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
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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
10 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 |
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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Safety
Black-box Warning
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Adverse Events
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