Biopin-6 Active Implant With Naltrexone
Opioid Use Disorder
Phase I
Completed
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults
Dec 27, 2023
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ensifentrine
Chronic Obstructive Pulmonary Disease
Phase III
Completed
A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Feb 14, 2023
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Static - Pet/Ct Scan, Geh121224 (18F) Injection, Dynamic And Static - Pet/Ct Scan
Breast Cancer
Phase I
Withdrawn
Study to Evaluate Safety and Dosimetry of [18F]GEH121224 in Patients With Locally Advanced or Metastatic Breast Cancer
Nov 22, 2022
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Ocrelizumab
Multiple Sclerosis, Clinically Isolated Syndrome
Phase IV
Completed
A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab
Aug 06, 2021
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Ocrelizumab
Multiple Sclerosis, Clinically Isolated Syndrome
Phase IV
Completed
A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy
Aug 06, 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 Labcorp Holdings (N6B) have in its pipeline
N6B is currently developing the following drugs: Biopin-6 Active Implant With Naltrexone, ensifentrine, Static - Pet/Ct Scan, Geh121224 (18F) Injection, Dynamic And Static - Pet/Ct Scan. These drug candidates are in various stages of clinical development as the company works toward FDA approval.