VAMOROLONE
Agamree (vamorolone) is a small molecule pharmaceutical. Vamorolone was first approved as Agamree on 2023-10-26. It is used to treat duchenne muscular dystrophy in the USA. The pharmaceutical is active against glucocorticoid receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Agamree
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vamorolone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AGAMREE | Catalyst Pharmaceuticals | N-215239 RX | 2023-10-26 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| agamree | New Drug Application | 2024-06-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duchenne muscular dystrophy | EFO_0000429 | D020388 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VAMOROLONE, AGAMREE, CATALYST PHARMS | |||
| 2030-10-26 | ODE-450 | ||
| 2028-10-26 | NCE | ||
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | — | 6 | — | — | 2 | 8 |
| Muscular dystrophies | D009136 | HP_0003560 | G71.0 | — | 6 | — | — | 2 | 8 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 1 | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | 1 | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | VAMOROLONE |
| INN | vamorolone |
| Description | Vamorolone is a 3-oxo-Delta(1),Delta(4)-steroid that is pregna-1,4,9(11)-trien-17-ol substituted by oxo, oxo, and hydroxy groups at positions 3, 20, and 21, respectively. It is approved by the FDA for the treatment of patients with Duchenne muscular dystrophy aged 2 years and older. It has a role as an anti-inflammatory drug, an immunosuppressive agent and a glucocorticoid receptor agonist. It is a corticosteroid, a 3-oxo-Delta(1),Delta(4)-steroid, a 20-oxo steroid, a 17alpha-hydroxy steroid, a 21-hydroxy steroid, a primary alpha-hydroxy ketone and a tertiary alpha-hydroxy ketone. |
| Classification | Small molecule |
| Drug class | steroids (not prednisolone derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)[C@@]1(O)[C@H](C)C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@@]21C |
Identifiers
| PDB | — |
| CAS-ID | 13209-41-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707311 |
| ChEBI ID | — |
| PubChem CID | 3035000 |
| DrugBank | DB15114 |
| UNII ID | 8XP29XMB43 (ChemIDplus, GSRS) |
Target
Agency Approved
NR3C1
NR3C1
Organism
Homo sapiens
Gene name
NR3C1
Gene synonyms
GRL
NCBI Gene ID
Protein name
glucocorticoid receptor
Protein synonyms
Nuclear receptor subfamily 3 group C member 1, nuclear receptor subfamily 3 group C member 1 variant hGR-B(54), nuclear receptor subfamily 3 group C member 1 variant hGR-B(77), nuclear receptor subfamily 3 group C member 1 variant hGR-B(93), nuclear receptor subfamily 3, group C, member 1 (glucocorticoid receptor)
Uniprot ID
Mouse ortholog
Nr3c1 (14815)
glucocorticoid receptor (Q61629)
Alternate
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Variants
No data
Financial
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Agamree – Catalyst Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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