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filricianine

Phase 3

Ureter Injury | Small molecule | Other |Intuitive Surgical, Inc.|Last Updated: Jan 16, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07346066IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal SurgeryPHASE3 NOT YET_RECRUITING 146 — — Mar 31, 2026Aug 31, 2027Jan 16, 2026 - —
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Study Endpoints
Primary Endpoints
Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible.
10 minutes after first injection

Evaluate ureter visualization by each independent reader at (a) the pelvic brim (PB) and (b) Inferior Mesenteric Artery (IMA) locations in Sensitive Firefly (SFF) mode compared to white light mode up to 30 minutes after the first IS-001 injection.

Secondary Endpoints
Independent reader assessment of ureter length delineation by line drawing on recorded frame measured in arbitrary unit length
30 minutes after the first injection
Independent reader assessment of ureter visualization by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible
30 miinutes after second injection
Ureter visualization based on intraoperative surgeon's rating by 1-5 Likert visualization rating scale from 1 not visible, 2 questionably visible, 3 low visibility, 4 visible, 5 clearly visible
30 minutes after first IS-001 injection
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
IS-001 InjectionOTHERUreter visualization and delineation will be compared between white light (standard of care) and near-infrared (NIR) imaging mode after each of the two single intravenous injections of IS-001.
Interventions
NameTypeDescription
filricianineDRUGIV injection of IS-001 filricianine with near infrared (NIR) imaging
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Eligibility Criteria
Age Range16 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Male and female participants between the ages of 16 and 75, inclusive 2. Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X/Xi Surgical System with SFF Fluorescence Imaging Exclusion Criteria 1\. Participant is pregnant or nursing 2. Particip...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07346066primaryCompletionDate: changed
LOWMay 24, 2026NCT07346066studyFirstPostDate: changed