SELENIOUS ACID
Selenious acid is used for both adult and pediatric patients who require selenium as part of their parenteral nutrition. It helps patients who cannot receive adequate nutrition through oral or enteral routes due to medical contraindications or insufficiency. This injection serves as a vital source of the trace element selenium when normal feeding methods are not possible.
How SELENIOUS ACID Works
Selenious acid is converted in vivo to hydrogen selenide via glutathione-involved electron reductions. Hydrogen selenide serves as a metabolic pool for the synthesis of selenoproteins, including glutathione peroxidase, iodothyronine deiodinase, and thioredoxin reductases, which play critical roles in antioxidant defense and thyroid hormone metabolism.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-04-30
- Patent Cliff
- 2041
- Routes
- INTRAVENOUS, SOLUTION
- Dosage Forms
- SOLUTION, INJECTION
Companies
SELENIOUS ACID Approval History
What SELENIOUS ACID Treats
8 FDA approvalsOriginally approved for its first indication in 2019 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Apr 2019) PriorityLabel Letter
- • Approved indication (Feb 2025)Letter
- • Approved indication (Feb 2025)
- • Approved indication (Jun 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Dec 2025) New
- • Approved indication (Feb 2026) New
SELENIOUS ACID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06362005 RCT | AUAREC2023011-1 | Ph 4 | completed | The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus |
| NCT06117436 | CSDFU81 | Ph 2, Ph 3 | completed | Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients |
| NCT04080622 AutoSelenium | 2018-005033-21 | Ph 3 | completed | Evaluate the Efficacy of Selenium for the Prevention of Chemotherapy-induced Mucositis During Autologous Stem Cell Transplantation. |
| NCT05266794 | MS 381/2018 | Ph 4 | completed | A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients |
| NCT03476044 | Selenium and POM | Ph 2, Ph 3 | completed | Effect of Selenium on Succinylcholine-Induced POM |
| NCT00706121 ACP results posted | CDR0000593329 S0000D, U10CA037429 | Ph 3 | completed | S0000D: Effect of Vitamin E and/or Selenium on Colorectal Polyps in Men Enrolled on SELECT Trial SWOG-S0000 |
| NCT01212965 | 10/93 | Ph 1 | terminated | Selenium in the Treatment of Complicated Lymphatic Malformations |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SELENIOUS ACID FDA Label Details
Indications & Usage
FDA Label (PDF)Selenious Acid Injection is indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Selenious Acid Injection is a trace element indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
SELENIOUS ACID Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for SELENIOUS ACID
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 18 active patents
Trial Analysis
- • 7 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment