Nitric Oxide
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
- Nitric Oxide
- Pharmacist Assessment Report
- Nitric Oxide: Malformation syndrome with odontal and/or periodontal component
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Nitric Oxide: Malformation syndrome with odontal and/or periodontal component
One-Sentence Summary
Nitric Oxide is a pulmonary vasodilator originally used for pulmonary hypertension, including persistent fetal circulation syndrome and congenital alveolar capillary dysplasia. The TxGNN model predicts it may be effective for malformation syndrome with odontal and/or periodontal component, but this rests on the model score alone: 0 clinical trials are registered, and none of the 19 publications retrieved studies Nitric Oxide as a treatment for this condition.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Malformation syndrome with odontal and/or periodontal component |
| TxGNN Prediction Score | 0.9957 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data |
| Number of Listed Products | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available for this drug in the data compiled for this report. Nitric Oxide is generally known as a selective pulmonary vasodilator. It acts through the soluble guanylate cyclase and cGMP pathway, which relaxes vascular smooth muscle. Its efficacy in pulmonary hypertension is established. That effect is on blood vessels and has no evident connection to tooth or periodontal development.
The retrieved literature does not bridge this gap. It mostly covers periodontitis, gingival inflammation, bacterial lipopolysaccharide responses, and plant-extract anti-inflammatory activity. One group of papers touches on the oral microbiome’s nitrite-generating capacity, which is tangential. None concerns a developmental malformation syndrome, and none tests Nitric Oxide gas therapy. The very high TxGNN score is therefore not supported by clinical or mechanistic evidence for this drug.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of the publications below evaluates Nitric Oxide as a treatment for the predicted condition. They are background papers on periodontal biology and oral nitric oxide metabolism.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15505230 | 2004 | Review | Journal of Dental Research | Hypochlorous acid and taurine-N-monochloramine modulate the inflammatory response in chronic periodontitis |
| 42795495 | 2026 | Narrative review | Microorganisms | Oral-nasal gateway microbiome as a model linking oral, nasal and systemic health |
| 41952916 | 2026 | Narrative review | Journal of Dental Anesthesia and Pain Medicine | Role of Porphyromonas gingivalis in pain modulation in periodontal disease |
| 35574962 | 2022 | Cohort | Journal of the American Heart Association | Oral microbiome nitrite generation and depletion capacity is linked to cardiometabolic risk |
| 28387609 | 2017 | Animal study | Journal of Periodontology | Carvacrol reduced periodontal damage in a rat model of ligation-induced periodontitis |
| 36312752 | 2022 | In vitro | PeerJ | Cystatin C showed antimicrobial and anti-inflammatory activity on gingival fibroblasts exposed to P. gingivalis |
| 24670812 | 2014 | Metagenomic study | PLoS One | Nitrate-reducing oral bacteria contribute to nitric oxide homeostasis through the entero-salivary pathway |
| 20646228 | 2011 | In vitro | Oral Diseases | P. gingivalis vesicles induced iNOS expression and NO production in mouse macrophage cells |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 84602 | FabiSpray Nasal Spray (Glenmark Pharmaceuticals Ltd) | Bottle of 25 ml nasal spray | Not specified in the registration data |
Safety Considerations
- Contraindication-related conditions (from the knowledge graph, not label text): methemoglobinemia, sulfhemoglobinemia, heart failure.
- Drug Interactions: 61 interacting drugs were identified, but most have no severity rating.
- Major: nitrous acid.
- Moderate: topical tetracaine (ophthalmic), topical lidocaine and topical benzocaine.
- Unrated: morphine, omeprazole, epinephrine, atropine, heparin, epoprostenol and others.
Please refer to the package insert for warnings and complete safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on the model score alone. There are no registered trials, no mechanistic rationale, and no literature testing Nitric Oxide in this condition. Within the same data set, other predicted indications are far better supported. One example is pulmonary arteriovenous malformation (small cohort studies, evidence level L3). If the goal is to advance Nitric Oxide, this deserves priority over this prediction.
To proceed, the following is needed:
- Any direct preclinical or clinical evidence linking Nitric Oxide to this malformation syndrome
- Mechanism of action data for the drug
- Package insert warnings and contraindications for the registered product
- Clarification of the registered product’s formulation and indication, since the single registration is a nasal spray with no indication text recorded
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.