MG-101 (ALLN) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by Allena Pharmaceuticals have evaluated treatments for hyperuricemia, gout, and hyperuricemia in patients with chronic kidney disease. These completed Phase 1 and Phase 2 studies included single and multiple ascending dose protocols in hyperuricemic cohorts, as well as an inpatient trial assessing therapeutic efficacy and safety in patients with co-occurring chronic kidney disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04987242	Completed	Hyperuricemia\|Gout\|Chronic Kidney Diseases	Allena Pharmaceuticals	2021-07-16	Phase 2
NCT04829435	Completed	Hyperuricemia\|Gout	Allena Pharmaceuticals	2021-04-21	Phase 1
NCT04236219	Completed	Hyperuricemia	Allena Pharmaceuticals	2020-09-02	Phase 1

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

Check the MG-101 (ALLN) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MG-101 (ALLN) functions as a cell-permeable inhibitor that directly targets cysteine proteases, including calpains and lysosomal cathepsins, thereby blocking downstream substrate cleavage and suppressing intracellular protein degradation cascades. This targeted inhibition prevents catabolic tissue remodeling and pro-inflammatory cellular responses, providing therapeutic potential for clinical conditions such as hyperuricemia, gout, and chronic kidney 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>).