Clinical Trials

Numerous clinical trials investigate the therapeutic, diagnostic, and metabolic effects of biotin across diverse conditions, including hematologic disorders, dermatological issues, breast cancer, cardiac arrest, and nutritional deficiency. Spanning Early Phase 1 through Phase 4, these studies evaluate biotin supplementation and diagnostic protocols, encompassing completed, recruiting, terminated, and not yet recruiting stages. Interventions are supported by commercial entities, academic universities, and government research institutions such as the National Institutes of Health.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07302880 RECRUITING
Blood Sample; Interference With Routine Analyical Tests; Biotin Ingestion
University of Copenhagen
 2026-03-17
NCT06313398 RECRUITING
Sickle Cell Disease; Thalassemia; Hemoglobinopathy
National Heart, Lung, and Blood Institute (NHLBI)
 2024-05-17 EARLY_PHASE1
NCT07446647 RECRUITING
Healthy Volunteer Red Blood Cell Labeling Study; Not Disease Focused
Jose Cancelas
 2026-04-01 PHASE1
NCT07513532 COMPLETED
Healthy Volunteers
Bloodworks
 2026-04-06 PHASE1
NCT06740240 RECRUITING
Tumor
First Affiliated Hospital of Fujian Medical University
 2024-03-01 EARLY_PHASE1
NCT07520019 ACTIVE_NOT_RECRUITING
Hair Thinning
Nutra Harmony LLC
 2026-01-15
NCT07348120 COMPLETED
Telogen Effluvium
Kasr El Aini Hospital
 2025-05-01
NCT02646839 ENROLLING_BY_INVITATION
Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndromes
Michael Pulsipher
 2015-10 PHASE2
NCT04478734 RECRUITING
Huntington Disease
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2023-04-12 PHASE2
NCT04426591 COMPLETED
Sickle Cell Disease
Marianne Yee
 2021-10-29 PHASE1
NCT06390241 TERMINATED
Breast Cancer
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
 2024-06-19 PHASE1
NCT05832190 TERMINATED
Severe Obesity; Metabolic Syndrome
Assistance Publique - Hôpitaux de Paris
 2023-07-24
NCT06788080 COMPLETED
Measuring Red Blood Cell Survival After Transfusion
Vitalant Research Institute
 2024-03-07 EARLY_PHASE1
NCT05632549 UNKNOWN
Moderate Persistent Asthma
Tanta University
 2022-08-08 PHASE3
NCT06605768 COMPLETED
Hair Thinning
Nutra Harmony LLC
 2024-02-19
NCT06390241 Not yet recruiting
Breast Cancer
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
 2024-06 Phase 1
NCT06010745 UNKNOWN
Hair Thinning; Facial Skin Texture; Skin Ageing
Nutrition 21, Inc.
 2023-08-11
NCT07559617 COMPLETED
Cosmetic Management of Oily Scalp
Chadi Khatib
 2024-04-06
NCT06313398 Recruiting
Sickle Cell Disease|Thalassemia|Hemoglobinopathy
National Heart Lung and Blood Institute (NHLBI)|Children''s National Research Institute|National Institutes of Health Clinical Center (CC)
 2024-05-15 Early Phase 1
NCT06242288 Recruiting
Acne Vulgaris
Mostafa Bahaa|Tanta University
 2024-01-30 Phase 3
NCT05972512 COMPLETED
Hair Falling; Thin Hair; Dry Hair; Brittle Hair; Dry Skin
NovoBliss Research Pvt Ltd
 2023-08-22
NCT05450900 COMPLETED
Healthy
Sports Medicine Research and Testing Laboratory
 2022-10-27 EARLY_PHASE1
NCT04476277 COMPLETED
Sickle Cell Disease; Sickle Cell Anemia
National Heart, Lung, and Blood Institute (NHLBI)
 2021-04-19 EARLY_PHASE1
NCT05800496 COMPLETED
Hair Thinning; Hair Brittle; Dry Hair
NovoBliss Research Pvt Ltd
 2022-10-31
NCT05945979 COMPLETED
Hair Loss; Nails, Ingrown
