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FibroGen (FGEN)
NASDAQ:FGEN
Fg-3246
Metastatic Castration-Resistant Prostate Cancer
Phase II
Not Yet Recruiting
A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Feb 19, 2025
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Roxadustat, Sepo®
Chemotherapy Induced Anemia
Phase III
Completed
A Study to Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia in Participants Receiving Chemotherapy Treatment for Non-Myeloid Malignancies
Mar 19, 2022
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Corticosteroids, Pamrevlumab
Duchenne Muscular Dystrophy
Phase III
Terminated
Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD
Nov 12, 2020
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Roxadustat
Anemia Associated With Chronic Kidney Disease
Phase III
Withdrawn
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
Nov 03, 2020
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Roxadustat
Anemia Associated With End Stage Renal Disease
Phase III
Completed
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Jul 21, 2020
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Pamrevlumab
Covid-19
Phase II
Terminated
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
Jun 12, 2020
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Pamrevlumab
Idiopathic Pulmonary Fibrosis
Phase III
Terminated
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Jun 03, 2020
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Roxadustat
Anemia Associated With End Stage Renal Disease (Esrd)
Phase III
Completed
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
May 27, 2020
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Corticosteroids, Pamrevlumab
Duchenne Muscular Dystrophy
Phase III
Terminated
Phase 3 Trial of Pamrevlumab or Placebo With Systemic Corticosteroids in Participants With Non-ambulatory Duchenne Muscular Dystrophy (DMD)
Apr 29, 2020
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Roxadustat
Chemotherapy Induced Anemia
Phase II
Completed
Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia
Aug 30, 2019
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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 FibroGen (FGEN) have in its pipeline
FGEN is currently developing the following drugs: Fg-3246, Roxadustat, Sepo®, Corticosteroids, Pamrevlumab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.