AGAMREE (vamorolone)
Agamree is a corticosteroid used for patients two years of age and older who have Duchenne muscular dystrophy. It helps patients with this progressive muscle-wasting condition by providing anti-inflammatory and immunosuppressive support. This medication is prescribed to manage the symptoms of the disease in both pediatric and adult populations.
How AGAMREE Works
Agamree works by targeting and binding to the glucocorticoid receptor. This interaction triggers anti-inflammatory and immunosuppressive responses within the body. Although these specific effects are known, the exact process by which the drug improves the condition of patients with Duchenne muscular dystrophy remains unknown.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-10-26
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
AGAMREE Approval History
What AGAMREE Treats
1 indicationsAGAMREE is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duchenne Muscular Dystrophy
AGAMREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AGAMREE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AGAMREE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to AGAMREE
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06689527 results posted | SNT-I-VAM-025 2024-513845-36-00 | Ph 1 | completed | Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics |
| NCT05185622 results posted | VBP15-006 | Ph 2 | completed | A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD) |
| NCT05166109 | VBP15-BMD-001 1R01FD007284-01 | Ph 2 | completed | A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD) |
| NCT06649409 results posted | SNT-I-VAM-026 2024-512101-60-00, N-A-PH1-23-067 | Ph 1 | completed | Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects |
| NCT03439670 results posted | VBP15-004 | Ph 2 | completed | A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AGAMREE FDA Label Details
Indications & Usage
FDA Label (PDF)AGAMREE is indicated for the treatment of Duchenne Muscular Dystrophy.
AGAMREE Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for AGAMREE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 7 active patents
Trial Analysis
- • 8 total trials
- • Stage: Declining
Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment