FL118 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A Phase I clinical trial sponsored by Roswell Park Cancer Institute aimed to assess the safety and preliminary activity of FL118 in patients with advanced pancreatic ductal adenocarcinoma, including locally advanced, metastatic, refractory, unresectable, and stage II through IV disease. However, recruitment for the trial was withdrawn, and no active Phase II or Phase III trials are currently listed on record. Overall, clinical evaluation of FL118 remains in its preliminary stages.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06206876	WITHDRAWN	Advanced Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Refractory Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma	Roswell Park Cancer Institute	2025-10-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-01-17)

Check the FL118 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FL118, a camptothecin analog, directly inhibits Survivin while selectively downregulating Mcl-1, XIAP, and cIAP2, thereby blocking anti-apoptotic signaling pathways and inducing apoptosis in malignant cells. This disruption of cellular survival networks reduces tumor growth and overcomes apoptotic resistance, offering potential therapeutic utility against aggressive malignancies such as advanced pancreatic ductal adenocarcinoma.

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>).