Product Description
Clene engineered its lead drug candidate, CNM-Au8, to optimally enhance critical cellular energy producing reactions necessary for repairing and reversing neuronal and oligodendroglial damage.
Mechanisms of Action: Immunomodulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Accelerated Approval - Amyotrophic Lateral Sclerosis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Clene Nanomedicine
Company Location: Western America
Company Founding Year: None
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Clene Nanomedicine presented P2 Multiple Sclerosis results on 2025-09-25 for CNM-Au8
- Clinical Outcomes Reported - Clene Nanomedicine presented P0 Parkinson's Disease results on 2025-09-04 for CNM-Au8
- Clinical Outcomes Reported - Clene Nanomedicine presented P2 Multiple Sclerosis results on 2025-04-08 for CNM-Au8
Highest Development Phases
Phase 3: Multiple Sclerosis
Phase 2: Multiple Sclerosis, Progressive
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03993171 |
REPAIR-MS | P2 |
Completed |
Multiple Sclerosis, Progressive |
2025-05-27 |
2% |
2025-12-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT04626921 |
VISIONMS-LTE | P3 |
Completed |
Multiple Sclerosis |
2023-05-29 |
17% |
2023-12-09 |
Primary Endpoints |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/16/2026 |
News Article |
Clene to Present at the Emerging Growth Conference |
|
01/12/2026 |
News Article |
Clene Announces Additional CNM-Au8 Biomarker Data Supporting Potential NDA Filing for Upcoming In-Person FDA Meeting |
|
01/09/2026 |
News Article |
Clene Announces Registered Direct Offering of Over $28 Million |
|
12/09/2025 |
News Article |
Clene to Present at the Emerging Growth Conference |
|
03/14/2024 |
PubMed |
Protein Corona Composition of Gold Nanocatalysts. |
|
02/22/2024 |
PubMed |
Gold Nanoparticles in Parkinson's Disease Therapy: A Focus on Plant-Based Green Synthesis. |
|
01/03/2024 |
PubMed |
Correction: Evidence of brain target engagement in Parkinson's disease and multiple sclerosis by the investigational nanomedicine, CNM- Au8, in the REPAIR phase 2 clinical trials. |