Clinical Trials

Multiple completed Phase 1 and Phase 1/2 clinical trials sponsored by Nivalis Therapeutics, Inc. have evaluated the safety, tolerability, pharmacokinetics, and efficacy of N6022. Conducted in healthy volunteers as well as patients with asthma or cystic fibrosis, these studies investigated dose escalation, bronchoprotective effects, and therapeutic response. Overall, this clinical program highlights the early-stage translation of N6022 for respiratory and inflammatory indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01746784 COMPLETED
Cystic Fibrosis
Nivalis Therapeutics, Inc.
 2014-02 PHASE1
NCT01316315 COMPLETED
Asthma
Nivalis Therapeutics, Inc.
 2011-03 PHASE1; PHASE2
NCT01339897 COMPLETED
Healthy
Nivalis Therapeutics, Inc.
 2011-04 PHASE1
NCT01147406 COMPLETED
Healthy
Nivalis Therapeutics, Inc.
 2010-08 PHASE1
NCT01316315 Completed
Asthma
Nivalis Therapeutics Inc.
 2011-03 Phase 1|Phase 2
NCT01147406 Completed
Healthy
Nivalis Therapeutics Inc.
 2010-08 Phase 1

(data from https://clinicaltrials.gov, updated on 2014-11-24)

Check the N6022 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

N6022 acts as a potent and selective reversible inhibitor of S-nitrosoglutathione reductase (GSNOR) with an IC50 of 8 nM, preventing the enzymatic degradation of S-nitrosoglutathione and preserving endogenous S-nitrosothiol levels. This inhibition enhances nitric oxide-mediated signaling to alleviate airway hyperresponsiveness and inflammation, providing therapeutic relevance for clinical conditions such as asthma and 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>).

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