Product Description
an orally administered PPAR_ modulator
Mechanisms of Action: PPAR-d Modulator
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Mitochondrial Myopathies *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Astellas Pharma
Company Location:
Company Founding Year: 2005
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Mitochondrial Diseases|Mitochondrial Myopathies
Phase 1: Healthy Volunteers|Muscular Dystrophy, Duchenne|Acute Respiratory Distress Syndrome|Mitochondrial Myopathies|Other|Kidney Diseases
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04855201 |
0367-CL-1101 | P1 |
Terminated |
Other |
2022-12-16 |
50% |
2023-12-16 |
Primary Endpoints|Start Date|Treatments |
NCT05117294 |
0367-CL-1111 | P1 |
Completed |
Kidney Diseases |
2022-11-13 |
69% |
2023-11-27 |
Primary Endpoints|Start Date|Treatments |
NCT04184882 |
0367-CL-0102 | P1 |
Terminated |
Muscular Dystrophy, Duchenne |
2022-09-04 |
50% |
2022-11-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05217901 |
0367-CL-1103 | P1 |
Completed |
Acute Respiratory Distress Syndrome|Mitochondrial Myopathies|Muscular Dystrophy, Duchenne |
2022-04-30 |
88% |
2022-05-27 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04942964 |
0367-CL-1102 | P1 |
Completed |
Healthy Volunteers |
2022-01-11 |
50% |
2023-01-25 |
Primary Endpoints|Start Date|Treatments |
NCT03682484 |
0367-CL-0001 | P1 |
Completed |
Healthy Volunteers |
2018-03-26 |
2019-03-22 |
Treatments |
|
NCT04641962 |
MOUNTAINSIDE | P2 |
Terminated |
Mitochondrial Diseases|Mitochondrial Myopathies |
2024-05-08 |
2025-06-18 |
Primary Endpoints|Start Date |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
10/20/2020 |
News Article |
U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARĪ“ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies |