Riboflavin

Phase 1Small molecule

CCornea and Laser Eye Institute

Riboflavin is one of 143 small molecule programs targeting Eye Disease. It is currently in Phase 1.

Indications

Total Trials

Active Trials

142

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Eye DiseaseUnknown

AcneUnknown

Iron Deficiency AnemiaUnknown

KeratitisActive, not recruiting

Anemia (phenotype)Unknown

Folate DeficiencyUnknown

Ehlers-Danlos SyndromeActive, not recruiting

Chronic Kidney DiseaseUnknown

Keratoconus, UnstableNot yet recruiting

Eye DiseasePreclinical

Unknown

AcnePreclinical

Unknown

Iron Deficiency AnemiaPreclinical

Unknown

KeratitisPreclinical

Active, not recruiting

Anemia (phenotype)Preclinical

Unknown

Folate DeficiencyPreclinical

Unknown

Ehlers-Danlos SyndromePreclinical

Active, not recruiting

Chronic Kidney DiseasePreclinical

Unknown

Keratoconus, UnstablePhase 1

Not yet recruiting

Competition

Competitive Landscape

169 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Jesduvroq

GGlaxo Dba Glaxosmithkline

Phase 3

11 2

Riboflavin

CCornea and Laser Eye Institute

Phase 1

42 3

Uloric

Takeda

Preclinical

2 4

Lorelco

Sanofi

Preclinical

1 5

Sovaldi

Gilead

Preclinical

1 6

Glucotrol

Pfizer

Preclinical

1 7

Vemlidy

Gilead

Preclinical

1 8

Activase

Flomax

PROCRIT

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Not yet recruiting

Study completion

NCT04731727

Clinical

Trials by Indication[1]

Keratoconus19 trials

Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

Unknown status·CCornea and Laser Eye Institute·Phase 3·NCT05027295·170 enrolled

Safety Study of the VEGA UV-A System to Treat Keratoconus

Terminated·TTopcon Medical Systems, Inc.·Phase 3·NCT01190306·127 enrolled

Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Unknown status·CCornea and Laser Eye Institute·Phase 3·NCT01464268·160 enrolled

Show 16 more trials

Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs

Unknown status·—·Phase 2/3·NCT01081561·600 enrolled

Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia

Completed·CCxlusa··NCT01726283·22 enrolled

Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

Terminated·TTopcon Medical Systems, Inc.·Phase 3·NCT01398852·500 enrolled

Treatment of Keratoconus With Advanced CXL-II

Unknown status·UUmeå University·Phase 2·NCT02514200·50 enrolled

Corneal Collagen Crosslinking and Intacs for Keratoconus and Ectasia

Unknown status·CCornea and Laser Eye Institute·Phase 3·NCT01112072·160 enrolled

Corneal Crosslinking in Keratoconus and Corneal Ectasia

Withdrawn·OOhio State University·Phase 2/3·NCT00679666

Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

Unknown status·CCornea and Laser Eye Institute·Phase 3·NCT04897503·170 enrolled

Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

Completed·PPrice Vision Group·Phase 2·NCT01143389·510 enrolled

Safety and Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus

Terminated·GGlaukos Corporation·Phase 3·NCT01972854·92 enrolled

Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus

Completed·GGlaukos Corporation·Phase 3·NCT01344187·236 enrolled

Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus

Completed·GGlaukos Corporation·Phase 3·NCT01643226·230 enrolled

Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

Unknown status·CCornea and Laser Eye Institute·Phase 3·NCT04905108·160 enrolled

Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus

Completed·CCornea and Laser Eye Institute·Phase 3·NCT01672814·3 enrolled

Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

Terminated·AAmerican-European Congress of Ophthalmic Surgery·Phase 3·NCT01459679·1,721 enrolled

Corneal Collagen Cross-linking for Progressive Keratoconus

Completed·GGlaukos Corporation·Phase 3·NCT00647699·147 enrolled

Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.

Terminated·NNvision Laser Eye Centers·Phase 2·NCT02762253·320 enrolled

Treatment3 trials

Cross Linking for Treatment of Corneal Infection

Terminated·PPrice Vision Group·N/A·NCT00912509·30 enrolled

UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia

Unknown status·MMercy Center for Corrective Eye Surgery·Phase 2·NCT01325298·250 enrolled

Steroids and Cross-linking for Ulcer Treatment

Completed·TThomas M. Lietman·Phase 3·NCT04097730·280 enrolled

Age2 trials

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

Completed·JJoseph B. Ciolino, MD·Phase 1/2·NCT02863809·76 enrolled

Corneal Collagen Cross-Linking for Ectasia (CXL)

