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vamorolone

Generic: VAMOROLONE·Brand: AGAMREE, Agamree

vamorolone: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

vamorolone evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect vamorolone to CPRX; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could vamorolone → CPRX affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

treatment of Duchenne muscular dystrophy (DMD)Duchenne muscular dystrophy (DMD)Duchenne Muscular Dystrophy

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
CATALYST PHARMACEUTICALS, INC. (CPRX)
treatment of Duchenne muscular dystrophy (DMD)
Approved
CATALYST PHARMACEUTICALS, INC. (CPRX)
Duchenne muscular dystrophy (DMD)
Approved
Clinical Trials (1)

Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy [SUpplemental Patient dMd assessMents Investigating ouTcomes (SUMMIT)]

NCT06564974
Recruiting

Primary endpoint: Change in Height z-score

Observational250 targetStarted 2024-09Completion 2032-0233 sites · Puerto Rico, United StatesCatalyst Pharmaceuticals, Inc.
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. ( 1 )(CPRX)FDA ↗
NDA215239Type 1 - New Molecular EntityOrphan DrugStandardOralSuspension

Frequently asked questions

Who is developing vamorolone?

vamorolone is being developed by CATALYST PHARMACEUTICALS, INC..

How many clinical trials involve vamorolone?

BioSniper tracks 1 clinical trial involving vamorolone.

What is vamorolone's latest FDA decision?

The most recent tracked FDA decision for vamorolone is Approval for 1 INDICATIONS AND USAGE AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. ( 1 ), dated October 26, 2023.