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Amgen (AMGN)
NASDAQ:AMGN
Inebilizumab
Immunoglobulin G4-Related Disease
Phase II
Not Yet Recruiting
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
Oct 28, 2025
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Teprotumumab
Healthy Volunteers
Phase I
Active Not Recruiting
A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants
Aug 25, 2025
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Abiraterone, Darolutamide, Xaluritamig
Metastatic Hormone-Sensitive Prostate Cancer (Mhspc)
Phase I
Recruiting
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
Aug 21, 2025
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: Olpasiran, Moxifloxacin, Maridebart Cafraglutide, Maridebart Cafraglutide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.