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COMPANY

Xcovery

xcovery.com ↗

FDA-approved therapeutic company Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: Non-small Cell Lung Cancer Non-small Cell Lung Carcinoma Bioequivalency ALK Gene Rearrangement Positive X-396 (ensartinib) BPI-361175 Ensartinib

5Trials (company is sponsor)

Timeline

  1. Trial start Phase 1/Phase 2: BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) source ↗
  2. Trial start Phase 1: A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions source ↗
  3. Trial start Phase 3: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients source ↗
  4. Trial start 1: Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 5

RecordTitlePhaseStatusStartPrimary completion
NCT01625234Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer1Completed2012-06Sep 17, 2020 (actual)
NCT02767804eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) PatientsPhase 3Active, not recruiting2016-06Dec 30, 2025 (estimated)
NCT05393466BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)Phase 1/Phase 2Not yet recruitingJul 1, 2026Jan 30, 2028 (estimated)
NCT05665283A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted ConditionsPhase 1CompletedNov 29, 2022Jan 18, 2023 (actual)
NCT04146571Expanded Access to Ensartinib for Participants With ALK+ NSCLCNot listedAvailableNot listedNot listed
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