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Sonrotoclax for

Phase 1

Healthy Volunteers | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07628881A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy AdultsPHASE1 NOT YET_RECRUITING 12Jun 18, 2026Sep 27, 2026Jun 5, 2026 -
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Study Endpoints
Primary Endpoints
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax
Approximately 20 days
Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) for Sonrotoclax
Approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax
Approximately 20 days
Secondary Endpoints
Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax
Approximately 20 days
Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax
Approximately 20 days
Apparent Total Clearance (CL/F) for Sonrotoclax
Approximately 20 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Sonrotoclax Tablet for Oral SuspensionEXPERIMENTALParticipants will receive each of the following treatments as a single dose on 3 separate occasions with an 8-day washout in between: 1. oral dose of sonrotoclax tablet for oral suspension administered in the fed state with a high-fat meal. 2. oral dose of sonrotoclax tablet for oral suspension administered after fasting 3. oral dose of sonrotoclax tablet administered in the fed state with a high-fat meal.
Interventions
NameTypeDescription
Sonrotoclax Tablet for Oral SuspensionDRUGAdministered orally
Sonrotoclax TabletDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Participants who are overtly healthy as determined by no clinica...

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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07628881NEW_TRIAL: changed
LOWJun 5, 2026NCT07628881NEW_TRIAL: changed
LOWJun 5, 2026NCT07628881NEW_TRIAL: changed
LOWJun 5, 2026NCT07628881NEW_TRIAL: changed