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filricianine

Phase 3

Ureter Injury | Small molecule | Other |Intuitive Surgical, Inc.|Last Updated: Aug 5, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

Clinical trial landscape

filricianine · 1 trial · 1 indication

Phase 3 1
NCT07346066IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal SurgeryUreter Injury
RECRUITING146 Analytics
PHASE3RECRUITING
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
Ureter Injury
NCT07346066146
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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 to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 5, 2026NCT07346066Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about filricianine

What is filricianine used for?

Filricianine is an investigational small molecule being studied for the prevention of ureter injury, specifically in patients undergoing robotic-assisted colorectal surgery. It is administered as an injection and is currently in Phase 3 clinical development. The drug is not yet approved and remains under investigation.

Who makes filricianine?

Filricianine is being developed by Intuitive Surgical, Inc., a company traded on NASDAQ under the ticker ISRG. The company is conducting a Phase 3 clinical trial of the drug in the United States for the prevention of ureter injury during robotic-assisted colorectal surgery.

What phase is filricianine in?

Filricianine is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is recruiting participants in the United States and is designed to evaluate the drug's safety and efficacy.

What clinical trials is filricianine in?

Filricianine is being evaluated in a single Phase 3 clinical trial with the identifier NCT07346066, titled 'IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery.' The trial is currently recruiting and aims to enroll 146 participants in the United States. It is an open-label, uncontrolled study.

How does filricianine work?

Filricianine is a small molecule designed to prevent ureter injury during robotic-assisted colorectal surgery. The specific molecular target and mechanism of action have not been disclosed. The drug is administered as an injection and is being studied for its ability to protect the ureter during surgical procedures.

Is filricianine FDA approved?

Filricianine is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials. The ongoing study, NCT07346066, is recruiting patients to evaluate the drug's safety and effectiveness in preventing ureter injury during robotic-assisted colorectal surgery. Approval status will depend on trial results.