Completed·GGlaukos Corporation·Phase 3·NCT00674661·130 enrolled

Concussion2 trials

The Impact of Riboflavin on Sports-related Concussion

Unknown status·UUniversity of Virginia·Phase 2·NCT02772237·500 enrolled

The Impact of Riboflavin on the Severity and Duration of Sports Related Concussion

Completed·UUniversity of Virginia·N/A·NCT02235337·248 enrolled

Keratitis1 trial

Pack Cross Linking for Infectious Keratitis

Unknown status·SSohag University·N/A·NCT05881187·60 enrolled

13 more indications

TED1 trial

Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Completed·MMedical University of Vienna·Phase 3·NCT03187912·60 enrolled

Myocardial Infarction1 trial

The Effects of mETHotrexate Therapy on ST Segment Elevation MYocardial InfarctionS (TETHYS Trial)

Unknown status·IInstituto de Cardiologia do Rio Grande do Sul·Phase 2·NCT01741558·80 enrolled

Drug1 trial

A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00037063

Donor1 trial

Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

Completed·JJoseph B. Ciolino, MD·Phase 1/2·NCT01582880·1 enrolled

Intraoperative1 trial

Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets

Completed·TTexas Tech University Health Sciences Center·Phase 1·NCT03432572·120 enrolled

ESS1 trial

Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes

Completed·SSteven Moore·Phase 1·NCT05907850·150 enrolled

Post-Operative Delirium1 trial

Ramelteon in the Prevention of Post-operative Delirium

Completed·JJohns Hopkins University·Phase 2·NCT02324153·80 enrolled

Psoriasis1 trial

The Effect of Riboflavin on Moderate to Severe Plaque Type Psoriasis

Completed·UUniversity of Michigan·Phase 2·NCT02622386·23 enrolled

Ehlers-Danlos syndrome1 trial

Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI

Unknown status·HHadassah Medical Organization·N/A·NCT01307527·1 enrolled

Alcohol Withdrawal1 trial

Riboflavin for Glutamate Reduction in Alcohol Withdrawal

Unknown status·OOregon Health and Science University·Phase 2·NCT04232800·40 enrolled

Chronic pain1 trial

Evaluation of a Compliance Marker in Prescription Opioid Abusers With Chronic Pain

Withdrawn·GGeorgetown University·Phase 2·NCT02276989

Myopia1 trial

Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure

Withdrawn·UUniversity of Missouri-Columbia·Phase 2·NCT03552016

Unspecified3 trials

Vitamin B Therapy for Hyperlactatemia

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00031057·225 enrolled

Safety Study of the VEGA UV-A System to Treat Ectasia

Terminated·TTopcon Medical Systems, Inc.·Phase 3·NCT01398839·103 enrolled

Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)

Not yet recruiting·—·Phase 1·NCT04731727·600 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 26, 2001

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Oct 3, 2001

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Jul 9, 2002

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Jul 10, 2002

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Feb 12, 2003

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Aug 22, 2006

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Dec 17, 2008

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Sep 4, 2014

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Nov 11, 2014

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Dec 2, 2015

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Mar 17, 2016

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Apr 15, 2016

PHOTREXA VISCOUS IN DEXTRAN 20%, PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

NDA NDA203324

Jul 15, 2016

PHOTREXA VISCOUS IN DEXTRAN 20%, PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

NDA NDA203324

Oct 29, 2018

PHOTREXA VISCOUS IN DEXTRAN 20%, PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

NDA NDA203324

Jan 25, 2019

PHOTREXA VISCOUS IN DEXTRAN 20%, PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

NDA NDA203324

Nov 6, 2024

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), INFUVITE PEDIATRIC

NDA NDA021265

Feb 7, 2025

PHOTREXA VISCOUS IN DEXTRAN 20%, PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA

NDA NDA203324

Oct 17, 2025

EPIOXA HD/EPIOXA KIT

NDA NDA219910

Apr 9, 2026

MULTIPLE VITAMINS INJECTION ADULT

NDA ANDA210273

Apr 9, 2026

MULTIPLE VITAMINS INJECTION ADULT

NDA ANDA210672

Apr 21, 2026

MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE)

NDA ANDA210456

Apr 21, 2026

MULTIPLE VITAMINS INJECTION PEDIATRIC

NDA ANDA210671

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Riboflavin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Riboflavin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Riboflavin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA ANDA210456). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cornea and Laser Eye Institute company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: CCornea and Laser Eye Institute

Riboflavin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Keratoconus19 trials

Treatment3 trials

Age2 trials

Concussion2 trials

Keratitis1 trial

TED1 trial

Myocardial Infarction1 trial

Drug1 trial

Donor1 trial

Intraoperative1 trial

ESS1 trial

Post-Operative Delirium1 trial

Psoriasis1 trial

Ehlers-Danlos syndrome1 trial

Alcohol Withdrawal1 trial

Chronic pain1 trial

Myopia1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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