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14 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Catena (idebenone) / Chiesi
2019-001493-28: Raxone® treatment for patients with autosomal dominant optic atrophy (inherited optic nerve disorder) Raxone® Behandlung bei Patienten mit autosomal dominanter Optikusatrophie (erblich bedingte Erkrankung des Sehnerves).

Ongoing
2
16
Europe
Raxone 150 mg film-coated tablets, Film-coated tablet, Raxone 150 mg film-coated tablets
Medizinische Universität Graz, Univ.-Augenklinik, Chiesi Pharmaceuticals GmbH
Autosomal dominant optic atrophy (ADOA) Autosomal dominante Optikusatrophie, inherited disorder of the optic nerve erblich bedingte Erkrankung des Sehnervs, Diseases [C] - Eye Diseases [C11]
 
 
NCT03433807: Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

No Longer Available
N/A
US
Idebenone
Santhera Pharmaceuticals
Duchenne Muscular Dystrophy
 
 
US EAP LHON, NCT04381091: Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

No Longer Available
N/A
NA
Idebenone 150 MG Oral Tablet
Santhera Pharmaceuticals
Leber's Hereditary Optic Neuropathy
 
 
Omigapil (SNT-317) / Santhera
NCT02326831: Congenital Muscular Dystrophy Study Analyzing Pharmacokinetics at Three Dose Levels in Children and Adolescents With Assessment of Safety and Tolerability of Omigapil

Recruiting
1
30
US
Omigapil
National Institute of Neurological Disorders and Stroke (NINDS)
Dystrophy
07/17
07/17
Agamree (vamorolone) / Santhera
GUARDIAN, NCT06713135: A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

Recruiting
4
80
Europe, RoW
vamorolone 40 mg/mL oral suspension, vamorolone
Santhera Pharmaceuticals
Duchenne Muscular Dystrophy
09/28
09/28
2022-000844-31: Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy Studio del Vamorolone vs Placebo nel trattamento della Distrofia Muscolare di Becker

Not yet recruiting
2
39
Europe
vamorolone, [vamorolone], Oral drops, powder for suspension
ReveraGen BioPharma Inc., National Institute of health (NIH), Food and Drug administration (FDA), Foundation to Eradicate Duchenne (FED)
Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Diseases [C] - Musculoskeletal Diseases [C05]
 
 
NCT05185622 / 2025-000201-16: A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)

Completed
2
54
Canada
Vamorolone, VBP15
Santhera Pharmaceuticals, Santhera Pharmaceuticals (Schweiz) AG
Duchenne Muscular Dystrophy
07/24
07/24
NCT05166109 / 2022-000844-31: A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)

Active, not recruiting
2
39
Europe, US
Vamorolone, VBP15, Placebo, Placebo to vamorolone
ReveraGen BioPharma, Inc., Santhera Pharmaceuticals
Becker Muscular Dystrophy
06/25
06/25
ChiCTR2300078541: A Randomized, Cross-over, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Vamorolone Oral Suspension Given as A Single Dose in Healthy Chinese Adult Male Subjects

Recruiting
1
32
 
2mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period; 2mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period; 6mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period; 6mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period
Shanghai Xuhui Central Hospital; Santhera Pharmaceuticals (Switzerland) Ltd., self found
Duchenne Muscular Dystrophy
 
 
SNT-I-VAM-026, NCT06649409: Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

Completed
1
30
Europe
Vamorolone, experimental drug, Eplerenone, positive control, Fludrocortisone, auxiliary medicinal product - mineralocorticoid agonist
Santhera Pharmaceuticals
Pharmacodynamic
06/24
07/24
NCT06689527: Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

Completed
1
18
Europe
Vamorolone, Test Drug, Midazolam, Reference Drug
Santhera Pharmaceuticals
Drug Interaction Potentiation
09/24
10/24
NCT03863119: Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

Approved for marketing
N/A
US
Vamorolone
Santhera Pharmaceuticals
Duchenne Muscular Dystrophy
 
 
NCT06564974: Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy.

Recruiting
N/A
250
US
Vamorolone, AGAMREE®
Catalyst Pharmaceuticals, Inc.
Duchenne Muscular Dystrophy
09/30
11/30
lonodelestat (POL6014) / Spexis, Cold Spring Harbor Laboratory
2018-002550-71: A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis

Ongoing
1/2
40
Europe
POL6014, Nebuliser solution
Santhera Pharmaceuticals (Switzerland) Ltd, Santhera Pharmaceuticals (Switzerland) Ltd
Cystic fibrosis, mucoviscidosis, Diseases [C] - Respiratory Tract Diseases [C08]
 
 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Catena (idebenone) / Chiesi
2019-001493-28: Raxone® treatment for patients with autosomal dominant optic atrophy (inherited optic nerve disorder) Raxone® Behandlung bei Patienten mit autosomal dominanter Optikusatrophie (erblich bedingte Erkrankung des Sehnerves).

