Health · Pharma & Biotech · 3 hrs ago
Idorsia begins Phase 3 trial of Lucerastat for Fabry disease
Idorsia has started a Phase 3 trial of Lucerastat for Fabry disease, a rare metabolic condition.
The study will involve 16 adult men with the disease.
It will test whether the drug reduces Gb3, a substance that builds up in the kidneys.
The trial is a key step in testing whether Lucerastat could become a treatment.
Idorsia aims to apply for approval from 2029, depending on the results.
Nxera has also secured exclusive rights to develop and sell the drug in Japan and selected Asia-Pacific markets outside China, and will pay Idorsia 7 million Swiss francs and share global trial costs.
Idorsia has begun a Phase 3 trial of lucerastat for Fabry disease.
The study will examine whether lucerastat reduces deposits of globotriaosylceramide, or Gb3, in the kidneys.
It will involve 16 adult men with Fabry disease.
Idorsia aims to submit an application for approval from 2029, based on the results.
Nxera has received exclusive development and marketing rights for Japan and selected Asia-Pacific markets, excluding China.
- Who
- Idorsia is conducting the study; it will involve 16 adult men with Fabry disease.
- What
- A Phase 3 trial is testing whether lucerastat reduces Gb3 deposits in the kidneys.
- When
- The trial has begun; Idorsia aims to apply for approval from 2029.
- Where
- Japan and selected Asia-Pacific markets, excluding China, are covered by Nxera’s rights. The trial location is not stated.
- Why
- To assess whether lucerastat reduces kidney deposits of Gb3 in people with Fabry disease.
This story does not have two clearly opposing sides.
- Trial phase
- Phase 3
- Participants
- 16 adult men with Fabry disease
- Drug candidate
- Lucerastat
- Target substance
- Globotriaosylceramide (Gb3)
- Approval application
- Idorsia aims to apply from 2029
- Nxera payment
- 7 million Swiss francs