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Amgen (AMGN)
NASDAQ:AMGN
Docetaxel, Abiraterone Acetate, Cabazitaxel, Xaluritamig
Metastatic Castration-Resistant Prostate Cancer
Phase III
Recruiting
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer
Sep 18, 2025
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Sotorasib, Panitumumab
Advanced Solid Tumors
Phase II
Not Yet Recruiting
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
Sep 08, 2025
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Maridebart Cafraglutide
Type 2 Diabetes Mellitus
Phase I
Recruiting
A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus
Aug 29, 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
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Olpasiran
Cardiovascular Disease
Phase III
Recruiting
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
Aug 18, 2025
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Blinatumomab
Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia, Minimal Residual Disease + B-Cell Acute Lymphoblastic Leukemia
Phase I/II
Not Yet Recruiting
A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia
Aug 14, 2025
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Pembrolizumab, Panitumumab, Amg 410
Kras Altered Advanced Or Metastatic Solid Tumors
Phase I
Recruiting
AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
Jul 23, 2025
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Tarlatamab, Ab248
Extensive Stage Small Cell Lung Cancer
Phase I
Recruiting
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
Jun 17, 2025
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Maridebart Cafraglutide
Obesity, Atherosclerotic Cardiovascular Disease, Overweight
Phase III
Recruiting
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Jun 16, 2025
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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 Amgen (AMGN) have in its pipeline
AMGN is currently developing the following drugs: Docetaxel, Abiraterone Acetate, Cabazitaxel, Xaluritamig, Sotorasib, Panitumumab, Maridebart Cafraglutide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.