THERAPY DOSSIER · th-16c404722a91

Topical ointment containing nitric oxide-loaded zinc-exchanged zeolite A, releasing nitric oxide on contact with water

Drug · Soluble guanylate cyclase activator

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Evidence & regulatory context

Mechanism: Soluble guanylate cyclase activator
Target: CHEMBL2111348 (soluble guanylate cyclase; beta subunit binding site)
Injury models: Wound
Reported indication: Nitric oxide is approved as INHALED nitric oxide (INOmax) for hypoxic respiratory failure/persistent pulmonary hypertension of the newborn; the topical NO wound formulation is investigational
First approval: 1999
Development stage: Molecule approved as inhaled NO for PPHN; topical NO for wounds/ulcers remains in trials
ChEMBL record: CHEMBL1200689 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Nitric oxide; INOmax; Inovent; Genosyl; Nitrosyl radical; OHM-11771
Note: Not recorded

Clinical trials 4

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT06954597 ↗PHASE2recruiting

Topical TOP-N53, a nitric oxide-releasing PDE5 inhibitor, on digital ulcers in systemic sclerosis

Digital Ulcers in Systemic Sclerosis

Enrolment: 15 · Results not recorded

NCT01351493 ↗PHASE1/PHASE2unknown

Randomised placebo-controlled safety and efficacy of nitric oxide gel in subjects with pressure sore

Pressure Ulcer

Enrolment: 40 · Results not recorded

NCT00771368 ↗PHASE1/PHASE2terminated

Clinical trial on reduction of bacteria (including MRSA) in MRSA-positive ulcers and lesions (topical nitric oxide)

Leg Ulcer · Pressure Ulcer

Enrolment: 20 · Results not recorded

NCT01316796 ↗PHASE1completed

Phase I topical sodium nitrite for chronic leg ulcers in adults with haemolytic disorders

Sickle Cell Anemia · Sickle Cell Disease · Chronic Hemolytic Disorders

Enrolment: 28 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 24196133 ↗2013Reported benefit

Antimicrobial efficacy and wound-healing property of a topical ointment containing nitric-oxide-loaded zeolites.

MixedWoundZucker obese ratsmaleTopicalMinimum microbicidal concentrations in vitro 50 to 100 mg o…

Model: Full-thickness cutaneous wounds in Zucker obese rats, with parallel in vitro infection models using Escherichia coli, Acinetobacter baumannii, Staphylococcus epidermidis, meticillin-resistant Staphylococcus aureus and Candida albicans

Five to eight log reductions in bacterial viability and three log reductions in fungal viability were seen after 8 hours of exposure compared with untreated organisms, while 3T3 fibroblasts remained viable after 24 hours at the same concentration. Full-thickness cutaneous wounds on Zucker obese rat…

Extraction: extract · Supplied extraction confidence: 0.7. Machine-extracted fields require source verification.

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