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CMS-D002

Phase 2

Uterine Fibroids With Menorrhagia | Small molecule | Other |Co-Diagnostics, Inc.|Last Updated: Mar 11, 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 Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07402369Phase II Study of CMS-D002 Capsule for Uterine Fibroids With MenorrhagiaPHASE2 RECRUITING 120Feb 19, 2026Dec 31, 2027Mar 11, 20261 China
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Study Endpoints
Primary Endpoints
Percentage of participants with menstrual bleeding < 80 mL and a reduction of ≥50% from baseline
12 weeks
Secondary Endpoints
Changes in maximum fibroid volume from baseline
12weeks
Changes in uterine volume from baseline
12weeks
Percentage of participants without menstrual bleeding or spotting
4、8、12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CMS-D002 Capsules 10 mgEXPERIMENTALCMS-D002 Capsules 10 mg, QD
CMS-D002 Capsules 25 mgEXPERIMENTALCMS-D002 Capsules 25 mg, QD
CMS-D002 Capsules 50 mgEXPERIMENTALCMS-D002 Capsules 50 mg, QD
PlaceboPLACEBO_COMPARATORPlacebo, QD
Interventions
NameTypeDescription
CMS-D002 Capsules 10 mgDRUGCMS-D002 Capsules 10 mg, QD
CMS-D002 Capsules 25 mgDRUGCMS-D002 Capsules 25 mg, QD
CMS-D002 Capsules 50 mgDRUGCMS-D002 Capsules 50 mg, QD
PlaceboDRUGPlacebo, QD
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Eligibility Criteria
Age Range18 Years — 50 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1.Non-menopausal females aged 18-50 years. * 2\. Body Mass Index (BMI) ≥ 18 kg/m². * 3\. Participant was diagnosed with uterine fibroids by ultrasound at the time of screening, and has one or more fibroids with a diameter of at least 2 cm (longest diameter). * 4\. Participant'...

Countries:China
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