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Enlivex Therapeutics Ltd (ENLV)
NASDAQ:ENLV
Allocetra
Arthritis, Psoriatic
Phase I
Recruiting
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Jul 07, 2024
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Allocetra
Osteoarthritis, Knee
Phase I/II
Active Not Recruiting
Study of Intra-articular Allocetra in Knee Osteoarthritis
Jan 22, 2024
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Allocetra-Ots
Urinary Tract Infections, Sepsis, Community-Acquired Pneumonia, Cholecystitis, Acute, Cholangitis Acute, Intraabdominal Infections
Phase II
Completed
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
Oct 26, 2020
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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 Enlivex Therapeutics Ltd (ENLV) have in its pipeline
ENLV is currently developing the following drugs: Allocetra, Allocetra, Allocetra-Ots. These drug candidates are in various stages of clinical development as the company works toward FDA approval.