Anle138b Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Several Phase 1 clinical trials have evaluated Anle138b in healthy volunteers and patients with Parkinson's disease, with all studies reaching completed recruitment status. Led by industry and academic sponsors—including MODAG GmbH, Aptuit, Quotient Sciences, and Nottingham University Hospitals NHS Trust—these investigations encompass first-in-human safety, tolerability, and pharmacokinetic assessments, CYP1A2 and CYP3A4 drug-drug interaction studies, and multiple ascending dose evaluations. Together, these early-stage studies establish the clinical safety and pharmacokinetic profile of the compound.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05532358	COMPLETED	Healthy Volunteers	MODAG GmbH	2022-09-12	PHASE1
NCT04685265	COMPLETED	Parkinson Disease	MODAG GmbH	2020-12-22	PHASE1
NCT04685265	Completed	Parkinson Disease	MODAG GmbH\|Aptuit\|Quotient Sciences\|Nottingham University Hospitals NHS Trust	2020-12-22	Phase 1
NCT04208152	COMPLETED	Healthy Volunteers	MODAG GmbH	2019-12-06	PHASE1
NCT04208152	Completed	Healthy Volunteers	MODAG GmbH\|Quotient Sciences\|Aptuit	2019-12-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2023-03-23)

Check the Anle138b product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Anle138b selectively binds to pathological oligomeric structures to inhibit the toxic aggregation and propagation of alpha-synuclein and prion proteins within the central nervous system. By blocking neurotoxic oligomer formation and preserving neuronal structural integrity, this mechanism directly addresses the pathological drivers of neurodegenerative disorders such as Parkinson's disease.

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>).