drug · small molecule
vamorolone
Marketedupdated 3mo agoby ReveraGen BioPharma Inc🔗 ChEMBL
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for duchenne muscular dystrophy and 5 investigational indications.
indications
investigational
Duchenne Muscular Dystrophy
targets
Glucocorticoid receptorMineralocorticoid receptor
all catalysts(0)
nothing on the calendar yet
Trials studying vamorolone
- phase4A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy
- —Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy-SUMMIT
- —Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy
- phase1Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics
- phase2A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)
- phase2A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)
- phase1Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 26, 2028
~2.2 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (7)
- Jul 16, 2040compositionUS 11382922
- Mar 17, 2040method-of-use (U-3747)US 11471471
- Mar 17, 2040compositionUS 12201639
- Mar 7, 2033method-of-use (U-3747)US 11690853
- May 28, 2029formulationUS 108571612.8y
- May 28, 2029formulationUS 118331592.8y
- May 28, 2029method-of-use (U-3747)US 83342792.8y
FDA exclusivities (2)
- Oct 26, 2030ODE-450Orphan Drug (7y)4.2y
- Oct 26, 2028NCENew Chemical Entity (5y)2.2y
News(2)
- Angelini to buy Catalyst in $4B play for rare neuro drugsThe acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.biopharma_dive · 3mo ago
- Angelini fortifies neurology portfolio with $4.1B buyout of CatalystAngelini Pharma is spending $4.1 billion to buy Catalyst Pharmaceuticals and its trio of FDA-approved treatments for rare neurological diseases. The buyout will add three medicines to Angelini’s po…endpoints · 3mo ago
Data sources
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