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Ensacove

(Ensartinib Hydrochloride)

Small molecule

XXcovery Holdings, Inc.

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Clinical

Trials by Indication[1]

Single Dose1 trial

A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions

Completed·XXcovery Holdings, Inc.·Phase 1·NCT05665283·32 enrolled

Regulatory

FDA Approval Timeline[3]

Dec 18, 2024

ENSACOVE

NDA NDA218171

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Ensartinib Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ensartinib Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA218171). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Xcovery Holdings, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: XXcovery Holdings, Inc.

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