Clinical Trials

Multiple clinical trials evaluate therapeutic interventions across diverse conditions, including smoking cessation, chronic pain, severe eosinophilic asthma, Clostridium difficile infection, and steroid-resistant acute graft-versus-host disease. These Phase 2, Phase 3, Phase 4, and combined Phase 2/3 studies are sponsored by academic, government, and commercial entities, such as the Population Health Research Institute, Sustained Therapeutics, and the University Health Network, Toronto. Their recruitment statuses vary across active recruiting, active non-recruiting, completed, and terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05132166 ACTIVE_NOT_RECRUITING
Graft Vs Host Disease
University Health Network, Toronto
 2021-12-22 PHASE2
NCT05102123 Recruiting
Smoking (Tobacco) Addiction|Smoking Cessation
Population Health Research Institute
 2024-01-15 Phase 3
NCT05707208 Recruiting
Chronic Pain
Sustained Therapeutics Inc.
 2023-03-21 Phase 2
NCT04102800 Completed
Asthma
NHS Greater Glasgow and Clyde|University of Glasgow|AstraZeneca|Queen''s University Belfast|Bosch Healthcare Solutions GmbH|InHealthcare|University of Leicester|University of Plymouth|Vitalograph
 2019-09-30 Phase 4
NCT03005379 Terminated
Clostridium Difficile Infection
VA Office of Research and Development
 2018-11-15 Phase 2|Phase 3

(data from https://clinicaltrials.gov, updated on 2025-06-22)

Check the AT-56 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AT-56 selectively binds to lipocalin-type prostaglandin D synthase (L-PGDS), inhibiting its enzymatic conversion of prostaglandin H2 into prostaglandin D2. This block in prostaglandin D2 biosynthesis attenuates downstream inflammatory signaling pathways and cell-mediated immune responses, thereby reducing airway hyperresponsiveness and nociceptive sensitization relevant to conditions such as asthma and chronic pain.

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>).

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Note: Technical data last updated: Sep 1, 2026.