2-Aminoethanethiol Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated 2-aminoethanethiol across genetic and metabolic disorders, primarily cystinosis and cystic fibrosis, encompassing Phase 1/2, Phase 2, and Phase 3 interventional evaluations alongside observational cohort studies. Sponsored by biopharmaceutical companies and healthcare institutions, all of these registered trials have completed recruitment. Together, they establish a valuable clinical foundation regarding the safety, pharmacokinetics, and therapeutic efficacy of cysteamine formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03000348	Completed	Cystic Fibrosis	NovaBiotics Ltd.\|Agility Clinical Inc.\|PSR Group B.V.	2016-12	Phase 2
NCT02212431	Completed	Cystic Fibrosis	University of Aberdeen\|Cystic Fibrosis Trust\|NHS Grampian\|University of Huddersfield	2014-08	Phase 1\|Phase 2
NCT01733316	Completed	Cystinosis	Horizon Pharma USA Inc.	2013-01-31	Phase 3
NCT01744782	Completed	Cystinosis	Horizon Pharma USA Inc.	2012-12-20	Phase 3
NCT02012114	Completed	Cystinosis	Hospices Civils de Lyon	2011-12	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

2-Aminoethanethiol (cysteamine) acts by reacting with lysosomal cystine to form mixed cysteine-cysteamine disulfides, which readily exit the lysosome via alternative amino acid transporters to clear pathological intracellular cystine accumulation and attenuate oxidative stress. This biochemical clearing mechanism and free-radical scavenging capability provide direct clinical relevance by preventing organ-damaging cystine crystallization in cystinosis and mitigating inflammatory mucosal pathologies in cystic fibrosis.

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>).