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
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Daybue
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Trofinetide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DAYBUE | Acadia Pharmaceuticals | N-217026 RX | 2023-03-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| daybue | New Drug Application | 2025-08-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rett syndrome | Orphanet_778 | D015518 | F84.2 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
TROFINETIDE, DAYBUE, ACADIA PHARMS INC | |||
| 2030-03-10 | ODE-425 | ||
| 2028-03-10 | NCE | ||
ATC Codes
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Clinical
Clinical Trials
13 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 4 | 4 | — | 1 | 8 |
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | — | 3 | 4 | — | 1 | 7 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain injuries | D001930 | — | S06.9 | 1 | 3 | — | — | — | 4 |
| Traumatic brain injuries | D000070642 | — | S06 | 2 | 1 | — | — | — | 3 |
| Brain concussion | D001924 | — | S06.0 | — | 1 | — | — | — | 1 |
| Post-concussion syndrome | D038223 | EFO_1001827 | F07.81 | — | 1 | — | — | — | 1 |
| Fragile x syndrome | D005600 | — | Q99.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Trofinetide |
| INN | trofinetide |
| 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 class | peptides: 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-ID | 853400-76-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL197084 |
| ChEBI ID | — |
| PubChem CID | 11318905 |
| DrugBank | DB06045 |
| UNII ID | Z2ME8F52QL (ChemIDplus, GSRS) |
Target
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Trends
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Additional graphs summarizing 209 documents
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Safety
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Adverse Events
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5,585 adverse events reported
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