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Selenium

ApprovedSmall molecule

SSWOG Cancer Research Network

Selenium is a mineral supplement used to support immune system function and act as an antioxidant to protect cells from damage. It may be used to treat or prevent selenium deficiency, which can occur in certain medical conditions or dietary insufficiencies.[2] Selenium is currently approved and in use across 8 indications[4].[1]

Selenium is one of 185 small molecule programs targeting HIV infection. It is currently in Approved.

8

Indications

26

Total Trials

2

Active Trials

184

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

Cirrhosis of LiverActive, not recruiting

Oral Lichen PlanusCompleted

ThyroiditisActive, not recruiting

Alzheimer DiseaseActive, not recruiting

Chronic Obstructive Pulmonary DiseaseCompleted

Graves OphthalmopathyActive, not recruiting

Peripartum CardiomyopathyActive, not recruiting

HIV InfectionPreclinical

Active, not recruiting

Cirrhosis of LiverPreclinical

Active, not recruiting

Oral Lichen PlanusApproved

Completed

ThyroiditisPreclinical

Active, not recruiting

Alzheimer DiseasePreclinical

Active, not recruiting

Chronic Obstructive Pulmonary DiseaseApproved

Completed

Graves OphthalmopathyPreclinical

Active, not recruiting

Peripartum CardiomyopathyPreclinical

Active, not recruiting

Competition

Competitive Landscape

123 competitors in HIV Infection

#DrugCompanyPhaseTrials

Videx

Bristol-Myers Squibb

Selenium

SSWOG Cancer Research Network

Mycobutin

Cabenuva

Golytely

Hepsera

Zofran

Viread

Incivek

Vertex Pharmaceuticals

Lotrimin

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

Timeline

Expected Milestones

Q4 2029

N/ANot yet recruiting

Peripartum Cardiomyopathy

NCT07334197

Clinical

Trials by Indication[1]

Mucositis2 trials

Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation.

Completed·UUniversity Hospital, Angers·Phase 3·NCT04080622·100 enrolled

Oral Selenium Therapy for the Prevention of Mucositis

Unknown status·TTehran University of Medical Sciences·Phase 1/2·NCT01432873·76 enrolled

Bladder Cancer2 trials

Different Factors Affecting Patients With Newly Diagnosed Bladder Cancer

Unknown status·UUniversity Hospital Birmingham·Phase 3·NCT00553124·3,400 enrolled

Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer

Unknown status·UUniversity of Birmingham·Phase 3·NCT00553345·515 enrolled

Prostate Cancer2 trials

S0000 Selenium and Vitamin E in Preventing Prostate Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT00006392·35,533 enrolled

Selenium in Treating Patients Who Are Undergoing Brachytherapy for Stage I or Stage II Prostate Cancer

Completed·RRoswell Park Cancer Institute·Phase 1·NCT00217516·18 enrolled

Immunology1 trial

TB Nutrition, Immunology and Epidemiology

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00170404·887 enrolled

Non-Small Cell Lung Cancer1 trial

Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer

Completed·EECOG-ACRIN Cancer Research Group·Phase 3·NCT00008385·1,772 enrolled

18 more indications

Alzheimer's Disease1 trial

Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)

Completed·FFrederick Schmitt··NCT00040378·4,246 enrolled

Prevention1 trial

The CRISIS Prevention Study

Terminated·MMichael Dean·Phase 3·NCT00395161·293 enrolled

Oral Lichen Planus1 trial

The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus

Completed·—·Phase 4·NCT06362005·50 enrolled

Dialysis Patients1 trial

A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients

Completed·—·Phase 4·NCT05266794·68 enrolled

LCH1 trial

Effect of Selenium on Succinylcholine-Induced POM

Completed·—·Phase 2/3·NCT03476044·80 enrolled

Graves ophthalmopathy1 trial

Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy

Not yet recruiting·—·N/A·NCT06413043·78 enrolled

Adenoma1 trial

Selenium for Prevention of Adenomatous Colorectal Polyps

Terminated·UUniversity of Arizona·Phase 3·NCT00078897·1,621 enrolled

Melatonin1 trial

Effects of Selenium and Melatonin on Ocular Ischemic Syndrome

Completed·—·Phase 1·NCT04005222·28 enrolled

Peripartum Cardiomyopathy1 trial

Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy

Not yet recruiting·TTanta University·N/A·NCT07334197·25 enrolled

Follicular Lymphoma1 trial

Dietary Intervention in Follicular Lymphoma

Unknown status·OOslo University Hospital·Phase 2·NCT00455416·45 enrolled

COVID-191 trial

Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.

Unknown status·CCHRISTUS Health·Phase 2·NCT04869579·100 enrolled

Thyroiditis1 trial

Study on the Effect of Selenium Supplementation on the Structure and Function of Autoimmune Thyroiditis

Unknown status·—·N/A·NCT04942769·30 enrolled

Lymphatic Malformation1 trial

Selenium in the Treatment of Complicated Lymphatic Malformations

Terminated·MMedical College of Wisconsin·Phase 1·NCT01212965·5 enrolled

Treatment1 trial

Selenium Treatment and Chagasic Cardiopathy (STCC)

Unknown status·OOswaldo Cruz Foundation·Phase 3·NCT00875173·130 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Selenium Supplementation in Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed·SSt. Joseph's Health Care London·Phase 4·NCT00186706·60 enrolled

Age-Related Macular Degeneration1 trial

S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000

Completed·SSWOG Cancer Research Network·Phase 3·NCT00784225·13,475 enrolled

Colorectal Polyps1 trial

S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000

Completed·SSWOG Cancer Research Network·Phase 3·NCT00706121·8,094 enrolled

Diabetic Foot1 trial

Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients

Completed·—·Phase 2/3·NCT06117436·206 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 10, 1991

SELENIUM SULFIDE

NDA ANDA089996

Jan 28, 1997

SELENIUM SULFIDE

NDA ANDA089996

Jan 14, 2005

SELENIUM SULFIDE

NDA ANDA089996

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Selenium. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Selenium drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Selenium compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Selenium. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA ANDA089996). U.S. Food & Drug Administration.
[6]
SEC EDGAR — SWOG Cancer Research Network company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSWOG Cancer Research Network

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