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Santhera Pharmaceuticals Holding (SPHDF)
OTHER OTC:SPHDF
Vamorolone 40 Mg/Ml Oral Suspension
Duchenne Muscular Dystrophy
Phase IV
Recruiting
A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy
Nov 16, 2024
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Midazolam, Vamorolone
Drug Interaction Potentiation
Phase I
Completed
Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics
Sep 05, 2024
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Vamorolone, Eplerenone, Fludrocortisone
Pharmacodynamic
Phase I
Completed
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
Sep 05, 2024
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Vamorolone
Becker Muscular Dystrophy
Phase II
Completed
A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)
Dec 08, 2021
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Vamorolone
Duchenne Muscular Dystrophy
Phase II
Completed
A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)
Nov 09, 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 Santhera Pharmaceuticals Holding (SPHDF) have in its pipeline
SPHDF is currently developing the following drugs: Vamorolone 40 Mg/Ml Oral Suspension, Midazolam, Vamorolone, Vamorolone, Eplerenone, Fludrocortisone. These drug candidates are in various stages of clinical development as the company works toward FDA approval.