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Oral Fosmanogepix, Iv Fosmanogepix
Healthy
Phase I
Completed
A Study of Fosmanogepix in Healthy Adult Chinese Subjects
Apr 24, 2025
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Pitavastatin, Pitavastatin Single Dose Combined With Ceftobiprole
Drug-Drug Interaction Study
Phase I
Completed
A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
Jan 09, 2025
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Esomeprazole, Ceftibuten, Ledaborbactam Etzadroxil, Ceftibuten-Ledaborbactam Etzadroxil
Drug-Drug Interaction (Ddi), Fdc, Healthy Volunteer, Pharmacokinetics, Safety
Phase I
Recruiting
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Dec 10, 2024
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Ceftibuten, Ledaborbactam Etzadroxil
Pharmacokinetics, Healthy Volunteers
Phase I
Completed
Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age
Oct 29, 2024
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Ceftobiprole Medocaril
Neonatal Sepsis
Phase III
Completed
Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
Apr 17, 2023
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Apx001, Apx001a
Invasive Fungal Infections
Phase I
Completed
A Bioequivalence Study of APX001 High-load and Low-load Tablets
Aug 04, 2022
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Derazantinib, Derazantinib-Paclitaxel-Ramucirumab Combination
Gastric Adenocarcinoma
Phase I/II
Terminated
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
Oct 21, 2020
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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 Basilea Pharmaceutica (BSLN) have in its pipeline
BSLN is currently developing the following drugs: Oral Fosmanogepix, Iv Fosmanogepix, Fosmanogepix Iv Infusion, Standard Of Care Antifungal Therapy, Fosmanogepix Oral Tablet, Pitavastatin, Pitavastatin Single Dose Combined With Ceftobiprole. These drug candidates are in various stages of clinical development as the company works toward FDA approval.