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Basilea Pharmaceutica (CH:BSLN)
:BSLN
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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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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Fosmanogepix
Hepatic Impairment
Phase I
Active Not Recruiting
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
Oct 12, 2022
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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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[14C]-Apx001 Oral Solution, [14C]-Apx001 Solution For Infusion
Fungal Infection
Phase I
Completed
A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males
Oct 01, 2020
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Fosmanogepix
Invasive Fungal Infections
Phase II
Terminated
Open-label Study of APX001 for Treatment of Patients With Invasive Mold Infections Caused by Aspergillus or Rare Molds
Jan 22, 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.