Evrysdi(risdiplam)
Evrysdi (risdiplam) is a small molecule pharmaceutical. Risdiplam was first approved as Evrysdi on 2020-08-07. It has been approved in Europe to treat spinal muscular atrophy.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
nervous system diseases | D009422 |
Trade Name
FDA
EMA
Evrysdi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Risdiplam
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
EVRYSDI | Genentech | N-213535 RX | 2020-08-07 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
evrysdi | New Drug Application | 2020-09-30 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
RISDIPLAM, EVRYSDI, GENENTECH INC | |||
2029-05-27 | ODE-400 | ||
2027-08-07 | ODE-334 | ||
2025-08-07 | NCE | ||
2025-05-27 | NPP |
HCPCS
No data
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Spinal muscular atrophy | D009134 | EFO_0008525 | G12.1 | 4 | 5 | 3 | 2 | 2 | 13 |
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | RISDIPLAM |
INN | risdiplam |
Description | Risdiplam, sold under the brand name Evrysdi, is a medication used to treat spinal muscular atrophy (SMA) and the first oral medication approved to treat this disease.
|
Classification | Small molecule |
Drug class | survival motor neurin SMN1 and SMN2 splicing modulators |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Cc1cn2nc(-c3cc(=O)n4cc(N5CCNC6(CC6)C5)ccc4n3)cc(C)c2n1 |
Identifiers
PDB | — |
CAS-ID | 1825352-65-5 |
RxCUI | — |
ChEMBL ID | CHEMBL4297528 |
ChEBI ID | — |
PubChem CID | 118513932 |
DrugBank | DB15305 |
UNII ID | 76RS4S2ET1 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Evrysdi - Roche
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 479 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,101 adverse events reported
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