Product Description
Mechanisms of Action: No Mechanism
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Austria | Belgium | Canada | Chile | China | Colombia | Croatia | Czech | Denmark | Dominican Republic | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | India | Ireland | Israel | Italy | Korea | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Peru | Poland | Portugal | Romania | Russia | Serbia | Slovakia | Slovenia | South Africa | Spain | Sweden | Turkey | Ukraine | United Kingdom | Uruguay
Approved Indications: None
Known Adverse Events: None
Company: Santhera
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Optic Atrophy, Autosomal Dominant
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2019-001493-28 |
OPA1 | P2 |
Active, not recruiting |
Optic Atrophy, Autosomal Dominant |
2024-07-21 |
2022-03-13 |
Treatments |
|
CTR20220888 |
CTR20220888 | P3 |
Recruiting |
Unknown |
None |
2025-04-29 |
Patient Enrollment|Start Date|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
09/22/2025 |
News Article |
Idebenone Accepted by FDA for Priority Review for Leber Hereditary Optic Neuropathy (LHON) |
|
04/29/2025 |
News Article |
Santhera Full Year Results for the Year Ended 31 December 2024 |
|
03/17/2025 |
News Article |
GenSight Biologics Announces LUMEVOQ® Scientific Updates at NANOS 2025 |
|
10/28/2024 |
News Article |
GenSight Biologics Announces Publication of Meta-Analyses Showing Better Outcomes for ND4-LHON Patients Treated with LUMEVOQ® |