Drugs / Riboflavin-5-phosphate
Riboflavin-5-phosphate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BEROCCA PN | — | 1947-07-28 | fda.gov ↗ |
Trials 3
194619471948194919501951195219531954195519561957195819591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT04708340 Comparator | Mar 2021 → Oct 2022 | COVID-19, acute respiratory distress syndrome | Reven Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| — | NCT04584125 Background | Jan 2027 → May 2028 expected | keratoconus | Joseph B. Ciolino, MD | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-10-07 | Glaukos Corporation | Results Glaukos Announces Positive Three-Year Epioxa® Results Demonstrating Durable Clinical Outcomes in Keratoconus glaukos.com ↗
The long-term follow-up results demonstrated durable efficacy and a favorable long-term safety profile through three years following a single Epioxa treatment, with no additional intervention during the extension period. |
| 2025-10-20 | Glaukos Corporation | Regulatory Glaukos Announces FDA Approval of Epioxa™ glaukos.com ↗
Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases, announced today the U.S. Food and Drug Administration (FDA) approved its Epioxa™ HD / Epioxa™ (“Epioxa”) New Drug Application (NDA). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-10-07 | Glaukos Corporation | Glaukos Announces Positive Three-Year Epioxa® Results Demonstrating Durable Clinical Outcomes in Keratoconus glaukos.com ↗ |
| 2025-10-20 | Glaukos Corporation | Glaukos Announces FDA Approval of Epioxa™ glaukos.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 ↗ |