FDL169 Clinical Trials

Size	Price	Qty
5mg	USD 217
25mg	USD 570

Clinical Trials

Flatley Discovery Lab LLC has completed several clinical trials evaluating FDL169 for the treatment of cystic fibrosis across Phase I and Phase I/II studies. These investigations assessed the safety, tolerability, pharmacokinetics, and oral bioavailability of the drug in healthy volunteers and patients with cystic fibrosis. Overall, these studies established the preliminary safety and pharmacokinetic profiles necessary to support further therapeutic development.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03527095	Completed	Cystic Fibrosis	Flatley Discovery Lab LLC	2018-04-05	Phase 1
NCT02767297	Completed	Cystic Fibrosis	Flatley Discovery Lab LLC	2016-04	Phase 1\|Phase 2
NCT02680418	Completed	Cystic Fibrosis	Flatley Discovery Lab LLC	2015-12	Phase 1
NCT02359357	Completed	Cystic Fibrosis	Flatley Discovery Lab LLC	2015-01	Phase 1

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

Check the FDL169 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FDL169 acts as a CFTR corrector by binding defective cystic fibrosis transmembrane conductance regulator proteins, thereby facilitating proper protein folding and cellular trafficking to the plasma membrane. This restored CFTR function promotes transepithelial chloride ion transport, mitigating the sticky mucus accumulation and respiratory complications associated with cystic fibrosis.

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>).