Ct001
Pain
Phase II/III
Completed
Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
Apr 02, 2024
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Sufentanil, Ketamine, Ct001
Pain
Phase II/III
Completed
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001
Aug 17, 2022
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Ct001
Analgesia
Phase II
Completed
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
May 14, 2021
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Sufentanil, Ketamine, Ct001
Bioavailability
Phase I
Completed
Study of CT001 in Healthy Volunteers
Mar 17, 2021
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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 Cessatech A/S (8GN) have in its pipeline
8GN is currently developing the following drugs: Ct001, Sufentanil, Ketamine, Ct001, Ct001. These drug candidates are in various stages of clinical development as the company works toward FDA approval.