Riboflavin phosphate sodium Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate riboflavin phosphate sodium across ophthalmologic conditions—including keratoconus, corneal ectasia, infectious keratitis, and axial myopia—and gastrointestinal disorders such as Crohn's disease. Sponsored by diverse academic medical centers and specialized organizations, these investigations assess techniques like photochemical corneal collagen cross-linking across completed, recruiting, and withdrawn recruitment statuses. Overall, the evidence base highlights the compound's established utility in ocular tissue stabilization alongside exploratory applications in systemic health.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04094090	RECRUITING	Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Ectasia	Goodman Eye Center	2019-10-19	PHASE2
NCT04584125	NOT_YET_RECRUITING	Keratoconus	Joseph B. Ciolino, MD	2027-01-01
NCT03041883	RECRUITING	Corneal Melting in Boston Keratoprosthesis Type I	Centre hospitalier de l'Université de Montréal (CHUM)	2017-01-04
NCT07629557	RECRUITING	Keratoconus	Glaukos Corporation	2026-05-11	PHASE4
NCT07410052	NOT_YET_RECRUITING	Cognitive Deficits, Mild	Center for Health Sciences, Serbia	2026-04-15
NCT04731727	NOT_YET_RECRUITING	Keratoconus, Unstable	Kent Wellish MD	2021-06-30	EARLY_PHASE1
NCT07093463	RECRUITING	Microbiome Dysbiosis; Gut Health	dsm-firmenich Switzerland AG	2025-07-18
NCT04787471	RECRUITING	Corneal Neovascularization	Price Vision Group	2021-05-03	PHASE2; PHASE3
NCT03922542	RECRUITING	Keratoconus; Ectasia Corneal	Price Vision Group	2019-04-16	PHASE2; PHASE3
NCT06100939	COMPLETED	Keratoconus	Epion Therapeutics	2023-10-30	PHASE3
NCT06100952	COMPLETED	Keratoconus	Epion Therapeutics	2023-11-01	PHASE3
NCT06260072	RECRUITING	Concussion, Intermediate	University of Virginia	2020-02-10	PHASE2
NCT03012529	COMPLETED	Osteomyelitis; Diabetes; Amputation	VA Office of Research and Development	2018-01-22	PHASE4
NCT05027295	UNKNOWN	Keratoconus; Corneal Ectasia	Cornea and Laser Eye Institute	2021-07-30	PHASE3
NCT04897503	UNKNOWN	Keratoconus; Corneal Ectasia	Cornea and Laser Eye Institute	2021-04-16	PHASE3
NCT04905108	UNKNOWN	Keratoconus; Corneal Ectasia	Cornea and Laser Eye Institute	2021-06-02	PHASE3
NCT07559149	COMPLETED	Infected Corneal Ulcers; CXL	Gadjah Mada University	2024-07-07	PHASE2
NCT06425081	COMPLETED	Microbial Colonization	dsm-firmenich Switzerland AG	2024-09-09
NCT01152541	UNKNOWN	Keratoconus; Corneal Ectasia	Cornea and Laser Eye Institute	2010-06	PHASE3
NCT01464268	UNKNOWN	Keratoconus; Corneal Ectasia	Cornea and Laser Eye Institute	2011-11	PHASE3
NCT01112072	UNKNOWN	Keratoconus; Corneal Ectasia	Cornea and Laser Eye Institute	2010-04	PHASE3
NCT04427956	COMPLETED	Progressive Keratoconus	Region Skane	2017-05-23	PHASE4
NCT04667572	COMPLETED	Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Degeneration; Corneal Ectasia	Cornea Associates of Texas	2021-02-01	PHASE1
NCT04213885	COMPLETED	Keratoconus, Unstable; Ectasia Corneal; Bacterial Keratitis	Eye Specialists of Indiana	2020-05-04	PHASE2
NCT05935787	COMPLETED	Stroke	POLYSAN Scientific & Technological Pharmaceutical Company	2023-06-30	PHASE3
