Clinical Trials

Multiple clinical trials evaluate NEM formulations across indications including osteoarthritis, fibromyalgia, exercise-induced joint pain, stiffness, and cartilage turnover. Spanning Phase 2 investigations and non-interventional stages, these studies are sponsored by commercial entities like ESM Technologies LLC and Generica Pharmaceuticals, alongside clinical institutions such as the Children's Hospital of Philadelphia. Displaying recruitment statuses ranging from active recruiting to completed and terminated, these trials evaluated safety and symptomatic efficacy in patients with joint degradation or exercise-related discomfort.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07766720 RECRUITING
Exercise-induced Muscle Soreness; Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Cartilage Turnover
ESM Technologies, LLC
 2026-02-01
NCT03769857 COMPLETED
Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Joint Cartilage Turnover
ESM Technologies, LLC
 2019-01-13
NCT04215198 COMPLETED
Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Joint Cartilage Turnover
ESM Technologies, LLC
 2018-09-20
NCT03679923 COMPLETED
Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Joint Cartilage Turnover
ESM Technologies, LLC
 2018-09-20
NCT02751944 COMPLETED
Exercise-induced Joint Pain Stiffness and Cartilage Turnover
ESM Technologies, LLC
 2015-12
NCT01407991 TERMINATED
Enteral Tube Placement
Children's Hospital of Philadelphia
 2011-07 PHASE2
NCT02291757 COMPLETED
Osteoarthritis, Knee
Generica Pharmaceuticals
 2013-10
NCT00750477 COMPLETED
Osteoarthritis
ESM Technologies, LLC
 2004-12
NCT00750477 Completed
Osteoarthritis
ESM Technologies LLC
 2004-12 Not Applicable
NCT00750854 COMPLETED
Osteoarthritis; Fibromyalgia
ESM Technologies, LLC
 2003-11
NCT00750230 COMPLETED
Osteoarthritis; Fibromyalgia
ESM Technologies, LLC
 2003-10
NCT00750230 Completed
Osteoarthritis|Fibromyalgia
ESM Technologies LLC
 2003-10 Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-08-14)

Check the N-Ethylmaleimide (NEM) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

N-Ethylmaleimide (NEM) irreversibly alkylates active-site cysteine thiol groups, thereby blocking the catalytic function of cysteine peptidases, deubiquitinating enzymes, and mitochondrial phosphate transporters to disrupt protein turnover and oxidative energy generation. This comprehensive enzymatic inhibition impairs catabolic signaling and cellular metabolic flux, offering biochemical utility in modulating inflammatory pathways and matrix degradation associated with clinical conditions like osteoarthritis and joint stiffness.

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>).

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Note: Technical data last updated: Sep 1, 2026.