Xocova

(Ensitrelvir)

Phase 2Small molecule

Shionogi

Xocova is one of 26 small molecule programs targeting Inflammation. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

COVID-19Recruiting

COVID-19Phase 2

Recruiting

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Xocova

Shionogi

Phase 2

1 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Tricor

1 9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 10

Benadryl

PParkedale

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

COVID-19

NCT05041907

Clinical

Trials by Indication[1]

Interaction1 trial

A Drug-Drug Interaction Study of S-217622 With Combined Oral Contraceptives in Healthy Adult Female Participants

Completed· Shionogi logo

Shionogi·Phase 1·NCT06775730·24 enrolled

COVID-191 trial

Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Recruiting·UUniversity of Oxford·Phase 2·NCT05041907·3,800 enrolled

Inflammation1 trial

Ensitrelvir for Viral Persistence and Inflammation in People Experiencing Long COVID

Active, not recruiting·TTimothy Henrich·Phase 2·NCT06161688·40 enrolled

Regulatory

FDA Approval Timeline[4]

May 29, 2026

XOCOVA

NDA NDA220442

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Ensitrelvir. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ensitrelvir compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ensitrelvir. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220442). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xocova. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Shionogi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Shionogi

Patent Landscape[5]

Patent Cliff

Dec 11, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9150546Dec 11, 2030

12559474Apr 30, 2042

11814368Apr 30, 2042

Xocova

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Interaction1 trial

COVID-191 trial

Inflammation1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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