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Biotest AG (GB:0N70)
LSE:0N70
Trimodulin
Community-Acquired Pneumonia
Phase III
Recruiting
Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)
Jan 11, 2023
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Trimodulin
Covid-19, Pneumonia, Acute Respiratory Distress Syndrome, Respiratory Infection, Community-Acquired Pneumonia, Viral Pneumonia, Bacterial Pneumonia, Fungal Pneumonia
Phase III
Terminated
Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia
Aug 26, 2022
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Bt097
Congenital Cytomegalovirus Infection
Phase III
Terminated
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
Oct 19, 2021
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Bt524, Ffp/Cryo
Bleeding Disorder, Hypofibrinogenemia; Acquired
Phase III
Completed
Adjusted Fibrinogen Replacement Strategy
Dec 19, 2017
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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 Biotest AG (0N70) have in its pipeline
0N70 is currently developing the following drugs: Trimodulin, Trimodulin, Bt097. These drug candidates are in various stages of clinical development as the company works toward FDA approval.