Eltanexor (KPT-8602) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 297

Clinical Trials

Eltanexor (KPT-8602), a nuclear export inhibitor, is evaluated in several clinical trials across Phase I and Phase II studies as monotherapy and combination therapy. These trials target hematologic malignancies and advanced solid tumors, including acute myeloid leukemia, myelodysplastic syndromes, relapsed or refractory multiple myeloma, metastatic colorectal cancer, and metastatic castration-resistant prostate cancer. Sponsored by industry, academic, and government entities such as Karyopharm Therapeutics, the National Cancer Institute, and Vanderbilt-Ingram Cancer Center, statuses span recruiting, active not recruiting, completed, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06399640	RECRUITING	Relapsed Myelodysplastic Syndrome; Refractory Myelodysplastic Syndrome; Acute Myeloid Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	Vanderbilt-Ingram Cancer Center	2024-08-14	PHASE1
NCT05918055	TERMINATED	Myelodysplastic Syndromes	National Cancer Institute (NCI)	2023-11-14	PHASE1; PHASE2
NCT02649790	COMPLETED	Relapsed/Refractory Multiple Myeloma (RRMM); Metastatic Colorectal Cancer (mCRC); Metastatic Castration-Resistant Prostate Cancer (mCRPC); Higher-Risk Myelodysplastic Syndrome (HR-MDS); Acute Myeloid Leukemia (AML); Newly Diagnosed Intermediate/High-Risk MDS	Karyopharm Therapeutics Inc	2016-01	PHASE1; PHASE2
NCT05918055	Recruiting	Myelodysplastic Syndromes	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2023-11-14	Phase 1\|Phase 2
NCT02649790	Active not recruiting	Relapsed/Refractory Multiple Myeloma (RRMM)\|Metastatic Colorectal Cancer (mCRC)\|Metastatic Castration-Resistant Prostate Cancer (mCRPC)\|Higher-Risk Myelodysplastic Syndrome (HR-MDS)\|Acute Myeloid Leukemia (AML)\|Newly Diagnosed Intermediate/High-Risk MDS	Karyopharm Therapeutics Inc	2016-01	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the Eltanexor (KPT-8602) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eltanexor is a second-generation, orally bioavailable inhibitor of exportin-1 that selectively binds XPO1 to block the nuclear export of tumor suppressor proteins, leading to nuclear protein accumulation, cell cycle arrest, and apoptosis in malignant cells. This mechanism of nuclear transport inhibition underlies its clinical evaluation for conditions such as acute myeloid leukemia, myelodysplastic syndromes, multiple myeloma, and advanced solid tumors.

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>).