Drugs / Riboflavin-5-phosphate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) BEROCCA PN 1947-07-28 fda.gov

Trials 3 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05366933 Aug 2022 → Jul 2027 expected optic nerve disorder National Aeronautics and Space Administration (NASA) Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00841386 Sep 2008 → Dec 2011 keratoconus University at Buffalo Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT03245853 Jul 2017 → Sep 2019 keratoconus Comprehensive EyeCare of Central Ohio Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT04708340 Comparator Mar 2021 → Oct 2022 COVID-19, acute respiratory distress syndrome Reven Pharmaceuticals, Inc. Unknown No outcome recorded
Phase not applicable1 trial
NCT04584125 Background Jan 2027 → May 2028 expected keratoconus Joseph B. Ciolino, MD Not yet recruiting No outcome recorded

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Riboflavin 5'-phosphate “Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and...” NCT04708340
4

“Vitamin B-Complex Supplement containing: 5-methyltetrahydrofolate, riboflavin 5 phosphate, pyridoxal phosphate, and methylcobalamin” NCT05366933

NCT04584125

NCT03245853

NCT00841386

Known as Riboflavin Riboflavin 0.1% (10 mg riboflavin-5-phosphate in 10 ml dextran T-500 20% solution, supplied in a sterile, single dose container)” NCT00841386
Known as riboflavin phosphate “instillation of 0.1% riboflavin phosphate-20% dextran T 500 solution at 5 minutes before UVA irradiation and every 5 minutes for a total of 30 minutes.” PMID 17457184 May 2007
Modality Other / unclassified “daily nutraceutical supplement containing bioactive B vitamins” NCT05366933
Route Topical “Riboflavin solution (0.1% riboflavin and 20% dextran supplied in a sterile, single-dose container) will be applied to the cornea every 2 minutes for 30 minutes.” NCT04584125