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BioVersys AG (CH:BIOV)
:BIOV
Itraconazole 200 Mg, Bv100 (300 Mg)
Bacterial Infections
Phase I
Completed
To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100
Jan 05, 2023
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Bv100
Bacterial Infections
Phase I
Completed
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
Jan 05, 2023
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Bat, Bv100 Plus Polymyxin B
Ventilator Associated Pneumonia
Phase II
Completed
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
Jan 04, 2023
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Bv100
Healthy Participants
Phase I
Completed
A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment
Sep 08, 2022
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Midazolam, Bv100
Healthy Volunteers
Phase I
Completed
A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants
Sep 07, 2022
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Bv100
Renal Impairment
Phase I
Completed
Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment
Oct 08, 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 BioVersys AG (BIOV) have in its pipeline
BIOV is currently developing the following drugs: Itraconazole 200 Mg, Bv100 (300 Mg), Bv100, Bat, Bv100 Plus Polymyxin B. These drug candidates are in various stages of clinical development as the company works toward FDA approval.