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Intuitive Surgical (ISRG)
NASDAQ:ISRG
Administration Of Is-002, Firefly Fluorescent Imaging, Robotic-Assisted Laparoscopic Prostatectomy With Pelvic Lymph Node Dissection
Prostate Cancer
Phase II
Completed
IS-002 Phase 2 Prostate Cancer Study
Jun 28, 2023
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Is-001
Ureter Injury
Phase III
Recruiting
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
Jun 01, 2023
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Is-001
Ureter Injury
Phase II
Completed
A Safety and Feasibility Study of IS-001 Injection in Patients Undergoing Robotic Colorectal Surgery
Jan 31, 2023
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Is-002
Prostate Cancer
Phase I
Completed
A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
Sep 15, 2020
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No Treatment, Is-001
Ureter Injury
Phase II
Completed
A Safety and Efficacy Study of IS-001 Injection in Patients Undergoing Robotic Hysterectomy
Apr 29, 2019
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Is-001, Da Vinci® Si/Xi Surgical System
Hysterectomy, Surgery
Phase I
Completed
IS-001 Injection Phase-1 Safety, Tolerance and Pharmacokinetics
Dec 14, 2016
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Intuitive Surgical (ISRG) have in its pipeline
ISRG is currently developing the following drugs: Administration Of Is-002, Firefly Fluorescent Imaging, Robotic-Assisted Laparoscopic Prostatectomy With Pelvic Lymph Node Dissection, Is-001, Is-001. These drug candidates are in various stages of clinical development as the company works toward FDA approval.