PAC-1 Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Multiple clinical trials evaluate this compound across indications including solid tumors, neuroendocrine tumors, metastatic renal cell carcinoma, glioblastoma multiforme, anaplastic astrocytoma, uveal melanoma, healthy volunteers, and vascular thrombosis models. Spanning Early Phase 1 to Phase 1/Phase 2, these studies are supported by sponsors such as Vanquish Oncology, Inc., HealthPartners Institute, Universitaire Ziekenhuizen KU Leuven, and individual academic investigators. Trial recruitment statuses across the portfolio range from recruiting and completed—such as a completed evaluation of PAC-1 in advanced malignancies—to terminated and withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05967741	Recruiting	Platelet Aggregation Spontaneous\|Vascular Thrombosis	University of California Davis	2023-07-20	Not Applicable
NCT04589832	TERMINATED	Uveal Melanoma	Arkadiusz Z. Dudek, MD	2021-01-11	PHASE1; PHASE2
NCT03332355	TERMINATED	Glioblastoma Multiforme; Anaplastic Astrocytoma	Vanquish Oncology, Inc.	2017-10-01	PHASE1
NCT03927248	WITHDRAWN	Metastatic Renal Cell Carcinoma	HealthPartners Institute	2020-09	PHASE1; PHASE2
NCT03927248	Withdrawn	Metastatic Renal Cell Carcinoma	HealthPartners Institute	2020-09	Phase 1\|Phase 2
NCT02355535	COMPLETED	Solid Tumor; Pancreatic Neuroendocrine Tumor; Neuroendocrine Tumors	Vanquish Oncology, Inc.	2015-02	PHASE1
NCT03441412	Completed	Healthy Volunteers	Vastra Gotaland Region\|Gothia Forum - Center for Clinical Trial\|Uppsala University	2018-02-28	Phase 1
NCT02355756	COMPLETED	Healthy Volunteers	Universitaire Ziekenhuizen KU Leuven	2015-01	EARLY_PHASE1

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

Check the PAC-1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PAC-1 acts as a potent procaspase-3 activator by chelating inhibitory zinc ions, which relieves zinc-mediated enzyme repression and promotes the autocatalytic cleavage of procaspase-3 into active caspase-3. This rapid accumulation of active caspase-3 triggers widespread apoptotic cascades in malignant cells, providing a therapeutic rationale for suppressing tumor growth in clinical trial conditions such as glioblastoma multiforme, neuroendocrine tumors, and solid malignancies.

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>).