Farmoquimica S.A.
 2022-03-07
NCT06891469 COMPLETED
Healthy, Young Adults; Athletic Performance
Democritus University of Thrace
 2022-01-22
NCT03427086 COMPLETED
Amyotrophic Lateral Sclerosis
American University of Beirut Medical Center
 2018-01-29 PHASE2
NCT03364686 TERMINATED
Healthy Volunteers
Gladwin, Mark, MD
 2019-09-16 PHASE2
NCT02836340 TERMINATED
Cardiac Arrest; Hypoxic Ischemic Brain Injury
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2016-05 PHASE1; PHASE2
NCT02483000 TERMINATED
Burkitt Lymphoma; CD20-Positive Neoplastic Cells Present; Diffuse Large B-Cell Lymphoma; Indolent Non-Hodgkin Lymphoma; Mantle Cell Lymphoma; Recurrent B-Cell Non-Hodgkin Lymphoma; Refractory Mature B-Cell Non-Hodgkin Lymphoma
Fred Hutchinson Cancer Center
 2017-02-01 PHASE1
NCT03073070 COMPLETED
Diabetes; Red Blood Cell Survival
Guohua An
 2017-11-15 PHASE1
NCT03188328 TERMINATED
Inoperable Solid Tumors or Lymphomas
Alfasigma S.p.A.
 2017-08-07 PHASE1
NCT02053324 TERMINATED
Liver Metastases
Alfasigma S.p.A.
 2013-11-11 PHASE1
NCT02077751 COMPLETED
Anemia
John A Widness
 2013-05 PHASE1
NCT03995277 COMPLETED
Biotin Ingestion; Interference With Routine Analyical Tests
Dr. med. Mahir Karakas
 2019-01-11 PHASE4
NCT03746821 COMPLETED
Healthy Volunteers; Biotin Excretion
SPD Development Company Limited
 2018-11-07
NCT02757898 COMPLETED
Anemia
Emory University
 2017-01-11 PHASE1
NCT03300440 UNKNOWN
Mood Disorders; Depression
Medical University of Graz
 2017-06-21
NCT00731588 COMPLETED
Neonatal Anemia
John A Widness
 2008-06 PHASE2
NCT03034707 COMPLETED
Thoracic Diseases; Parathyroid Diseases
University of Minnesota
 2016-04
NCT01204216 TERMINATED
Diabetes Mellitus; Impaired Fasting Glucose; Prediabetes
VA Office of Research and Development
 2010-09-01
NCT01572506 COMPLETED
Anemia
National Institute on Aging (NIA)
 2012-03-29 PHASE1
NCT00894920 COMPLETED
Biotin Deficiency
University of Arkansas
 2009-08
NCT00988715 COMPLETED
Chronic Myelomonocytic Leukemia; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Refractory Anemia With Excess Blasts; Refractory Cytopenia With Multilineage Dysplasia; Refractory Cytopenia With Multilineage Dysplasia and Ringed Sideroblasts; Secondary Acute Myeloid Leukemia
Fred Hutchinson Cancer Center
 2010-04-21 PHASE1
NCT02011191 COMPLETED
End Stage Renal Disease; Restless Legs Syndrome
Heidi Moretti, MS, RD
 2006-12
NCT00289354 COMPLETED
Diabetes Mellitus, Type 2
Nutrition 21, Inc.
 2003-03
NCT00308451 COMPLETED
Diabetes Mellitus, Type 2
Nutrition 21, Inc.
 2003-11

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the Biotin (Vitamin B7) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Biotin functions as an essential metabolic coenzyme that covalently attaches to lysine residues on carboxylase enzymes and histones, thereby regulating fatty acid synthesis, amino acid catabolism, and chromatin-mediated gene expression. This dual role in energy metabolism and epigenetic regulation promotes cell growth and structural integrity, establishing its clinical relevance in managing biotin deficiency, hair thinning, and diagnostic cell labeling in hematologic and oncologic conditions.

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>).

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Note: Technical data last updated: Sep 1, 2026.