NCT05907850	COMPLETED	Muscle Soreness	Steven Moore	2023-06-23	EARLY_PHASE1
NCT04097730	COMPLETED	Keratitis Bacterial	Thomas M. Lietman	2020-09-24	PHASE3
NCT04631484	COMPLETED	Head Trauma,Closed	POLYSAN Scientific & Technological Pharmaceutical Company	2020-11-22	PHASE3
NCT05881187	UNKNOWN	Infectoius Keratitis	Sohag University	2023-06-15
NCT05457647	COMPLETED	Keratoconus	Regensight	2022-04-27
NCT06535555	WITHDRAWN	Surgical Procedure, Unspecified	Activ Surgical	2023-03
NCT05255107	UNKNOWN	Keratitis; Corneal Ulcer	Peschke GmbH	2022-03-14	PHASE2; PHASE3
NCT05255016	UNKNOWN	Keratitis; Corneal Ulcer	Peschke GmbH	2022-03-14	PHASE2; PHASE3
NCT05803811	COMPLETED	Quality of Life	dsm-firmenich Switzerland AG	2022-12-12
NCT05488106	UNKNOWN	Blood Pressure; Hypertension	University of Ulster	2022-09-01
NCT01789333	WITHDRAWN	Keratoconus; Ectasia	Stephen Trokel	2010-09-01
NCT04232800	UNKNOWN	Alcohol Withdrawal; Nutrition Disorders; Alcohol Use Disorder	Oregon Health and Science University	2021-12-01	PHASE2
NCT04723836	ACTIVE_NOT_RECRUITING	Blood Pressure; Pregnancy	University of Ulster	2017-03-01
NCT04401865	UNKNOWN	Corneal Ectasia; Keratoconus; Pellucid Marginal Corneal Degeneration	Colorado Eye Consultants/Cornea Consultants of Colorado	2020-06-01	PHASE1; PHASE2
NCT04177082	COMPLETED	Keratoconus; Pellucid Marginal Corneal Degeneration; Corneal Degeneration; Corneal Ectasia	Cornea Associates of Texas	2020-01-10	PHASE1
NCT04481841	UNKNOWN	Burning Mouth Syndrome; Oral Mucosa Disease	Second Affiliated Hospital, Zhejiang University, School of Medicine	2020-07-27	EARLY_PHASE1
NCT03801590	UNKNOWN	Infectious Keratitis	Assiut University	2021-12-01
NCT04669119	UNKNOWN	Breast Cancer Female; Pain, Postoperative	University of Bari Aldo Moro	2020-12-31	PHASE4
NCT03552016	WITHDRAWN	Axial Myopia; Refractive Errors	University of Missouri-Columbia	2018-10-10	PHASE2
NCT03089671	COMPLETED	Pelvic Floor Disorders; Ureter; Kink	Mount Sinai Hospital, Canada	2017-12-07
NCT02863809	COMPLETED	Keratolysis	Joseph B. Ciolino, MD	2017-03-15	PHASE1; PHASE2
NCT04649203	COMPLETED	Diabetic Neuropathies	POLYSAN Scientific & Technological Pharmaceutical Company	2020-11-25	PHASE3
NCT03095235	TERMINATED	Keratoconus; Cornea Ectasia	University of Missouri-Columbia	2017-05-01
NCT05019768	COMPLETED	Keratoconus	Ciro Caruso	2017-09-01
NCT01081561	UNKNOWN	Keratoconus; Ectasia	Yaron S. Rabinowitz M.D.	2009-01-21	PHASE2; PHASE3
NCT03432572	COMPLETED	Ureteral Injury	Texas Tech University Health Sciences Center	2018-06-27	EARLY_PHASE1
NCT02622386	COMPLETED	Psoriasis	University of Michigan	2016-08-11	PHASE2
NCT03187912	COMPLETED	Keratoconus	Medical University of Vienna	2016-09-19	PHASE3
NCT04062435	COMPLETED	Keratoconus	Luzerner Kantonsspital	2019-12-01
NCT03190044	UNKNOWN	Migraine Disorders	University of Roma La Sapienza	2017-06-06
NCT02514200	UNKNOWN	Keratoconus	Umeå University	2014-03	PHASE2
NCT03245853	COMPLETED	Keratoconus; Keratoconus, Unstable	Comprehensive EyeCare of Central Ohio	2017-07-18	PHASE4
NCT04278378	COMPLETED	Blood Pressure	University of Ulster	2011-06-28
NCT02324153	COMPLETED	Delirium; Delirium, Dementia, Amnestic, Cognitive Disorders; Delayed Emergence From Anesthesia; Cognitive Disorders	Johns Hopkins University	2017-03-24	PHASE2
