Abexinostat (PCI-24781) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Multiple clinical trials evaluate abexinostat (PCI-24781) across Phase 1, Phase 2, and Phase 3 development as both monotherapy and combination regimens. Sponsored by pharmaceutical companies such as Xynomic Pharmaceuticals alongside academic institutions, these studies target hematologic malignancies—including diffuse large B-cell, follicular, and mantle cell lymphomas—and solid tumors, such as renal cell carcinoma, recurrent high-grade gliomas, and metastatic breast cancer. With recruitment statuses including actively recruiting, active not recruiting, and completed, these studies evaluate the agent across both early- and late-stage clinical settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03600441	ACTIVE_NOT_RECRUITING	Follicular Lymphoma	Xynomic Pharmaceuticals, Inc.	2018-08-27	PHASE2
NCT05698524	RECRUITING	Recurrent High Grade Glioma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Glioblastoma; Gliosarcoma	University of Nebraska	2023-06-26	PHASE1
NCT03592472	RECRUITING	Renal Cell Carcinoma	Xynomic Pharmaceuticals, Inc.	2018-07-17	PHASE3
NCT03936153	RECRUITING	Diffuse Large B-cell Lymphoma (DLBCL)	Xynomic Pharmaceuticals, Inc.	2020-01-20	PHASE2
NCT04498520	WITHDRAWN	Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Hormone Receptor Positive Breast Carcinoma; Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Metastatic Endometrioid Adenocarcinoma; Metastatic Fallopian Tube Carcinoma; Metastatic HER2 Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Ovarian Carcinoma; Metastatic Primary Peritoneal Carcinoma; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Refractory Breast Carcinoma; Stage IV Fallopian Tube Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8; Stage IVA Fallopian Tube Cancer AJCC v8; Stage IVA Ovarian Cancer AJCC v8; Stage IVA Primary Peritoneal Cancer AJCC v8; Stage IVA Uterine Corpus Cancer AJCC v8; Stage IVB Fallopian Tube Cancer AJCC v8; Stage IVB Ovarian Cancer AJCC v8; Stage IVB Primary Peritoneal Cancer AJCC v8; Stage IVB Uterine Corpus Cancer AJCC v8	Pamela Munster	2021-03-31	PHASE1
NCT03939182	COMPLETED	Diffuse Large B-cell Lymphoma; Mantle Cell Lymphoma	Memorial Sloan Kettering Cancer Center	2019-05-29	PHASE1
NCT03934567	ACTIVE_NOT_RECRUITING	Lymphoma, Follicular	Xynomic Pharmaceuticals, Inc.	2020-04-22	PHASE2
NCT04024696	ACTIVE_NOT_RECRUITING	Non Hodgkin Lymphoma	Xynomic Pharmaceuticals, Inc.	2020-01-08	PHASE1; PHASE2
NCT01543763	COMPLETED	Metastatic Solid Tumors	Pamela Munster	2012-06-25	PHASE1
NCT03590054	COMPLETED	Stage III Cutaneous Melanoma; Stage IV Cutaneous Melanoma; Locally Advanced Melanoma; Locally Advanced Solid Neoplasm; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Metastatic Urothelial Carcinoma; Non-Small Cell Lung Carcinoma; Stage IB Lung Cancer AJCC v7; Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage III Lung Cancer AJCC v8; Stage III Ureter Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Ureter Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	Rahul Aggarwal	2018-08-20	PHASE1
NCT05698524	Recruiting	Recurrent High Grade Glioma\|Anaplastic Astrocytoma\|Anaplastic Oligodendroglioma\|Glioblastoma\|Gliosarcoma	University of Nebraska\|Xynomic Pharmaceuticals Inc.	2023-06-26	Phase 1
NCT03934567	Recruiting	Lymphoma Follicular	Xynomic Pharmaceuticals Inc.	2020-04-22	Phase 2
NCT03939182	Active not recruiting	Diffuse Large B-cell Lymphoma\|Mantle Cell Lymphoma	Memorial Sloan Kettering Cancer Center\|Janssen Scientific Affairs LLC\|Xynomic Pharmaceuticals Inc.	2019-05-29	Phase 1
NCT03600441	Active not recruiting	Follicular Lymphoma	Xynomic Pharmaceuticals Inc.	2018-08-27	Phase 2
NCT01027910	COMPLETED	Sarcoma	Massachusetts General Hospital	2009-02	PHASE1; PHASE2
NCT01149668	COMPLETED	Lymphoma; Non-Hodgkin's Lymphoma; Hodgkin Disease; Multiple Myeloma; Leukemia; Lymphocytic	Pharmacyclics LLC.	2010-06	PHASE1
NCT00724984	COMPLETED	Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin	Pharmacyclics LLC.	2008-07	PHASE1; PHASE2
NCT01543763	Active not recruiting	Metastatic Solid Tumors	Pamela Munster\|Pharmacyclics LLC.\|Novartis\|Xynomic Pharmaceuticals Inc.\|GlaxoSmithKline Research and Education Foundation for Cardiovascular Disease\|University of California San Francisco	2012-06-25	Phase 1
NCT00562224	COMPLETED	Neoplasms by Site; Lymphoma, Non-hodgkin; Hodgkin Disease; Multiple Myeloma; Leukemia, Lymphocytic, Chronic	Pharmacyclics LLC.	2007-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-04-10)

Check the Abexinostat (PCI-24781) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Abexinostat (PCI-24781) is a potent hydroxamic acid-based pan-histone deacetylase inhibitor that selectively targets HDAC enzymes, primarily binding HDAC1 with a Ki of 7 nM to block deacetylase catalytic activity and disrupt downstream epigenetic gene regulation. This suppression of histone deacetylation impairs cell survival and promotes apoptosis, driving significant antitumor activity in clinical trial settings including follicular lymphoma, renal cell carcinoma, and high-grade glioma.

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>).