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Santhera Pharmaceuticals Holding (SANN) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| 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 | ― |
| Midazolam, Vamorolone | Drug Interaction Potentiation | Phase I | Completed | Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics | Sep 05, 2024 | ― |
| Vamorolone, Eplerenone, Fludrocortisone | Pharmacodynamic | Phase I | Completed | Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects | Sep 05, 2024 | ― |
| Vamorolone | Becker Muscular Dystrophy | Phase II | Completed | A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD) | Dec 08, 2021 | ― |
| 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 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Vamorolone 40 Mg/Ml Oral Suspension | Phase IV | Duchenne Muscular Dystrophy | Recruiting | A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy | Nov 16, 2024 | ― |
| Midazolam, Vamorolone | Phase I | Drug Interaction Potentiation | Completed | Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics | Sep 05, 2024 | ― |
| Vamorolone, Eplerenone, Fludrocortisone | Phase I | Pharmacodynamic | Completed | Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects | Sep 05, 2024 | ― |
| Vamorolone | Phase II | Becker Muscular Dystrophy | Completed | A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD) | Dec 08, 2021 | ― |
| Vamorolone | Phase II | Duchenne Muscular Dystrophy | 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 | ― |
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
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 Ag (CH:SANN) have in its pipeline
Santhera Pharmaceuticals Holding CH:SANN is currently developing the following drugs: Vamorolone 40 Mg/Ml Oral Suspension, Midazolam, Vamorolone, Vamorolone, Eplerenone, Fludrocortisone, Vamorolone. These drug candidates are in various stages of clinical development as the company works toward FDA approval.