SANTHERA PHARMACEUTICALS (USA), INC.

🇺🇸United States

Country: 🇺🇸United States

Ownership: Private

Employees: -

Market Cap: $123.5M

Website

Clinical Trials

A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

Phase 4

Recruiting

Conditions: Duchenne Muscular Dystrophy

Interventions: Drug: vamorolone 40 mg/mL oral suspension

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

and more 9 locations

Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

Phase 1

Completed

Conditions: Drug Interaction Potentiation

Interventions: Drug: Vamorolone
Drug: Midazolam

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

Phase 1

Completed

Conditions: Pharmacodynamic

Interventions: Drug: Fludrocortisone
Drug: Vamorolone
Drug: Eplerenone

First Posted Date: 2024-10-18

Last Posted Date: 2024-10-18

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)

Phase 2

Completed

Conditions: Duchenne Muscular Dystrophy

Interventions: Drug: Vamorolone

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
🇨🇦
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
🇨🇦
The Hospital for Sick Children, Toronto, Ontario, Canada

and more 2 locations

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

Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

Conditions: Duchenne Muscular Dystrophy

First Posted Date: 2019-03-05

Last Posted Date: 2023-11-09

Lead Sponsor: Santhera Pharmaceuticals

Registration Number: NCT03863119

Locations: 🇺🇸
Duke University, Durham, North Carolina, United States
🇺🇸
University of California Davis, Davis, California, United States
🇺🇸
Nemours Children's Hospital, Orlando, Florida, United States

and more 9 locations

Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF

Phase 1

Completed

Conditions: Cystic Fibrosis

Interventions: Drug: POL6014
Drug: Placebo

First Posted Date: 2018-11-20

Last Posted Date: 2021-09-28

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 32

Registration Number: NCT03748199

Locations: 🇩🇪
Inamed GmbH, clinical unit, Gauting, Germany
🇩🇪
Charité - Uniklinik Berlin, Klinik für Pädiatrie,Pneumologie, Immunologie, Erwachsenene-Mucoviszidose, Berlin, Germany
🇩🇪
IKF Pneumologie GmbH & Co. KG, Institut für klinische Forschung Pneumologie, Frankfurt, Germany

and more 1 locations

Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)

Phase 3

Terminated

Conditions: Duchenne Muscular Dystrophy

Interventions: Drug: idebenone 150 mg film-coated tablets

First Posted Date: 2018-07-27

Last Posted Date: 2021-12-03

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 161

Registration Number: NCT03603288

Locations: 🇺🇸
Gillette Children's Specialty Healthcare, Saint Paul, Minnesota, United States
🇺🇸
Banner University of Arizona Medical Center, Tucson, Arizona, United States
🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States

and more 36 locations

Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

Conditions: Duchenne Muscular Dystrophy

First Posted Date: 2018-02-15

Last Posted Date: 2023-04-21

Lead Sponsor: Santhera Pharmaceuticals

Registration Number: NCT03433807

Locations: 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Yale New Haven Hospital, New Haven, Connecticut, United States
🇺🇸
Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

and more 9 locations

A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate

Phase 1

Completed

Conditions: Drug-Drug Interaction

First Posted Date: 2016-09-02

Last Posted Date: 2017-10-05

Lead Sponsor: Santhera Pharmaceuticals

Target Recruit Count: 32

Registration Number: NCT02887443

Locations: 🇫🇷
Eurofins Optimed, Gières, France

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