Olesoxime (TRO 19622) Clinical Trials

Size	Price	Qty
5mg	USD 99
25mg	USD 297

Clinical Trials

Several clinical trials have evaluated Olesoxime across Phase I and Phase II investigations, examining pharmacokinetics in healthy volunteers as well as safety and efficacy in neurodegenerative and neuropathic conditions. These studies specifically targeted spinal muscular atrophy, chemotherapy-induced peripheral neuropathy, and painful diabetic neuropathy. Sponsored by industry entities including Hoffmann-La Roche, Trophos SA, and Ergomed GmbH, all recorded trials have successfully reached completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02628743	Completed	Muscular Atrophy Spinal	Hoffmann-La Roche	2016-01-20	Phase 2
NCT02835976	Completed	Healthy Volunteer	Hoffmann-La Roche\|Trophos SA	2014-07	Phase 1
NCT00876538	Completed	Chemotherapy-Induced Peripheral Neuropathy	Hoffmann-La Roche	2009-03	Phase 2
NCT00496457	Completed	Diabetic Neuropathy	Hoffmann-La Roche\|Ergomed GmbH	2007-05	Phase 2

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

Check the Olesoxime (TRO 19622) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olesoxime selectively binds to outer mitochondrial membrane proteins, preventing permeability transition pore opening and inhibiting the release of pro-apoptotic factors to preserve neuronal mitochondrial function. This neuroprotective mechanism enhances motor neuron survival and axonal integrity, supporting its clinical evaluation for motor neuron diseases such as spinal muscular atrophy and various peripheral neuropathies.

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>).