Ongoing
2
16
Europe
Raxone 150 mg film-coated tablets, Film-coated tablet, Raxone 150 mg film-coated tablets
Medizinische Universität Graz, Univ.-Augenklinik, Chiesi Pharmaceuticals GmbH
Autosomal dominant optic atrophy (ADOA) Autosomal dominante Optikusatrophie, inherited disorder of the optic nerve erblich bedingte Erkrankung des Sehnervs, Diseases [C] - Eye Diseases [C11]
 
 
NCT03433807: Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

No Longer Available
N/A
US
Idebenone
Santhera Pharmaceuticals
Duchenne Muscular Dystrophy
 
 
US EAP LHON, NCT04381091: Expanded Access Program for Idebenone in Patients With Leber's Hereditary Optic Neuropathy Who Completed the LEROS Study

No Longer Available
N/A
NA
Idebenone 150 MG Oral Tablet
Santhera Pharmaceuticals
Leber's Hereditary Optic Neuropathy
 
 
Omigapil (SNT-317) / Santhera
NCT02326831: Congenital Muscular Dystrophy Study Analyzing Pharmacokinetics at Three Dose Levels in Children and Adolescents With Assessment of Safety and Tolerability of Omigapil

Recruiting
1
30
US
Omigapil
National Institute of Neurological Disorders and Stroke (NINDS)
Dystrophy
07/17
07/17
Agamree (vamorolone) / Santhera
GUARDIAN, NCT06713135: A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

Recruiting
4
80
Europe, RoW
vamorolone 40 mg/mL oral suspension, vamorolone
Santhera Pharmaceuticals
Duchenne Muscular Dystrophy
09/28
09/28
2022-000844-31: Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy Studio del Vamorolone vs Placebo nel trattamento della Distrofia Muscolare di Becker

Not yet recruiting
2
39
Europe
vamorolone, [vamorolone], Oral drops, powder for suspension
ReveraGen BioPharma Inc., National Institute of health (NIH), Food and Drug administration (FDA), Foundation to Eradicate Duchenne (FED)
Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Diseases [C] - Musculoskeletal Diseases [C05]
 
 
NCT05185622 / 2025-000201-16: A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)

Completed
2
54
Canada
Vamorolone, VBP15
Santhera Pharmaceuticals, Santhera Pharmaceuticals (Schweiz) AG
Duchenne Muscular Dystrophy
07/24
07/24
NCT05166109 / 2022-000844-31: A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)

Active, not recruiting
2
39
Europe, US
Vamorolone, VBP15, Placebo, Placebo to vamorolone
ReveraGen BioPharma, Inc., Santhera Pharmaceuticals
Becker Muscular Dystrophy
06/25
06/25
ChiCTR2300078541: A Randomized, Cross-over, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Vamorolone Oral Suspension Given as A Single Dose in Healthy Chinese Adult Male Subjects

Recruiting
1
32
 
2mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period; 2mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period; 6mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period; 6mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period
Shanghai Xuhui Central Hospital; Santhera Pharmaceuticals (Switzerland) Ltd., self found
Duchenne Muscular Dystrophy
 
 
SNT-I-VAM-026, NCT06649409: Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

Completed
1
30
Europe
Vamorolone, experimental drug, Eplerenone, positive control, Fludrocortisone, auxiliary medicinal product - mineralocorticoid agonist
Santhera Pharmaceuticals
Pharmacodynamic
06/24
07/24
NCT06689527: Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

Completed
1
18
Europe
Vamorolone, Test Drug, Midazolam, Reference Drug
Santhera Pharmaceuticals
Drug Interaction Potentiation
09/24
10/24
NCT03863119: Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

Approved for marketing
N/A
US
Vamorolone
Santhera Pharmaceuticals
Duchenne Muscular Dystrophy
 
 
NCT06564974: Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy.

Recruiting
N/A
250
US
Vamorolone, AGAMREE®
Catalyst Pharmaceuticals, Inc.
Duchenne Muscular Dystrophy
09/30
11/30
lonodelestat (POL6014) / Spexis, Cold Spring Harbor Laboratory
2018-002550-71: A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis

Ongoing
1/2
40
Europe
POL6014, Nebuliser solution
Santhera Pharmaceuticals (Switzerland) Ltd, Santhera Pharmaceuticals (Switzerland) Ltd
Cystic fibrosis, mucoviscidosis, Diseases [C] - Respiratory Tract Diseases [C08]
 
 

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