Milnacipran HCl Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Several clinical trials spanning Phase 2 through Phase 4 evaluate the efficacy of Milnacipran in chronic pain conditions, primarily focusing on osteoarthritis and fibromyalgia, including primary fibromyalgia. Sponsored by diverse industry, academic, and governmental organizations—such as Forest Laboratories, Cypress Bioscience, Eli Lilly and Company, Banner Health, University of California San Diego, and the US Department of Veterans Affairs—the study portfolio includes both completed and terminated trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01329406	Unknown status	Osteoarthritis	Analgesic Solutions\|Forest Laboratories	2011-07	Phase 4
NCT01328002	Terminated	Primary Fibromyalgia	Forest Laboratories\|Cypress Bioscience Inc.	2011-04-30	Phase 2
NCT01418651	Terminated	Fibromyalgia	Banner Health\|Forest Laboratories	2011-03	Phase 3
NCT01288807	Completed	Fibromyalgia	University of California San Diego\|Forest Laboratories\|US Department of Veterans Affairs	2011-02	Phase 4
NCT00725101	Completed	Fibromyalgia	Eli Lilly and Company	2008-06	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Milnacipran selectively inhibits the norepinephrine transporter (NET) and serotonin transporter (SERT) with IC50 values of 77 nM and 420 nM, respectively, thereby preventing monoamine reuptake and elevating extracellular concentrations of norepinephrine and serotonin. This sustained neurotransmitter elevation enhances descending inhibitory pain pathways within the central nervous system, providing the mechanism by which it alleviates chronic pain in clinical conditions such as fibromyalgia and osteoarthritis.

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>).