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Z-Endoxifen

Phase 2

Breast Density | Small molecule | Other |Atossa Therapeutics, Inc.|Last Updated: May 20, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
ORPHAN_DRUGRARE_PEDIATRIC_DISEASE
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05068388Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast DensityPHASE2 COMPLETED 240Dec 21, 2021Mar 12, 2026May 20, 20261 Sweden
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Study Endpoints
Primary Endpoints
Change of mammographic density area (cm2) assessed by iCAD® software
6 months

Change from baseline

Secondary Endpoints
Change of mammographic density area (cm2) assessed by iCAD® software
3 months
Change of mammographic density area (cm2) assessed by Stratus software
6 months
Change from baseline responses to the Breast Cancer Prevention Trial Eight Symptom Scale (BESS)
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORoral capsule
1 mg (Z)-endoxifenEXPERIMENTALoral capsule
2 mg (Z)-endoxifenEXPERIMENTALoral capsule
Interventions
NameTypeDescription
Z-EndoxifenDRUGZ-Endoxifen
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range40 Years — 55 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Premenopausal women (defined as having at least one menstruation during the prior 12 months; women with an intrauterine device are considered premenopausal if \<52 years) 2. Women of childbearing potential using a highly effective method of birth control\* throughout the stud...

Countries:Sweden
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT05068388Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT05068388studyFirstPostDate: changed