Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vitamin A · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sepsis - vitamin A |
| 2 | PLACEBO_COMPARATOR | Sepsis - placebo |
| 3 | EXPERIMENTAL | NEC - vitamin A |
| 4 | PLACEBO_COMPARATOR | NEC - Placebo |
| Name | Type | Description |
|---|---|---|
| Vitamin A | DIETARY_SUPPLEMENT | 50,000 IU of Vitamin A 50,000 IU of vegetable oil |
Inclusion Criteria: * newborns less than 29 days with clinical sepsis Exclusion Criteria: * healthy infants * major congenital abnormalities * known inborn error(s) of metabolism * chronic disorders of other organs (e.g. cholestasis) * definite or severe NEC (\> stage 2) * congenital heart diseas...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 3 | - | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | N/A | Undisclosed |
Vitamin A is being studied as a treatment for neonatal sepsis, a severe bloodstream infection in newborns. A Phase 3 clinical trial evaluated its effect on neonatal sepsis and necrotizing enterocolitis, a serious intestinal condition. The trial also included patients with meningitis and pneumonia. Vitamin A is an investigational therapy for these conditions and is not yet approved.
United Therapeutics Corporation (NASDAQ: UTHR) is the developer of Vitamin A for the treatment of sepsis. The company conducted a Phase 3 clinical trial to evaluate the drug's efficacy in neonatal sepsis and necrotizing enterocolitis. United Therapeutics is responsible for the clinical development of this investigational therapy.
Vitamin A is in Phase 3 clinical development for the treatment of sepsis. A Phase 3 trial, which was completed, evaluated the drug in 424 patients with neonatal sepsis and necrotizing enterocolitis. The trial was randomized, double-blind, and placebo-controlled. Vitamin A remains investigational and has not been approved for this use.
Vitamin A was studied in a Phase 3 clinical trial with the identifier NCT00707785, titled "Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis." The trial enrolled 424 participants in Bangladesh, including newborns as young as one day old. The study was completed and included patients with sepsis, necrotizing enterocolitis, meningitis, and pneumonia.
Vitamin A is a fat-soluble vitamin that includes several related compounds, such as retinol, retinal, and retinoic acid. In the context of the clinical trial for sepsis, Vitamin A was administered as a therapeutic agent. The trial did not specify which exact form of Vitamin A was used, but retinol is a common dietary form of Vitamin A.