James M Youakim
Overview
Explore the profile of James M Youakim including associated specialties, affiliations and a list of published articles.
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Articles
27
Citations
451
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Recent Articles
1.
Percy A, Ryther R, Marsh E, Neul J, Benke T, Berry-Kravis E, et al.
Med
. 2025 Mar;
:100608.
PMID: 40043705
Background: Trofinetide is the first available treatment for Rett syndrome (RTT) and is approved in the United States in adults and pediatric patients aged ≥2 years. The DAFFODIL study was...
2.
Barrett A, Olayinka-Amao O, Martin S, Doshi D, Bishop K, Youakim J
Clin Ther
. 2025 Jan;
47(3):181-188.
PMID: 39824747
Purpose: Rett syndrome (RTT) is a rare neurodevelopmental disorder that mainly affects girls and women. Trofinetide is approved for the treatment of RTT in adults and children aged ≥2 years....
3.
Darwish M, Passarell J, Maxwell K, Bradley H, Bishop K, Youakim J
Adv Ther
. 2024 Dec;
42(2):1009-1025.
PMID: 39692837
Introduction: Weight-banded trofinetide dosing improved physician- and caregiver-rated efficacy measures and had acceptable tolerability in patients aged 2‒4 years (DAFFODIL study) and 5‒20 years (LAVENDER study) with Rett syndrome (RTT)....
4.
Population Pharmacokinetic Modeling to Support Trofinetide Dosing for the Treatment of Rett Syndrome
Darwish M, Passarell J, Maxwell K, Youakim J, Bradley H, Bishop K
Adv Ther
. 2024 Dec;
42(2):1026-1043.
PMID: 39692836
Introduction: Oral trofinetide administered using a body weight-banded dosing regimen was approved in the US for the treatment of Rett syndrome (RTT) in patients aged ≥ 2 years. This approval...
5.
Darwish M, Marbury T, Nunez R, Youakim J, An D, Darling I, et al.
Eur J Drug Metab Pharmacokinet
. 2024 Nov;
50(1):23-38.
PMID: 39516357
Background And Objectives: Trofinetide, the first approved treatment for Rett syndrome (RTT), is primarily excreted unchanged in the urine; therefore, it is important to assess the extent to which the...
6.
Percy A, Neul J, Benke T, Berry-Kravis E, Glaze D, Marsh E, et al.
Med
. 2024 Jul;
5(10):1275-1281.e2.
PMID: 39025065
Background: Trofinetide was approved for the treatment of Rett syndrome (RTT) in patients aged ≥2 years based on the results of the 12-week, randomized, phase 3 LAVENDER study. In LILAC,...
7.
Darwish M, Obianom O, Youakim J, Darling I, Lukacova V, Bradley H
Adv Ther
. 2024 Jul;
41(8):3328-3341.
PMID: 38963587
Introduction: Trofinetide is the first drug to be approved for the treatment of Rett syndrome. Hepatic impairment is not expected to affect the pharmacokinetic (PK) profile of trofinetide because of...
8.
Percy A, Neul J, Benke T, Berry-Kravis E, Glaze D, Marsh E, et al.
Med
. 2024 Jun;
5(9):1178-1189.e3.
PMID: 38917793
Background: Trofinetide was approved for the treatment of Rett syndrome based on the results of the phase 3, randomized, placebo-controlled, 12-week LAVENDER study. Rett syndrome is a chronic disorder requiring...
9.
Darwish M, Passarell J, Youakim J, Bradley H, Bishop K
Adv Ther
. 2024 Feb;
41(4):1462-1480.
PMID: 38363467
Introduction: Trofinetide was recently approved for the treatment of Rett syndrome (RTT) on the basis of the efficacy and safety findings of the phase 3 LAVENDER study, which used a...
10.
Kennedy M, Glass L, Glaze D, Kaminsky S, Percy A, Neul J, et al.
Front Pharmacol
. 2024 Feb;
14:1341746.
PMID: 38318312
Rett syndrome (RTT) is rare neurodevelopmental disorder caused by mutations in the gene that encodes methyl-CpG-binding protein 2 (MeCP2), a DNA-binding protein with roles in epigenetic regulation of gene expression....