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Astellas Pharma Inc (ALPMF)
OTHER OTC:ALPMF
Panitumumab, Asp5834
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Non-Small-Cell Lung Cancer, Solid Tumor
Phase I
Recruiting
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Jul 23, 2025
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Avacincaptad Pegol
Age-Related Macular Degeneration, Geographic Atrophy
Phase IV
Recruiting
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
May 06, 2025
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Asp4396
Solid Tumor
Phase I
Recruiting
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
Apr 10, 2024
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Fezolinetant
Hot Flashes
Phase III
Active Not Recruiting
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause
Jan 04, 2024
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Fezolinetant
Hot Flashes
Phase III
Active Not Recruiting
A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause
Jan 04, 2024
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Pudexacianinium Chloride
Melanoma, Breast Cancer, Sentinel Lymph Node Biopsy
Phase II
Terminated
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery
Jul 11, 2022
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Gemcitabine, Pembrolizumab, Fluorouracil, Docetaxel, Irinotecan, Pemetrexed, Carboplatin, Cisplatin, Leucovorin, Cetuximab, Asp3082, Oxaplatin, Nanoparticle Albumin-Bound-Paclitaxel
Solid Tumor
Phase I
Recruiting
A Study of ASP3082 in Adults With Advanced Solid Tumors
May 16, 2022
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Enzalutamide, Zen003694
Metastatic Castration-Resistant Prostate Cancer
Phase II
Recruiting
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer
Jul 14, 2021
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Talazoparib Plus Enzalutamide
Prostate Cancer
Phase III
Active Not Recruiting
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC
Mar 25, 2021
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Gemcitabine, Pembrolizumab, Cisplatin, Enfortumab Vedotin (Ev), Rc + Plnd
Bladder Cancer
Phase III
Active Not Recruiting
Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304)
Jan 05, 2021
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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 Astellas Pharma Inc (ALPMF) have in its pipeline
ALPMF is currently developing the following drugs: Panitumumab, Asp5834, Avacincaptad Pegol, Asp4396. These drug candidates are in various stages of clinical development as the company works toward FDA approval.