monofluorophosphate
Approved
Aug 6, 1986
Monofluorophosphate (MFP) is an anion, which is a phosphate group with one oxygen atom substituted with a fluorine atom. Sodium Monofluorophosphate is intended to be used by both petitioners in food supplements as a source of fluoride in the forms of multi-vitamin, multi-mineral supplements, solid tablets or tablets dispersible in liquid. The toxic effects of Monofluorophosphate are attributable to the fluoride ion released by the in vivo hydrolysis of the parent compound. The Monofluorophosphate ion appears to play no role. The acute toxicity of Monofluorophosphate is somewhat less than that of NaF, due to the lesser availability of fluoride in the short term from Monofluorophosphate. In the long term, Monofluorophosphate produces virtually the same picture of renal effects and skeletal storage of fluoride as does NaF. Sodium Monofluorophosphate dissociates into sodium and Monofluorophosphate ions in the intestinal tract, the latter being absorbed mainly in the upper small intestine. — NCATS
Clinical trial activity
50 trials · 20 clinical orgs · 1 marketing orgs
Earliest trial started Nov 1, 1999 (NCT00138827)
Timeline
1980s
- Aug 6, 1986
Chesebrough-Ponds — Earliest FDA Approval
- Aug 6, 1986
Chesebrough-Ponds — NDA Organization
2020s
- Jan 1, 2025
Earliest Phase 1 Sponsor(trial)
Indications
Studied for
- Compliance · Phase 4
- Dental Calculus · Phase 2/Phase 3
- Dental Caries · Phase 3
- Dental Plaque · Phase 3
- Dentin Sensitivity · Phase 4
- Gingivitis · Phase 4
- Gonorrhea · Phase 2
- Head and Neck Neoplasms · Phase 4
- Hypersensitivity · Phase 2
- Oral Manifestations · Phase 3
- Stomatitis · Phase 3
- Tooth Erosion · Phase 2
- Urinary Bladder, Overactive · Phase 4
- Xerostomia · Phase 4
Mechanism of action
- Streptococcus mutansANTAGONIST
Streptococcus mutans antagonist
Approval history
- approvedAug 6, 1986
Chemistry & pharmacology
SMILES
[O-]P([O-])(F)=O- Mol. weight
- 97.9704 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- Yes
- Polymer
- No
- Delivery
- Topical
- Availability
- Discontinued
Oral
No
Parenteral
No
Topical
Yes
Sources
- WikipediaBiotene ↗
- NCATS4964UZ79MI ↗
- ChEMBLCHEMBL1908359 ↗
- WikipediaSodium monofluorophosphate ↗
- WikipediaMonofluorophosphate ↗
Also known as
- ammonium monofluorophosphate
- biotene
- calcium fluorophosphate
- calcium monofluorophosphate
- disodium fluorophosphate
- disodium monofluorophosphate
- extra-strength aim
- extra-strength aim
- extra-strength aim
- fluorophosphate
- fluorophosphate, barium salt
- fluorophosphate, calcium salt
- fluorophosphate, diammonium salt
- fluorophosphate, disodium salt
- fluorophosphate hydrate, calcium salt
- fluorophosphate, monoammonium salt
- fluorophosphate, potassium salt
- fluorophosphate, sodium salt
- fluorophosphate, tin salt
- fluorophosphate, vanadium salt
- monofluorophosphate
- monofluorophosphate
- monofluorophosphate
- mono-tridin
- mono-tridin
- mono-tridin
- na-mfp
- sodium fluorophosphate
- sodium monofluorophosphate
- sodium monofluorophosphate
- sodium monofluorophosphate
- sodium monofluorophosphate
- sodium monofluorophosphate
- sodium monofluorophosphate
- sodium monofluorophosphate
- sodium monofluorophosphate
- sodium monoflurophosphate
- sodium phosphorofluoridate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06962956 | Phase 1 | Apr 30, 2025 | Procter and Gamble, Salus Research |
| NCT06140784 | N/A | Sep 2, 2023 | Procter and Gamble |
| NCT06140758 | N/A | Jul 31, 2023 | Procter and Gamble |
| NCT05596149 | N/A | Nov 1, 2022 | University of Split, University of Zagreb |
| NCT06197555 | N/A | May 1, 2022 | Altinbas University |
| NCT06659471 | N/A | Mar 7, 2022 | Procter and Gamble |
| NCT05916521 | N/A | Nov 15, 2021 | Procter and Gamble |
| NCT06140771 | N/A | Oct 20, 2021 | Procter and Gamble |
| NCT04966507 | Phase 2 | Aug 31, 2021 | National Institute of Allergy and Infectious Diseases (NIAID), University of California, Los Angeles |
| NCT05916508 | N/A | Oct 19, 2020 | Procter and Gamble |
| NCT04537962 | N/A | Jun 11, 2020 | Albert Einstein Israelite Hospital, Colgate Palmolive, University of Sao Paulo |
| NCT03965039 | N/A | Jul 8, 2019 | Procter and Gamble |
| NCT03936569 | Phase 4 | Oct 29, 2018 | Procter and Gamble |
| NCT03936556 | Phase 4 | Feb 25, 2018 | Procter and Gamble |
| NCT07223073 | Phase 3 | Dec 21, 2017 | Colgate Palmolive, Mahidol University |
| NCT03310268 | N/A | Nov 18, 2017 | GlaxoSmithKline |
| NCT02937636 | N/A | Sep 19, 2017 | GlaxoSmithKline |
| NCT02522936 | Phase 4 | Aug 1, 2017 | University of Southern California |
| NCT07223060 | Phase 2/Phase 3 (Phase 3) | May 17, 2017 | Colgate Palmolive, Mahidol University |
| NCT02924350 | N/A | Nov 7, 2016 | GlaxoSmithKline |
Organizations
Research & Development (20)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 25 | 25 | 4 | 2008 |
| Procter and Gamble | For profit | 10 | 10 | 3 | 2018 |
| Colgate Palmolive | For profit | 6 | 5 | 3 | 2007 |
| Mahidol University | Academic/Hospital | 2 | 0 | 1 | 2017 |
| Albert Einstein Israelite Hospital | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Altinbas University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| BioSci Research | For profit | 1 | 0 | 1 | 2012 |
| Glo Science, Inc. | For profit | 1 | 1 | 1 | 2015 |
| Medical College of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2016 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 1 | 0 | 1 | 2021 |
| Salus Research | For profit | 1 | 0 | 1 | 2025 |
| The Forsyth Institute | Academic/Hospital | 1 | 0 | 1 | 2015 |
| University of California, Los Angeles | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Chile | Academic/Hospital | 1 | 1 | 1 | 2015 |
| University of Leeds | Academic/Hospital | 1 | 1 | 1 | 2016 |
| University of New South Wales | Academic/Hospital | 1 | 1 | 1 | 1999 |
| University of Sao Paulo | Academic/Hospital | 1 | 0 | 1 | 2020 |
| University of Southern California | Academic/Hospital | 1 | 1 | 1 | 2017 |
| University of Split | Academic/Hospital | 1 | 0 | 1 | 2022 |
| University of Zagreb | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Chesebrough-Ponds | For profit | NDA | Aug 6, 1986 |