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Desarrollo de Fármacos

Nadir Ulu1, Daniël Henri Swart2,3, Zafer Sezer4,5

  • 1Gen İlaç ve Sağlık Ürünleri A.Ş., Ankara, Turkey.

Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
PubMed
Resumen
Este resumen es generado por máquina.

SUL-238, una molécula novedosa dirigida a la disfunción mitocondrial, demostró seguridad y una farmacocinética favorable en un estudio en humanos por primera vez. Este fármaco muestra potencial para el tratamiento de enfermedades neurodegenerativas como el Alzheimer y el Parkinson.

Palabras clave:
AlzheimerParkinsonSUL-238Fase 1FarmacocinéticaLCRNeurodegeneraciónMitochondrialSeguridadTolerabilidad

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Área de la Ciencia:

  • Neurociencia y Farmacología; Biología Mitocondrial; Desarrollo de Fármacos

Sus antecedentes:

  • La disfunción mitocondrial está implicada en la patogénesis de la enfermedad de Alzheimer (EA) y la enfermedad de Parkinson (EP).; SUL-238, una molécula pequeña novedosa, mejora la función mitocondrial en modelos preclínicos.; SUL-238 ha mostrado potencial en un modelo de ratón de EA, mejorando la expresión de proteínas, reduciendo las placas amiloides y mejorando la memoria.

Objetivo del estudio:

  • Evaluar la seguridad, tolerabilidad y farmacocinética de dosis orales únicas de SUL-238 en adultos sanos.; Evaluar la penetración de SUL-238 en el líquido cefalorraquídeo (LCR).

Principales métodos:

  • Estudio de Fase 1, aleatorizado, doble ciego, controlado con placebo, de dosis oral única ascendente (SAD) en voluntarios sanos.; Las dosis oscilaron entre 50 mg y 2000 mg en 6 cohortes.; Se realizó un análisis farmacocinético (PK), incluida la evaluación del efecto de los alimentos y la concentración LCR/plasma.

Principales resultados:

  • SUL-238 fue seguro y bien tolerado en todas las dosis probadas (50-2000 mg), sin efectos adversos que limitaran la dosis.; Los eventos adversos fueron de leves a moderados y comparables entre los grupos de SUL-238 y placebo.; Se observó un perfil farmacocinético favorable, con alta penetración en LCR (porcentajes medios del 21,1% a las 2 horas y del 74,2% a las 8 horas post-dosis).

Conclusiones:

  • Las dosis orales únicas de SUL-238 (50-2000 mg) son seguras y bien toleradas en voluntarios sanos.; SUL-238 exhibe un perfil farmacocinético favorable.; El fármaco demuestra una penetración significativa en el líquido cefalorraquídeo, lo que respalda su potencial para aplicaciones neurológicas.