Parexel International Clinical Research gets CDSCO Panel nod to study Dexpramipexole dihydrochloride monohydrate

New Delhi: Parexel has a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the phase III clinical study of Dexpramipexole dihydrochloride monohydrate.

This came after Parexel International Clinical Research presented Phase III clinical study protocol No. AR-DEX-22-02, India Specific Amendment 1 dated 17-SEP-2024.

Dexpramipexole is an investigational small molecule drug used for amyotrophic lateral sclerosis that incidentally was noted to significantly decrease absolute eosinophil levels.

Dexpramipexole is a first-in-class oral investigational medicine that lowers blood and tissue eosinophils before they can cause damage to the target organ. Dexpramipexole is being developed by Areteia Therapeutics and has the potential to be the first oral treatment ever approved for eosinophilic asthma.

At the recent SEC meeting for pulmonary held on 3rd October 2024, the expert panel reviewed the Phase III clinical study protocol No. AR-DEX-22-02, India Specific Amendment 1 dated 17-SEP-2024.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

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