Sodium Fluoride
drug drugOn this page
Also known as DentalfluoroDentiplusDuraphatEn-de-kayFluor retFluor-a-dayFluoride (as sodium fluoride)Fluoride (as sodium)FluorigardFluorigard dailyFluorigard weeklyNafril retNatrii fluoridumNatrum fluoratumNeutral sodium fluorideNSC-77385OssinOsteofluorPergantenePoint-two
Summary
Sodium Fluoride (CHEMBL1528) is an approved small molecule (ATC A01AA51); indicated across 13 conditions including dental caries and gingivitis.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: A01AA51 (+2 more)
- Indications: 13 conditions
- Clinical trials: 43
- Chemistry: 41.9881724 Da · FNa
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1528 |
| Name | Sodium Fluoride |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 5235 |
| ChEBI | CHEBI:28741 |
| ATC | A01AA51, A12CD01, A01AA01 |
| Molecular formula | FNa |
| Molecular weight | 41.9881724 |
| InChIKey | PUZPDOWCWNUUKD-UHFFFAOYSA-M |
SMILES: [F-].[Na+]
IUPAC name: sodium fluoride
ChEBI definition: A metal fluoride salt with a Na(+) counterion.
Also known as: Dentalfluoro, Dentiplus, Duraphat, En-de-kay, Fluor ret, Fluor-a-day, Fluoride (as sodium fluoride), Fluoride (as sodium), Fluorigard, Fluorigard daily, Fluorigard weekly, Nafril ret
Parent form; salt/anhydrous children: CHEMBL1200744
Patent coverage: 51,795 distinct patent families (118,117 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 100,461 (85%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
3 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).
| Indication | Phase | MONDO | EFO |
|---|---|---|---|
| dental caries | 4 | MONDO:0005276 | EFO:0003819 |
| gingivitis | 4 | MONDO:0002508 | MONDO:0002508 |
| hypersensitivity reaction disease | 4 | MONDO:0000605 | EFO:1002003 |
10 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| periodontitis | 3 | MONDO:0005076 | EFO:0000649 |
| tooth disorder | 3 | MONDO:0006999 | EFO:1001216 |
| mucositis | 3 | MONDO:0020579 | EFO:1001898 |
| periodontal disorder | 3 | MONDO:0002635 | MONDO:0002635 |
| X-linked hypophosphatemic rickets | 3 | MONDO:0020720 | Orphanet:89936 |
| allergic disease | 3 | MONDO:0005271 | MONDO:0005271 |
| bacterial infectious disease | 3 | MONDO:0005113 | EFO:0000771 |
| prostate adenocarcinoma | 2 | MONDO:0005082 | EFO:0000673 |
| postmenopausal osteoporosis | 2 | MONDO:0008159 | EFO:0003854 |
| dental fluorosis | 1 | MONDO:0006722 | EFO:1000892 |
Clinical trials
Total trials: 43.
Phase distribution
| Phase | Trials |
|---|---|
| Not specified | 13 |
| PHASE2 | 12 |
| PHASE3 | 7 |
| PHASE4 | 5 |
| PHASE1 | 3 |
| PHASE2/PHASE3 | 2 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00723515 | PHASE4 | COMPLETED | Therapeutic Effect of Two Fluoride Varnishes on White Spot Lesions: a Clinical Study |
| NCT01038817 | PHASE4 | COMPLETED | Impact of Fluoride Vanish Application in Dental Prevention for Elderly |
| NCT01128946 | PHASE4 | COMPLETED | Enamel Remineralization Potential of Dentifrices in Situ |
| NCT01563172 | PHASE4 | COMPLETED | Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride |
| NCT01962493 | PHASE4 | COMPLETED | An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining |
| NCT00708097 | PHASE3 | COMPLETED | In Situ Caries Efficacy of Fluoride Toothpastes |
| NCT00708305 | PHASE3 | COMPLETED | Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes |
| NCT01641237 | PHASE3 | COMPLETED | Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions |
| NCT04249336 | PHASE3 | COMPLETED | Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH |
| NCT04484844 | PHASE2/PHASE3 | UNKNOWN | Clinical Evaluation of Efficacy of Shield Force Plus Varnish VS Sodium Fluoride on Dentin Hypersensitivity |
| NCT04485299 | PHASE2/PHASE3 | UNKNOWN | Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient |
