Methyldopa Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Several clinical trials investigate methyldopa applications and formulations across Phase 1, Phase 2, and unclassified phase protocols. These studies evaluate conditions such as aromatic L-amino acid decarboxylase deficiency, Parkinson's disease, Type 1 diabetes mellitus, and bioequivalence in healthy volunteers, with recruitment statuses ranging from active but not recruiting to completed. Research efforts are sponsored by corporate and academic organizations, including PTC Therapeutics, LobSor Pharmaceuticals, the Chinese University of Hong Kong, and the University of Colorado Denver in collaboration with the Juvenile Diabetes Research Foundation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04903288	Active not recruiting	AADC Deficiency	PTC Therapeutics	2021-05-12	Phase 2
NCT03210025	Completed	Healthy	Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited\|Chinese University of Hong Kong	2017-09-20	Phase 1
NCT02448914	Completed	Parkinson''s Disease	LobSor Pharmaceuticals AB\|TFS Trial Form Support	2015-05	Phase 1
NCT01883804	Completed	Diabetes Mellitus Type 1	University of Colorado Denver\|Juvenile Diabetes Research Foundation	2013-06	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methyldopa competitively inhibits aromatic L-amino acid decarboxylase, which prevents the enzymatic conversion of L-DOPA into dopamine and subsequently diminishes downstream catecholamine biosynthesis. This reduction in peripheral dopaminergic and adrenergic neurotransmission mediates sympatholytic activity, providing therapeutic relevance for clinical evaluations involving neurological disorders such as Parkinson's disease and aromatic L-amino acid decarboxylase deficiency.

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>).