Trofinetide information

Trofinetide
Clinical data
Trade names	Daybue
Other names	NNZ-2566
AHFS/Drugs.com	Monograph
MedlinePlus	a623019
License data	US DailyMed: Trofinetide;
Routes of; administration	By mouth
ATC code	None;
Legal status
Legal status	US: ℞-only;
Pharmacokinetic data
Bioavailability	84%
Metabolism	Insignificant
Elimination half-life	~ 1.5 h
Excretion	Urine
Identifiers
	IUPAC name (2S)-2-{[(2S)-1-(2-aminoacetyl)-2-methylpyrrolidine-2-carbonyl]amino}pentanedioic acid;
CAS Number	853400-76-7;
PubChem CID	11318905;
ChemSpider	9493869;
UNII	Z2ME8F52QL;
KEGG	D12400;
ChEBI	CHEBI:229599;
Chemical and physical data
Formula	C13H21N3O6
Molar mass	315.326 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES C[C@]1(CCCN1C(=O)CN)C(=O)N[C@@H](CCC(=O)O)C(=O)O;
	InChI InChI=1S/C13H21N3O6/c1-13(5-2-6-16(13)9(17)7-14)12(22)15-8(11(20)21)3-4-10(18)19/h8H,2-7,14H2,1H3,(H,15,22)(H,18,19)(H,20,21)/t8-,13-/m0/s1; Key:BUSXWGRAOZQTEY-SDBXPKJASA-N;

Trofinetide, sold under the brand name Daybue, is a medication used for the treatment of Rett syndrome.^[1] It is taken by mouth.^[1]

The most common adverse reactions include diarrhea and vomiting.^[2]

Trofinetide was approved for medical use in the United States in March 2023.^[1]^[2]^[3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.^[4]

^ ^a ^b ^c ^d "Daybue- trofinetide solution". DailyMed. 29 March 2023. Archived from the original on 2 July 2023. Retrieved 20 November 2023.
^ ^a ^b "FDA approves first treatment for Rett Syndrome". U.S. Food and Drug Administration (FDA). 13 March 2023. Archived from the original on 13 March 2023. Retrieved 13 March 2023. This article incorporates text from this source, which is in the public domain.
^ Keam SJ (June 2023). "Trofinetide: First Approval". Drugs. 83 (9): 819–824. doi:10.1007/s40265-023-01883-8. PMID 37191913. S2CID 258715933.
^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.

[Daybue_FDA_label-1] "Daybue- trofinetide solution". DailyMed. 29 March 2023. Archived from the original on 2 July 2023. Retrieved 20 November 2023.

[FDA_PR_20230313-2] "FDA approves first treatment for Rett Syndrome". U.S. Food and Drug Administration (FDA). 13 March 2023. Archived from the original on 13 March 2023. Retrieved 13 March 2023. This article incorporates text from this source, which is in the public domain.

[pmid37191913-3] Keam SJ (June 2023). "Trofinetide: First Approval". Drugs. 83 (9): 819–824. doi:10.1007/s40265-023-01883-8. PMID 37191913. S2CID 258715933.

[4] New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.

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