular cation influx, and rapid membrane depolarization in target cells. This primary receptor activation modulates downstream serotonergic signaling networks, which connects to the therapeutic investigation of metabolic and endocrine disorders such as polycystic ovary syndrome, type 2 diabetes, and obesity in 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>).