Amgen (AMGN)
NASDAQ:AMGN
Amg 732
Thyroid Eye Disease
Phase II
Not Yet Recruiting
An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease
Feb 23, 2026
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Amg 133
Hepatic Impairment
Phase I
Completed
A Study to Evaluate AMG 133 in Participants With Varying Degrees of Hepatic Impairment or Normal Hepatic Function
Feb 19, 2026
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Methotrexate, Pegloticase, Mtx
Uncontrolled Gout
Phase III
Recruiting
A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout
Jan 29, 2026
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 Amgen (AMGN) have in its pipeline
AMGN is currently developing the following drugs: Amg 732, Amg 133, Evolocumab Drug Substance A, Evolocumab Drug Substance B. These drug candidates are in various stages of clinical development as the company works toward FDA approval.