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Nacresertib

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: May 26, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07600762A Study to Assess Adverse Events, Tolerability and How a Single Oral Dose of Nacresertib Moves Through the Body In Healthy Adult Japanese ParticipantsPHASE1 NOT YET_RECRUITING 12Apr 25, 2026Jun 1, 2026May 26, 20261 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of Nacresertib
Up to 9 Days

Cmax of Nacresertib

Time to Cmax (Tmax) of Nacresertib
Up to 9 Days

Tmax of Nacresertib

Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of Nacresertib
Up to 9 Days

AUCt of Nacresertib

AUC From Time 0 to the Time Infinity (AUCinf) of Nacresertib
Up to 9 Days

AUCinf of Nacresertib

Terminal Phase Elimination Rate Constant (Beta) of Nacresertib
Up to 9 Days

Beta of Nacresertib

Terminal Phase Elimination Half-Life (t1/2) of Nacresertib
Up to 9 Days

t1/2 of Nacresertib

Number of Participants Experiencing Adverse Events (AEs)
Up to 42 Days

Any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
NacresertibEXPERIMENTALParticipants will receive a single dose of Nacresertib
Placebo for NacresertibPLACEBO_COMPARATORParticipants will receive a single dose of Placebo for Nacresertib
Interventions
NameTypeDescription
NacresertibDRUGOral tablet
Placebo for NacresertibDRUGOral tablet
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese male or female; 18 to 65 years of age at the time of screening. * Japanese participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also ...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 27, 2026NCT07600762Status: RECRUITING → NOT_YET_RECRUITING
MEDIUMMay 27, 2026NCT07600762Status: RECRUITING → NOT_YET_RECRUITING