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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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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
Brand Name
Status
Last Update
daybueNew Drug Application2023-03-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
rett syndromeEFO_0001079D015518F84.2
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 syndromeD015518F84.2—34——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain injuriesD001930S06.9—2———2
Fragile x syndromeD005600Q99.2—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Traumatic brain injuriesD000070642S062————2
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)
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
DrugBank—
UNII IDZ2ME8F52QL (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 70 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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