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Drug ReportsTrofinetide
Trofinetide
Daybue (trofinetide) is a small molecule pharmaceutical. Trofinetide was first approved as Daybue on 2023-03-10. It is used to treat rett syndrome in the USA.
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Daybue
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Trofinetide
Tradename
Company
Number
Date
Products
DAYBUEAcadia PharmaceuticalsN-217026 RX2023-03-10
1 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
rett syndromeOrphanet_778D015518F84.2
Agency Specific
FDA
EMA
Expiration
Code
TROFINETIDE, DAYBUE, ACADIA PHARMS INC
2030-03-10ODE-425
2028-03-10NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Trofinetide, Daybue, Acadia Pharms Inc
113707552040-08-03DS, DP
92122042032-01-27U-3556
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rett syndromeD015518Orphanet_778F84.2346
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain injuriesD001930S06.922
Fragile x syndromeD005600Q99.211
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Traumatic brain injuriesD000070642S0622
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTrofinetide
INNtrofinetide
Description
Trofinetide, sold under the brand name Daybue, is a medication used for the treatment of Rett syndrome. It is taken by mouth.
Classification
Small molecule
Drug classpeptides: neuropeptide Y (NPY) receptors and analogues
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@@]1(C(=O)N[C@@H](CCC(=O)O)C(=O)O)CCCN1C(=O)CN
Identifiers
PDB
CAS-ID853400-76-7
RxCUI
ChEMBL IDCHEMBL197084
ChEBI ID
PubChem CID11318905
DrugBankDB06045
UNII IDZ2ME8F52QL (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 103 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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