NDAORALSUSPENSION
Approved
Oct 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
6/8 — Strong
AGAMREE (vamorolone) by Catalyst Pharmaceuticals is anti-inflammatory and immunosuppressive effects. First approved in 2023.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AGAMREE (vamorolone) is an oral suspension small molecule approved in October 2023 for Duchenne muscular dystrophy (DMD). It exerts anti-inflammatory and immunosuppressive effects, though its precise mechanism in DMD remains incompletely understood. The drug represents a novel corticosteroid-sparing approach to managing muscle degeneration in this rare, severe genetic disorder.
Growth14.1 years to LOE
Early-stage growth product with minimal current spending data suggests nascent market penetration and team-building opportunities in a specialty rare disease franchise.
Mechanism of Action
anti-inflammatory and immunosuppressive effects. The precise mechanism by which vamorolone exerts its effect in patients with DMD is unknown.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy
Started Nov 2024
80 enrolled
Duchenne Muscular Dystrophy
Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT
Started Sep 2024
250 enrolled
Duchenne Muscular Dystrophy
Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics
Started Aug 2024
18 enrolled
Drug Interaction
Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
Started Jun 2024
30 enrolled
Pharmacodynamic
A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)
Started Jul 2022
46 enrolled
Becker Muscular Dystrophy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.