NCT03151096	TERMINATED	High Blood Pressure; MTHFR C677T Genotype	London School of Hygiene and Tropical Medicine	2018-05-02
NCT03760770	UNKNOWN	Keratoconus; Crosslinking	Instituto de Oftalmología Fundación Conde de Valenciana	2018-02-01
NCT02772237	UNKNOWN	Sports-related Concussion	University of Virginia	2016-08	PHASE2
NCT02929459	COMPLETED	Gut Microbiota	dsm-firmenich Switzerland AG	2016-11-01	PHASE2
NCT03426553	COMPLETED	Oncologic Disorders; Hematologic Diseases	Federal Research Institute of Pediatric Hematology, Oncology and Immunology	2018-01-15	PHASE3
NCT02463513	UNKNOWN	Participants With the MTHFR 677TT Genotype	University of Ulster	2013-02
NCT01672814	COMPLETED	Keratoconus	Cornea and Laser Eye Institute	2012-08	PHASE3
NCT01143389	COMPLETED	Keratoconus; Post-Refractive Ectasia	Price Vision Group	2010-05	PHASE2
NCT02538354	COMPLETED	Crohn Disease	University Medical Center Groningen	2016-03
NCT01956474	TERMINATED	Keratoconus	Cxlusa	2013-01	PHASE2
NCT02009709	UNKNOWN	Keratoconus; Corneal Ectasia	Robert Mack, M.D.	2013-10	PHASE1
NCT02769494	WITHDRAWN	Crohn's Disease; Oral Ulcer	Xijing Hospital of Digestive Diseases	2016-03	PHASE3
NCT02883478	UNKNOWN	Keratoconus; Corneal Ectasia	Oslo University Hospital	2012-08	PHASE1; PHASE2
NCT02095730	UNKNOWN	Unstable Corneas	Crowd Health Research, LTD	2014-05	PHASE3
NCT02475343	UNKNOWN	Keratoconus	Zhiwei Li	2015-02
NCT02344238	COMPLETED	Medication Adherence	Medical University of South Carolina	2015-07
NCT02762253	TERMINATED	Keratoconus	Nvision Laser Eye Centers	2012-09	PHASE2
NCT01972854	TERMINATED	Keratoconus	Glaukos Corporation	2013-11	PHASE3
NCT01381354	COMPLETED	Multiple Sclerosis	University of Iowa	2010-10	PHASE1
NCT01459679	TERMINATED	Keratoconus; Corneal Ectasia	American-European Congress of Ophthalmic Surgery	2012-07	PHASE3
NCT02276989	WITHDRAWN	Compliance; Chronic Pain	Georgetown University	2014-12	PHASE2
NCT02638376	UNKNOWN	Keratoconus; Post LASIK Keratectasia	Singapore Eye Research Institute	2013-03	PHASE3
NCT02068430	COMPLETED	Corneal Ulcers	Stephen Trokel	2008-11	PHASE1
NCT02446977	COMPLETED	Ischemic Stroke	Castillo, José, M.D.	2015-03	PHASE2
NCT02507362	UNKNOWN	Keratoconus	Tehran University of Medical Sciences	2014-08	PHASE1; PHASE2
NCT02235337	COMPLETED	Sports Related Concussion	University of Virginia	2014-09
NCT01643226	COMPLETED	Keratoconus	Glaukos Corporation	2012-07	PHASE3
NCT02415777	COMPLETED	Fatigue	Daewoong Pharmaceutical Co. LTD.	2014-10	PHASE4
NCT03598634	COMPLETED	Keratoconus	University of Molise	2014-06-01
NCT01344187	COMPLETED	Keratoconus	Glaukos Corporation	2012-07	PHASE3
NCT01893359	TERMINATED	Hyperopia; Hyperopic Astigmatism	Glaukos Corporation	2013-08	PHASE1; PHASE2
NCT02456961	COMPLETED	Keratoconus	Ufa Eye Research Institute	2010-01
NCT02349165	COMPLETED	Keratoconus	Nienke Soeters	2011-05
NCT01741558	UNKNOWN	Myocardial Infarction	Instituto de Cardiologia do Rio Grande do Sul	2013-04	PHASE2
NCT01739673	COMPLETED	Infectious Keratitis	Cxlusa	2011-08
NCT01582880	COMPLETED	Chemical Injuries; Unspecified Complication of Corneal Transplant; Autoimmune Diseases; Ocular Cicatricial Pemphigoid; Stevens Johnson Syndrome; Lupus Erythematosus, Systemic; Rheumatoid Arthritis; Other Autoimmune Diseases	Joseph B. Ciolino, MD	2012-03	PHASE1; PHASE2
NCT01325298	UNKNOWN	Keratoconus; Ectasia; Corneal Ectasia	Mercy Center for Corrective Eye Surgery	2011-03	PHASE2
NCT00912509	TERMINATED	Infectious Keratitis	Price Vision Group	2009-05
NCT00626717	COMPLETED	Keratoconus	University Hospital Freiburg	2007-08	PHASE2; PHASE3
NCT01398839	TERMINATED	Ectasia	Topcon Medical Systems, Inc.	2010-12	PHASE3
NCT01398852	TERMINATED	Keratoconus and Ectasia	Topcon Medical Systems, Inc.	2010-12	PHASE3
NCT01190306	TERMINATED	Keratoconus	Topcon Medical Systems, Inc.	2010-08	PHASE3
NCT00841386	UNKNOWN	Keratoconus	University at Buffalo	2008-09	PHASE2; PHASE3
NCT00674661	COMPLETED	Ectasia	Glaukos Corporation	2007-12	PHASE3
NCT01485211	COMPLETED	Progressive Keratoconus; Thin Corneas	Instituto de Olhos de Goiania	2010-01	PHASE4
NCT00647699	COMPLETED	Progressive Keratoconus	Glaukos Corporation	2007-12	PHASE3
NCT00777322	COMPLETED	Keratoconus; Pellucid Marginal Degeneration	Moorfields Eye Hospital NHS Foundation Trust	2008-10
NCT01123057	UNKNOWN	Corneal Ectasia	Singapore National Eye Centre	2008-08
NCT00890266	COMPLETED	Keratoconus	Moorfields Eye Hospital NHS Foundation Trust	2009-04-22
NCT00679666	WITHDRAWN	Progressive Keratoconus; Corneal Ectasia	Ohio State University	2008-04	PHASE2; PHASE3
NCT00815256	UNKNOWN	Cornea Degeneration; Progressive Keratoconus	Federal University of São Paulo	2008-08	PHASE3
NCT00435799	UNKNOWN	Keratoconus	Ullevaal University Hospital	2007-02	PHASE2; PHASE3
NCT00642044	UNKNOWN	Keratoconus	Universidade Federal do Rio de Janeiro	2007-02
NCT00832897	COMPLETED	Keratoconus	Federal University of São Paulo	2008-03
NCT00202228	COMPLETED	HIV Infections; AIDS; Lactic Acidosis; Lipodystrophy	Queen's University	2002-07	PHASE4
NCT00143702	COMPLETED	Acidosis, Lactic	University of British Columbia	2001-08	PHASE2; PHASE3
NCT00031057	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)
NCT01307527	UNKNOWN	Brittle Cornea Syndrome; Ehlers-Danlos Syndrome Type 6	Hadassah Medical Organization
NCT00037063	WITHDRAWN	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)
NCT01643252	WITHDRAWN	Corneal Ectasia	Glaukos Corporation	2012-07	PHASE3
NCT00220532	TERMINATED	Cervical Cancer	Sheffield Teaching Hospitals NHS Foundation Trust	2005-07	PHASE1; PHASE2
NCT00925327	UNKNOWN	Progressive Keratoconus	Peschke Meditrade, GmbH		PHASE2
NCT01106274	COMPLETED	Bullous Keratopathy	Mashhad University of Medical Sciences	2008-11

(data from https://clinicaltrials.gov, updated on 2025-10-20)

Check the Riboflavin phosphate sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Riboflavin phosphate sodium functions as an essential cofactor for flavin-dependent oxidoreductases and acts as a photosensitizer that generates reactive oxygen species upon blue-light or ultraviolet photoactivation. This photochemical reaction induces covalent cross-linking among corneal collagen fibrils, enhancing stromal biomechanical stability to halt disease progression in clinical conditions such as keratoconus and corneal ectasia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).