Olitigaltin (TD139) Clinical Trials

Size	Price	Qty
5mg	USD 490
25mg	USD 1,470

Clinical Trials

Multiple clinical trials across Phase 1 and Phase 2 development have evaluated the galectin-3 inhibitor olitigaltin (TD139) for the therapeutic management of idiopathic pulmonary fibrosis and COVID-19. Sponsored by entities including Galecto Biotech AB and the University of Edinburgh, these completed studies assessed the drug's safety, tolerability, pharmacokinetics, and efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04473053	COMPLETED	COVID-19	University of Edinburgh	2020-07-03	PHASE1; PHASE2
NCT02257177	COMPLETED	Idiopathic Pulmonary Fibrosis	Galecto Biotech AB	2014-09	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-08-07)

Check the Olitigaltin (TD139) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Olitigaltin selectively binds galectin-3 with a dissociation constant of 0.036 µM, inhibiting galectin-3-mediated cross-linking and downstream pro-fibrotic signaling to suppress aberrant macrophage activation and tissue myofibroblast differentiation. By blunting these pathologic inflammatory and fibrotic cascades, olitigaltin limits progressive extracellular matrix accumulation, providing the mechanistic basis for its investigation in idiopathic pulmonary fibrosis and COVID-19.

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>).