| NCT05614518 | PHASE3 | COMPLETED | Diagnostic Performance and Safety of 18F-NaF-PET/CT in Bone Metastases Compared With 99mTc⁃MDP-BS±SPECT |
| NCT05642494 | PHASE3 | COMPLETED | Silver Diamine Fluoride(SDF) Versus SDF Combined With Sodium Fluoride Varnish in the Arrest of Early Childhood Caries |
| NCT06486974 | PHASE3 | COMPLETED | Efficacy of Manual Toothbrushes in Removing Tooth Stains |
| NCT06174012 | PHASE2 | NOT_YET_RECRUITING | The Effect of Sodium Fluoride Application on the Prevention of Radiation Caries in NPC Patients |
| NCT00752089 | PHASE2 | COMPLETED | Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model |
| NCT01128972 | PHASE2 | COMPLETED | Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion |
| NCT02207400 | PHASE2 | COMPLETED | To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms |
| NCT02207907 | PHASE2 | COMPLETED | To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste |
| NCT02226562 | PHASE2 | COMPLETED | Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity |
| NCT02598778 | PHASE2 | TERMINATED | Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction |
| NCT03238352 | PHASE2 | COMPLETED | A Study to Assess Efficacy of an Experimental Oral Rinse in Providing Long Term Relief From Dentinal Hypersensitivity |
| NCT03353103 | PHASE2 | UNKNOWN | Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy |
| NCT03865680 | PHASE2 | COMPLETED | Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth |
| NCT04075474 | PHASE2 | UNKNOWN | Preventing Early Childhood Caries With Silver Diamine Fluoride |
| NCT04399369 | PHASE2 | COMPLETED | Preventing Caries with Silver Diamine Fluoride |
| NCT07027566 | PHASE1 | NOT_YET_RECRUITING | Effect of an Experimental Cannabidiol Gel on Tooth Sensitivity |
| NCT06182267 | PHASE1 | COMPLETED | Maximal Use Study to Determine the Pharmacokinetics of L-arginine After Exaggerated Oral Use of COL101 |
| NCT06316323 | PHASE1 | COMPLETED | The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish |
| NCT03089567 | EARLY_PHASE1 | WITHDRAWN | Comparison of the Salivary Levels of Streptococcus Mutans in Pediatric Patients With Early Childhood Caries After the Application of Silver Diamine Fluoride or 5% Sodium Fluoride Varnish |
| NCT00612469 | Not specified | COMPLETED | The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries |
| NCT01629290 | Not specified | COMPLETED | In Vivo Comparison of Salivary Fluoride Levels Following the Application of Different 5% NaF Varnishes |
| NCT01657903 | Not specified | COMPLETED | Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion |
| NCT02191943 | Not specified | WITHDRAWN | Lesion Progression of Approximal Caries After Resin Infiltration |
| NCT02195583 | Not specified | COMPLETED | The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ |
| NCT02371616 | Not specified | COMPLETED | Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity |
| NCT02533466 | Not specified | COMPLETED | In Vivo Investigation of Initial Stages of Enamel Erosion |
| NCT02809014 | Not specified | COMPLETED | In Vivo Evaluation of an Experimental Fluoride-containing Dentifrice With Hydrocolloid |
| NCT03625310 | Not specified | COMPLETED | Effectiveness Fluoride Varnishes in Children With Early Childhood Caries |
| NCT04124887 | Not specified | COMPLETED | Remineralization Effect of Fluoride Varnishes on Permanent Molars |
| NCT04156152 | Not specified | UNKNOWN | Effectiveness of the Use of Desensitizing Dentifrices Based on Nanocrystals of Hydroxyapatite / 5% Potassium Nitrate / 1450ppm Sodium Monofluorophosphate and Potassium Nitrate 5% / 1426ppm Sodium Floride in the Treatment of Dentine Hypersensitivity. Test Randomized Clinical |
| NCT04855279 | Not specified | COMPLETED | Prevention of Bleaching Induced Sensitivity |
| NCT04964063 | Not specified | COMPLETED | A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).