Tacedinaline (CI994) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Several clinical trials have evaluated the therapeutic potential of Tacedinaline (CI-994) across advanced oncological indications, including lung cancer, pancreatic cancer, and advanced multiple myeloma. Sponsored by pharmaceutical industry and academic research partners such as Pfizer and the H. Lee Moffitt Cancer Center and Research Institute, these Phase II and Phase III evaluations tested the compound as a single agent or in combination regimens. All of these recorded trials have reached completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00005624	COMPLETED	Multiple Myeloma	H. Lee Moffitt Cancer Center and Research Institute	1997-08	PHASE2
NCT00005093	COMPLETED	Lung Cancer	Pfizer	1999-12	PHASE3
NCT00004861	COMPLETED	Pancreatic Cancer	Pfizer	1999-10	PHASE2

(data from https://clinicaltrials.gov, updated on 2012-09-25)

Check the Tacedinaline (CI994) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tacedinaline selectively inhibits class I histone deacetylases (HDAC1, HDAC2, and HDAC3), preventing histone deacetylation and inducing hyperacetylation to re-express silenced tumor suppressor genes. This downstream chromatin remodeling arrests cell cycle progression and induces apoptosis in malignant cells, providing the biological rationale for its clinical investigation in solid tumors and hematologic malignancies such as lung cancer, pancreatic cancer, and multiple myeloma.

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>).