Clinical Trials

Multiple clinical trials across Phase 1, Phase 1/2, and unallocated phases are evaluating therapeutic candidates and diagnostic protocols for multiple sclerosis, advanced EGFR-mutant non-small cell lung cancer, relapsed or refractory lymphoma, and advanced solid tumors. Sponsored by entities including Innodem Neurosciences and EpimAb Biotherapeutics, these studies range in status from active recruitment to not yet recruiting. Together, they assess novel biomarker tracking technologies as well as targeted bispecific and combination biological regimens across neurodegenerative and oncological pathologies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06283524 Not yet recruiting
Multiple Sclerosis
Innodem Neurosciences
2024-03-18 --
NCT05661266 Recruiting
Multiple Sclerosis
Innodem Neurosciences
2023-08-16 --
NCT05498389 Not yet recruiting
Metastatic Lung Non-Small Cell Carcinoma|Advanced Lung Non-Small Cell Carcinoma|Stage IV Lung Cancer AJCC v8|Stage IVA Lung Cancer AJCC v8|Stage IVB Lung Cancer AJCC v8|Stage III Lung Cancer AJCC v8|Stage IIIA Lung Cancer AJCC v8|Stage IIIB Lung Cancer AJCC v8|EGFR Mutation-Related Tumors
Shanghai EpimAb Biotherapeutics Co. Ltd.|Labcorp Corporation of America Holdings Inc
2023-06 Phase 1|Phase 2
NCT05607498 Recruiting
Advanced/Metastatic Solid Tumors|Relapse/Refractory Lymphoma
EpimAb Biotherapeutics (Suzhou)Co. Ltd.
2023-03-01 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Emamectin Benzoate functions by activating the gamma-aminobutyric acid (GABA) transporter, which stimulates the intracellular generation of reactive oxygen species and leads to subsequent DNA double-strand breaks. This accumulating oxidatively induced genomic damage ultimately triggers programmed cell death (apoptosis), offering mechanistic utility in suppressing malignant cell growth across advanced solid tumors and refractory lymphoproliferative malignancies under clinical investigation.

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>).

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