---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-126974"
form_type: "8-K"
ticker: "QNRX"
cik: "0001671502"
company_name: "Quoin Pharmaceuticals, Ltd."
filed_at: "2023-12-18T23:59:59+00:00"
generated_at: "2026-06-07T11:20:11.108880+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Quoin receives FDA clearance to expand QRX003 trials; blinded trial to 30 subjects, dose changed to 4% twice daily

## Summary
- FDA cleared protocol amendments for both ongoing QRX003 trials for Netherton Syndrome.
- Blinded trial increased from 18 to 30 subjects; lower 2% dose eliminated, all now receive 4% QRX003 or placebo twice daily.
- Open-label trial expanded from 10 to 20 subjects; dosing frequency changed to twice daily with continued off-label systemic therapy.
- Decision based on positive initial data and clean safety profile; all clinical endpoints unchanged.
- Quoin plans to open additional clinical sites to accommodate increased enrollment.

## SEC filing metadata
- accession: 0001104659-23-126974
- form_type: 8-K
- ticker: QNRX
- cik: 0001671502
- company_name: Quoin Pharmaceuticals, Ltd.
- filed_at: 2023-12-18T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671502/000110465923126974/0001104659-23-126974-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671502/000110465923126974/tm2333160d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-126974
- JSON: https://secwatch.observer/filing/0001104659-23-126974.json
- Plain text: https://secwatch.observer/filing/0001104659-23-126974.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.