Aminopterin Clinical Trials

Size	Price	Qty
5mg	USD 70

Clinical Trials

A clinical trial evaluated the safety and oral pharmacokinetic profile of aminopterin in patients with psoriasis. This completed Phase 1 study was conducted through a collaboration between industry and government sponsors, specifically Syntrix Biosystems Inc. and the National Institute of Allergy and Infectious Diseases. Overall, the investigation represents early-stage clinical research focused on evaluating safety and pharmacokinetics for inflammatory dermatological conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00937027	Completed	Psoriasis	Syntrix Biosystems Inc.\|National Institute of Allergy and Infectious Diseases (NIAID)	2009-06	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aminopterin functions as a potent folic acid antagonist that competitively inhibits dihydrofolate reductase (DHFR) with a Ki of 3.7 pM, thereby blocking the reduction of dihydrofolate to tetrahydrofolate and suppressing essential nucleotide synthesis. By disrupting DNA replication and arresting the proliferation of rapidly dividing cells, this pathway limits the hyperproliferative cellular responses characteristic of autoimmune and inflammatory diseases such as psoriasis.

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>).