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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-10-21T17:45:50+05:30 | Updated On 21 Oct 2024 5:45 PM IST

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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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751