Clinical Trials
31
Trial Phases
4 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
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Clinical Trials
Distribution across different clinical trial phases (24 trials with phase data)• Click on a phase to view related trials
A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- First Posted Date
- 2024-12-03
- Last Posted Date
- 2024-12-03
- Lead Sponsor
- Santhera Pharmaceuticals
- Target Recruit Count
- 80
- Registration Number
- NCT06713135
- Locations
- 🇧🇪
UZ Gent (Universitair Ziekenhuis Gent), Gent, Belgium
🇧🇪UZ Leuven (Universitair Ziekenhuis Leuven), Leuven, Belgium
🇨🇿University Hospital Brno, Brno, Czechia
Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics
- First Posted Date
- 2024-11-14
- Last Posted Date
- 2024-11-14
- Lead Sponsor
- Santhera Pharmaceuticals
- Target Recruit Count
- 18
- Registration Number
- NCT06689527
- Locations
- 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
- Conditions
- Pharmacodynamic
- Interventions
- First Posted Date
- 2024-10-18
- Last Posted Date
- 2025-09-11
- Lead Sponsor
- Santhera Pharmaceuticals
- Target Recruit Count
- 30
- Registration Number
- NCT06649409
- Locations
- 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany
A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)
- First Posted Date
- 2022-01-11
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Santhera Pharmaceuticals
- Target Recruit Count
- 54
- Registration Number
- NCT05185622
- Locations
- 🇨🇦
Alberta's Children Hospital, Calgary, Alberta, Canada
🇨🇦British Columbia Children's Hospital, Vancouver, British Columbia, Canada
🇨🇦Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study
- Conditions
- Leber's Hereditary Optic Neuropathy
- First Posted Date
- 2020-05-08
- Last Posted Date
- 2023-04-21
- Lead Sponsor
- Santhera Pharmaceuticals
- Registration Number
- NCT04381091
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News
Taiho's Pizuglanstat Fails to Meet Primary Endpoint in Phase III Duchenne Muscular Dystrophy Trial
Taiho Pharmaceutical's pizuglanstat (TAS-205) failed to demonstrate significant improvement in time to rise from floor compared to placebo in the Phase III REACH-DMD study.
Satellos Reports Promising Efficacy Signals for Novel DMD Treatment in Adult Patients
Satellos Bioscience's investigational treatment for Duchenne muscular dystrophy (DMD) has demonstrated encouraging efficacy signals in adult patients, offering potential new options in a challenging therapeutic area.
DMD Market Set to More Than Double to $5.2 Billion by 2033, Driven by Novel Therapies
The Duchenne muscular dystrophy market across seven major markets is projected to grow from $2.3 billion in 2023 to $5.2 billion by 2033, fueled by recent approvals of Elevidys and Agamree.
FDA Requests Additional Phase 3 Trial for Santhera's DMD Drug Raxone, Delaying Approval
The FDA has requested Santhera Pharmaceuticals to conduct a second Phase 3 trial for Raxone (idebenone) in Duchenne muscular dystrophy treatment, potentially delaying approval until 2020.
Agamree Receives Positive Recommendation in Scotland and NICE Guidance in the UK for Duchenne Muscular Dystrophy
The Scottish Medicines Consortium (SMC) has accepted Agamree (vamorolone) for use within NHS Scotland for treating Duchenne muscular dystrophy (DMD) in patients aged four and older.
Santhera's Agamree Receives NICE Recommendation and China NMPA Approval for Duchenne Muscular Dystrophy Treatment
The National Institute for Health and Care Excellence (NICE) has recommended Agamree (vamorolone) for treating Duchenne muscular dystrophy (DMD) in patients aged four and older in England, Wales, and Northern Ireland.
Vamorolone Demonstrates Dual Mechanism as Mineralocorticoid Receptor Antagonist in LIONHEART Study
Vamorolone (Agamree) showed a statistically significant increase in the urinary sodium/potassium ratio compared to placebo in the LIONHEART study, indicating mineralocorticoid receptor antagonism.
Swissmedic Accepts Santhera's Marketing Application for AGAMREE® in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals announced that Swissmedic has accepted the marketing authorization application for AGAMREE® (vamorolone) for treating Duchenne muscular dystrophy (DMD).
FDA Approves Santhera's Agamree (Vamorolone) for Duchenne Muscular Dystrophy
The FDA has approved Agamree (vamorolone) for treating Duchenne Muscular Dystrophy (DMD) in patients aged two years and older, offering a novel corticosteroid treatment option.