TheraRadar
Data updated: Jun 28, 2026

XOCOVA (ensitrelvir)

Approved 2026-05-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-05-29
Routes
ORAL
Dosage Forms
TABLET

Companies

SHIONOGI
Active Ingredient: ENSITRELVIR

XOCOVA Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
May 2026 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What XOCOVA Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)

SHIONOGI's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

FETROJA
2019
CEFIDEROCOL SULFATE TOSYLATE
2 designations
RADICAVA
2017
EDARAVONE
2 designations
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT06161688 PREVAIL-LC results posted 23-38752 Ph 2 active not recruiting Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID
NCT05041907 PLATCOV VIR21001 Ph 2 recruiting Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
NCT06775730 2403T1219 Ph 1 completed A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

XOCOVA FDA Label Details

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Data Sources

FDA Approval: NDA220442 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.