Overview
Vamorolone is under investigation in clinical trial NCT03439670 (A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)).
Indication
Vamorolone is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients ≥2 years of age.
Associated Conditions
- Duchenne Muscular Dystrophy (DMD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/03 | Phase 4 | Recruiting | |||
2024/11/14 | Phase 1 | Completed | |||
2024/10/18 | Phase 1 | Completed | |||
2024/08/21 | N/A | Recruiting | |||
2022/01/11 | Phase 2 | Completed | |||
2021/12/21 | Phase 2 | Active, not recruiting | |||
2020/04/16 | Phase 1 | Withdrawn | |||
2019/03/05 | N/A | APPROVED_FOR_MARKETING | |||
2018/02/20 | Phase 2 | Completed | |||
2017/01/31 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/14/2023 | ||
Authorised | 12/14/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AGAMREE ORAL SUSPENSION 40MG/ML | N/A | N/A | N/A | 12/17/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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