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Icon plc (ICLR)
NASDAQ:ICLR
Belimumab
Bronchial Diseases
Phase III
Recruiting
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
Nov 29, 2024
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Mtx-463
Healthy
Phase I
Completed
A First-in-Human Safety Trial of MTX-463
Apr 22, 2024
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H1 Influenza Antigen
Influenza
Phase I
Completed
Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP
Oct 30, 2023
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Prx-102 1 Mg/Kg Every Two Weeks
Fabry Disease
Phase II/III
Recruiting
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease
Aug 10, 2023
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Jcxh-105, Active Control (Shingrix)
Infectious Disease, Herpes Zoster (Hz), Shingles
Phase I
Completed
A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine
May 03, 2023
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Jcxh-221
Infectious Disease, Covid-19
Phase I
Completed
A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine
Feb 22, 2023
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Altb-268
Healthy Volunteers
Phase I
Completed
A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers
Jan 20, 2023
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Sp-420
Beta Thalassemia Major Anemia
Phase II
Unknown
A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia
Dec 22, 2022
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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 Icon plc (ICLR) have in its pipeline
ICLR is currently developing the following drugs: Petrelintide, Kedrion Ivig 10%, Belimumab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.